9 unchanged sentences
Risk Factors.”
−Removed: We are a medical device company
−Removed: that is designing, developing, and commercializing innovative technologies that enable mobility and wellness in rehabilitation and daily
−Removed: life for individuals with neurological conditions.
−Removed: Our initial product offerings were the ReWalk Personal and ReWalk Rehabilitation
−Removed: Exoskeleton devices for individuals with spinal cord injury (“SCI Products”).
−Removed: These devices are robotic exoskeletons
−Removed: that are designed for individuals with paraplegia that use our patented tilt-sensor technology and an onboard computer and motion sensors
−Removed: to drive motorized legs that power movement.
−Removed: These SCI Products allow individuals with spinal cord injury the ability to stand and
−Removed: walk again during everyday activities at home or in the community.
−Removed: We have sought to expand our
−Removed: product offerings beyond the SCI Products through internal development and distribution agreements.
−Removed: We have developed our ReStore
−Removed: Exo-Suit device, which we began commercializing in June 2019.
−Removed: The ReStore is a powered, lightweight soft exo-suit intended for use during
−Removed: the rehabilitation of individuals with lower limb disabilities due to stroke.
−Removed: During the second quarter of 2020, we finalized and moved
−Removed: to implement two separate agreements to distribute additional product lines in the United States.
−Removed: We are the exclusive distributor of
−Removed: the MYOLYN MyoCycle FES Pro cycles to U.S.
−Removed: rehabilitation clinics and for the MyoCycle Home cycles available to US veterans through the
−Removed: Department of Veterans Affairs (“VA”) hospitals.
−Removed: In the second quarter of 2020, we also became the exclusive distributor
−Removed: of the MediTouch Tutor movement biofeedback systems in the United States;
−Removed: however, due to unsatisfactory sales performance of the MediTouch
−Removed: product lines, we terminated this agreement as of January 31, 2023.
−Removed: We refer to the MediTouch and MyoCycle devices as our “Distributed
−Removed: Products.” We will continue to evaluate other products for distribution or acquisition that can broaden our product offerings further
−Removed: to help individuals with neurological injury and disability.
−Removed: We are in the research stage
−Removed: of ReBoot, a personal soft exo-suit for home and community use by individuals post-stroke, and we are currently evaluating the reimbursement
−Removed: landscape and the potential clinical impact of this device.
−Removed: This product would be a complementary product to ReStore as it provides active
−Removed: assistance to the ankle during plantar flexion and dorsiflexion for gait and mobility improvement in the home environment, and it received
−Removed: Breakthrough Device Designation from the U.S.
−Removed: Food and Drug Administration (“FDA”) in November 2021.
−Removed: Further investment
−Removed: in the development path of the ReBoot has been temporarily paused in 2023 pending further determination about the clinical and commercial
−Removed: opportunity of this device.
−Removed: Our principal markets are
−Removed: the United States and Europe.
−Removed: In Europe, we have a direct sales operation in Germany and work with distribution partners in certain other
−Removed: major countries.
−Removed: We have offices in Marlborough, Massachusetts, Berlin, Germany and Yokneam, Israel, from where we operate our business.
−Removed: We have in the past generated
−Removed: and expect to generate in the future revenue from a combination of third-party payors (including private and government payors) and self-pay
−Removed: While a broad uniform policy of coverage and reimbursement by third-party commercial payors currently does not exist in the
−Removed: United States for exoskeleton technologies such as the ReWalk Personal Exoskeleton, we are pursuing various paths of reimbursement and
−Removed: support fundraising efforts by institutions and clinics, such as the VA policy that was issued in December 2015 for the evaluation, training,
−Removed: and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans suffering from spinal cord injury (“SCI”)
−Removed: across the United States.
−Removed: We have also been pursuing
−Removed: updates with the Centers for Medicare and Medicaid Services (“CMS”), to clarify the Medicare coverage category (i.e., benefit
−Removed: category) applicable for personal exoskeletons.
