What changed in this filing

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Item 1. Business

2026-03-18 compared with 2025-03-07 · 1345 added, 841 removed, 82 unchanged (96% of the section changed)

We are a medical device company that designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community.

Our initial product offerings were the ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices for individuals with spinal cord injury (“SCI Products”).

These devices are robotic exoskeletons that are designed for individuals with paraplegia that use our patented tilt-sensor technology and an onboard computer and motion sensors to drive motorized legs that power movement.

These SCI Products allow individuals with spinal cord injury (“SCI”) the ability to stand and walk again during everyday activities at home or in the community.

are a medical device company that designs, develops, and commercializes life-changing solutions that span the continuum of care in physical

rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community.

Our initial product offerings were the ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices for individuals with spinal cord

injury (“SCI Products”).

These devices are robotic exoskeletons that are designed for individuals with paraplegia that use

our patented tilt-sensor technology and an onboard computer and motion sensors to drive motorized legs that power movement.

Products allow individuals with spinal cord injury (“SCI”) the ability to stand and walk again during everyday activities

at home or in the community.

In March 2023, we received clearance of our premarket notification (“510(k)”) from the U.S.

Food and Drug Administration (“FDA”) for the ReWalk Personal Exoskeleton with stair and curb functionality, which adds usage on stairs and curbs to the indication for use for the device in the U.S.

and Drug Administration (“FDA”) for the ReWalk Personal Exoskeleton with stair and curb functionality, which adds usage on

stairs and curbs to the indication for use for the device in the U.S.

The clearance permits U.S.

customers to participate in more walking activities in real-world environments in their daily lives where stairs or curbs may have previously limited them when using the exoskeleton for its intended, FDA-indicated uses.

This feature has been available in Europe since initial CE Clearance, and real-world data from a cohort of 47 European users throughout a period of over seven years consisting of over 18,000 stair steps was collected to demonstrate the safety and efficacy of this feature and support the FDA submission.

In June 2024, we submitted to the FDA a 510(k) premarket notification for ReWalk 7 Personal Exoskeleton device, a next-generation ReWalk model, and such 510(k) is pending FDA review.

We have sought to expand our product offerings beyond the SCI Products through internal development, distribution agreements, and acquisitions.

We have developed our ReStore Exo-Suit device, which we began commercializing in June 2019 (we ceased sales in the EU in May 2024).

The ReStore is a powered, lightweight soft exo-suit intended for use during the rehabilitation of individuals with lower limb disabilities due to stroke.

In the second quarter of 2020, we finalized and moved to implement two separate agreements to distribute additional product lines in the United States, one of which we later discontinued.

We are the exclusive distributor of the MYOLYN MyoCycle FES Pro cycles to U.S.

customers to participate in more walking

activities in real-world environments in their daily lives where stairs or curbs may have previously limited them when using the exoskeleton

for its intended, FDA-indicated uses.

This feature has been available in Europe since initial CE Clearance, and real-world data from a

cohort of 47 European users throughout a period of over seven years consisting of over 18,000 stair steps, were collected to demonstrate

the safety and efficacy of this feature and support the FDA submission.

In March 2025, we received 510(k) clearance from the U.S.

and Drug Administration (“FDA”) for the ReWalk 7 Personal Exoskeleton device, a next-generation ReWalk model.

have sought to expand our product offerings beyond the SCI Products through internal development, distribution agreements, and acquisitions.

We have developed our ReStore Exo-Suit device, which we began commercializing in June 2019.

The ReStore is a powered, lightweight soft

exo-suit intended for use during the rehabilitation of individuals with lower limb disabilities due to stroke.

Sales of the device in

the European Union ceased in May 2024.

In the second quarter of 2020, we signed an agreement to become the exclusive distributor of the

MYOLYN MyoCycle FES Pro cycles to U.S.

rehabilitation clinics and for the MyoCycle Home cycles available to U.S.

veterans through the Veterans Health Administration (“VHA”) hospitals.

In August 2023, we made our first acquisition to supplement our internal growth when we acquired AlterG, a leading provider of Anti-Gravity systems for use in physical and neurological rehabilitation.

We paid a cash purchase price of approximately $19 million at closing and additional cash earnout payments may be paid based upon a percentage of AlterG’s revenue growth over the two years following the closing.

The AlterG Anti-Gravity systems use patented, National Aeronautics and Space Administration (“NASA”) derived differential air pressure (“DAP”) technology to reduce the effects of gravity and allow patients to rehabilitate with finely calibrated support and reduced pain.

AlterG Anti-Gravity systems are utilized in over 4,000 facilities globally in more than 40 countries.

We will continue to evaluate other products for distribution or acquisition that can broaden our product offerings further to help individuals with neurological injury and disability.

In March 2025, we announced an agreement to increase our penetration of SCI Products into the workers’ compensation market in which CorLife, LLC., a Delaware limited liability company (“CorLife”) and a division of Numotion, the nation’s leading and largest provider of products and services that provide mobility, health and personal independence.

Pursuant to the agreement, CorLife became the exclusive distributor for the ReWalk Personal Exoskeleton for individuals with workers’ compensation claims.

The agreement leverages CorLife’s extensive network of credentialed providers and experts to include the ReWalk Personal Exoskeleton among the services and equipment they provide to thousands of injured workers each year.

Under the agreement, the CorLife reimbursement team manages all workers’ compensation claims submissions for the ReWalk Personal Exoskeleton.

We believe this agreement will build awareness of the benefits of the ReWalk Personal Exoskeleton among individuals with workers’ compensation coverage and gain us access to the resources of CorLife to facilitate efficient processing of claims.

We are in the research stage of ReBoot, a personal soft exo-suit for home and community use by individuals post-stroke, and we are currently evaluating the reimbursement landscape and the potential clinical impact of this device.

This product would be a complementary product to ReStore as it provides active assistance to the ankle during plantar flexion and dorsiflexion for gait and mobility improvement in the home environment, and it received Breakthrough Device Designation from the FDA in November 2021.

Further investment in the development path of the ReBoot was paused in 2023 pending determination regarding the clinical and commercial opportunity of this device and at this time it remains on hold.

Our principal markets are primarily in the United States and Europe with some lesser sales in Asia, the Middle East and South America.

We sell our products primarily directly in the United States, through a combination of direct sales and distributors (depending on the product line) in Germany and Canada, and primarily through distributors in other markets.

In markets where we sell direct to consumers, we have established relationships with clinics and rehabilitation centers, professional and college sports teams, and individuals and organizations in the SCI community, and in markets where we do not sell direct to consumers, our distributors maintain these relationships.

We have primary offices in Yokneam, Israel, Marlborough, Massachusetts, and Berlin, Germany.

We also had offices in Fremont, California and Queens, New York where we ceased operations as of December 31, 2024.

We have in the past generated and expect to generate in the future revenue from a combination of clinics and rehabilitation centers, commercial distributors, third-party payors (including private and government payors), professional and college sports teams, and self-pay individuals.

While a broad uniform policy of coverage and reimbursement by third-party commercial payors currently does not exist in the United States for exoskeleton technologies such as the ReWalk Personal Exoskeleton, we are pursuing various paths of reimbursement and support fundraising efforts by institutions and clinics, such as the VHA policy that was issued in December 2015 for the evaluation, training, and procurement of ReWalk Personal Exoskeleton systems for all qualifying veterans living with SCI across the United States.

We have also been pursuing updates with the CMS to clarify the Medicare coverage category (i.e., benefit category) applicable for personal exoskeletons.

In 2022, the National Spinal Cord Injury Statistical Center (“NSCISC”), which maintains the world’s largest database on spinal cord injury research, reported that CMS is the primary payor for approximately 57% of the SCI population which are at least five years post their injury date, with Medicare representing a majority of this percentage.

In July 2020, following a successful submission and hearing process, a code was issued for ReWalk Personal Exoskeleton, which may be used for purposes of claim submission to Medicare, Medicaid, and other payors.

On November 1, 2023, CMS released the Calendar Year 2024 Home Health Prospective Payment System Final Rule, CMS-1780-F (“Final Rule”), which was adopted through the notice and comment rulemaking process.

The Final Rule includes a policy confirming that personal exoskeletons are included in the Medicare brace benefit category, as of January 1, 2024.

Medicare personal exoskeleton claims with dates of service on or after January 1, 2024 that are billed using HCPCS code K1007 are assigned to the brace benefit category.

CMS reimburses items classified under the brace benefit category using a lump sum payment methodology.

On April 11, 2024, CMS revised its April 2024 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (“DMEPOS”) Fee Schedule to include a final lump-sum Medicare purchase fee schedule amount for personal exoskeletons (HCPCS code K1007) with an established rate of $91,032.

The final payment determination was made by CMS by applying a “gap filling” process, which was used in light of CMS determining that the code describing the technology has no fee schedule pricing history and that lower extremity exoskeletons incorporate “revolutionary features” that cannot be described by or considered comparable to any other existing code or combination of codes.

As part of gap-filling, CMS utilizes verifiable supplier or commercial pricing information and adjusts this pricing information according to a deflation and update factor methodology.

In applying this formula to the K1007 code describing the ReWalk Personal Exoskeleton, CMS says that it calculated this final payment amount by averaging pricing information for exoskeleton devices from Lifeward and other manufacturers.

In Germany, we continue to make progress toward achieving coverage from the various government, private and worker’s compensation payors for our SCI products.

In September 2017, each of German insurer BARMER GEK (“BARMER”) and national social accident insurance provider Deutsche Gesetzliche Unfallversicherung (“DGUV”) indicated that they will provide coverage to users who meet certain inclusion and exclusion criteria.

In February 2018, the head office of German Statutory Health Insurance (“SHI”) Spitzenverband (“GKV”) confirmed its decision to list the ReWalk Personal Exoskeleton system in the German Medical Device Directory.

This decision means that ReWalk is listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis.

During the year 2020 and 2021, we announced several new agreements with German SHIs, including TK and DAK Gesundheit, as well as the first German Private Health Insurer (“PHI”), which outline the process of obtaining our devices for eligible insured patients.

In February 2025, we finalized an agreement with BARMER to formalize the reimbursement process for the provision of ReWalk exoskeletons to medically eligible beneficiaries.

We are also currently working with several additional SHIs on securing a formal operating contract that will establish the process of obtaining a ReWalk Personal Exoskeleton for their beneficiaries within their system.

veterans through the

Veterans Health Administration (“VHA”) hospitals.

We continue to distribute these products;

however, our distribution rights

are no longer exclusive.

August 2023, we made our first acquisition to supplement our internal growth when we acquired AlterG, a leading provider of Anti-Gravity

systems for use in physical and neurological rehabilitation.

We paid a cash purchase price of approximately $19 million at closing.

purchase agreement also provided for the potential of additional cash earnout payments based on AlterG’s revenue growth over the

two years following the closing;

however, no earnout payments were earned.

The AlterG Anti-Gravity systems use patented, National

Aeronautics and Space Administration (“NASA”) derived differential air pressure (“DAP”) technology to reduce the

effects of gravity and allow patients to rehabilitate with finely calibrated support and reduced pain.

AlterG Anti-Gravity systems are

utilized in over 6,000 facilities globally in more than 40 countries.

We will continue to evaluate other products for distribution or

acquisition that can broaden our product offerings further to help individuals with injury and disability.

February 2026, we entered into an Intellectual Property Assignment and Technology Transfer Agreement with Skelable Ltd., an Israeli technology

company, pursuant to which we agreed to acquire certain intellectual property and related technology assets associated with a powered

upper-body robotic orthotic system designed to assist individuals with impaired upper-limb function, including stroke survivors.

The transaction

remains subject to customary closing conditions.

As part of the transaction, certain key employees of Skelable are expected to join our

The consideration consists primarily of our ordinary shares and is subject to the achievement of certain milestones.

The technology

remains under development and is intended to expand our neurorehabilitation platform beyond lower-limb exoskeleton systems.

March 2025, we announced an agreement with CorLife, LLC., a Delaware limited liability company (“CorLife”) and a division

of Numotion, the nation’s leading and largest provider of products and services that provide mobility, health and personal independence,

to increase our penetration of SCI Products into the workers’ compensation market.

Pursuant to the agreement, CorLife became the

exclusive distributor for the ReWalk Personal Exoskeleton for individuals with workers’ compensation claims.

The agreement leverages

CorLife’s extensive network of credentialed providers and experts to include the ReWalk Personal Exoskeleton among the services

and equipment they provide to thousands of injured workers each year.

Under the agreement, the CorLife reimbursement team manages all

workers’ compensation claims submissions for the ReWalk Personal Exoskeleton.

We believe this agreement will build awareness of

the benefits of the ReWalk Personal Exoskeleton among individuals with workers’ compensation coverage and gain us access to the

resources of CorLife to facilitate efficient processing of claims.

December 2025, we announced a distribution agreement with Verita Neuro, a provider of intensive neurological rehabilitation services.

Pursuant to the agreement, Verita Neuro will serve as a distributor of the ReWalk Personal Exoskeleton in certain international markets,

including Mexico, Thailand and the United Arab Emirates.

Through its network of rehabilitation centers, Verita Neuro integrates advanced

technologies and therapies to support individuals with neurological injuries.

We believe this agreement will expand access to the ReWalk

Personal Exoskeleton in additional international markets and support broader adoption of our technology.

principal markets are primarily in the United States and Europe with some lesser sales in Asia, the Middle East and South America.

sell our products primarily directly in the United States, through a combination of direct sales and distributors (depending on the product

line) in Germany and Canada, and primarily through distributors in other markets.

In markets where we sell direct to consumers, we have

established relationships with clinics and rehabilitation centers, professional and college sports teams, individuals and organizations

in the SCI community, and in markets where we do not sell direct to consumers, our distributors maintain these relationships.

primary offices in Yokneam, Israel, Hudson, Massachusetts, and Berlin, Germany.

have in the past generated and expect to generate in the future revenue from a combination of clinics and rehabilitation centers, commercial

distributors, third-party payors (including private and government payors), professional and college sports teams, and self-pay individuals.

While a broad uniform policy of coverage and reimbursement by third-party commercial payors currently does not exist in the United States

for exoskeleton technologies such as the ReWalk Personal Exoskeleton, we are pursuing various paths of reimbursement, such as the VHA

policy that was issued in December 2015 for the evaluation, training, and procurement of ReWalk Personal Exoskeleton systems for all qualifying

veterans living with SCI across the United States.

have engaged with CMS regarding the Medicare coverage framework applicable to personal exoskeletons.

In 2024, the National Spinal Cord

Injury Statistical Center (“NSCISC”), which maintains the world’s largest database on spinal cord injury research, reported

that CMS is the primary payor for approximately 57% of the SCI population that is at least five years post-injury, with Medicare representing

a majority of this percentage.

In July 2020, following a successful submission and hearing process, a code was issued for ReWalk Personal

Exoskeleton, which may be used for purposes of claim submission to Medicare, Medicaid, and other payors.

November 1, 2023, CMS released the Calendar Year 2024 Home Health Prospective Payment System Final Rule, CMS-1780-F (“Final Rule”),

which was adopted through the notice and comment rulemaking process.

The Final Rule includes a policy confirming that personal exoskeletons

are included in the Medicare brace benefit category, as of January 1, 2024.

Medicare personal exoskeleton claims with dates of service

on or after January 1, 2024 that are billed using HCPCS code K1007 are assigned to the brace benefit category.

CMS reimburses items classified

under the brace benefit category using a lump-sum payment methodology.

April 11, 2024, CMS revised its April 2024 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (“DMEPOS”)

Fee Schedule to include a final lump-sum Medicare purchase fee schedule amount for personal exoskeletons (HCPCS code K1007) with an established

rate of $91,032.

CMS determined this payment rate using a “gap-filling” methodology, which is applied when a technology

has no prior fee schedule pricing history.

In establishing the payment amount for HCPCS code K1007, CMS considered available pricing information

for exoskeleton devices from Lifeward and other manufacturers.

June 2025, an Administrative Law Judge (“ALJ”) ruled in favor of a Medicare beneficiary’s appeal and determined that

their ReWalk Personal Exoskeleton shall be covered and reimbursed by Medicare as a “reasonable and necessary” medical device

that enables walking after SCI.

This ruling established a legal basis that the ReWalk system constitutes a reasonable and necessary medical

intervention for paralyzed individuals.

Germany, we continue to make progress toward achieving coverage from the various government, private and worker’s compensation payors

for our SCI Products.

In September 2017, each of German insurer BARMER GEK (“BARMER”) and national social accident insurance

provider Deutsche Gesetzliche Unfallversicherung (“DGUV”) indicated that they will provide coverage to users who meet certain

inclusion and exclusion criteria.

In February 2018, the head office of German Statutory Health Insurance (“SHI”) Spitzenverband

(“GKV”) confirmed its decision to list the ReWalk Personal Exoskeleton system in the German Medical Device Directory.

decision means that ReWalk is listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary

on a case-by-case basis.

During the year 2020 and 2021, we announced several new agreements with German SHIs, including TK and DAK Gesundheit,

as well as the first German Private Health Insurer (“PHI”), which outline the process of obtaining our devices for eligible

insured patients.

In February 2025, we finalized an agreement with BARMER to formalize the reimbursement process for the provision of

ReWalk exoskeletons to medically eligible beneficiaries.

We are also currently working with several additional SHIs on securing a formal

operating contract that will establish the process of obtaining a ReWalk Personal Exoskeleton for their beneficiaries within their system.

Additionally, to date, several private insurers in the United States and Europe are providing reimbursement for ReWalk in certain cases.

ReWalk Personal Exoskeleton and ReWalk Rehabilitation Exoskeleton

Development of our SCI Products took over a decade and was spurred by the experiences of our founder, Dr.

Amit Goffer, who became a quadriplegic due to an accident.

Current ReWalk designs are intended for people with paraplegia, an SCI resulting in complete or incomplete paralysis of the legs, who have the use of their upper bodies and arms.

January 12, 2026, we entered into a Share Purchase Agreement with Oramed Pharmaceuticals, Inc.

(“Oramed”) and Oratech Pharma,

(“Oratech”), pursuant to which we agreed to acquire all of the outstanding equity interests of Oratech, a wholly owned

subsidiary of Oramed.

Upon closing of the transaction, and subject to the satisfaction of customary closing conditions, we will issue

to Oramed ordinary shares and pre-funded warrants representing up to 49.99% of our fully diluted equity capitalization, with the number

of ordinary shares issued at closing not exceeding 45% of our outstanding ordinary shares immediately after closing.

We will also issue

transaction warrants and agreed to make quarterly revenue sharing payments equal to 4% of net revenues from sales of our ReWalk Personal

Exoskeleton products and related extended warranties, subject to certain caps and termination events.

connection with the transaction, we also entered into a Securities Purchase Agreement with Oramed and certain investors providing for

the issuance of up to $20.0 million of senior secured convertible notes, including $10.0 million to be issued at closing, together with

accompanying warrants.

March 12, 2026, our shareholders approved the transaction.

We anticipate closing the transaction following the satisfaction of customary

closing conditions.

connection with the anticipated transaction, we received bridge financing from Oramed.

On November 14, 2025, we entered into a Secured

Promissory Note (the “Initial Secured Promissory Note”) with Oramed Ltd., pursuant to which we issued to Oramed Ltd.

promissory note in the principal amount of $3.0 million.

The loan bears interest at a rate of 15% per annum, is secured by a lien on our

cash and matures on May 14, 2026.

February 12, 2026, we entered into an additional Secured Promissory Note (the “Subsequent Secured Promissory Note”) with Oramed,

pursuant to which we issued a secured promissory note in the initial principal amount of $525,000, which amount may be increased by up

to an additional $975,000 upon the mutual consent of the parties.

The Subsequent Secured Promissory Note is secured by a lien on our cash,

accrues interest at a rate of 24% per annum and matures on the earlier of August 12, 2026, or the failure to obtain shareholder approval

of the transactions contemplated by the Securities Purchase Agreement and the Share Purchase Agreement described above.

March 11, 2026, we and Oramed agreed to increase the principal amount available under the Subsequent Secured Promissory Note by an additional

$500,000, resulting in an aggregate principal amount of $1,025,000 available under such note.

Personal Exoskeleton and ReWalk Rehabilitation Exoskeleton

of our SCI Products took over a decade and was spurred by the experiences of our founder, Dr.

Amit Goffer, who became a quadriplegic due

to an accident.

Current ReWalk designs are intended for people with paraplegia, an SCI resulting in complete or incomplete paralysis of

the legs, who have the use of their upper bodies and arms.

We currently offer two products in this category:

the ReWalk Personal Exoskeleton and the ReWalk Rehabilitation Exoskeleton.

The ReWalk Rehabilitation Exoskeleton is substantially similar to the ReWalk Personal Exoskeleton system except that it is sold with multiple sizes of our adjustable parts to allow different users the ability to train within a clinic.

In recent years, substantially all the ReWalk units sold by the Company have been ReWalk Personal systems and we expect our commercial efforts to continue to focus on this model.