−Removed: In 2021, the National Spinal Cord Injury Statistical Center (“NSCISC”) reported
−Removed: the Medicare and Medicaid are the primary payors for approximately 56% of the spinal cord injury population which are at least five years
−Removed: post their injury date.
−Removed: In July 2020, following a successful submission and hearing process, a code was issued for ReWalk Personal Exoskeleton
−Removed: (effective October 1, 2020), which may be used for purposes of claim submission to Medicare, Medicaid, and other payors.
−Removed: currently seeking a nationwide Medicare benefit category determination from CMS to designate the relevant Medicare benefit category.
−Removed: CMS has stated that, until a nationwide benefit category determination is issued, coverage and payment can be adjudicated on a case-by-case
−Removed: basis by the Medicare Administrative contractors (“MACs”).
−Removed: In Germany, we continue to
−Removed: make progress toward achieving coverage from the various government, private and worker’s compensation payors for our SCI products.
−Removed: In September 2017, each of German insurer BARMER GEK (“BARMER”) and national social accident insurance provider Deutsche Gesetzliche
−Removed: Unfallversicherung (“DGUV”), indicated that they will provide coverage to users who meet certain inclusion and exclusion criteria.
−Removed: In February 2018, the head office of German Statutory Health Insurance (“SHI”) Spitzenverband (“GKV”) confirmed
−Removed: their decision to list the ReWalk Personal Exoskeleton system in the German Medical Device Directory.
−Removed: This decision means that ReWalk
−Removed: is listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis.
−Removed: During the year 2020 and 2021, we announced several new agreements with German SHIs, including TK and DAK Gesundheit, as well as the first
−Removed: German Private Health Insurer (“PHI”), which outline the process of obtaining our devices for eligible insured patients.
−Removed: are also currently working with several additional SHIs on securing a formal operating contract that will establish the process of obtaining
−Removed: a ReWalk Personal Exoskeleton for their beneficiaries within their system.
−Removed: Additionally, to date, several private insurers in the
−Removed: United States and Europe are providing reimbursement for ReWalk in certain cases.
+Added: We are a medical device company that designs, develops, and commercializes
+Added: life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health
+Added: benefits in clinical settings as well as in the home and community.
+Added: Our initial product offerings were the ReWalk Personal and ReWalk
+Added: Rehabilitation Exoskeleton devices for individuals with spinal cord injury (“SCI Products”).
+Added: These devices are robotic
+Added: exoskeletons that are designed for individuals with paraplegia that use our patented tilt-sensor technology and an onboard computer and
+Added: motion sensors to drive motorized legs that power movement.
+Added: These SCI Products allow individuals with spinal cord injury (“SCI”)
+Added: the ability to stand and walk again during everyday activities at home or in the community.
+Added: In March 2023, we received clearance of our
+Added: premarket notification (“510(k)”) from the U.S.
+Added: Food and Drug Administration (“FDA”) for the ReWalk Personal Exoskeleton
+Added: with stair and curb functionality, which adds usage on stairs and curbs to the indication for use for the device in the United States
+Added: The clearance permits U.S.
+Added: customers to participate in more walking activities in real-world environments in their daily lives
+Added: where stairs or curbs may have previously limited them when using the exoskeleton for its intended, FDA-indicated uses.
+Added: This feature has
+Added: been available in Europe since initial CE Clearance, and real-world data from a cohort of 47 European users throughout a period of over
+Added: seven years consisting of over 18,000 stair steps was collected to demonstrate the safety and efficacy of this feature and support the
+Added: FDA submission.
+Added: We have sought to expand our product offerings beyond the SCI Products
+Added: through internal development and distribution agreements and acquisitions.
+Added: We have developed our ReStore Exo-Suit device, which
+Added: we began commercializing in June 2019.
+Added: The ReStore is a powered, lightweight soft exo-suit intended for use during the rehabilitation
+Added: of individuals with lower limb disabilities due to stroke.
+Added: During the second quarter of 2020, we finalized and moved to implement two
+Added: separate agreements to distribute additional product lines in the United States.
+Added: We are the exclusive distributor of the MYOLYN MyoCycle
+Added: FES Pro cycles to U.S.