The ReWalk Personal Exoskeleton is a novel product that seeks to fundamentally change the health and life experiences of users.

Designed for daily use, the device is battery-powered and consists of a wearable exoskeleton with integrated motors at the joints, an array of sensors and a computer-based control system to power knee and hip movement.

The user controls the device movement using a combination of user inputs on the wrist-worn controller, as well as through subtle weight shifts of the upper body.

Because the exoskeleton supports its own weight and facilitates the user’s gait, users do not expend unnecessary energy while walking.

The ReWalk Personal Exoskeleton also allows users to sit, stand and climb and descend stairs and curbs.

In March 2023, the FDA cleared the ReWalk Personal Exoskeleton for use on stairs and curbs, allowing users to participate in walking activities in more real-world environments in their daily lives and experience more opportunities to enjoy the health benefits of walking.

● ReWalk Personal Exoskeleton :

the ReWalk Personal Exoskeleton

and the ReWalk Rehabilitation Exoskeleton.

The ReWalk Rehabilitation Exoskeleton is substantially similar to the ReWalk Personal Exoskeleton

system except that it is sold with multiple sizes of our adjustable parts to allow different users the ability to train within a clinic.

In recent years, substantially all the ReWalk units sold by the Company have been ReWalk Personal systems and we expect our commercial

efforts to continue to focus on this model.

ReWalk Personal Exoskeleton is a novel product that seeks to fundamentally change the health and life experiences of users.

daily use, the device is battery-powered and consists of a wearable exoskeleton with integrated motors at the joints, an array of sensors

and a computer-based control system to power knee and hip movement.

The user controls the device movement using a combination of user

inputs on the wrist-worn controller, as well as through subtle weight shifts of the upper body.

Because the exoskeleton supports its own

weight and facilitates the user’s gait, users do not expend unnecessary energy while walking.

The ReWalk Personal Exoskeleton also

allows users to sit, stand and climb and descend stairs and curbs.

In March 2023, the FDA cleared the ReWalk Personal Exoskeleton for

use on stairs and curbs, allowing users to participate in walking activities in more real-world environments in their daily lives and

experience more opportunities to enjoy the health benefits of walking.

Personal Exoskeleton :

intended for everyday use at home, at work or in the community with a trained companion.

We began marketing ReWalk Personal Exoskeleton in Europe with CE mark clearance at the end of 2012.

We received FDA de novo authorization to market the ReWalk Personal Exoskeleton in the United States in June 2014.

FDA subsequently cleared 510(k) premarket notifications for modifications to the ReWalk, including for use of the ReWalk on curbs and stairs.

ReWalk Personal Exoskeleton units are all manufactured according to the same mechanical specifications.

Each unit is then permanently sized to fit the individual user and the software is configured for the user’s specifications by the rehabilitation center, clinic, or distributor.

We are currently offering our 6 th generation device, and in June 2024 we submitted a premarket notification to FDA for our 7 th generation ReWalk design.

The submission is currently pending FDA review.

● ReWalk Rehabilitation Exoskeleton :

the current offering for clinics who wish to implement exoskeleton training is composed of our ReWalk Personal Exoskeleton unit along with multiple sizing of different parts, enabling multiple patient use.

The ReWalk Rehabilitation Exoskeleton provides a valuable means of exercise, training, and therapy.

Use of the ReWalk Rehabilitation Exoskeleton in the clinic also enables individuals to evaluate their capacity for using the ReWalk Personal Exoskeleton in the future.

ReWalk Personal Exoskeleton

Additionally, we have received regulatory approval to sell the ReWalk Personal Exoskeleton device in other countries.

In the future we intend to seek approval from the applicable regulatory agencies in other jurisdictions where we may seek to market ReWalk Personal Exoskeleton.

For more information about the safety of using our SCI products see “Part I, Item 1A.

Risk Factors—Risks Related to our Business and our Industry— Defects in our products or the software that drives them could adversely affect the results of our operations.”

Overview of Spinal Cord Injury

Spinal Cord Injury

The spine is the central core of the human skeleton and provides structural support, alignment, and flexibility to the body.

The spinal cord, housed inside the bones of the spinal column, is a complex bundle of nerves serving as the main pathway for information connecting the brain, and nervous system.

Spinal cord injury is a serious medical condition that occurs as a result of physical damage to the nerves of the spinal cord, resulting in a loss of function, such as mobility or feeling.

In most people who have spinal cord injury, the spinal cord is intact.

We began marketing

ReWalk Personal Exoskeleton in Europe with CE mark clearance at the end of 2012.

We received FDA de novo authorization to market the ReWalk

Personal Exoskeleton in the United States in June 2014.

FDA subsequently cleared 510(k) premarket notifications for modifications to the

ReWalk, including for use of the ReWalk on curbs and stairs.

ReWalk Personal Exoskeleton units are all manufactured according to

the same mechanical specifications.

Each unit is then permanently sized to fit the individual user and the software is configured for

the user’s specifications by the rehabilitation center, clinic, or distributor.

In March 2025, we received 510(k) clearance from

the FDA for the ReWalk™ 7, the seventh generation of the ReWalk system, which includes innovative new and enhanced features such

as cloud connectivity, an improved user interface, crutch-mounted push-button control, customizable walking speeds, and seamless activation

for stairs and curbs.

The ReWalk™ 7 received CE Mark approval in September 2025.

Rehabilitation Exoskeleton :

the current offering for clinics who wish to implement exoskeleton training is composed of our ReWalk

Personal Exoskeleton unit along with multiple sizing of different parts, enabling multiple patient use.

The ReWalk Rehabilitation Exoskeleton

provides a valuable means of exercise, training, and therapy.

Use of the ReWalk Rehabilitation Exoskeleton in the clinic also enables

individuals to evaluate their capacity for using the ReWalk Personal Exoskeleton in the future.

Personal Exoskeleton

Additionally,

we have received regulatory approval to sell the ReWalk Personal Exoskeleton device in other countries.

In the future we intend to seek

approval from the applicable regulatory agencies in other jurisdictions where we may seek to market ReWalk Personal Exoskeleton.

information about the safety of using our SCI products see “Part I, Item 1A.

Risk Factors—Risks Related to our Business and

our Industry— Defects in our products or the software that drives them could adversely affect the results of our operations.”

of Spinal Cord Injury

spine is the central core of the human skeleton and provides structural support, alignment, and flexibility to the body.

The spinal cord,

housed inside the bones of the spinal column, is a complex bundle of nerves serving as the main pathway for information connecting the

brain, and nervous system.

Spinal cord injury is a serious medical condition that occurs as a result of physical damage to the nerves

of the spinal cord, resulting in a loss of function, such as mobility or feeling.

In most people who have spinal cord injury, the spinal

cord is intact.

Spinal cord injury is not the same as back injury, which may result from pinched nerves or ruptured disks.

Even when a person sustains a break in a vertebra or vertebrae, there may not be any spinal cord injury if the spinal cord itself is not affected.

person sustains a break in a vertebra or vertebrae, there may not be any spinal cord injury if the spinal cord itself is not affected.

There are two types of spinal cord injury – complete and incomplete.

In a complete injury, a person loses all ability to feel and voluntarily move below the level of the injury.

In a complete injury, a person loses all ability to feel and

voluntarily move below the level of the injury.

In an incomplete injury, there is some functioning below the level of the injury.

Upon medical examination, a patient is assigned a level of injury depending on the location of the spinal cord injury.

Cervical level injuries cause paralysis or weakness in both arms and legs and is referred to as quadriplegia.

Sometimes this type of injury is accompanied by loss of physical sensation, respiratory issues, bowel, bladder, and sexual dysfunction.

Thoracic level injuries can cause paralysis or weakness of the legs (paraplegia) along with loss of physical sensation, bowel, bladder, and sexual dysfunction.

In most cases, arms and hands are not affected.

medical examination, a patient is assigned a level of injury depending on the location of the spinal cord injury.

Cervical level injuries

cause paralysis or weakness in both arms and legs and is referred to as quadriplegia.

Sometimes this type of injury is accompanied by

loss of physical sensation, respiratory issues, bowel, bladder, and sexual dysfunction.

Thoracic level injuries can cause paralysis or

weakness of the legs (paraplegia) along with loss of physical sensation, bowel, bladder, and sexual dysfunction.

In most cases, arms and

hands are not affected.

Lumbar level injuries result in paralysis or weakness of the legs (paraplegia).

Loss of physical sensation, bowel, bladder, and sexual dysfunction can occur.

Loss of physical sensation, bowel,

bladder, and sexual dysfunction can occur.

The shoulder, arm, and hand functions are usually unaffected.

Sacral level injuries primarily cause loss of bowel and bladder function as well as sexual dysfunction.

Clinical Evidence

Published clinical studies indicate the ReWalk Personal Exoskeleton’s ability to deliver a functional walking speed.

In addition, certain potential secondary health benefits have been reported in literature as well as by healthcare practitioners and ReWalk users, including study participants.

Although these benefits have not been established as conclusive clinical data in randomized controlled trials, these reported secondary health benefits include:

● reduced pain;

● improved bowel and urinary tract function;

● reduced spasticity;

● increases in joint range of motion for the hip and ankle joints;

● improved sleep and reduced fatigue;

● improved mental health and quality of life;

● increase in oxygen uptake and heart rate as a result of walking as opposed to sitting and standing;

● ability to ambulate at a speed greater than 0.4 meters per second, which is considered to be conducive to outdoor related community ambulation;

● reduced hospitalizations.

We believe that using our SCI Products may have the ability to reduce the lifetime healthcare costs of individuals with spinal cord injuries, which we believe will make our SCI Products economically attractive for individuals and third-party payors.

While we believe that using our SCI Products could potentially offer significant advantages over competing technologies and therapies, disadvantages include the time it takes for a user to put on the device, the slower pace of the device compared to a wheelchair, the training required by the user and companion to use the device, the weight of the device when carried, which makes it more burdensome for a companion to transport than a wheelchair, and the requirement that users be accompanied by a trained companion.

Market Opportunity

Current and near-term market opportunities include providing a solution for persons with SCI that can be used in the clinic and/or home settings.

For persons with SCI, reduced physical activity and the predominance of seated activities can lead to severe physical and psychological deterioration, resulting in bad health, poor quality of life, low self-esteem, and high medical expenses.

In addition, the secondary medical consequences of paralysis can include difficulty with bowel and urinary tract function, osteoporosis, loss of lean mass, gain in fat mass, insulin resistance, diabetes, and heart disease.

Sacral level injuries primarily

cause loss of bowel and bladder function as well as sexual dysfunction.

clinical studies indicate the ReWalk Personal Exoskeleton’s ability to deliver a functional walking speed.

In addition, certain

potential secondary health benefits have been reported in literature as well as by healthcare practitioners and ReWalk users, including

study participants.

Although these benefits have not been established as conclusive clinical data in randomized controlled trials, these

reported secondary health benefits include:

of functional ambulation (permitting community access);

Cardiopulmonary

health improvement;

of muscle spasticity;

and reversal of bone mineral density loss;

and bladder management (improved autonomic function);

Multidimensional

quality of life improvements.

believe that using our SCI Products may have the ability to reduce the lifetime healthcare costs of individuals with spinal cord injuries,

which we believe will make our SCI Products economically attractive for individuals and third-party payors.

While we believe that using

our SCI Products could potentially offer significant advantages over competing technologies and therapies, disadvantages include the time

it takes for a user to put on the device, the slower pace of the device compared to a wheelchair, the training required by the user and

companion to use the device, the weight of the device when carried, which makes it more burdensome for a companion to transport than a

wheelchair, and the requirement that users be accompanied by a trained companion.

and near-term market opportunities include providing a solution for persons with SCI that can be used in the clinic and/or home settings.

For persons with SCI, reduced physical activity and the predominance of seated activities can lead to severe physical and psychological

deterioration, resulting in bad health, poor quality of life, low self-esteem, and high medical expenses.

In addition, the secondary medical

consequences of paralysis can include difficulty with bowel and urinary tract function, osteoporosis, loss of lean mass, gain in fat mass,

insulin resistance, diabetes, and heart disease.

The cost of treating these conditions is substantial.

The NSCISC estimates that complications related to paraplegia cost approximately $670,000 in the first-year post-injury, excluding indirect costs such as loss in wages, fringe benefits, and productivity, and significant additional amounts over the course of an individual’s lifetime.

Further, secondary complications related to spinal cord injury can reduce life expectancies for SCI patients.

The young average age at time of injury and significant remaining life expectancy, the likelihood of living at home, and the lifetime cost of treatment highlight the need for an out-of-hospital solution with demonstrated health and social benefits.

The NSCISC estimates according to its 2024 SCI Fact Sheet that there are 305,000 people in the United States living with SCI, with an annual incidence of approximately 18,000 new cases per year.

According to the VHA data there are approximately 42,000 of such patients who are veterans and are eligible for medical care and other benefits from the VHA, out of which the VHA states that 27,000 veterans are receiving SCI treatment annually.

With 25 VHA spinal cord injury centers designated SCI/D Hub locations, the VHA has the largest single network of spinal cord injury care in the United States.

According to the NSCISC, since 2015 motor vehicle crashes have been the leading cause of reported spinal cord injury cases (38%), followed by falls (32%), acts of violence (15%) and sports injuries (8%).

The National Spinal Cord Injury

Statistical Center (“NSCISC”) estimates that complications related to paraplegia cost approximately $670,000 in the

first-year post-injury, excluding indirect costs such as loss in wages, fringe benefits, and productivity, and significant additional

amounts over the course of an individual’s lifetime.

Further, secondary complications related to spinal cord injury can reduce life

expectancies for SCI patients.

The young average age at time of injury and significant remaining life expectancy, the likelihood of living

at home, and the lifetime cost of treatment highlight the need for an out-of-hospital solution with demonstrated health and social benefits.

NSCISC estimates according to its 2025 SCI Fact Sheet that there are approximately 308,000 people in the United States living with

SCI, with an annual incidence of approximately 18,000 new cases per year.

According to the VHA data there are approximately 42,000 of

such patients who are veterans and are eligible for medical care and other benefits from the VHA, out of which the VHA states that 27,000

veterans are receiving SCI treatment annually.

With 25 VHA spinal cord injury centers designated SCI/D Hub locations, the VHA has the

largest single network of spinal cord injury care in the United States.

to the NSCISC, since 2015 motor vehicle crashes have been the leading cause of reported spinal cord injury cases (37%), followed by falls

(32%), acts of violence (15%) and sports injuries (8%).

Approximately 78% of spinal cord injuries occur among the male population.

According to NSCISC data, upon hospital discharge, 87% of persons with spinal cord injuries are sent to private, non-institutional residence (in most cases, their homes prior to injury).

Based on information from the 2023 annual report published by the NSCISC, 40% of the total U.S.

population of SCI patients suffered injuries between levels T4 and L5.

Four published ReWalk trials for SCI patients had an aggregate screening acceptance rate of 50% considering all current FDA limitations, resulting in an estimated 20% of the total population of SCI patients can be considered as candidates for current ReWalk Personal Exoskeleton or ReWalk Rehabilitation Exoskeleton according to the device instructions for use.

For important qualifying information about this determination, see “Part I, Item 1A.

Risk Factors—Risks Related to our Business and our Industry—The market for medical exoskeletons, including soft exo-suit devices, remains relatively new and unproven, and important assumptions about the potential market for our current and future products may be inaccurate.”

Third-Party Reimbursements

United States

In the U.S., individuals typically obtain a ReWalk Personal Exoskeleton for home use through third-party medical coverage.

For an individual who suffered an SCI through a work-related incident, workers’ compensation insurance can be a source of funding to purchase the device.

to NSCISC data, upon hospital discharge, 87% of persons with spinal cord injuries are sent to private, non-institutional residence (in

most cases, their homes prior to injury).

on information from the 2023 annual report published by the NSCISC, 40% of the total U.S.

population of SCI patients suffered injuries

between levels T4 and L5.

Four published ReWalk trials for SCI patients had an aggregate screening acceptance rate of 50% considering

all current FDA limitations, resulting in an estimated 20% of the total population of SCI patients can be considered as candidates for

current ReWalk Personal Exoskeleton or ReWalk Rehabilitation Exoskeleton according to the device instructions for use.

For important qualifying

information about this determination, see “Part I, Item 1A.

Risk Factors—Risks Related to our Business and our Industry—The

market for medical exoskeletons, including soft exo-suit devices, remains relatively new and unproven, and important assumptions about

the potential market for our current and future products may be inaccurate.”

Reimbursements

the U.S., individuals typically obtain a ReWalk Personal Exoskeleton for home use through third-party medical coverage.

For an individual

who suffered an SCI through a work-related incident, workers’ compensation insurance can be a source of funding to purchase the

Similarly, for U.S.

veterans, an individual may be covered by the VHA for the purchase of the device regardless of whether the SCI occurred during active military service.

In December 2015, the VHA issued a national policy or standard operating procedure (“SOP”) for the evaluation, training, and procurement of ReWalk Personal Exoskeleton systems for all qualifying veterans across the United States and U.S.

The VHA SOP is the first national coverage policy in the United States for qualifying individuals who are living with spinal cord injury.

In June 2018, the VHA updated the SOP, in part, to expand training options for individuals who could not complete the mandatory training due to excessive distance/drive times from a VHA-designated site.

veterans, an individual may be covered by the VHA for the purchase of the device regardless of whether the

SCI occurred during active military service.

December 2015, the VHA issued a national policy or standard operating procedure (“SOP”) for the evaluation, training, and

procurement of ReWalk Personal Exoskeleton systems for all qualifying veterans across the United States and U.S.

SOP is the first national coverage policy in the United States for qualifying individuals who are living with spinal cord injury.

2018, the VHA updated the SOP, in part, to expand training options for individuals who could not complete the mandatory training due to

excessive distance/drive times from a VHA-designated site.

As of December 31, 2025, we had placed 51 units as part of the VHA policy.

The VHA accounted for 3.8% of our total revenue for the year ended December 31, 2025.

We continue to work with the VHA to both accelerate the pace of implementation of the current VHA policy nationally, and to again expand opportunities for veterans to gain access to assessments, training, and devices in facilities outside VHA’s traditional spinal cord injury “hub and spoke” infrastructure.

Community-based, non-VHA clinics are also being leveraged to allow veterans to be trained closer to their homes, while still being reimbursed by the VHA as part of the VHA’s Community Care Network program.

Successful commercialization depends in significant part on adequate coverage and reimbursement from third party payors, which may include government payors (such as Medicare and Medicaid programs in the United States), managed care organizations, and private health insurers.

In general, each third-party payor decides which devices will be covered and reimbursed, establishes reimbursement and co-pay levels and sets conditions for coverage and reimbursement.

While no broad uniform policy of coverage and reimbursement for electronic exoskeleton medical technology exists among commercial insurance payors in the United States, reimbursement may be evaluated by the payor on a case-by-case basis.

To date, payments for the ReWalk Personal Exoskeleton have been made primarily through case-by-case determinations by third-party payors, including commercial insurers in the United States, by self-payors and donations and, to a lesser extent, through the use of funds from insurance and/or accident settlements.

According to the NSCISC 2023 annual report, approximately 57% of the spinal cord injury population received primary coverage from Medicare and Medicaid within five years after their injury date, with Medicare representing the majority of cases.

In order to be covered and reimbursed by Medicare, the ReWalk Personal Exoskeleton must, among other things, be classified into an applicable Medicare benefit category.

In addition, appropriate codes describing the technology must also be established to facilitate billing and claims processing.

In December 2019, we submitted the first application for a unique code to describe the ReWalk Personal Exoskeleton and, in July 2020, a unique code was issued for ReWalk Personal Exoskeleton.

On April 11, 2024, CMS revised its April 2024 DMEPOS Fee Schedule to include a final lump-sum Medicare purchase fee schedule amount for personal exoskeletons (HCPCS code K1007) with an established rate of $91,032.

As part of gap-filling, CMS utilizes verifiable supplier or commercial pricing information and adjusts this pricing information according to a deflation and update factor methodology.

For more information about coverage and reimbursement risk factors, see “Part I, Item 1A.

Risk Factors—Risks Related to our Business and our Industry.”

As part of our plan for growth, we intend to continue working with both national and regional commercial insurance companies, health care practitioners, physicians, researchers, and the SCI community to support efforts to demonstrate the benefits of our SCI Products.

In addition, we plan to pursue potential coverage policies with third party payors based on supportive data and appeal rulings that have deemed exoskeleton devices medically necessary and not investigational for individuals with SCI.

Our efforts in the future will be focused on continued education of third-party payors through data application, published clinical literature, and work with advocacy groups and health and care providers.

In addition, we will continue ongoing communication to seek greater clarity regarding Medicare coverage and reimbursement standards applicable to the ReWalk Personal Exoskeleton.

Reimbursement for ReWalk in Europe varies by country and historically certain third-party payors have provided reimbursement for our products in certain cases in Germany and Italy.