+Added: rehabilitation clinics and for the MyoCycle Home cycles available to US veterans through the Veterans Health Administration
+Added: (“VHA”) hospitals.
+Added: In the second quarter of 2020, we also became the exclusive distributor of the MediTouch Tutor movement
+Added: biofeedback systems in the United States;
+Added: however, due to unsatisfactory sales performance of the MediTouch product lines, we terminated
+Added: this agreement as of January 31, 2023.
+Added: We refer to the MediTouch and MyoCycle devices as our “Distributed Products.”
+Added: On August 11, 2023, we made our first acquisition to supplement our internal growth
+Added: when we acquired AlterG, Inc.
+Added: (“AlterG”), a leading provider of Anti-Gravity systems for use in physical and neurological
+Added: rehabilitation.
+Added: Our AlterG Anti-Gravity systems use patented, National Aeronautics and Space Administration (“NASA”) derived
+Added: differential air pressure (“DAP”) technology to reduce the effects of gravity and allow patients to rehabilitate with finely
+Added: calibrated support and reduced pain.
+Added: AlterG Anti-Gravity systems are utilized in over 4,000 facilities globally in more than 40 countries.
+Added: We will continue to evaluate other products for distribution or acquisition that can broaden our product offerings further to help individuals
+Added: with neurological injury and disability.
+Added: We are in the research stage of ReBoot, a personal soft exo-suit
+Added: for home and community use by individuals post-stroke, and we are currently evaluating the reimbursement landscape and the potential clinical
+Added: impact of this device.
+Added: This product would be a complementary product to ReStore as it provides active assistance to the ankle during plantar
+Added: flexion and dorsiflexion for gait and mobility improvement in the home environment, and it received Breakthrough Device Designation from
+Added: the FDA in November 2021.
+Added: Further investment in the development path of the ReBoot was paused in 2023 pending determination regarding
+Added: the clinical and commercial opportunity of this device.
+Added: Our principal markets are primarily in the United States and Europe
+Added: with some lesser sales in Asia, the Middle East and South America.
+Added: We sell our products primarily directly in the United States, through
+Added: a combination of direct sales and distributors (depending on the product line) in Germany, Canada, and Australia, and primarily through
+Added: distributors in other markets.
+Added: In markets where we sell direct to consumers, we have established relationships with clinics and rehabilitation
+Added: centers, professional and college sports teams, and individuals and organizations in the SCI community, and in markets where we do not
+Added: sell direct to consumers, our distributors maintain these relationships.
+Added: We have primary offices in Marlborough, Massachusetts, Fremont,
+Added: California, Berlin, Germany and Yokneam, Israel, from where we operate our business.
+Added: We have in the past generated and expect to generate in the future
+Added: revenue from a combination of clinics and rehabilitation centers, commercial distributors, third-party payors (including private and government
+Added: payors), professional and college sports teams, and self-pay individuals.
+Added: While a broad uniform policy of coverage and reimbursement by
+Added: third-party commercial payors currently does not exist in the United States for exoskeleton technologies such as the ReWalk Personal Exoskeleton,
+Added: we are pursuing various paths of reimbursement and support fundraising efforts by institutions and clinics, such as the VHA policy that
+Added: was issued in December 2015 for the evaluation, training, and procurement of ReWalk Personal Exoskeleton systems for all qualifying veterans
+Added: living with SCI across the United States.
+Added: We have also pursued updates with the Centers for Medicare &
+Added: Medicaid Services (“CMS”) to clarify the Medicare coverage category (i.e., benefit category) applicable for personal exoskeletons.
+Added: In 2022, the National Spinal Cord Injury Statistical Center (“NSCISC”) reported that CMS is the primary payor for approximately
+Added: 57% of the SCI population which are at least five years post their injury date, with Medicare representing a majority of this percentage.
+Added: In July 2020, following a successful submission and hearing process, a code was issued for ReWalk Personal Exoskeleton, which may be used
+Added: for purposes of claim submission to Medicare, Medicaid, and other payors.