We initially focused our European efforts in Germany where we continue to make progress toward achieving ReWalk coverage from the various government, private, and workers’ compensation payors.

continue to work with the VHA to both accelerate the pace of implementation of the current VHA policy nationally, and to again expand

opportunities for veterans to gain access to assessments, training, and devices in facilities outside VHA’s traditional spinal cord

injury “hub and spoke” infrastructure.

Community-based, non-VHA clinics are also being leveraged to allow veterans to be trained

closer to their homes, while still being reimbursed by the VHA as part of the VHA’s Community Care Network program.

commercialization depends in significant part on adequate coverage and reimbursement from third party payors, which may include government

payors (such as Medicare and Medicaid programs in the United States), managed care organizations, and private health insurers.

each third-party payor decides which devices will be covered and reimbursed, establishes reimbursement and co-pay levels and sets conditions

for coverage and reimbursement.

no broad uniform policy of coverage and reimbursement for electronic exoskeleton medical technology exists among commercial insurance

payors in the United States, reimbursement may be evaluated by the payor on a case-by-case basis.

To date, payments for the ReWalk Personal

Exoskeleton have been made primarily through case-by-case determinations by third-party payors, including commercial insurers in the United

States, by self-payors and donations and, to a lesser extent, through the use of funds from insurance and/or accident settlements.

to the NSCISC 2024 annual report, approximately 57% of the spinal cord injury population received primary coverage from Medicare and Medicaid

within five years after their injury date, with Medicare representing the majority of cases.

order to be covered and reimbursed by Medicare, the ReWalk Personal Exoskeleton must, among other things, be classified into an applicable

Medicare benefit category.

In addition, appropriate codes describing the technology must also be established to facilitate billing and

claims processing.

December 2019, we submitted the first application for a unique code to describe the ReWalk Personal Exoskeleton and, in July 2020, a unique

code was issued for ReWalk Personal Exoskeleton.

On April 11, 2024, CMS revised its April 2024 DMEPOS Fee Schedule to include

a final lump-sum Medicare purchase fee schedule amount for personal exoskeletons (HCPCS code K1007) with an established rate of $91,032.

The final payment determination was made by CMS by applying a “gap filling” process, which was used in light of CMS determining

that the code describing the technology has no fee schedule pricing history and that lower extremity exoskeletons incorporate “revolutionary

features” that cannot be described by or considered comparable to any other existing code or combination of codes.

As part of gap-filling,

CMS utilizes verifiable supplier or commercial pricing information and adjusts this pricing information according to a deflation and update

factor methodology.

In applying this formula to the K1007 code describing the ReWalk Personal Exoskeleton, CMS says that it calculated

this final payment amount by averaging pricing information for exoskeleton devices from Lifeward and other manufacturers.

more information about coverage and reimbursement risk factors, see “Part I, Item 1A.

Risk Factors—Risks Related to our Business

and our Industry.”

part of our plan for growth, we intend to continue working with both national and regional commercial insurance companies, health care

practitioners, physicians, researchers, and the SCI community to support efforts to demonstrate the benefits of our SCI Products.

we plan to pursue potential coverage policies with third party payors based on supportive data and appeal rulings that have deemed exoskeleton

devices medically necessary and not investigational for individuals with SCI.

Our efforts in the future will be focused on continued education

of third-party payors through data application, published clinical literature, and work with advocacy groups and health and care providers.

In addition, we will continue ongoing communication to seek greater clarity regarding Medicare coverage and reimbursement standards applicable

to the ReWalk Personal Exoskeleton.

Reimbursement

for ReWalk in Europe varies by country and historically certain third-party payors have provided reimbursement for our products in certain

cases in Germany and Italy.

initially focused our European efforts in Germany where we continue to make progress toward achieving ReWalk coverage from the various

government, private, and workers’ compensation payors.

Specifically:

● In September 2017, the German insurer BARMER confirmed it will provide ReWalk systems to all qualifying beneficiaries.

BARMER provides coverage for nearly nine million people in Germany, as a member of the SHI network and one of the most significant national insurers in the country.

Exoskeletons are provided to users that meet certain inclusion criteria and assessment by the German Health Insurance Medical Service (Medizinischer Dienst der Krankenversicherungen) before and after training.

● In September 2017 Germany’s national social accident insurance provider, DGUV, indicated that the DGUV’s member payors, including the health insurance association Berufsgenossenschaft (also known as BG) and state insurers, will approve the supply of exoskeleton systems for qualifying beneficiaries on a case-by-case basis.

DGUV is comprised of 33 different insurers, which provide coverage for more than 80 million individuals in Germany.

Per the agreement, eligible individuals go to BG clinics for evaluation as a part of the procurement.

In May 2020 the DGUV agreed to a binding offer to the evaluation, training, and supply of the ReWalk Personal Exoskeleton to qualified individuals.

● In February 2018, the GKV-Spitzenverband (Central Federal Association of (the) Statutory Health Insurance Funds) confirmed its decision to list the ReWalk Personal Exoskeleton system in the German MDD, a comprehensive list of all medical devices which are principally and regularly reimbursed by German SHI and PHI providers.

The ReWalk Personal was added to the official German list of medical aids, code number 23.29.01.2001, in June 2018.

This decision means that ReWalk Personal Exoskeleton is listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis.

● During the year 2020 we announced several new agreements with SHIs such as TK and DAK-Gesundheit and others as well as the first PHI that chose to enter into an agreement with us that outline the process to obtaining a device for eligible insured patients.

● In March 2021 we entered into a contract with BKK Mobile Oil health insurance to supply ReWalk’s Personal Exoskeleton to eligible persons in Germany.

● In June 2020, BARMER appealed the decision of the State Social Court, which ordered the supply of the SHI’s insured SCI person with ReWalk.

September 2017, the German insurer BARMER confirmed it will provide ReWalk systems to all qualifying beneficiaries.

BARMER provides coverage

for nearly nine million people in Germany, as a member of the SHI network and one of the most significant national insurers in the country.

Exoskeletons are provided to users that meet certain inclusion criteria and assessment by the German Health Insurance Medical Service

(Medizinischer Dienst der Krankenversicherungen) before and after training.

September 2017 Germany’s national social accident insurance provider, DGUV, indicated that the DGUV’s member payors, including

the health insurance association Berufsgenossenschaft (also known as BG) and state insurers, will

approve the supply of exoskeleton systems for qualifying beneficiaries on a case-by-case basis.

DGUV is comprised of 33 different insurers,

which provide coverage for more than 80 million individuals in Germany.

Per the agreement, eligible individuals go to BG clinics for evaluation

as a part of the procurement.

In May 2020 the DGUV agreed to a binding offer to the evaluation, training, and supply of the ReWalk Personal

Exoskeleton to qualified individuals.

February 2018, the GKV-Spitzenverband (Central Federal Association of (the) Statutory Health Insurance Funds) confirmed its decision to

list the ReWalk Personal Exoskeleton system in the German MDD, a comprehensive list of all medical devices which are principally and regularly

reimbursed by German SHI and PHI providers.

The ReWalk Personal was added to the official German list of medical aids, code number 23.29.01.2001,

in June 2018.

This decision means that ReWalk Personal Exoskeleton is listed among all medical devices for compensation, which SHI providers

can procure for any approved beneficiary on a case-by-case basis.

the year 2020 we announced several new agreements with SHIs such as TK and DAK-Gesundheit and others as well as the first PHI that chose

to enter into an agreement with us that outline the process to obtaining a device for eligible insured patients.

March 2021 we entered into a contract with BKK Mobile Oil health insurance to supply ReWalk’s Personal Exoskeleton to eligible persons

June 2020, BARMER appealed the decision of the State Social Court, which ordered the supply of the SHI’s insured SCI person with

The State Social Court ruled and deemed ReWalk as the medical aid which will directly compensate the plaintiff’s disability.

BARMER initially appealed this ruling with the Federal Social Court ( Bundessozialgericht ), but later, in November 2022, withdrew its pending case and accepted the prior ruling from the state court that exoskeletons are considered as a direct disability compensation.

This outcome means that an eligible insured person with SCI in Germany has a legal basis for the supply of an exoskeleton as an orthopedic aid for direct disability compensation.

Patients in Germany who are covered under these contracts and policies must be medically evaluated for their eligibility to use the ReWalk Personal Exoskeleton device.

If medically qualified, the patient, along with his or her physician, must apply for coverage of the device.

If a patient is found eligible and medically fit to use our ReWalk Personal Exoskeleton device, we first enter into a rental agreement which allows the patient the necessary period to train on how to use the device which usually takes between 3 to 6 months and then, after approval from the insurer, the patient receives a personal device to use at home and in the community.

● In February 2025, we finalized an agreement with BARMER to formalize the reimbursement process for the provision of ReWalk exoskeletons to medically eligible beneficiaries.

With the completion of the BARMER contract, approximately 45% of the 70 million people in Germany covered by Statutory Health Insurance now have coverage policies with a defined reimbursement process for personal exoskeletons.

We are currently working with several additional SHIs and PHIs on securing a formal operating contract that will establish the process of obtaining a ReWalk Personal Exoskeleton for their beneficiaries within their system.

As of December 31, 2024, there were 44 insurance cases pending in Germany.

We believe that our recent coverage decisions and the existing claims will eventually lead other German insurers to provide coverage on a broader scale, but this is not guaranteed.

For more information, see “Part I, Item 1A.

Risk Factors—Risks Related to our Business and our Industry— We may fail to secure or maintain adequate insurance coverage or reimbursement for our products by third-party payors which risk may be heightened if insurers find the products to be investigational or experimental or if new government regulations change existing reimbursement policies.

Additionally, such coverage or reimbursement, even if maintained, may not produce revenue that is high enough to allow us to sell our products profitably.”

We continue to support clinical research and academic publications, which we believe will further support the case for coverage.

We have distribution agreements in several European countries where we also had success with reimbursement by private insurers and worker’s compensation.

One of the examples was achieved in March 2018, when the Italian Ministry of Labor and Social Policy’s statutory insurance corporation put in place a coverage policy that will provide exoskeleton systems for all qualifying beneficiaries.

This policy, the first of its kind in Italy, provides individuals with spinal cord injury access to obtain their own ReWalk Personal Exoskeleton device so that they can stand and walk again.

Since the initiation of coverage, we have supplied 10 units through our Italian distributor to individuals covered by this policy.

Other Funding Sources

In addition to being funded by third-party payors, including private insurance plans, government programs such as the VHA, and workers’ compensation plans, ReWalk Personal Exoskeleton is also funded by self-payors.

This includes individuals who purchase ReWalk with funds from legal settlements with insurance companies or third parties.

AlterG Anti-Gravity System

The DAP technology that underpins our AlterG Anti-Gravity technology originated from researchers at the NASA Moffet Field Research Center to help astronauts maintain their muscle strength and bone density during extended periods in space outside of the effects of earth’s gravity.

The DAP technology was used to create a pressurized bubble that could exert pressure on an astronaut while exercising to simulate the impact of gravity.

BARMER initially appealed this ruling with the Federal Social Court ( Bundessozialgericht ), but

later, in November 2022, withdrew its pending case and accepted the prior ruling from the state court that exoskeletons are considered

as a direct disability compensation.

This outcome means that an eligible insured person with SCI in Germany has a legal basis for the

supply of an exoskeleton as an orthopedic aid for direct disability compensation.

Patients in Germany who are covered under these contracts

and policies must be medically evaluated for their eligibility to use the ReWalk Personal Exoskeleton device.

If medically qualified,

the patient, along with his or her physician, must apply for coverage of the device.

If a patient is found eligible and medically fit

to use our ReWalk Personal Exoskeleton device, we first enter into a rental agreement which allows the patient the necessary period to

train on how to use the device which usually takes between 3 to 6 months and then, after approval from the insurer, the patient receives

a personal device to use at home and in the community.

February 2025, we finalized an agreement with BARMER to formalize the reimbursement process for the provision of ReWalk exoskeletons to

medically eligible beneficiaries.

With the completion of the BARMER contract, approximately 45% of the 70 million people in Germany

covered by Statutory Health Insurance now have coverage policies with a defined reimbursement process for personal exoskeletons.

We are currently working with several additional SHIs and PHIs on securing a formal operating contract that will establish the process

of obtaining a ReWalk Personal Exoskeleton for their beneficiaries within their system.

of December 31, 2025, there were 49 insurance cases pending in Germany.

We believe that our recent coverage decisions and the existing

claims will eventually lead other German insurers to provide coverage on a broader scale, but this is not guaranteed.

For more information,

see “Part I, Item 1A.

Risk Factors—Risks Related to our Business and our Industry— We may fail to secure or maintain

adequate insurance coverage or reimbursement for our products by third-party payors which risk may be heightened if insurers find the

products to be investigational or experimental or if new government regulations change existing reimbursement policies.

Additionally,

such coverage or reimbursement, even if maintained, may not produce revenue that is high enough to allow us to sell our products profitably.”

continue to support clinical research and academic publications, which we believe will further support the case for coverage.

have distribution agreements in several European countries where we also had success with reimbursement by private insurers and worker’s

compensation.

One of the examples was achieved in March 2018, when the Italian Ministry of Labor and Social Policy’s statutory insurance

corporation put in place a coverage policy that will provide exoskeleton systems for all qualifying beneficiaries.

This policy, the first

of its kind in Italy, provides individuals with spinal cord injury access to obtain their own ReWalk Personal Exoskeleton device so that

they can stand and walk again.

Since the initiation of coverage, we have supplied 10 units through our Italian distributor to individuals

covered by this policy.

Funding Sources

addition to being funded by third-party payors, including private insurance plans, government programs such as the VHA, and workers’

compensation plans, ReWalk Personal Exoskeleton is also funded by self-payors.

This includes individuals who purchase ReWalk with funds

from legal settlements with insurance companies or third parties.

Anti-Gravity System

DAP technology that underpins our AlterG Anti-Gravity technology originated from researchers at the NASA Moffet Field Research Center

to help astronauts maintain their muscle strength and bone density during extended periods in space outside of the effects of earth’s

The DAP technology was used to create a pressurized bubble that could exert pressure on an astronaut while exercising to simulate

the impact of gravity.

While the technology ultimately was never implemented by NASA, it also had promise for use on earth.

The DAP technology was modified by the founders of AlterG, Inc.

for the opposite purpose of using the buoyancy of a pressurized air chamber to uniformly reduce gravitational load and body weight.

With subsequent product development, the initial AlterG Anti-Gravity system design was supplemented with other complementary features.

Our current models utilize a precise air calibration system which modulates the air pressure supporting the user 100 times a second to ensure precise and consistent weight displacement that allows for modification of the pressurized support in one-percent increments of each user’s weight.

Additionally, the AlterG systems can be fitted with cameras for live video monitoring and pressure sensors that track the user’s gait pattern.

Our proprietary Stride Smart software can provide real-time data and analytics so that the user can watch and self-correct gate abnormalities.

DAP technology was modified by the founders of AlterG, Inc.

for the opposite purpose of using the buoyancy of a pressurized air chamber

to uniformly reduce gravitational load and body weight.

With subsequent product development, the initial AlterG Anti-Gravity system design

was supplemented with other complementary features.

Our current models utilize a precise air calibration system which modulates the air

pressure supporting the user 100 times a second to ensure precise and consistent weight displacement that allows for modification of the

pressurized support in one-percent increments of each user’s weight.

Additionally, the AlterG systems can be fitted with cameras

for live video monitoring and pressure sensors that track the user’s gait pattern.

proprietary Stride Smart software can provide real-time data and analytics so that the user can watch and self-correct gait abnormalities.

Clinicians also can simultaneously read and respond to five gait assessment key performance indicators (“KPIs”).

The five KPIs include:

● weight-bearing symmetry;

● step length symmetry;

● stance time symmetry;

● cadence (stepping frequency);

● pain level.

The Stride Smart software provides clinicians with clear, objective data with which to assess, adjust, and modify a patient’s rehabilitation progress.

Since Stride Smart collects and presents patient gait data automatically, clinicians can focus their efforts rehabbing the patient and selecting the data most useful to their gait analysis and correction recommendations.

Based on usage patterns and feedback of clinicians, we believe that the AlterG Anti-Gravity system provides a versatile tool for the rehabilitation of lower extremity injuries and conditions.

By treating a broad range of conditions and facilitating faster recovery times, the AlterG Anti-Gravity system enables rehabilitation clinics the opportunity to gain more referrals, increase the throughput of the facility, and improve the productivity of the staff.

We offer a range of AlterG Anti-Gravity systems depending on the needs and budget of each customer as follows:

• NEO – Introduced in 2024, this is the entry-level and most accessible model of Anti-Gravity system to enable increased adoption of Anti-Gravity technology across a broader range of clinics and training facilities.

The NEO model delivers the same patented DAP technology with an updated platform and new electronic handrail height adjustment.

The NEO is equipped to run at up to 10 miles per hour (“mph”) in forward and 3 mph in reverse with a maximum incline of 15 degrees;

• NEO+ – The most versatile offering within the AlterG family builds upon the benefits of the NEO with added speed up to 12 mph and an integrated camera.

The NEO+ also offers additional options for further customization, including a high-speed option of up to 15 mph and the addition of our Stride Smart gait analytics software package.;

• PRO – The PRO is our top-of-the-line model for sports medicine and elite sports applications with utilization by professional and collegiate athletes.

The PRO is designed for robust performance with a slat-belt design equipped to run at up to 18 mph in forward and 10 mph in reverse, with all software and speed options included as standard.

In addition to sales of the AlterG Anti-Gravity systems, we also provide consumables and services that support the utilization of the installed base.

For example, the AlterG systems require the users to wear proprietary shorts that zip the user into the air chamber to create the seal to maintain the air pressurize.

With frequent use, these shorts need to be periodically replaced.

Additionally, we maintain a network of approximately 40 contract service engineers who perform the installation, maintenance, and repair work.

As the 12-month assurance warranties expire, we market extended service contracts which can provide a recurring revenue base that can grow with the size of the installed base.

The potential market for AlterG Anti-Gravity systems is large and fragmented with several types of facilities that treat patients with conditions who could benefit from rehabilitation using partial weight displacement.

KPIs include:

weight-bearing

length symmetry;

time symmetry;

(stepping frequency);

Stride Smart software provides clinicians with clear, objective data with which to assess, adjust, and modify a patient’s rehabilitation

Since Stride Smart collects and presents patient gait data automatically, clinicians can focus their efforts rehabbing the patient

and selecting the data most useful to their gait analysis and correction recommendations.

on usage patterns and feedback of clinicians, we believe that the AlterG Anti-Gravity system provides a versatile tool for the rehabilitation

of lower extremity injuries and conditions.

By treating a broad range of conditions and facilitating faster recovery times, the AlterG

Anti-Gravity system enables rehabilitation clinics the opportunity to gain more referrals, increase the throughput of the facility, and

improve the productivity of the staff.

offer a range of AlterG Anti-Gravity systems depending on the needs and budget of each customer as follows:

– Introduced in 2024, this is the entry-level and most accessible model of Anti-Gravity system to enable increased adoption of Anti-Gravity

technology across a broader range of clinics and training facilities.

The NEO model delivers the same patented DAP technology with

an updated platform and new electronic handrail height adjustment.

The NEO is equipped to run at up to 10 miles per hour (“mph”)

in forward and 3 mph in reverse with a maximum incline of 15 degrees;

NEO+ – The most versatile offering within the AlterG family builds upon the benefits

of the NEO with added speed up to 12 mph and an integrated camera.

The NEO+ also offers additional options for further customization,

including a high-speed option of up to 15 mph and the addition of our Stride Smart gait analytics software package;

PRO – The PRO is our top-of-the-line model for sports medicine and elite sports

applications with utilization by professional and collegiate athletes.

The PRO is designed for robust performance with a slat-belt design

equipped to run at up to 18 mph in forward and 10 mph in reverse, with all software and speed options included as standard.

In addition to sales of the AlterG Anti-Gravity systems, we also provide

consumables and services that support the utilization of the installed base.

For example, the AlterG systems require the users to wear

proprietary shorts that zip the user into the air chamber to create the seal to maintain the air pressure.

With frequent use, these shorts

need to be periodically replaced.

Additionally, we maintain a network of approximately 40 contract service engineers who perform the installation,

maintenance, and repair work.

As the 12-month assurance warranties expire, we market extended service contracts which can provide a recurring

revenue base that can grow with the size of the installed base.

The potential market for AlterG Anti-Gravity systems is large and fragmented

with several types of facilities that treat patients with conditions who could benefit from rehabilitation using partial weight displacement.

According to the MedPAC 2025 Report, there are approximately 1,200 certified inpatient rehabilitation facilities in the U.S.

These facilities treat patients with a range of conditions including stroke, lower extremity fractures, joint replacements, neurological conditions and brain injury, cardiac conditions, and other types of orthopaedic conditions.

Depending on the specific details of each case, many of these patients are candidates for therapy using partial weight displacement.

Globally, we estimate that there are approximately 3,500 inpatient rehabilitation facilities that are comparable in budget and quality of care to those in the U.S.

The largest potential market for the AlterG Anti-Gravity systems are outpatient clinics, some of which are in national and regional affiliations and most of which are independent facilities.

According to the IBIS World Industry Report (which tracks the number of physical therapy rehabilitation centers), there were approximately 54,000 outpatient clinics in the U.S.

These facilities treat patients with less severe conditions than inpatient facilities with a greater mix of patients skewed towards lower extremity fractures, joint replacements, and other types of orthopedic conditions.

Globally, we estimate that there are over 100,000 outpatient clinics based on scaling of population and standard of living that there are over 100,000 outpatient clinics.

One other major segment of the market for AlterG systems consists of professional and elite level sports teams, including major university and college sports programs.

These teams use the AlterG Anti-Gravity system to assist their players in maintaining higher levels of fitness and accelerating the recovery time from sports-related injuries.

Based on our internal estimates of the market, we believe that there are approximately 1,400 sports programs in the U.S.

These facilities

treat patients with a range of conditions including stroke, lower extremity fractures, joint replacements, neurological conditions and

brain injury, cardiac conditions, and other types of orthopaedic conditions.

Depending on the specific details of each case, many of these

patients are candidates for therapy using partial weight displacement.

Globally, we estimate that there are approximately 3,500 inpatient

rehabilitation facilities that are comparable in budget and quality of care to those in the U.S.

The largest potential market for the AlterG Anti-Gravity systems are

outpatient clinics, some of which are in national and regional affiliations and most of which are independent facilities.

the IBIS World Industry Report (which tracks the number of physical therapy rehabilitation centers), there were approximately 54,000 outpatient

clinics in the U.S.

These facilities treat patients with less severe conditions than inpatient facilities with a greater mix

of patients skewed towards lower extremity fractures, joint replacements, and other types of orthopedic conditions.

Globally, we estimate

that there are over 100,000 outpatient clinics based on scaling of population and standard of living that there are over 100,000 outpatient

One other major segment of the market for AlterG systems consists of professional and elite level sports teams, including major

university and college sports programs.

These teams use the AlterG Anti-Gravity system to assist their players in maintaining higher levels

of fitness and accelerating the recovery time from sports-related injuries.

Based on our internal estimates of the market, we believe

that there are approximately 1,400 sports programs in the U.S.

who are potential AlterG customers.

Globally, we estimate this figure to be greater than 4,000 teams.

Globally, we estimate this figure to

be greater than 4,000 teams.

ReStore Exo-Suit

In June 2017, we unveiled our lightweight ReStore Exo-Suit system designed initially for rehabilitation of stroke patients.

The patented soft exo-suit technology was originally developed at Harvard University’s Wyss Institute for Biologically Inspired Engineering (“Harvard”), where it also underwent initial clinical testing that demonstrated potential to improve walking for stroke survivors.

ReWalk and Harvard entered into a multi-year research collaboration agreement in 2016 which provides ReWalk license to intellectual property relating to lightweight exo-suit system technologies for lower limb disabilities and provides access to future innovations that emerge from this collaboration and may be relevant to additional stroke products or other therapies.

In June 2017, we unveiled our lightweight ReStore Exo-Suit system designed

initially for rehabilitation of stroke patients.

The patented soft exo-suit technology was originally developed at Harvard University’s

Wyss Institute for Biologically Inspired Engineering (“Harvard”), where it also underwent initial clinical testing that demonstrated

potential to improve walking for stroke survivors.

ReWalk and Harvard entered into a multi-year research collaboration agreement in 2016

which provides ReWalk license to intellectual property relating to lightweight exo-suit system technologies for lower limb disabilities

and provides access to future innovations that emerge from this collaboration and may be relevant to additional stroke products or other

The development and regulatory clearance process for ReStore took us approximately three years.

We received FDA clearance for ReStore in June 2019.

We also obtained a CE mark in May 2019 but because the ReStore product was not planned for MDR conformity we had to cease sales in the EU in May 2024.

Following the regulatory clearances, we began to commercialize the ReStore product.

For more information on the collaboration with Harvard, see “Research and Development-Research and Development Collaborations.”

We received FDA clearance for

ReStore in June 2019, and also obtained a CE mark in May 2019.

Following the regulatory clearances, we began to commercialize the ReStore

product but because the ReStore product was not planned for MDR conformity we had to cease sales in the EU in May 2024.

For more information

on the collaboration with Harvard, see “Research and Development-Research and Development Collaborations.”

ReStore Exo-Suit

The ReStore product consists of a soft, fabric-based design that connects to a lightweight waist pack and mechanical cables that help lift the patient’s affected leg in synchronized timing with their natural walking pattern.

The lightweight structure wraps around the waist and supports an actuator with a motor, computer, and cable, along with sensors attached to a stable point on the user’s calf and footplate in the user’s shoe.

This design provides targeted mechanical assistance to the patient’s ankle during forward propulsion (plantarflexion) and ground clearance (dorsiflexion), two key phases of the gait cycle.

The ReStore system is designed to provide advantages to stroke rehabilitation clinics and therapists as compared to other traditional therapies and devices by enabling the therapist to specifically target and train for improved propulsion symmetry, which is a key contributor to improved walking speed and efficiency for patients recovering from stroke.

Published clinical trials using the soft exo-suit design on stroke patients have shown varying levels of improvements, with the main ones being improved walking speed, improved propulsion symmetry, reductions in compensatory behaviors including paretic hip hiking and circumduction as well as reduction in metabolic burden associated with post stroke walking.

There are additional studies on-going with the ReStore device that examine the improvement in walking speed following training with the soft exo-suit as well as comparing the results of traditional training with soft exo-suit training.

The main market for ReStore is rehabilitation clinics with a stroke therapy program or clinics that would like to broaden their stroke presence.

This product is marketed and sold directly to rehabilitation clinics for use during the treatment of their patients which is generally reimbursed by commercial and government payors.

During the second half of 2019 we expanded our sales and

marketing presence in the United States to accelerate product penetration after receiving FDA clearance and CE mark.

These efforts were adversely impacted by the COVID-19 pandemic, as clinics and hospitals shifted resources and attention during the

During 2024, new research was published on the clinical efficacy using ReStore in stroke rehabilitation and we see this technology as a building block for future portfolio development.

Stroke incidence rate in the United States is approximately 800,000 incidences per year and the survival rate is approximately 80%.

Of this stroke

population, 80% are left with some type of lower limb disability.

This patient population seeks treatment in one of the approximately 1,600 primary and comprehensive inpatient, outpatient, and rehabilitation clinics providing therapy to stroke

With the clinical evidence we have to date on ReStore, its unique design and its cost-effectiveness compared to other products, we believe the ReStore soft exosuit has an opportunity to be adopted by clinics for use in therapy of their

stroke patients.

However, we also recognize that the process to achieve that might be long and will likely only occur once national or regional healthcare providers include the device within their stroke therapy programs.

We also believe that to

accelerate adoption, further clinical evidence is required as well as continued education on the new ReStore design and its unique advantages compared to current therapies and products.

As of December 31, 2024, and December 31, 2023, we had placed 43 and 42 ReStore units, respectively.

The ReStore product consists of a soft, fabric-based design that connects

to a lightweight waist pack and mechanical cables that help lift the patient’s affected leg in synchronized timing with their natural

walking pattern.

The lightweight structure wraps around the waist and supports an actuator with a motor, computer, and cable, along with

sensors attached to a stable point on the user’s calf and footplate in the user’s shoe.

This design provides targeted mechanical

assistance to the patient’s ankle during forward propulsion (plantarflexion) and ground clearance (dorsiflexion), two key phases

of the gait cycle.

The ReStore system is designed to provide advantages to stroke rehabilitation clinics and therapists as compared to

other traditional therapies and devices by enabling the therapist to specifically target and train for improved propulsion symmetry, which

is a key contributor to improved walking speed and efficiency for patients recovering from stroke.

Published clinical trials comparing the use of the soft exo-suit design

versus traditional rehabilitation training with stroke patients have shown varying levels of improvements, with the main ones being improved

walking speed, improved propulsion symmetry, reductions in compensatory behaviors including paretic hip hiking and circumduction as well

as reduction in metabolic burden associated with post stroke walking.

The main market for ReStore is rehabilitation clinics with a stroke

therapy program or clinics that would like to broaden their stroke presence.

This product is marketed and sold directly to rehabilitation

clinics for use during the treatment of their patients which is generally reimbursed by commercial and government payors.

During the second

half of 2019 we expanded our sales and marketing presence in the United States to accelerate product penetration after receiving FDA clearance

These efforts were adversely impacted by the COVID-19 pandemic, as clinics and hospitals shifted resources and attention

during the pandemic.

During 2024, new research was published on the clinical efficacy using ReStore in stroke rehabilitation and we see

this technology as a building block for future portfolio development.

Stroke incidence in the United States is estimated at approximately

800,000 cases per year, with roughly 75–80% of individuals surviving the acute event.

Among stroke survivors, motor impairments

are common, and an estimated 30–40% experience persistent lower-limb gait or mobility limitations requiring rehabilitation.

In the United States, individuals recovering from stroke receive therapy

across inpatient rehabilitation facilities, hospital-based rehabilitation programs, and outpatient physical therapy clinics, representing

several thousand sites of care nationwide.

With the clinical evidence we have to date on ReStore, its unique design

and its cost-effectiveness compared to other products, we believe the ReStore soft exosuit has the potential to be adopted by clinics

for use in the therapy of their stroke patients.

However, we also recognize that the process to achieve this may be lengthy and will likely

occur only once national or regional healthcare providers include the device within their stroke therapy programs.

We also believe that

accelerating adoption may require additional clinical evidence as well as continued education regarding the ReStore design and its potential

advantages compared to existing therapies and products.

As of December 31, 2025, and December 31, 2024, we had placed 48 and

43 ReStore units, respectively.

ReBoot Product

We are also in the research stage of ReBoot, a soft exoskeleton for stroke home and community use, and are currently evaluating the reimbursement

landscape and the potential clinical impact of this device.

We are also in the research stage of ReBoot, a soft exoskeleton for

stroke home and community use, and are currently evaluating the reimbursement landscape and the potential clinical impact of this device.

This product would be a complementary product to ReStore, and it received Breakthrough Device Designation from the FDA in November 2021.

The ReBoot is a lightweight, battery-powered

exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries, such as stroke.

The ReBoot is a customizable personalized device intended for home and community use with an estimated

market of approximately 400,000 annual stroke patients who require walking assistance after being discharged home.

Further investment in the development path of the ReBoot was paused in 2023 pending further determination about the clinical and

commercial opportunity of this device and at this time it remains on hold.

The ReBoot is a lightweight, battery-powered exo-suit intended to assist ambulatory functions in individuals with reduced ankle function

related to neurological injuries, such as stroke.

The ReBoot is a customizable personalized device intended for home and community use

with an estimated market of approximately 400,000 annual stroke patients who require walking assistance after being discharged home.

investment in the development path of the ReBoot was paused in 2023 pending further determination about the clinical and commercial opportunity

of this device and at this time it remains on hold.

Sales and Marketing Activities

With added resources from acquiring AlterG, Inc., we have created a U.S.

commercial team that we believe has the capacity and capabilities to

support a broad range of physical and neurological rehabilitation products for use in facilities, the home and the community.

As part of this integration, we have rebranded our company under the name Lifeward, to emphasize our commitment to

pioneering a portfolio of innovative technologies to empower the pursuit of life’s ambitions in the face of physical limitation or disability.

For the sake of clarity, we will continue to use the ReWalk name to designate our line of exoskeleton

products and the AlterG name to describe our line of Anti-Gravity systems.

In the U.S., our commercial efforts are direct sales focused generally on rehabilitation centers, hospitals, rehabilitation clinics, and similar

facilities that treat patients who could benefit from offerings within our portfolio of products.

We market our facility-based products, such as the AlterG and the MyoCycle Pro to these institutions for their use in providing care to their

We also market our home-based products, such as the ReWalk Personal Exoskeleton or MyoCycle Home, to physicians and physical therapists for referrals to individuals who could benefit from these devices as part of a home-based activity

regimen that elevates the health and wellness of these individuals.

Additionally, some sales of the ReWalk Personal Exoskeleton or MyoCycle Home are also generated from referrals through the spinal cord injury community and direct inquiries from

potential users through our different marketing efforts.

Beyond healthcare facilities, we also market our AlterG systems to professional and college sports teams who use the systems to help their athletes recover from lower extremity sports

Outside the U.S., our distribution varies depending on the product and the geographic market.

We market our ReWalk Personal Exoskeleton product

directly in Germany and primarily through third-party distributors, who maintain the customer relationships, in our other markets.

We market our AlterG systems directly in Canada, and in other territories utilize a network of over 40 third-party

distributors who generally have exclusivity in their respective geographic territories.

As of December 31, 2024, we had placed 131 ReWalk Rehabilitation Exoskeleton units in use at rehabilitation centers and 689 ReWalk Personal

Exoskeleton units in a home or community use, compared to 131 ReWalk Rehabilitation Exoskeleton units and 616 ReWalk Personal Exoskeleton units as of December 31, 2023.

We estimate the installed base of AlterG systems is over 6,000 installed units

worldwide as of December 31, 2024.

With the finalization of the Medicare payment rates for exoskeletons that was effective April 1, 2024, we have begun to aggressively target the eligible Medicare customer base for growth while also continuing to

focus on expanding commercial and other reimbursement coverage.

Additionally, with our increased direct sales resources and distributor network, we also expect to greater penetrate the base of facilities which could utilize AlterG systems for

rehabilitation of their patients.

The market in which we operate is characterized by active competition and rapid technological change, and we expect competition to increase.

Competition arises from providers of other mobility systems and prosthetic devices used in the clinic and/or home settings.

We are aware of several other companies developing competing technology and devices, and some of these competitors may have greater resources,

greater name recognition, broader product lines, or larger customer bases than we do.

Our principal competitors in the medical exoskeleton market consist of Ekso Bionics (NASDAQ:

EKSO), Rex Bionics Pty, Cyberdyne (Tokyo Stock

7779), FREE Bionics, DIH (formerly known as Hocoma), Wandercraft, and Bioness (acquired by Bioventus (NASDAQ:

The competitors’ products may also compete with the ReStore Exo-Suit, as well as manual forms of gait training which do

not involve robotic assistive devices.

We believe that our ReWalk Personal Exoskeleton possesses key competitive advantages over these companies’ products, such as our tilt-sensor

technology that provides a self-initiated walking experience, six degrees of freedom which enable a more natural gait, faster functional walking speed, the ability to support its own weight, and robust durability in real-world conditions.

addition, ReWalk Personal Exoskeleton is the only medical exoskeleton with FDA and CE clearance for use on stairs and curbs, which greatly improves the ability to use the device in everyday real-world environments.

We believe that our ReStore Exo-Suit device has several competitive advantages over the products of our competitors, including a design that

facilitates a natural, functional walking pattern through flexible materials, sensors, and powered plantarflexion as well as dorsiflexion, making it the only solution of its type of which we are aware of that supports such movements, achieving that

with a lower cost and weight than rigid exoskeletal devices.

In addition, are aware of a number of academic and early stage research into exoskeletons for various applications.

Other medical device or

robotics companies, academic and research institutions, or others may develop new technologies or therapies that provide a superior walking experience, are more effective in treating the secondary medical conditions that we target or are less

expensive than our current or future products.

Our technologies and products could be rendered obsolete by such developments.

We may also compete with other treatments and technologies that address the secondary medical conditions that ReWalk seeks to mitigate.

With added resources from acquiring AlterG, Inc., we have created a

commercial team that we believe has the capacity and capabilities to support a broad range of physical and neurological rehabilitation

products for use in facilities, the home and the community.

As part of this integration, we have rebranded our company under the name

Lifeward, to emphasize our commitment to pioneering a portfolio of innovative technologies to empower the pursuit of life’s ambitions

in the face of physical limitation or disability.

For the sake of clarity, we will continue to use the ReWalk name to designate our line

of exoskeleton products and the AlterG name to describe our line of Anti-Gravity systems.

In the U.S., our commercial efforts are direct sales focused generally

on rehabilitation centers, hospitals, rehabilitation clinics, and similar facilities that treat patients who could benefit from offerings

within our portfolio of products.

We market our facility-based products, such as the AlterG and the MyoCycle Pro to these institutions

for their use in providing care to their patients.

We also market our home-based products, such as the ReWalk Personal Exoskeleton or

MyoCycle Home, to physicians and physical therapists for referrals to individuals who could benefit from these devices as part of a home-based

activity regimen that elevates the health and wellness of these individuals.

Additionally, some sales of the ReWalk Personal Exoskeleton

or MyoCycle Home are also generated from referrals through the spinal cord injury community and direct inquiries from potential users

through our different marketing efforts.

Beyond healthcare facilities, we also market our AlterG systems to professional and college sports

teams who use the systems to help their athletes recover from lower extremity sports injuries.

Outside the U.S., our distribution varies depending on the product and

the geographic market.

We market our ReWalk Personal Exoskeleton product directly in Germany and primarily through third-party distributors,

who maintain the customer relationships, in our other markets.

We market our AlterG systems directly in Canada, and in other territories

utilize a network of over 40 third-party distributors who generally have exclusivity in their respective geographic territories.

As of December 31, 2025, we had placed 131 ReWalk Rehabilitation Exoskeleton

units in use at rehabilitation centers and 778 ReWalk Personal Exoskeleton units in a home or community use, compared to 131 ReWalk Rehabilitation

Exoskeleton units and 689 ReWalk Personal Exoskeleton units as of December 31, 2024.

We estimate the installed base of AlterG systems

is over 6,000 installed units worldwide as of December 31, 2025.

With the finalization of the Medicare payment rates for exoskeletons

that was effective April 1, 2024, we have begun to aggressively target the eligible Medicare customer base for growth while also continuing

to focus on expanding commercial and other reimbursement coverage.

Additionally, with our increased direct sales resources and distributor

network, we also expect to further penetrate the base of facilities which could utilize AlterG systems for rehabilitation of their patients.

The market in which we operate is characterized by active competition

and rapid technological change, and we expect competition to increase.

Competition arises from providers of other mobility systems and

prosthetic devices used in the clinic and/or home settings.

We are aware of several other companies developing competing technology

and devices, and some of these competitors may have greater resources, greater name recognition, broader product lines, or larger customer

bases than we do.

In the market for anti-gravity rehabilitation systems, our AlterG systems

compete with other treadmill-based rehabilitation technologies offered by various medical device and rehabilitation equipment manufacturers,

including systems offered by companies such as BTL Industries and other providers of rehabilitation treadmills and gait-training technologies

used in clinical rehabilitation and sports performance settings.

We believe that our AlterG systems differentiate themselves through their

proprietary Differential Air Pressure technology, which allows precise and comfortable body-weight support during rehabilitation and athletic

Our principal competitors in the medical exoskeleton market consist

of Ekso Bionics (NASDAQ:

EKSO), Rex Bionics Pty, Cyberdyne (Tokyo Stock Exchange:

7779), FREE Bionics, DIH (formerly known as Hocoma),

Wandercraft, and Bioness (acquired by Bioventus (NASDAQ:

The competitors’ products may also compete with the ReStore Exo-Suit,

as well as manual forms of gait training which do not involve robotic assistive devices.

We believe that our ReWalk Personal Exoskeleton possesses key competitive

advantages over these companies’ products, such as our tilt-sensor technology that provides a self-initiated walking experience,

six degrees of freedom which enable a more natural gait, the ability to support its own weight, and robust durability in real-world conditions.

In addition, ReWalk Personal Exoskeleton is the only medical exoskeleton with FDA and CE clearance for use on stairs and curbs, which

greatly improves the ability to use the device in everyday real-world environments.

We believe that our ReStore Exo-Suit device has several competitive

advantages over the products of our competitors, including a design that facilitates a natural, functional walking pattern through flexible

materials, sensors, and powered plantarflexion as well as dorsiflexion, making it the only solution of its type of which we are aware

of that supports such movements, achieving that with a lower cost and weight than rigid exoskeletal devices.

In addition, we are aware of a number of academic and early stage research

into exoskeletons for various applications.

Other medical device or robotics companies, academic and research institutions, or others

may develop new technologies or therapies that provide a superior walking experience, are more effective in treating the secondary medical

conditions that we target or are less expensive than our current or future products.

Our technologies and products could be rendered obsolete

by such developments.

We may also compete with other treatments and technologies that address

the secondary medical conditions that ReWalk seeks to mitigate.

Community Engagement and Education

We devote significant resources to engagement with and education of the spinal cord injury community with respect to the benefits of our SCI

We actively seek opportunities to partner with hospitals, rehabilitation centers and key opinion leaders to engage in research and development and clinical activities.

We also seek to educate and gain support from organizations such as

patient advocacy groups and clinician societies with the goal of promoting adoption of exoskeleton technology from patient, clinician, and payor communities.

We believe that our success has been and will continue to be driven in part by our

reputation and acceptance within the spinal cord injury community.

To date, multiple advocacy groups have issued public endorsements of the ReWalk Personal Exoskeleton, including leading United States-based

national organizations such as the United Spinal Association and the Dana and Christopher Reeves Foundation, as well as others.

In addition, the National Institute for Health and Care excellence in the United Kingdom (also known as “NICE”) has

issued a public announcement regarding the ReStore device.

We devote significant resources to engagement with and education of

the spinal cord injury community with respect to the benefits of our SCI Products.

We actively seek opportunities to partner with hospitals,

rehabilitation centers and key opinion leaders to engage in research and development and clinical activities.

We also seek to educate

and gain support from organizations such as patient advocacy groups and clinician societies with the goal of promoting adoption of exoskeleton

technology from patient, clinician, and payor communities.

We believe that our success has been and will continue to be driven in part

by our reputation and acceptance within the spinal cord injury community.

To date, multiple advocacy groups have issued public endorsements of

the ReWalk Personal Exoskeleton, including leading United States-based national organizations such as the United Spinal Association and

the Dana and Christopher Reeves Foundation, as well as others.

In addition, the National Institute for Health and Care excellence in the

United Kingdom (also known as “NICE”) has issued a public announcement regarding the ReStore device.

Services and Customer Support

Our commercial centers of operations in Marlborough, Massachusetts and Berlin, Germany coordinate all customer support and product service

functions for North America and Europe, respectively, through dedicated technical service personnel who provide product services and customer support through training to healthcare providers and support to product users.

We also had a commercial

location in Fremont, California where we ceased operations as of December 31, 2024.

Our commercial centers of operations in Hudson, Massachusetts and Berlin,

Germany coordinate all customer support and product service functions for North America and Europe, respectively, through dedicated technical

service personnel who provide product services and customer support through training to healthcare providers and support to product users.

Research and Development

We are committed to investing in a robust research and development program to support our current product line and to potentially develop our

pipeline of new and complementary products, and we believe that ongoing research and development efforts are essential to our success.

Our research and development team consists of both in-house and external staff, including engineers, machinists,

researchers and marketing, quality, manufacturing, regulatory and clinical personnel, which we employ as efficiently as possible meet our current and future needs, and who work closely together to design, enhance, and validate our technologies.

This research and development team conceptualizes technologies and then builds and tests prototypes before refining and/or redesigning, as necessary.

Our regulatory and clinical personnel work in parallel with engineers and researchers, allowing us

to anticipate and resolve potential issues at early stages in the development cycle.

Our level of research and development investment depends on our available resources, business plans, and future needs.

We are committed to investing in a robust research and development program

to support our current product line and to potentially develop our pipeline of new and complementary products, and we believe that ongoing

research and development efforts are essential to our success.

Our research and development team consists of both in-house and external

staff, including engineers, machinists, researchers and marketing, quality, manufacturing, regulatory and clinical personnel, which we

employ as efficiently as possible meet our current and future needs, and who work closely together to design, enhance, and validate our

technologies.

This research and development team conceptualizes technologies and then builds and tests prototypes before refining and/or

redesigning, as necessary.

Our regulatory and clinical personnel work in parallel with engineers and researchers, allowing us to anticipate

and resolve potential issues at early stages in the development cycle.

Our level of research and development investment depends on our

available resources, business plans, and future needs.

For more information, see “Part I, Item 1A.

Risk Factors — Risks Related to Our Business and Our Industry — Our future growth and operating results will depend on our ability to develop, receive regulatory clearance for, and commercialize new products and penetrate new product and geographic

We are working on product design improvements and expanded labeling for the ReWalk Personal Exoskeleton product which we plan to launch following

obtaining regulatory clearance and approvals.

In the longer term we are conducting research for our next generation exoskeleton with design improvements and advanced robotic technologies such machine vision, AI and sensor fusion as part of the

Human Robot Interaction Consortium research program.

New medical indications impacting the ability to walk that we may pursue include multiple sclerosis, cerebral palsy, Parkinson’s disease, and elderly assistance.

We are also considering new generations of anti-gravity systems utilizing our DAP technology, including the NEO which was introduced in 2024 as an

entry-level and most accessible model of Anti-Gravity™ system to enable increased adoption of Anti-Gravity™ technology across a broader range of clinics and training facilities.

Additionally, we are evaluating other applications for DAP technology

to create entirely new rehabilitation systems for our facility-based customers.

We conduct our research and development efforts mainly at our facility in Yokneam, Israel.

We believe that the close interaction among our

research and development and manufacturing groups allows for timely and effective realization of our new product concepts.

Our research and development efforts have been financed, in part, through funding from the Israel Innovation Authority (formerly known as Office

of the Chief Scientist in the Israel Ministry of Economy) (the “IIA”).

From our inception through December 31, 2024, we received funding totalling $2.8 million from the IIA.

For more information regarding our research and development financing

arrangements, see “Part II.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” and “—Grants and Other Funding.”

Risk Factors — Risks Related

to Our Business and Our Industry — Our future growth and operating results will depend on our ability to develop, receive regulatory

clearance for, and commercialize new products and penetrate new product and geographic markets.”

We have implemented product design improvements for the ReWalk Personal

Exoskeleton, including enhancements incorporated into the ReWalk 7 system, which received regulatory clearance and has been commercially

In the longer term we are conducting research on our next generation

exoskeleton with design improvements and advanced robotic technologies such as AI and sensor fusion.

New medical indications impacting

the ability to walk that we may pursue include multiple sclerosis, cerebral palsy, Parkinson’s disease, and assistance for elderly

We are also considering new generations of anti-gravity systems utilizing

our DAP technology, including the NEO which was introduced in 2024 as an entry-level and most accessible model of Anti-Gravity™

system to enable increased adoption of Anti-Gravity™ technology across a broader range of clinics and training facilities.

Additionally,

we are evaluating other applications for DAP technology to create entirely new rehabilitation systems for our facility-based customers.

We conduct our research and development efforts mainly at our facility

in Yokneam, Israel.

We believe that the close interaction among our research and development and manufacturing groups allows for timely

and effective realization of our new product concepts.

Our research and development efforts have been financed, in part, through

funding from the Israel Innovation Authority (formerly known as Office of the Chief Scientist in the Israel Ministry of Economy) (the

From our inception through December 31, 2025, we received funding totaling $2.8 million from the IIA.

For more information

regarding our research and development financing arrangements, see “Part II.

Management’s Discussion and Analysis

of Financial Condition and Results of Operations—Liquidity and Capital Resources” and “—Grants and Other Funding.”

Research and Development Collaborations

On April 1, 2022, we entered a research and development cooperation agreement with several companies and universities in the Human Robot

Interaction (“HRI”) Consortium, part of the IIA’s MAGNET incentive program.

This incentive program provides grants for R&D collaboration as part of a consortium comprised of private businesses and leading academic centers.

The goals of the HRI

consortium are to “develop advanced technologies aimed at providing robots with social capabilities, enabling them to carry out various tasks and effective interactions with different users in diverse operational environments.” The total program

has a budget of NIS 57 million, which includes funding for research and development grants to help drive technological innovation.

The Consortium is a 3-year program which has allocated NIS 1.745 million to fund ReWalk-specific projects over the

first 18-month period of the program.

In November 2023, we entered the second 18-month period of the program, the Consortium has allocated NIS 1.336 million to fund ReWalk-specific projects over the second 18-month period.

As of December 31, 2024,

the Company spent total funds in the amount of NIS 2.903 million.

As a member of the HRI Consortium, we collaborate with several universities to develop advanced technologies aimed at improving the human-exoskeleton interaction.

This research

collaboration with top researchers in the fields of robotics, behavioral sciences and human-computer interaction will seek to make the use of exoskeletons easier and more natural to promote wider adoption of the technology.

On May 16, 2016, we entered into the Research Collaboration Agreement (“Collaboration Agreement”) and the Exclusive License Agreement (“Harvard

License Agreement”) with Harvard.

Under the Collaboration Agreement, we and Harvard agreed to collaborate on research regarding the development of lightweight soft suit exoskeleton system technologies for lower limb disabilities, which are intended

to treat stroke, multiple sclerosis, mobility limitations for the elderly and other medical applications.

Under the Collaboration Agreement, we paid Harvard quarterly installment payments to help fund the research.

Subject to the terms of the

Collaboration Agreement, we and Harvard were required to report our respective research results and findings to each other on a regular basis.

The Collaboration Agreement governed ownership of the research results and inventions generated in

performance of the research collaboration and provided us the option to negotiate with Harvard for a license to certain new inventions of Harvard conceived in performance of the collaboration.

On April 1, 2022, we entered a research and development cooperation

agreement with several companies and universities in the Human Robot Interaction (“HRI”) Consortium, part of the IIA’s

MAGNET incentive program.

This incentive program provides grants for R&D collaboration as part of a consortium comprised of private

businesses and leading academic centers.

The goals of the HRI consortium are to “develop advanced technologies aimed at providing

robots with social capabilities, enabling them to carry out various tasks and effective interactions with different users in diverse operational

environments.” The total program has a budget of NIS 57 million, which includes funding for research and development grants to help

drive technological innovation.

The Consortium is a 3-year program which has allocated NIS 1.745 million to fund ReWalk-specific projects

over the first 18-month period of the program.

In November 2023, we entered the second 18-month period of the program, the Consortium

has allocated NIS 1.336 million to fund ReWalk-specific projects over the second 18-month period.

As of December 31, 2025, the Company

spent total funds in the amount of NIS 3.0 million.

As a member of the HRI Consortium, we collaborate with several universities to develop

advanced technologies aimed at improving the human-exoskeleton interaction.

This research collaboration with top researchers in the fields

of robotics, behavioral sciences and human-computer interaction will seek to make the use of exoskeletons easier and more natural to promote

wider adoption of the technology.

On May 16, 2016, we entered into the Research Collaboration Agreement

(“Collaboration Agreement”) and the Exclusive License Agreement (“Harvard License Agreement”) with Harvard.

the Collaboration Agreement, we and Harvard agreed to collaborate on research regarding the development of lightweight soft suit exoskeleton

system technologies for lower limb disabilities, which are intended to treat stroke, multiple sclerosis, mobility limitations for the

elderly and other medical applications.

Under the Collaboration Agreement, we paid Harvard quarterly installment payments to help fund

the research.

Subject to the terms of the Collaboration Agreement, we and Harvard were required to report our respective research results

and findings to each other on a regular basis.

The Collaboration Agreement governed ownership of the research results and inventions generated

in performance of the research collaboration and provided us the option to negotiate with Harvard for a license to certain new inventions

of Harvard conceived in performance of the collaboration.

The Collaboration Agreement concluded on March 31, 2022.

Under the Harvard License Agreement, we have been granted an exclusive, worldwide royalty-bearing license under certain patents of Harvard

relating to lightweight “soft suit” exoskeleton system technologies for lower limb disabilities, a royalty-free license under certain related know-how and the option to obtain a license to certain inventions conceived under our joint research

collaboration.

Harvard retains the right to practice the patents for research, educational and scholarly purposes.

We are required to use commercially reasonable efforts to develop products under the Harvard License Agreement in accordance with an

agreed-upon development plan and to introduce and market such products commercially.

In addition to an upfront fee and royalties on net sales, we are obligated to pay Harvard certain milestone payments upon the achievement of certain product

development and commercialization milestones.

We have also agreed to reimburse Harvard for expenses incurred in connection with the filing, prosecution, and maintenance of the licensed patents.

The Harvard License Agreement will continue in full force and effect until the expiration of the last-to-expire valid claim of the licensed

patents, or it is terminated in accordance with its terms.

We may terminate the License Agreement for any reason upon 60 days’ prior written notice, while Harvard may terminate the License Agreement if we do not maintain requisite insurance or

become insolvent.

The Harvard License Agreement may also be terminated by Harvard or us due to the other party’s material uncured breach.

The Harvard License Agreement contains, as applicable, customary representations and warranties and customary enforcement, indemnification, and

insurance provisions.

For further discussion of the Collaboration Agreement and Harvard License Agreement, see Note 10 to our consolidated financial statements for the fiscal year ended December 31, 2024 included elsewhere in this annual report.

Under the Harvard License Agreement,

we have been granted an exclusive, worldwide royalty-bearing license under certain patents of Harvard relating to lightweight “soft

suit” exoskeleton system technologies for lower limb disabilities, a royalty-free license under certain related know-how and the

option to obtain a license to certain inventions conceived under our joint research collaboration.

Harvard retains the right to practice

the patents for research, educational and scholarly purposes.

We are required to use commercially reasonable efforts to develop products

under the Harvard License Agreement in accordance with an agreed-upon development plan and to introduce and market such products commercially.

In addition to an upfront fee and royalties on net sales, we are obligated to pay Harvard certain milestone payments upon the achievement

of certain product development and commercialization milestones.

We have also agreed to reimburse Harvard for expenses incurred in connection

with the filing, prosecution, and maintenance of the licensed patents.

The Harvard License Agreement will

continue in full force and effect until the expiration of the last-to-expire valid claim of the licensed patents, or it is terminated

in accordance with its terms.

We may terminate the License Agreement for any reason upon 60 days’ prior written notice, while Harvard

may terminate the License Agreement if we do not maintain requisite insurance or become insolvent.

The Harvard License Agreement may also

be terminated by Harvard or us due to the other party’s material uncured breach.

The Harvard License Agreement contains, as applicable,

customary representations and warranties and customary enforcement, indemnification, and insurance provisions.

Intellectual Property

Protection of our intellectual property is important to our business.

We seek to protect our intellectual property through a combination of

patents, trademarks, confidentiality, and assignment agreements with our employees and certain of our contractors and confidentiality agreements with certain of our consultants, scientific advisors and other vendors and contractors.

In addition, we

rely on trade secrets law to protect our proprietary software and product candidates/products in development.

In addition to our portfolio of issued patents and pending patent applications, we license certain patented and patented pending technology from a

third party as described above under the “Research and Development” section.

For our ReWalk product line, as of December 31, 2024, we have 12 issued patents in the United States and 24 issued patents outside of the United

States, as well as 11 pending patent applications for our technology in the United States, China, and Europe, including one pending international PCT application.

For our patents associated with DAP and other AlterG technology, as of December 31,

2024, we have 28 issued patents in the United States and 9 patents issued outside the United States, as well as 10 pending patent applications for anti-gravity associated technology in the United States.

In the United States and Europe, we have apparatus patent claims covering aspects of both our exoskeleton and our anti-gravity products and

similar devices or systems, which focus on protecting our products in terms of structural characteristics and functionality.

Moreover, we also have method patent claims covering certain methods of operation and control of our exoskeleton and

anti-gravity products, which provide additional protection for our technology.

We do not currently license any of the technology contained in our currently commercialized ReWalk and AlterG products, other than with respect to technology that is

generally publicly available, but we may do so in the future.

Patents filed both in the United States and Europe (as well as other countries) generally have a term of 20 years from their earliest effective

filing date, although they can be slightly longer depending upon a local jurisdiction’s rules and laws.

For example, the oldest of our issued patents relating to our tilt-sensor technology was filed in May 2001 in the United States and would

typically expire in May 2021.

However, this patent actually expired in April of 2023 due to patent term adjustment (PTA) of 689 days for delays in examination by the United States Patent and Trademark Office.

We currently hold a registered trademark in the United States, Europe, Israel, and the United Kingdom, for the mark

We currently hold a registered trademark in United States, Europe and the United Kingdom for the mark ReStore®.

We currently hold the trademarks Alter G™ and Anti-Gravity Treadmill™ in the United States, Canada and Japan.

The trademark

Alter G™ is also held in the United Kingdom and Europe.

We currently hold the registered trademark Defy Gravity® in the United States.

We also hold a registered trademark for Lifeward® in the Europe, the United Kingdom, and Israel.

application to register the trademark Lifeward™ is pending in the United States.

We cannot be sure that our intellectual property will provide us with a competitive advantage especially as some of our older patents begin to

expire, or that we will not infringe on the intellectual property rights of others.

In addition, we cannot be sure that any patents will be granted in a timely manner or at all with respect to any of our patent pending applications.

comprehensive discussion of the risks related to our intellectual property, see “Part I, Item 1A.

We seek to protect our intellectual property through a combination of patents, trademarks, confidentiality, and assignment agreements

with our employees and certain of our contractors and confidentiality agreements with certain of our consultants, scientific advisors

and other vendors and contractors.

In addition, we rely on trade secrets law to protect our proprietary software and product candidates/products

in development.

In addition to our portfolio of issued patents and pending patent applications,

we license certain patented and patented pending technology from a third party as described above under the “Research and Development”

For our ReWalk product line, as of December 31, 2025, we have 12 issued

patents in the United States and 34 issued patents outside of the United States, as well as 7 pending patent applications for our technology

in the United States, China, and Europe, including one pending international PCT application.

For our patents associated with DAP

and other AlterG technology, as of December 31, 2025, we have 30 issued patents in the United States and 7 patents issued outside the

United States, as well as 2 pending patent applications for anti-gravity associated technology in the United States and one pending international

PCT application.

In the United States and Europe, we have apparatus patent claims covering

aspects of both our exoskeleton and our anti-gravity products and similar devices or systems, which focus on protecting our products in

terms of structural characteristics and functionality.

Moreover, we also have method patent claims covering certain methods of operation

and control of our exoskeleton and anti-gravity products, which provide additional protection for our technology.

We do not currently

license any of the technology contained in our currently commercialized ReWalk and AlterG products, other than with respect to technology

that is generally publicly available, but we may do so in the future.

Patents filed both in the United States and Europe (as well as other

countries) generally have a term of 20 years from their earliest effective filing date, although they can be slightly longer depending

upon a local jurisdiction’s rules and laws.

For example, the oldest of our issued patents relating to our tilt-sensor technology

was filed in May 2001 in the United States and would typically expire in May 2021.

However, this patent actually expired in April of 2023

due to patent term adjustment (PTA) of 689 days for delays in examination by the United States Patent and Trademark Office.

We currently hold a registered trademark in the United States, Europe,

Israel, and the United Kingdom, for the mark ReWalk®.

We currently hold a registered trademark in United States, Europe and the United

Kingdom for the mark ReStore®.

We currently hold the trademarks Alter G™ and Anti-Gravity Treadmill™ in the United States,

Canada and Japan.

The trademark Alter G™ is also held in the United Kingdom and Europe.

We currently hold the registered trademark

Defy Gravity® in the United States.

We also hold a registered trademark for Lifeward® in the Europe, the United Kingdom, and

The application to register the trademark Lifeward™ is pending in the United States.

We cannot be sure that our intellectual property will provide

us with a competitive advantage especially as some of our older patents begin to expire, or that we will not infringe on the intellectual

property rights of others.

In addition, we cannot be sure that any patents will be granted in a timely manner or at all with respect to

any of our patent pending applications.

For a more comprehensive discussion of the risks related to our intellectual property, see “Part

Risk Factors—Risks Related to Our Intellectual Property.”

Government Regulation

Our medical products and manufacturing operations are regulated by the FDA and other federal and state agencies.

Our products are regulated as

medical devices in the United States under the Federal Food, Drug, and Cosmetic Act, or the FFDCA, as implemented and enforced by the FDA.

The FDA regulates the development, testing, manufacturing, labeling, storage, installation, servicing,

advertising, promotion, marketing, distribution, import, export, and market surveillance of our medical devices.

Our medical products and manufacturing operations are regulated by the

FDA and other federal and state agencies.

Our products are regulated as medical devices in the United States under the Federal Food, Drug,

and Cosmetic Act, or the FFDCA, as implemented and enforced by the FDA.

The FDA regulates the development, testing, manufacturing, labeling,

storage, installation, servicing, advertising, promotion, marketing, distribution, import, export, and market surveillance of our medical

Premarket Regulatory Requirements

Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket

notification, approval of a premarket approval application (PMA), or issuance of a de novo classification order.

Under the FFDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of

risk associated with each medical device and the extent of control needed to provide reasonable assurance of safety and effectiveness.

Classification of a device is important because the class to which a device is assigned determines, among other

things, the necessity and type of FDA review required prior to marketing the device.

Class I devices are those for which reasonable assurance of safety and effectiveness can be assured by adherence to general controls that include compliance with

the applicable portions of the FDA’s Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.

Class I also includes devices for which there is insufficient information to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide

such assurance, but that are not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and that do not present a potential unreasonable risk of illness of injury.

Class II devices are those for which general controls alone are insufficient to provide reasonable assurance of safety and effectiveness and there

is sufficient information to establish “special controls.” These special controls can include performance standards, post-market surveillance, and patient registries.

While most Class I devices are exempt from the 510(k) premarket notification

requirement, most Class II devices require a 510(k) premarket notification to be marketed in the U.S.

As a result, manufacturers of most Class II devices are required to submit to the FDA premarket notifications under Section 510(k) of the FFDCA in

order to market or commercially distribute those devices.

To obtain 510(k) clearance, manufacturers must demonstrate that the proposed device is “substantially equivalent” to a predicate device already on the market.

A predicate device is a legally

marketed device that is not subject to premarket approval, or PMA, meaning, (i) a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, (ii) a device that has been reclassified from

Class III to Class II or I, or (iii) a device that was found substantially equivalent through the 510(k) process.

If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k)

clearance to commercially market the device.

If the device is not “substantially equivalent” to a previously cleared device, the device is automatically a Class III device.

The device sponsor must then fulfill more rigorous premarket approval

requirements or can request a risk-based classification determination for the device in accordance with the “de novo” classification process, which is a route to market for medical devices that are low to moderate risk but are not substantially

equivalent to a predicate device.

Devices that are intended to be life sustaining or life supporting, devices that are implantable, devices that present a potential unreasonable

risk of harm or are of substantial importance in preventing impairment of health, and devices that are not substantially equivalent to a predicate device are placed in Class III and generally require approval of a PMA, unless the device is a

pre-amendment device not yet subject to a regulation requiring premarket approval.

The PMA process is more demanding than the 510(k) premarket notification process.

In a PMA, the manufacturer must demonstrate that the device is safe and effective,

and the PMA must be supported by extensive data, including data from preclinical studies and clinical trials.

The PMA must also contain a full description of the device and its components, a full description of the methods, facilities and controls

used for manufacturing, and proposed labeling.

Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive review.

If the FDA accepts the application for review, it has 180 days under the

FFDCA to complete its review of a PMA, although in practice, the FDA’s review often takes significantly longer and can take one year or more.

Clinical trials are almost always required to support PMAs and are sometimes required to support 510(k) submissions.

All clinical investigations

of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations that govern investigational device labeling, prohibit promotion of the investigational device, and

specify recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

If the device presents a “significant risk,” as defined by the FDA, the agency requires the device sponsor to submit an IDE application to

the FDA, which must become effective prior to commencing human clinical trials.

The IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA denies the application or notifies the company that the investigation may

If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the study, the FDA may permit a clinical trial to proceed under a conditional approval.

In addition, the study must be approved

by, and conducted under the oversight of, an Institutional Review Board, or IRB, for each clinical site.

If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by

one or more IRBs without separate approval from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping

requirements.

In June 2014, the FDA granted our request for “de novo” classification, and classified ReWalk as a Class II powered exoskeleton device subject to

special controls.

The ReWalk is intended to enable individuals with spinal cord injuries to perform ambulatory functions under supervision of a specially trained companion, and inside rehabilitation institutions.

The special controls established in

the de novo classification order for all powered exoskeleton devices include the following:

clinical testing to demonstrate safe and effective use considering the level of supervision necessary and the use environment;

non-clinical safety and

performance testing, including durability testing to demonstrate that the device performs as intended under anticipated conditions of use;

Unless an exemption applies, each medical device commercially distributed

in the United States requires either FDA clearance of a 510(k) premarket notification, approval of a premarket approval application (PMA),

or issuance of a de novo classification order.

Under the FFDCA, medical devices are classified into one of three classes—Class I,

Class II or Class III—depending on the degree of risk associated with each medical device and the extent of control needed to provide

reasonable assurance of safety and effectiveness.

Classification of a device is important because the class to which a device is assigned

determines, among other things, the necessity and type of FDA review required prior to marketing the device.

Class I devices are those

for which reasonable assurance of safety and effectiveness can be assured by adherence to general controls that include compliance with

the applicable portions of the FDA’s Quality Management System Regulation, or QMSR, facility registration and product listing, reporting

of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.

includes devices for which there is insufficient information to determine that general controls are sufficient to provide reasonable assurance

of the safety and effectiveness of the device or to establish special controls to provide such assurance, but that are not life-supporting

or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and that do not present a

potential unreasonable risk of illness of injury.

Class II devices are those for which general controls alone are insufficient

to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish “special controls.”

These special controls can include performance standards, post-market surveillance, and patient registries.

While most Class I devices

are exempt from the 510(k) premarket notification requirement, most Class II devices require a 510(k) premarket notification to be marketed

As a result, manufacturers of most Class II devices are required to submit to the FDA premarket notifications under Section

510(k) of the FFDCA in order to market or commercially distribute those devices.

To obtain 510(k) clearance, manufacturers must demonstrate

that the proposed device is “substantially equivalent” to a predicate device already on the market.

A predicate device is

a legally marketed device that is not subject to premarket approval, or PMA, meaning, (i) a device that was legally marketed prior to

May 28, 1976 (pre-amendments device) and for which a PMA is not required, (ii) a device that has been reclassified from Class III to Class

II or I, or (iii) a device that was found substantially equivalent through the 510(k) process.

If the FDA agrees that the device is substantially

equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market the device.

If the device

is not “substantially equivalent” to a previously cleared device, the device is automatically a Class III device.

sponsor must then fulfill more rigorous premarket approval requirements or can request a risk-based classification determination for the

device in accordance with the “de novo” classification process, which is a route to market for medical devices that are low

to moderate risk but are not substantially equivalent to a predicate device.

Devices that are intended to be life sustaining or life supporting,

devices that are implantable, devices that present a potential unreasonable risk of harm or are of substantial importance in preventing

impairment of health, and devices that are not substantially equivalent to a predicate device are placed in Class III and generally require

approval of a PMA, unless the device is a pre-amendment device not yet subject to a regulation requiring premarket approval.

The PMA process

is more demanding than the 510(k) premarket notification process.

In a PMA, the manufacturer must demonstrate that the device is safe

and effective, and the PMA must be supported by extensive data, including data from preclinical studies and clinical trials.

also contain a full description of the device and its components, a full description of the methods, facilities and controls used for

manufacturing, and proposed labeling.

Following receipt of a PMA, the FDA determines whether the application is sufficiently complete

to permit a substantive review.

If the FDA accepts the application for review, it has 180 days under the FFDCA to complete its review

of a PMA, although in practice, the FDA’s review often takes significantly longer and can take one year or more.

Clinical trials are almost always required to support PMAs and are sometimes

required to support 510(k) submissions.

All clinical investigations of devices to determine safety and effectiveness must be conducted

in accordance with the FDA’s investigational device exemption, or IDE, regulations that govern investigational device labeling,

prohibit promotion of the investigational device, and specify recordkeeping, reporting and monitoring responsibilities of study sponsors

and study investigators.

If the device presents a “significant risk,” as defined by the FDA, the agency requires the device

sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials.

The IDE will automatically

become effective 30 days after receipt by the FDA, unless the FDA denies the application or notifies the company that the investigation

may not begin.

If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the study,

the FDA may permit a clinical trial to proceed under a conditional approval.

In addition, the study must be approved by, and conducted

under the oversight of, an Institutional Review Board, or IRB, for each clinical site.

If the device presents a non-significant risk to

the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval

from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators

obtain informed consent, and labeling and record-keeping requirements.

In June 2014, the FDA granted our request for “de novo”

classification, and classified ReWalk as a Class II powered exoskeleton device subject to special controls.

The ReWalk is intended to

enable individuals with spinal cord injuries to perform ambulatory functions under supervision of a specially trained companion, and inside

rehabilitation institutions.

The special controls established in the de novo classification order for all powered exoskeleton devices

include the following:

clinical testing to demonstrate safe and effective use considering the level of supervision necessary and the use

non-clinical safety and performance testing, including durability testing to demonstrate that the device performs as intended

under anticipated conditions of use;

a training program;

and labeling related to device use and user training.

The special controls of this de

novo order also apply to competing powered exoskeleton products seeking FDA clearance.

In June 2019, the FDA issued a 510(k) clearance for ReStore, which means that the device can be marketed in the

ReStore is intended to be used to assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia or hemiparesis due to stroke.

ReStore complies with special controls for

powered exoskeletons as described above.

In order for us to market ReStore and ReWalk, we must comply with both these special controls as well as general controls, including controls related to quality, facility registration, reporting of adverse

events and labelling.

Failure to comply with the general and special controls could lead to removal of ReStore or ReWalk from the market, which would have a material adverse effect on our business.

In March 2023, we received 510(k) clearance for the ReWalk Personal Exoskeleton with an indication for standing and

walking on level surfaces and mild slopes and ascending and descending stairs and curbs.

In June 2024, we submitted a 510(k) premarket notification for the ReWalk 7 Personal Exoskeleton, a next-generation ReWalk model, and the 510(k) is

currently pending review by the FDA.

The special controls of

this de novo order also apply to competing powered exoskeleton products seeking FDA clearance.

In June 2019, the FDA issued a 510(k) clearance for ReStore, which means

that the device can be marketed in the U.S.

ReStore is intended to be used to assist ambulatory functions in rehabilitation institutions

under the supervision of a trained therapist for people with hemiplegia or hemiparesis due to stroke.

ReStore complies with special controls

for powered exoskeletons as described above.

In order for us to market ReStore and ReWalk, we must comply with both these special controls

as well as general controls, including controls related to quality, facility registration, reporting of adverse events and labelling.

Failure to comply with the general and special controls could lead to removal of ReStore or ReWalk from the market, which would have a

material adverse effect on our business.

In March 2023, we received 510(k) clearance for the ReWalk Personal

Exoskeleton with an indication for standing and walking on level surfaces and mild slopes and ascending and descending stairs and curbs.

In June 2024, we submitted a 510(k) premarket notification for the ReWalk 7 Personal Exoskeleton, a next-generation ReWalk model, and

the 510(k) was cleared by FDA in March 2025.

For more information, see “Part I, Item 1A.

Risk Factors-Risks Related to Government Regulation-We are subject to

extensive governmental regulations relating to the manufacturing, labelling and marketing of our products, and a failure to comply with such regulations could lead to withdrawal or recall of our products from the market.”

Risk Factors-Risks

Related to Government Regulation-We are subject to extensive governmental regulations relating to the manufacturing, labelling and marketing

of our products, and a failure to comply with such regulations could lead to withdrawal or recall of our products from the market.”

Expedited Development and Review Programs

FDA’s Breakthrough Devices Program is a voluntary program offered to manufacturers of certain medical devices and device-led combination products

that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the program is to provide patients and health care providers with more timely access to qualifying

devices by expediting their development, assessment and review, while preserving the statutory standards for marketing authorization.

The program is available to medical devices that meet certain eligibility criteria, including that the device provides more effective treatment or

diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and that the device meets one of the following criteria:

(i) the device represents a breakthrough technology, (ii) no approved or cleared alternatives exist, (iii)

the device offers significant advantages over existing approved or cleared alternatives, or (iv) the availability of the device is in the best interest of patients.

Breakthrough Device designation provides certain benefits to device developers,

including more interactive and timely communications with FDA staff, use of post market data collection, when scientifically appropriate, to facilitate expedited and efficient development and review of the device, opportunities for efficient and

flexible clinical study design, and prioritized review of premarket submissions.

FDA’s Breakthrough Devices Program is a voluntary program offered

to manufacturers of certain medical devices and device-led combination products that may provide for more effective treatment or diagnosis

of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the program is to provide patients and health care

providers with more timely access to qualifying devices by expediting their development, assessment and review, while preserving the statutory

standards for marketing authorization.

The program is available to medical devices that meet certain eligibility

criteria, including that the device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases

or conditions, and that the device meets one of the following criteria:

(i) the device represents a breakthrough technology, (ii) no approved

or cleared alternatives exist, (iii) the device offers significant advantages over existing approved or cleared alternatives, or (iv)

the availability of the device is in the best interest of patients.

Breakthrough Device designation provides certain benefits to device

developers, including more interactive and timely communications with FDA staff, use of post market data collection, when scientifically

appropriate, to facilitate expedited and efficient development and review of the device, opportunities for efficient and flexible clinical

study design, and prioritized review of premarket submissions.

Post-Market Regulatory Requirements

After a device is cleared for marketing, numerous regulatory requirements apply.

After a device is cleared for marketing, numerous regulatory requirements

These include:

establishment registration and device listing;

development of a quality assurance system, including establishing and implementing procedures to design and manufacture devices;

labeling regulations that prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

FDA’s Unique Device Identification requirements that call for a unique device identifier (UDI) on device labels and packages and submission of data to the FDA’s Global Unique Device Identification Database (GUDID);

medical device reporting regulations that require manufacturers to report to the FDA if a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or

serious injury if it were to recur;

and corrections and removal reporting regulations that require manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the

device or to remedy a violation of the FFDCA that may present a risk to health;

development of a quality assurance system, including establishing and implementing procedures

to design and manufacture devices;

labeling regulations that prohibit the promotion of products for unapproved or “off-label”

uses and impose other restrictions on labeling;

FDA’s Unique Device Identification requirements that call for a unique device identifier

(UDI) on device labels and packages and submission of data to the FDA’s Global Unique Device Identification Database (GUDID);

medical device reporting regulations that require manufacturers to report to the FDA

if a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute

to a death or serious injury if it were to recur;

and corrections and removal reporting regulations that require manufacturers report

to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy

a violation of the FFDCA that may present a risk to health;

post-market surveillance.

Our manufacturing processes are required to comply with the applicable portions of the FDA’s Quality System Regulation (“QSR”) that covers the

methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.

2024, the FDA issued the Quality Management System Regulation (“QMSR”) Final Rule to amend the QSR, incorporating by reference the international standard for medical device quality management systems set by the International Organization for

Standardization (ISO), ISO 13485:2016.

The rule will become effective on February 2, 2026.

Until then, manufacturers are required to comply with the QSR.

We actively maintain compliance with the FDA’s QSR, and the European Union’s Quality

Management Systems requirements, ISO 13485:2016.

As a manufacturer, we are subject to periodic scheduled or unscheduled inspections by the FDA.

If the FDA believes we or any of our contract

manufacturers are not in compliance with the quality system requirements, or other post-market requirements, it has significant enforcement authority.

Specifically, if the FDA determines that we failed to comply with applicable regulatory

requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

Our manufacturing processes are required to comply with the applicable

portions of the FDA’s Quality Management System Regulation (“QMSR”) that covers the methods and the facilities and controls

for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation,

and servicing of finished devices intended for human use.

The QMSR became effective in February 2026 and replaced the Quality System

Regulation (“QSR”).

The QMSR incorporates by reference the international standard for medical device quality management

systems set by the International Organization for Standardization (ISO), ISO 13485:2016.

We actively maintain compliance with the FDA’s

QMSR, and the European Union’s Quality Management Systems requirements, ISO 13485:2016.

As a manufacturer, we are subject to periodic scheduled or unscheduled

inspections by the FDA.

If the FDA believes we or any of our contract manufacturers are not in compliance with the quality system requirements,

or other post-market requirements, it has significant enforcement authority.

Specifically, if the FDA determines that we failed to comply

with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

2 unchanged sentences

operating restrictions or partial suspension or total shutdown of production;

refusing or delaying requests for approval of pre-market approval applications relating to new products or modified products;

withdrawing PMA approval or reclassifying our devices;

refusing or delaying requests for approval of pre-market approval applications relating

to new products or modified products;

withdrawing PMA approval;

refusal to grant export approvals for our products;

pursuing criminal prosecution.

Any such action by the FDA would have a material adverse effect on our business.

In addition, these regulatory controls, as well as any changes in

FDA policies, can affect the time and cost associated with the development, introduction, and continued availability of new products.

Where possible, we anticipate these factors in our product development processes.

Any such action by the FDA would have a material adverse effect on our

In addition, these regulatory controls, as well as any changes in FDA policies, can affect the time and cost associated with

the development, introduction, and continued availability of new products.

Where possible, we anticipate these factors in our product

development processes.

Regulation Outside of the U.S.

In addition to the United States regulations, we are subject to a variety of foreign regulations governing clinical trials and commercial sales

and distribution of our products.

In the E.U., medical devices are regulated by the European Union Medical Devices Regulation (EU) 2017/745 or MDR, which became applicable on May 26, 2021, and replaced the E.U.

Medical Devices Directive 93/42/EEC,

The MDR and its associated guidance documents and harmonized standards, govern, among other things, device design and development, preclinical and clinical or performance testing, premarket conformity assessment, registration,

manufacturing, labeling, claims, distribution, export and import and post-market surveillance, vigilance, and market surveillance.

Before a device can be placed on the market in the E.U., compliance with the MDR requirements must be demonstrated

in order to affix the CE mark to the product.

The method of assessing conformity varies depending on the class of the product but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a “Notified

Body.” This third-party assessment may consist of an audit of the manufacturer’s quality system or specific testing of the manufacturer’s product.

The Notified Body issues a CE Certificate of Conformity to confirm successful completion of a

conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the essential requirements provided in the MDR.

Under transitional provisions provided in the MDR, medical devices that had

valid CE Certificates of Conformity issued under the MDD prior to May 26, 2021 and that remained valid (and not withdrawn) on March 20, 2023, can continue to be placed on the EEA market until the end of December 2027 or 2028 (depending on the

class of device), provided the device’s manufacturer complies with certain requirements, including that there are no significant changes in the design and intended purpose of the applicable device.

After the expiry of any applicable transitional

period, only devices that have been CE marked on the basis of the MDR may be placed on the market in the EEA.

In addition to the United States regulations, we are subject to a variety

of foreign regulations governing clinical trials, manufacturing and commercial sales and distribution of our products.

In the E.U., medical

devices are regulated by the European Union Medical Devices Regulation (EU) 2017/745 or MDR, which became applicable on May 26, 2021,

and replaced the E.U.

Medical Devices Directive 93/42/EEC, or MDD.

The MDR and its associated guidance documents and harmonized standards,

govern, among other things, device design and development, preclinical and clinical or performance testing, premarket conformity assessment,

registration, manufacturing, labeling, claims, distribution, export and import and post-market surveillance, vigilance, and market surveillance.

Before a device can be placed on the market in the E.U., compliance

with the MDR requirements must be demonstrated in order to affix the CE mark to the product.

The method of assessing conformity varies

depending on the class of the product but normally involves a combination of self-assessment by the manufacturer and a third-party assessment

by a “Notified Body.” This third-party assessment may consist of an audit of the manufacturer’s quality system or specific

testing of the manufacturer’s product.

The Notified Body issues a CE Certificate of Conformity to confirm successful completion

of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the essential

requirements provided in the MDR.

Under transitional provisions provided in the MDR, medical devices that had valid CE Certificates of

Conformity issued under the MDD prior to May 26, 2021 and that remained valid (and not withdrawn) on March 20, 2023, can continue to be

placed on the EEA market until the end of December 2027 or 2028 (depending on the class of device), provided the device’s manufacturer

complies with certain requirements, including that there are no significant changes in the design and intended purpose of the applicable

After the expiry of any applicable transitional period, only devices that have been CE marked on the basis of the MDR may be placed

on the market in the EEA.

We comply with the E.U.

requirements and have received ta Notified Body Certificate of Conformity under the MDD for our ReWalk systems

which are distributed in the E.U.

This allows us to continue to apply the CE mark to our products and place them on the market throughout the E.U.

during the transition period or until we have completed an appropriate conformity assessment

procedure under the MDR.

On August 2024, we submitted our application for the MDR assessment of the ReWalk 7 Personal Exoskeleton, and the submission is currently being reviewed by our Notified Body.

The ReStore product was not planned for MDR

conformity and accordingly, we had to cease sales of the ReStore in the EU in May 2024.

requirements and have received a Notified Body Certificate of Conformity under the MDR

for ReWalk 7 Personal Exoskeleton.

Prior models of our ReWalk system are CE marked under the MDD and continue to be placed on the EU market

in compliance with the MDR transitional provisions.

The ReStore product was not planned for MDR conformity and accordingly, we had

to cease sales of the ReStore in the E.U.

Following the U.K.’s exit from the E.U.

(known as “Brexit”), the MDR does not apply in the United Kingdom (except for Northern Ireland, which

under the Northern Ireland Protocol is bound by certain E.U.

The medical device legislative framework in the United Kingdom is set out in the Medical Devices Regulations 2002, as amended.

These regulations are based on the previous medical

device directives of the E.U.

but have been amended so that they function properly now the United Kingdom is no longer part of the E.U.

The Medical Devices Regulations 2002 have introduced several changes including (but not limited to) replacing

the CE mark with a UKCA marking (although E.U.

CE marks will be recognized potentially up until June 2030), requiring manufacturers outside of the United Kingdom to appoint a “UK Responsible Person” if they place devices on the Great Britain market

and more wide-ranging device registration requirements.

Sales in other jurisdictions are subject to the foreign government regulations of the relevant jurisdiction, and in most cases, we must obtain

approval by the appropriate regulatory authorities before we can commence clinical trials or marketing activities in those countries.

The approval process varies from country to country, and the time may be longer or shorter than that required to

obtain a marketing authorization in the United States or the CE mark in the E.U.

The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

The policies of the FDA and foreign regulatory authorities may change, and additional government regulations may be enacted that could prevent or

delay regulatory approval of our products and could also increase the cost of regulatory compliance.

We cannot predict the likelihood, nature, or extent of adverse governmental regulation that might arise from future legislative or administrative

action, either in the United States or abroad.

Anti-Kickback, False Claims and Other Healthcare Fraud and Abuse Laws

In the United States, there are federal and state anti-kickback laws that prohibit the payment or receipt of kickbacks, bribes or other

remuneration intended to induce the purchase or recommendation of healthcare products and services.

Violations of these laws can lead to civil and criminal penalties, including exclusion from participation in federal healthcare programs.

apply to manufacturers of products, such as us, with respect to our financial relationship with hospitals, physicians and other potential purchasers or acquirers of our products.

(known as “Brexit”),

the MDR applies in Northern Ireland but does not apply in Great Britain (England, Scotland and Wales).

The medical device legislative

framework in Great Britain is set out in the Medical Devices Regulations 2002, as amended.

These regulations are based on the previous

medical device directives of the E.U.

but modified to operate independently of E.U.

The Medical Devices Regulations 2002 contain

certain Great Britan-specific requirements, including the introduction of the UK Conformity Assessed, or UKCA, marking (although

CE marks will be recognized potentially up until June 2030 or later (subject to further consultation)), the requirement for manufacturers

located outside of the U.K.

to appoint a “UK Responsible Person” if they place devices on the Great Britain market, and expanded

device registration requirements.

Sales in other jurisdictions are subject to the foreign government regulations

of the relevant jurisdiction, and in most cases, we must obtain approval by the appropriate regulatory authorities before we can commence

clinical trials or marketing activities in those countries.

The approval process varies from country to country, and the time may be longer

or shorter than that required to obtain a marketing authorization in the United States or the CE mark in the E.U.

The requirements governing

the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

The policies of the FDA and foreign regulatory authorities may change,

and additional government regulations may be enacted that could prevent or delay regulatory approval of our products and could also increase

the cost of regulatory compliance.

We cannot predict the likelihood, nature, or extent of adverse governmental regulation that might arise

from future legislative or administrative action, either in the United States or abroad.

Anti-Kickback, False Claims and Other Healthcare Fraud and Abuse

In the United States, there are federal and state anti-kickback laws

that prohibit the payment or receipt of kickbacks, bribes or other remuneration intended to induce the purchase or recommendation of healthcare

products and services.

Violations of these laws can lead to civil and criminal penalties, including exclusion from participation in federal

healthcare programs.

These laws apply to manufacturers of products, such as us, with respect to our financial relationship with hospitals,

physicians and other potential purchasers or acquirers of our products.

government has published regulations that identify “safe

harbors” or exemptions for certain practices from enforcement actions under the federal anti-kickback statute, and we will seek to comply with the safe harbors where possible.

The federal anti-kickback law also contains several statutory safe

harbor exceptions.

To qualify for a safe harbor, the activity must fit squarely within the safe harbor.

Arrangements that do not meet a safe harbor are not necessarily illegal but must be evaluated on a case-by-case basis.

A person or entity may be

found to violate the anti-kickback statute even absent actual knowledge of this statute or specific intent to violate it.

In addition, the government may assert that a claim that includes items or services resulting from a violation of the federal

anti-kickback statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (“FCA”).

The civil FCA prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent

claim for payment to, or approval by, the federal government, knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government, or avoiding, decreasing, or

concealing an obligation to pay money to the federal government.

A claim includes “any request or demand” for money or property presented to the U.S.

The civil FCA has been used to assert liability on the basis of kickbacks and other

improper referrals, improper use of Medicare provider or supplier numbers when detailing a provider of services, improper promotion of off-label uses not covered by a device’s clearance or approval, and allegations as to misrepresentations with

harbors” or exemptions for certain practices from enforcement actions under the federal anti-kickback statute, and we will seek

to comply with the safe harbors where possible.

The federal anti-kickback law also contains several statutory safe harbors.

for a safe harbor, the activity must fit squarely within the safe harbor.

Arrangements that do not meet a safe harbor are not necessarily

illegal but must be evaluated on a case-by-case basis.

A person or entity may be found to violate the anti-kickback statute even absent

actual knowledge of this statute or specific intent to violate it.

In addition, the government may assert that a claim that includes items

or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the

federal False Claims Act (“FCA”).

The civil FCA prohibits, among other things, any person or entity from

knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to, or approval by, the federal government,

knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal

government, or avoiding, decreasing, or concealing an obligation to pay money to the federal government.

A claim includes “any request

or demand” for money or property presented to the U.S.

The civil FCA has been used to assert liability on the basis

of kickbacks and other improper referrals, improper use of Medicare provider or supplier numbers when detailing a provider of services,

improper promotion of off-label uses not covered by a device’s clearance or approval, and allegations as to misrepresentations with

respect to products, contract requirements, and services rendered.

In addition, private payors have been filing follow-on lawsuits alleging fraudulent misrepresentation, although establishing liability and damages in these cases is more difficult

than under the FCA.

Intent to deceive is not required to establish liability under the civil FCA.

Civil FCA actions may be brought by the government or may be brought by private individuals on behalf of the government, called “qui tam” actions.

the government decides to intervene in a qui tam action and prevails in the lawsuit, the individual will share in the proceeds from any fines or settlement funds.

If the government declines to intervene, the individual may pursue the case alone.

The civil FCA provides for treble damages and a civil penalty for each false claim, such as an invoice or pharmacy claim for reimbursement, which can aggregate into millions of dollars.

For these reasons, FCA lawsuits against biopharmaceutical and

device companies have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, as much as $3.0 billion, regarding certain sales practices and promoting off label uses.

Civil FCA liability may

further be imposed for known Medicare or Medicaid overpayments that are not refunded within 60 days of discovering the overpayment, even if the overpayment was not caused by a false or fraudulent act.

In addition, conviction or civil judgment for

violating the FCA may result in exclusion from federal health care programs, and suspension and debarment from government contracts, and refusal of orders under existing government contracts.

The government may further prosecute conduct constituting a false claim under the criminal FCA.

The criminal FCA prohibits the making or

presenting of a claim to the government knowing such claim to be false, fictitious, or fraudulent and, unlike the civil FCA, requires proof of intent to submit a false claim.

The civil monetary penalties statute is another statute under which medical device companies may potentially be subject to enforcement.

other things, the civil monetary penalties statue imposes fines against any person who offers to provide remuneration to any individual eligible for benefits under Medicare or Medicaid that the offerer knows or should know is likely to influence

the individual to order or receive from a particular provider or supplier of any item or service reimbursable under those programs.

The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) also created federal criminal statutes that prohibit, among

other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or

control of, a healthcare benefit program, regardless of whether the payor is public or private, in connection with the delivery or payment for health care benefits, knowingly and willfully embezzling or stealing from a health care benefit program,

willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the

delivery of, or payment for, healthcare benefits, items, or services relating to healthcare matters.

Additionally, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or

collectively the “ACA”, amended the intent requirement of certain of these criminal statutes under HIPAA so that a person or entity no longer needs to have actual knowledge of the statute, or the specific intent to violate it, to have committed a

The Physician Payments Sunshine Act (“Sunshine Act”) requires annual reporting, by applicable device and drug manufacturers, of covered products,

payments, and other transfers of value to certain health care providers, and ownership and investment interests held by physicians and their immediate family members.

Further, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and its respective implementing regulations imposes certain requirements on covered entities relating to the privacy, security, and transmission

of certain individually identifiable health information, known as protected health information.

Among other things, HITECH, through its implementing regulations, makes HIPAA’s security standards and certain privacy standards directly applicable to

business associates, defined as a person or organization, other than a member of a covered entity’s workforce, that creates, receives, maintains, or transmits protected health information on behalf of a covered entity for a function or activity

regulated by HIPAA.

HITECH also strengthened the civil and criminal penalties that may be imposed against covered entities, business associates, and individuals, and gave state attorneys general new authority to file civil actions for damages or

injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

In addition, other federal and state laws may govern the privacy and security of health and other

information in certain circumstances, many of which differ from each other in significant ways and may not be pre-empted by HIPAA, thus complicating compliance efforts.

Many states have also adopted laws similar to each of the above federal laws, which may be broader in scope and apply to items or services

reimbursed by any third-party payor, including commercial insurers.

Certain states also require implementation of commercial compliance programs and compliance with the medical device industry’s voluntary compliance guidelines and the applicable

compliance guidance promulgated by the federal government, or otherwise restrict payments or the provision of other items of value that may be made to healthcare providers and other potential referral sources;

impose restrictions on marketing

or require companies to track and report information related to payments, and other items of value to physicians and other healthcare providers.

If our operations are found to be in violation of any of the laws or regulations described above or any other applicable laws, we may be subject

to penalties or other enforcement actions, including criminal and significant civil monetary penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government healthcare programs, corporate integrity agreements,

suspension and debarment from government contracts, and refusal of orders under existing government contracts, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could

adversely affect our ability to operate our business and our results of operations.

Enforcement actions can be brought by federal or state governments, or as “qui tam” actions brought by individual whistleblowers in the name of the government under

the civil FCA if the violations are alleged to have caused the government to pay a false or fraudulent claim.

To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may

include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare

professionals.

In addition, private payors have been filing follow-on lawsuits alleging

fraudulent misrepresentation, although establishing liability and damages in these cases is more difficult than under the FCA.

to deceive is not required to establish liability under the civil FCA.

Civil FCA actions may be brought by the government or may be brought

by private individuals on behalf of the government, called “qui tam” actions.

If the government decides to intervene in a

qui tam action and prevails in the lawsuit, the individual will share in the proceeds from any fines or settlement funds.

If the government

declines to intervene, the individual may pursue the case alone.

The civil FCA provides for treble damages and a civil penalty for each

false claim, such as an invoice or pharmacy claim for reimbursement, which can aggregate into millions of dollars.

For these reasons,

FCA lawsuits against biopharmaceutical and device companies have resulted in substantial civil and criminal settlements, as much as $3.0

billion, regarding certain sales practices and promoting off label uses.

Civil FCA liability may further be imposed for known Medicare

or Medicaid overpayments that are not refunded within 60 days of discovering the overpayment, even if the overpayment was not caused by

a false or fraudulent act.

In addition, conviction or civil judgment for violating the FCA may result in exclusion from federal health

care programs, and suspension and debarment from government contracts, and refusal of orders under existing government contracts.

The government may further prosecute conduct constituting a false claim

under the criminal FCA.

The criminal FCA prohibits the making or presenting of a claim to the government knowing such claim to be false,

fictitious, or fraudulent and, unlike the civil FCA, requires proof of intent to submit a false claim.

The civil monetary penalties statute is another statute under which

medical device companies may potentially be subject to enforcement.

Among other things, the civil monetary penalties statue imposes fines

against any person who offers to provide remuneration to any individual eligible for benefits under Medicare or Medicaid that the offerer

knows or should know is likely to influence the individual’s selection of a particular provider or supplier of any item or service

reimbursable under those programs.

The federal Health Insurance Portability and Accountability Act of 1996

(“HIPAA”) also created federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or

attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any of

the money or property owned by, or under the custody or control of, a healthcare benefit program, regardless of whether the payor is public

or private, in connection with the delivery or payment for health care benefits, knowingly and willfully embezzling or stealing from a

health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying,

concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery

of, or payment for, healthcare benefits, items, or services relating to healthcare matters.

Additionally, the Patient Protection and Affordable

Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively the “ACA”, amended

the intent requirement of certain of these criminal statutes under HIPAA so that a person or entity no longer needs to have actual knowledge

of the statute, or the specific intent to violate it, to have committed a violation.

The Physician Payments Sunshine Act (“Sunshine Act”) requires

annual reporting, by applicable device and drug manufacturers, of covered products, payments, and other transfers of value to certain

health care providers, and ownership and investment interests held by physicians and their immediate family members.

Further, we may be subject to data privacy and security regulation by

both the federal government and the states in which we conduct our business.

HIPAA, as amended by the Health Information Technology for

Economic and Clinical Health Act (“HITECH”) and its respective implementing regulations imposes certain requirements on covered

entities relating to the privacy, security, and transmission of certain individually identifiable health information, known as protected

health information.

Among other things, HITECH, through its implementing regulations, makes HIPAA’s security standards and certain

privacy standards directly applicable to business associates, defined as a person or organization, other than a member of a covered entity’s

workforce, that creates, receives, maintains, or transmits protected health information on behalf of a covered entity for a function or

activity regulated by HIPAA.

HITECH also strengthened the civil and criminal penalties that may be imposed against covered entities, business

associates, and individuals, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal

courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

other federal and state laws may govern the privacy and security of health and other information in certain circumstances, many of which

differ from each other in significant ways and may not be pre-empted by HIPAA, thus complicating compliance efforts.

Many states have also adopted laws similar to each of the above federal

laws, which may be broader in scope and apply to items or services reimbursed by any third-party payor, including commercial insurers.

Certain states also require implementation of commercial compliance programs and compliance with the medical device industry’s otherwise

voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments

or the provision of other items of value that may be made to healthcare providers and other potential referral sources;

impose restrictions

on marketing practices;

or require companies to track and report information related to payments, and other items of value to physicians

and other healthcare providers.

If our operations are found to be in violation of any of the laws or

regulations described above or any other applicable laws, we may be subject to penalties or other enforcement actions, including criminal

and significant civil monetary penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government healthcare

programs, corporate integrity agreements, suspension and debarment from government contracts, and refusal of orders under existing government

contracts, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which

could adversely affect our ability to operate our business and our results of operations.

Enforcement actions can be brought by federal

or state governments, or as “qui tam” actions brought by individual whistleblowers in the name of the government under the

civil FCA if the violations are alleged to have caused the government to pay a false or fraudulent claim.

To the extent that any of our products are sold in a foreign country,

we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including

safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers

of value to healthcare professionals.

Coverage and Reimbursement

The commercial success of our product candidates and our ability to commercialize any approved product candidates successfully will depend in part

on the extent to which governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers, and other third-party payors provide coverage for and establish adequate reimbursement levels for our

Government authorities, private health insurers, and other organizations generally decide which products and services they will pay for and establish reimbursement levels for healthcare.

Medicare is a federally funded program managed by

CMS through local fiscal intermediaries and carriers that administer coverage and reimbursement for certain healthcare items and services furnished to the elderly and disabled.

The commercial success of our product candidates and our ability to

commercialize any approved product candidates successfully will depend in part on the extent to which governmental payor programs at the

federal and state levels, including Medicare and Medicaid, private health insurers, and other third-party payors provide coverage for

and establish adequate reimbursement levels for our products.

Government authorities, private health insurers, and other organizations

generally decide which products and services they will pay for and establish reimbursement levels for healthcare.

Medicare is a federally

funded program managed by CMS through local fiscal intermediaries and carriers that administer coverage and reimbursement for certain

healthcare items and services furnished to the elderly and disabled.

Medicaid is an insurance program for certain categories of patients

whose income and assets fall below state defined levels and who are otherwise uninsured that is both federally and state funded and managed by each state.

In the United States, private health insurers and other third-party payors often provide

reimbursement for products and services based on the level at which the government provides reimbursement through the Medicare or Medicaid programs for such products and services.

In the United States, the European Union, and other potentially significant markets for our products, government authorities and third-party

payors are increasingly attempting to limit or regulate the price of medical products and services, particularly for new and innovative products and therapies, which often has resulted in average selling prices lower than they would otherwise be.

In the United States, it is also common for certain government and private health plans to use coverage determinations to leverage rebates from labelers to reduce the plans’ net costs.

These restrictions and limitations influence the purchase of

healthcare services and products and lower the realization on manufacturers’ sales of products.

Third-party payors are developing increasingly sophisticated methods of controlling healthcare costs.

whose income and assets fall below state defined levels and who are otherwise uninsured that is both federally and state funded and managed

by each state.

In the United States, private health insurers and other third-party payors often provide reimbursement for products and

services based on the level at which the government provides reimbursement through the Medicare or Medicaid programs for such products

and services.

In the United States, the European Union, and other potentially significant

markets for our products, government authorities and third-party payors are increasingly attempting to limit or regulate the price of

medical products and services, particularly for new and innovative products and therapies, which often has resulted in average selling

prices lower than they would otherwise be.

In the United States, it is also common for certain government and private health plans to

use coverage determinations to leverage rebates from labelers to reduce the plans’ net costs.

These restrictions and limitations

influence the purchase of healthcare services and products and lower the realization of manufacturers’ sales of products.

payors are developing increasingly sophisticated methods of controlling healthcare costs.

Third-party payors may limit coverage to specific

therapeutic products on an approved list, or formulary, which might not include all of the FDA-approved products for a particular indication or might impose high co-payment amounts to influence patient choice.

Third-party payors also control costs

by requiring prior authorization or imposing other restrictions.

Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and

Federal programs also impose price controls through mandatory ceiling prices on purchases by federal agencies and federally funded hospitals and

These restrictions and limitations influence the purchase of healthcare services and products.

Legislative proposals to reform healthcare or reduce costs under government programs may result in lower reimbursement for our products or

exclusion of our products.

Private payors often rely on the lead of the governmental payors in rendering coverage and reimbursement determinations.

Therefore, achieving

favorable CMS coverage and reimbursement is usually a significant gating issue for successful introduction of a new product.

Further, the increased emphasis on managed healthcare in the United States and on country and regional pricing and reimbursement controls in the

European Union will put additional pressure on product pricing, reimbursement, and utilization, which may adversely affect our future product sales and results of operations.

These pressures can arise from rules and practices of managed care

groups, competition from other products, judicial decisions and governmental laws and regulations related to Medicare, Medicaid, and healthcare reform, and pricing in general.

Patients who are prescribed treatments for their conditions and

providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.

Sales of our product candidates will therefore depend substantially, both domestically and abroad, on the

extent to which the costs of our products will be paid by health maintenance, managed care, and similar healthcare management organizations, or reimbursed by government health administration authorities, such as Medicare and Medicaid, private

health insurers, and other third-party payors.

Moreover, a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved or that

significant price concessions will not be required to avoid restrictive conditions.

therapeutic products on an approved list, or formulary, which might not include all the FDA-approved products for a particular indication

or might impose high co-payment amounts to influence patient choice.

Third-party payors also control costs by requiring prior authorization

or imposing other restrictions.

Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness

of medical products and services, in addition to their safety and efficacy.

Federal programs also impose price controls through mandatory ceiling

prices on purchases by federal agencies and federally funded hospitals and clinics.

These restrictions and limitations influence the purchase

of healthcare services and products.

Legislative proposals to reform healthcare or reduce costs under government programs may result in

lower reimbursement for our products or exclusion of our products.

Private payors often rely on the lead of the governmental payors in

rendering coverage and reimbursement determinations.

Therefore, achieving favorable CMS coverage and reimbursement is usually a significant

gating issue for successful introduction of a new product.

Further, the increased emphasis on managed healthcare in the United

States and on country and regional pricing and reimbursement controls in the European Union will put additional pressure on product pricing,

reimbursement, and utilization, which may adversely affect our future product sales and results of operations.

These pressures can arise

from rules and practices of managed care groups, competition from other products, judicial decisions and governmental laws and regulations

related to Medicare, Medicaid, and healthcare reform, and pricing in general.

Patients who are prescribed treatments for their conditions

and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare

Sales of our product candidates will therefore depend substantially, both domestically and abroad, on the extent to which the costs

of our products will be paid by health maintenance, managed care, and similar healthcare management organizations, or reimbursed by government

health administration authorities, such as Medicare and Medicaid, private health insurers, and other third-party payors.

Moreover, a payor’s decision to provide coverage for a product

does not imply that an adequate reimbursement rate will be approved or that significant price concessions will not be required to avoid

restrictive conditions.

High health plan co-payment requirements may result in patients seeking alternative therapies.

Adequate third-party reimbursement may not be available to enable us

to maintain price levels sufficient to realize an appropriate return on our investment.

Legislative proposals to reform healthcare or reduce costs under government insurance programs may result in lower reimbursement for our products or exclusion

of our products from coverage.

The cost containment measures that healthcare payors and providers are instituting and any healthcare reform could significantly reduce our revenue from the sale of any approved product candidates.

Adequate third-party

reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment.

Legislative proposals to reform healthcare or reduce costs under government insurance programs may result in lower reimbursement for our

products or exclusion of our products from coverage.

The cost containment measures that healthcare payors and providers are instituting

and any healthcare reform could significantly reduce our revenue from the sale of any approved product candidates.

Healthcare Reform Measures

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system.

United States government, state legislatures and foreign governments also have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on

reimbursement and requirements for substitution of generic products for branded prescription drugs.

The ACA substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the

pharmaceutical industry.

The ACA is intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and

health insurance industries, impose new taxes and fees on pharmaceutical and medical device manufacturers, and impose additional health policy reforms.

The ACA has been subject to challenges in the courts.

In the most recent judicial challenge to the ACA, the U.S.

Supreme Court ruled on June 17,

2021 that the plaintiffs lacked standing to challenge the law as they had not alleged personal injury traceable to the allegedly unlawful conduct.

As a result, the Supreme Court did not rule on the constitutionality of the ACA or any of its

The Budget Control Act of 2011, among other things, created the Joint Select Committee on Deficit Reduction to recommend proposals in spending

reductions to Congress.

The Joint Select Committee did not achieve its targeted deficit reduction of an amount greater than $1.2 trillion for the fiscal years 2012 through 2021, triggering the legislation’s automatic reductions to several

government programs.

These reductions included aggregate reductions to Medicare payments to healthcare providers of up to 2.0% per fiscal year.

The Bipartisan Budget Act of 2018 retained the federal budget “sequestration” Medicare payment

reductions of 2% and extended it through 2031.

Under the Consolidated Appropriations Acts of 2023 and 2024, the Medicare sequester percentage in FY2032 is scheduled to be 2% from April 1, 2032, through September 30, 2032, and 0% for October 1,

2032 through March 31, 2032 unless congressional action is taken.

On January 2, 2013, the American Taxpayer Relief Act was signed into law, which, among other things, reduced Medicare payments to several types of providers, including hospitals,

imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

The United States and many foreign jurisdictions have enacted or proposed

legislative and regulatory changes affecting the healthcare system.

The United States government, state legislatures and foreign governments

also have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs,

including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription

The ACA substantially changed the way healthcare is financed by both

governmental and private insurers and significantly impacts the pharmaceutical industry.

The ACA was intended to broaden access to health

insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency

requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical and medical device manufacturers,

and impose additional health policy reforms.

The Budget Control Act of 2011, among other things, created the Joint

Select Committee on Deficit Reduction to recommend proposals in spending reductions to Congress.

The Joint Select Committee did not achieve

its targeted deficit reduction of an amount greater than $1.2 trillion for the fiscal years 2012 through 2021, triggering the legislation’s

automatic reductions to several government programs.

These reductions included aggregate reductions to Medicare payments to healthcare

providers of up to 2.0% per fiscal year.

The Bipartisan Budget Act of 2018 retained the federal budget “sequestration” Medicare

payment reductions of 2% and extended it through 2031.

Under the Consolidated Appropriations Acts of 2023 and 2024, the Medicare

sequester percentage in FY2032 is scheduled to be 2% from April 1, 2032, through September 30, 2032, and 0% for October 1, 2032 through

March 31, 2032 unless congressional action is taken.

On January 2, 2013, the American Taxpayer Relief Act was signed into law, which,

among other things, reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment

centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Further legislative and regulatory changes remain possible.

It is unknown what form any such changes or any law would take, and how or whether it

may affect our business in the future.

We expect that changes or additions to the Medicare and Medicaid programs, and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other

legislation in individual states, could have a material adverse effect on the healthcare industry.

At the state level, legislatures may also increasingly pass legislation and implement regulations designed to control product pricing, including

price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures.

We expect that additional federal, state, and foreign healthcare reform measures will be adopted in the future, any of which could limit the

amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, or additional pricing pressures.

It is unknown

what form any such changes or any law would take, and how or whether it may affect our business in the future.

We expect that changes

or additions to the Medicare and Medicaid programs, and changes stemming from other healthcare reform measures, especially with regard

to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry.

At the state level, legislatures may also increasingly pass legislation

and implement regulations designed to control product pricing, including price or patient reimbursement constraints, discounts, restrictions

on certain product access and marketing cost disclosure and transparency measures.

We expect that additional federal, state, and foreign healthcare reform

measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare

products and services, which could result in limited coverage and reimbursement and reduced demand for our products, or additional pricing

Environmental Matters

We are subject to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater

discharges, noise emissions, the use, transport, management and disposal of chemicals and hazardous materials and wastes, the import, export and registration of chemicals, and the cleanup of contaminated sites.

Based on information currently

available to us, we do not expect environmental or health and safety costs and contingencies to have a material adverse effect on us.

We are subject to various environmental, health and safety laws and

regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, transport, management

and disposal of chemicals and hazardous materials and wastes, the import, export and registration of chemicals, and the cleanup of contaminated

Based on information currently available to us, we do not expect environmental or health and safety costs and contingencies to

have a material adverse effect on us.

The operation of our business and facilities, however, entails risks in these areas.

Significant expenditures

could be required in the future to comply with environmental or health and safety laws, regulations, or requirements.

In Israel, where our contract manufacturer produces our ReWalk products, businesses storing or using certain hazardous materials

(including materials necessary for our manufacturing process) are required, pursuant to the Israeli Dangerous Substances Law, 5753-1993, to obtain a toxin permit from the Ministry of Environmental Protection.

In the U.S., where we manufacture our

AlterG products in our Fremont, California facility, we do not utilize chemicals which require a toxic materials license.

We have a hazardous waste disposal license with the County of Alameda and dispose of our expired and empty containers

through a process in accordance with the license.

In the European marketplace, electrical and electronic equipment and its packaging is required to comply with a number of regulatory regimes aimed

at ensuring product safety and protecting the environment, including the Directive on Waste Electrical and Electronic Equipment, which aims to prevent waste by encouraging reuse and recycling, and the Directive on Restriction of Use of Certain

Hazardous Substances, which restricts the use of ten hazardous substances in electrical and electronic products.

expenditures could be required in the future to comply with environmental or health and safety laws, regulations, or requirements.

In Israel, where

we manufacture our ReWalk products at our facility, we do not utilize chemicals that require a toxic materials license.

In the U.S., where

our contract manufacturer produces our AlterG products, we do not utilize chemicals which require a toxic materials license.

manufacturer has a hazardous waste disposal license with the EPA ID# NHD500017052 and dispose of our expired and empty containers through

a process in accordance with the license supplier “Republic Services” with EPA ID# NHD500018452.

In the European marketplace, electrical and electronic equipment and

its packaging is required to comply with a number of regulatory regimes aimed at ensuring product safety and protecting the environment,

including the Directive on Waste Electrical and Electronic Equipment, which aims to prevent waste by encouraging reuse and recycling,

and the Directive on Restriction of Use of Certain Hazardous Substances, which restricts the use of ten hazardous substances in electrical

and electronic products.

Our products and certain components of such products “placed on the market” in the E.U.

(whether or not manufactured in the E.U.) are

subject to these and other legislative regimes.

Additionally, we are required to comply with certain laws, regulations, and directives, including the Toxic Substances Control Act in the United States and the REACH Regulation in the E.U., governing

These and similar laws and regulations require the testing, reporting, labelling, and registration of certain chemicals we use and ship.

We believe we comply in all material respects with applicable environmental and product conformity

laws and regulations.

or not manufactured in the E.U.) are subject to these and other legislative regimes.

Additionally, we are required to comply with certain

laws, regulations, and directives, including the Toxic Substances Control Act in the United States and the REACH Regulation in the E.U.,

governing chemicals.

These and similar laws and regulations require the testing, reporting, labelling, and registration of certain chemicals

we use and ship.

We believe we comply in all material respects with applicable environmental and product conformity laws and regulations.

Manufacturing

Our ReWalk exoskeletons, ReStore exo-suits, and AlterG Anti-Gravity systems include off-the-shelf and custom-made components produced to our

specifications by various third parties, for technical and cost-effectiveness.

We have contracted with Sanmina Corporation (“Sanmina”) and Cirtronics Corporation (“Cirtronics”), each a well-established contract manufacturer with expertise in the

medical device industry, for the manufacture by Sanmina of our SCI Products at its facility in Ma’alot, Israel and, starting in January 2025, by Cirtronics of the AlterG product at its facility in Milford, New Hampshire.

Each product line is

manufactured pursuant to the same applicable set of specifications.

We place our manufacturing orders with Sanmina, Cirtronics and other suppliers pursuant to purchase orders or by providing forecasts for future requirements.

We may terminate our

relationship with Cirtronics through notice at least one year prior to the expiration of the initial term or renewal term of the contract.

We may terminate our relationship with Sanmina or our other suppliers at any time upon written notice.

Either we, on the one hand, or either Sanmina or Cirtronics, on the other hand, may terminate the respective relationship in the event of a material breach, subject to a 30-day cure period in the case of Sanmina or a 45-day period in the case of

Each agreement with Sanmina and Cirtronics contains a limitation on liability that applies equally to us and Sanmina and Cirtronics, respectively.

We believe that these contract manufacturing relationships with Sanmina and Cirtronics allow us to operate our business efficiently by focusing

our internal efforts on the development and commercialization of our technology and our products and provides us with substantial scale-up capacity.

We regularly test quality on-site at each of Sanmina’s and Cirtronics’ facilities and we obtain

full quality inspection reports.

We maintain a non-disclosure agreement with each of Sanmina and Cirtronics.

We develop certain of the software components internally and license other software components that are generally available for commercial use as

open-source software.

Our ReWalk exoskeletons, ReStore exo-suits, and AlterG Anti-Gravity

systems include off-the-shelf and custom-made components produced to our specifications by various third parties for technical and cost-effectiveness.

During 2025, we terminated our contract manufacturing agreement with Sanmina Corporation for the manufacture of our ReWalk exoskeletons

and ReStore exo-suits.

We transitioned the manufacturing of ReWalk exoskeletons to the Lifeward Ltd.

We contracted with Cirtronics

Corporation (“Cirtronics”), a well-established contract manufacturer with expertise in the medical device industry, for the

manufacture of the AlterG product at its facility in Milford, New Hampshire beginning January 2025.

Each product line is manufactured

pursuant to the same applicable set of specifications.

We place our manufacturing orders with Cirtronics and other suppliers pursuant

to purchase orders or by providing forecasts for future requirements.

We may terminate our relationship with Cirtronics upon at least

one year’s notice prior to the expiration of the initial term or renewal term of the contract.

We may terminate our relationship

with other suppliers at any time upon written notice.

Either we or Cirtronics may terminate the relationship in the event of a material

breach, subject to a 45-day cure period in the case of Cirtronics.

The agreement with Cirtronics contains a limitation on liability that

applies equally to us and Cirtronics.

We believe that the contract manufacturing relationships with Cirtronics

and in-house production at the Lifeward Ltd.

allow us to operate our business efficiently by focusing our internal efforts on the development

and commercialization of our technology and products and provide us with substantial scale-up capacity.

We conduct regular on-site quality testing at Cirtronics’ facility

and obtain full quality inspection reports.

We maintain a non-disclosure agreement with Cirtronics.

We develop certain of the software components internally and license

other software components that are generally available for commercial use as open-source software.

We manufacture products based upon internal sales forecasts.

We deliver products to customers and distributors based upon purchase orders

received, and our goal is to fulfill each customer’s order for products in regular production within two weeks of receipt of the order.

We have contracted with Sanmina for the sourcing of all components and raw materials necessary for the manufacture of our ReWalk products and

with Cirtronics for the sourcing of all components and raw materials for the manufacture of our AlterG products, although there are instances that we purchase raw materials ourselves.

Components of our products and raw materials come from suppliers

in the United States, Europe, China, Taiwan, and Israel, and we depend on certain of these components and raw materials, including certain electronic parts, for the manufacture of our products.

To date, we have not experienced significant

volatility in the prices of these components and raw materials.

However, during the COVID-19 pandemic several specific parts, mainly electronic parts, experienced temporary price increases which have returned to more normal levels.

Such prices are

subject to a number of factors, including purchase volumes, general economic conditions, currency exchange rates, industry cycles, production levels, and scarcity of supply.

We believe that each of Sanmina’s and Cirtronics’ facilities, our contracted manufacturing arrangements, and our supply arrangements are

sufficient to support our potential capacity needs for the foreseeable future.

We deliver products to customers

and distributors based on purchase orders received, and our goal is to fulfill each customer’s order for products in regular production

within two weeks of receipt of the order.

We have contracted with Cirtronics for the sourcing of substantially

all components and raw materials for the manufacture of our AlterG products, although there are instances that we purchase raw materials

We are sourcing all components and raw materials for the manufacture of our ReWalk exoskeleton device.

Components of our products and raw materials are sourced from suppliers

in the United States, Europe, China, Taiwan, and Israel, and we depend on certain of these components and raw materials, including certain

electronic parts, for the manufacture of our products.

To date, we have not experienced significant volatility in the prices of these

components and raw materials.

However, prices may fluctuate due to a number of factors, including purchase volumes, general economic conditions,

currency exchange rates, industry cycles, production levels, supply availability, tariffs, and trade policies.

We believe that Cirtronics’ facility, together with our manufacturing

and supply arrangements, are sufficient to support our anticipated capacity needs for the foreseeable future.

Human Capital

As of December 31, 2024, we had 80 employees (including full-time and hourly employees), of whom 5 were located in the United States, 18 were

located in Israel and 10 were located in Europe.

The majority of our employees are, and have been, engaged in sales and marketing activities.

We do not employ a significant number of temporary or part time employees.

We are subject to labor laws and regulations within our locations mainly in the U.S., Germany, and Israel.

These laws and regulations principally

concern matters such as pensions, paid annual vacation, paid sick days, length of the workday and work week, minimum wages, overtime pay, insurance for work-related accidents, severance pay and other conditions of employment.

Our employees are not

represented by a labor union.

As of December 31, 2025, we had 81 employees (including full-time and

hourly employees), of whom 46 were located in the United States, 25 were located in Israel and 10 were located in Europe.

of our employees are, and have been, engaged in sales and marketing activities.

We do not employ a significant number of temporary or

part time employees.

We are subject to labor laws and regulations within our locations mainly

in the U.S., Germany, and Israel.

These laws and regulations principally concern matters such as pensions, paid annual vacation, paid

sick days, length of the workday and work week, minimum wages, overtime pay, insurance for work-related accidents, severance pay and other

conditions of employment.

Our employees are not represented by a labor union.

We consider our relationship with our employees to be good.

1 unchanged sentence

Compensation and Benefits

We provide our employees with competitive salaries and bonuses, opportunities for equity ownership, and a robust employment package that promotes

well-being across all aspects of our employees’ lives, including health care, retirement planning, and paid time off.

We also invest in the ongoing development of our employees through our internal training programs.

We provide our employees with competitive salaries and bonuses, opportunities

for equity ownership, and a robust employment package that promotes well-being across all aspects of our employees’ lives, including

health care, retirement planning, and paid time off.

We also invest in the ongoing development of our employees through our internal training

Diversity and Inclusion

We value the diversity of our employees and take pride in our commitment to diversity and inclusion across all levels of our organizational

We encourage a diversity of views and strive to create an equal opportunity workplace, including working with managers to develop strategies for building diverse teams and promoting the advancement of employees from diverse backgrounds.

Financial Information about Geographic Areas and Significant Customer Information

The following table sets forth the geographical breakdown of our revenue for each of the years ended December 31, 2024, and 2023 (in thousands):

We value the diversity of our employees and take pride in our commitment

to diversity and inclusion across all levels of our organizational structure.

We encourage a diversity of views and strive to create an

equal opportunity workplace, including working with managers to develop strategies for building diverse teams and promoting the advancement

of employees from diverse backgrounds.

Financial Information about Geographic Areas and Significant Customer

The following table sets forth the geographical breakdown of our revenue

for each of the years ended December 31, 2025, and 2024 (in thousands):

Year Ended December 31,

3 unchanged sentences

Total revenue

Additional discussion of financial information by reportable segment and geographic area and sales in excess of 10% of total revenue to certain of

discussion of financial information by reportable segment and geographic area and sales in excess of 10% of total revenue to certain of

our customers is contained in Note 13 to our consolidated financial statements set forth in “Part II.

Financial Statements and Supplementary Data” of this annual report.

Financial Statements

and Supplementary Data” of this annual report.

Recent Developments

In March 2025, we announced an agreement for CorLife, to become the exclusive distributor for the ReWalk Personal Exoskeleton for individuals

March 2026, we received written notification from The Nasdaq Stock Market LLC confirming that we had regained compliance with the minimum

bid price requirement for continued listing on The Nasdaq Capital Market following the effectiveness of the reverse share split.

March 2026, we announced a collaboration with Shirley Ryan AbilityLab to expand evaluation and access opportunities for the ReWalk Personal

Exoskeleton for individuals with spinal cord injuries in the United States.

February 2026, we entered into a definitive agreement to acquire certain technology assets and related intellectual property from Skelable

relating to a powered upper-extremity orthotic device under development.

The consideration for the transaction consists primarily

of our equity, payable upon the achievement of specified milestones.

February 2026, we effected a 1-for-12 reverse share split of our ordinary shares, which began trading on a split-adjusted basis on February

The reverse share split was implemented to regain compliance with the minimum bid price requirement of The Nasdaq Capital Market.

January 2026, we announced that we had entered into a strategic investment and collaboration agreement with Oramed, pursuant to which

the parties intend to collaborate on the development and commercialization of certain technologies and products.

The transaction contemplates

a strategic investment by Oramed in the Company and the transfer of certain intellectual property and technology rights, including rights

related to Oramed’s POD™ oral drug delivery platform, subject to the satisfaction of closing conditions and other customary

December 2025, we entered into an international distribution agreement with Verita Neuro pursuant to which Verita Neuro will serve as

the exclusive distributor of the ReWalk Personal Exoskeleton in certain international markets, initially including Mexico, Thailand, and

the United Arab Emirates.

December 2025, we announced expanded reimbursement coverage for the ReWalk 7 Personal Exoskeleton following prior authorization approval

under a Humana Medicare Advantage plan in the United States, which may expand patient access to the device.

November 2025, we announced that Aetna had issued a positive coverage decision for the ReWalk Personal Exoskeleton for eligible individuals

with spinal cord injuries, which may expand patient access to the device in the United States.

November 2025, we secured a $3.0 million bridge loan from Oramed Ltd.

as part of a broader strategic transaction, to support ongoing operations

and strategic initiatives.

September 2025, we received CE Mark approval for the ReWalk 7 Personal Exoskeleton, enabling commercial sales in Europe, which currently

represents approximately 40% of our exoskeleton sales.

June 2025, we completed a public offering generating gross proceeds of approximately $2.6 million to support continuing commercial efforts,

working capital, and general corporate purposes.

the second quarter of 2025, we successfully transitioned to in-house manufacturing of the ReWalk Personal Exoskeleton, concluding our

agreement with Sanmina and enabling cost savings, improved quality control, and greater production flexibility.

March 2025, we announced an agreement with CorLife, to become the exclusive distributor for the ReWalk Personal Exoskeleton for individuals

with workers' compensation claims.

In March 2025, we expanded our exclusive contract with MYOLYN so that we manage referrals and sales of the MyoCycle Home product for

patients that are transitioning from clinical use to home use.

This expanded contract builds upon the existing distribution agreement, under which we manage all hospital and clinic-based sales of the MyoCycle Pro product nationwide,

as well as home use sales for individuals with Veterans Benefits Administration and workers' compensation benefits.

In January 2025, Lifeward completed a registered direct offering priced $2.75 per share for gross proceeds of $5.0 million to fund continuing commercial efforts, working capital, and general corporate purposes.

We completed actions to streamline our U.S.

operations, including closing two U.S.

facilities and reducing our headcount by a cumulative 35% since the AlterG acquisition.

The actions are expected to save us approximately $3 million in

operating expenses and improve gross margins by approximately two percentage points when the full impact is achieved.

We began selling the AlterG product line through our German sales organization, which we expect will result in revenue growth from a more focused sales effort and higher margins with little incremental investment by utilizing our

existing sales and support infrastructure in Germany.

We completed our near-term plans to refresh our Board of Directors.

Joe Turk replaced Jeff Dykan as chairman following Mr.

Dykan’s retirement from the Board.

Additionally, the Board added Mike Swinford as a new director and Bob Marshall

as a new director and chairman of our audit committee.

We formally changed our name to Lifeward Ltd.

from ReWalk Robotics Ltd.

to complete the rebranding of the Company and reflect our expanded mission to transform the lives of people with physical limitations or disabilities.

We successfully launched the latest generation of Differential Air Pressure Anti-Gravity Technology with our new NEO product line.

The NEO was engineered with a new design to allow a lower price point to make the technology more

accessible to a broader range of customers.

Since the introduction of the NEO at the end of June 2024, we have generated orders for approximately 100 units, as the NEO is quickly becoming a growth driver for the AlterG product line.

We completed our FDA submission for our 7 th generation ReWalk design, which will further enhance use of the system in all aspects of daily life and further establish us as the most

advanced personal exoskeleton company in the world.

The CMS Home Health Rule and Medicare Pricing achieved by our efforts is in effect with a growing volume of claims approvals and payments from our 2024 Medicare submissions.

March 2025, we launched ReWalk 7, the newest generation of our personal exoskeleton, in the U.S.

market following FDA clearance.

February 2025, we announced an agreement with BARMER, Germany’s second largest statutory health insurance company, to streamline

access to ReWalk Personal Exoskeletons for eligible beneficiaries, adding approximately 8.5 million covered lives in Germany.

January 2025, we completed a registered direct offering for gross proceeds of approximately $5.0 million to fund continuing commercial

efforts, working capital, and general corporate purposes.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business