+Added: On November 1, 2023, CMS released the Calendar Year 2024 Home Health
+Added: Prospective Payment System Final Rule, CMS-1780-F (“Final Rule”), which was adopted through the notice and comment rulemaking
+Added: The Final Rule includes a policy confirming that personal exoskeletons are included in the Medicare brace benefit category, as
+Added: of January 1, 2024.
+Added: Medicare personal exoskeleton claims with dates of service on or after January 1, 2024 that are billed using HCPCS
+Added: code K1007 are assigned to the brace benefit category.
+Added: CMS reimburses items classified under the brace benefit category using a lump sum
+Added: payment methodology.
+Added: On November 29, 2023, CMS included the “ReWalk Personal Prosthetic
+Added: Exoskeleton System” in the HCPCS public meeting where it solicited feedback on a preliminary payment determination of $94,617
+Added: for HCPCS code K1007.
+Added: The preliminary payment determination was made by CMS by applying a “gap filling” process, which was
+Added: used in light of CMS determining that the code describing the technology has no fee schedule pricing history and that lower extremity
+Added: exoskeletons incorporate “revolutionary features” that cannot be described by or considered comparable to any other existing
+Added: code or combination of codes.
+Added: As part of gap-filling, CMS utilizes verifiable supplier or commercial pricing information and adjusts this
+Added: pricing information according to a deflation and update factor methodology.
+Added: In applying this formula to the K1007 code describing the
+Added: ReWalk Personal Exoskeleton, CMS says that it relied on information about average prices from 2020 market transactions for which CMS had
+Added: CMS solicited information on updated verifiable market transactions
+Added: from ReWalk, as well as any other makers of similar bilateral, lower limb exoskeletons, to “ensure that the Medicare payment amount
+Added: for this code accurately reflects the full market of devices that would be classified in this code.” We participated in the HCPCS
+Added: meeting process on November 29, 2023 to provide additional information to help ensure that the final payment determination accurately
+Added: reflects current pricing information related to the market of lower-limb exoskeleton devices, including the current ReWalk Personal Exoskeleton.
+Added: A final Medicare payment determination is expected from CMS in first quarter of 2024 with an April 1, 2024, effective date.
+Added: In Germany, we continue to make progress toward achieving coverage
+Added: from the various government, private and worker’s compensation payors for our SCI products.
+Added: In September 2017, each of German insurer
+Added: BARMER GEK (“BARMER”) and national social accident insurance provider Deutsche Gesetzliche Unfallversicherung (“DGUV”),
+Added: indicated that they will provide coverage to users who meet certain inclusion and exclusion criteria.
+Added: In February 2018, the head office
+Added: of German Statutory Health Insurance (“SHI”) Spitzenverband (“GKV”) confirmed their decision to list the ReWalk
+Added: Personal Exoskeleton system in the German Medical Device Directory.
+Added: This decision means that ReWalk is listed among all medical devices
+Added: for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis.
+Added: During the year 2020 and 2021,
+Added: we announced several new agreements with German SHIs, including TK and DAK Gesundheit, as well as the first German Private Health Insurer
+Added: (“PHI”), which outline the process of obtaining our devices for eligible insured patients.
+Added: We are also currently working with
+Added: several additional SHIs on securing a formal operating contract that will establish the process of obtaining a ReWalk Personal Exoskeleton
+Added: for their beneficiaries within their system.
+Added: Additionally, to date, several private insurers in the United States and Europe are providing reimbursement
+Added: for ReWalk in certain cases.
Components of Our Statements of Operations
−Removed: We currently rely, and in the future will rely,
−Removed: on sales and rentals of our ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices, and sales of our ReStore exo-suit device, additional
−Removed: Distributed Products such as the MyoCycle, and related extended service contracts for the SCI Products.
−Removed: Our revenue is generated from
−Removed: a combination of third-party payors, including private and government employers, institutions, and self-payors.
−Removed: Payments for our products
−Removed: by third party payors have been made primarily through case-by-case determinations.
−Removed: Third-party payors include, without limitation, private
−Removed: insurance plans and managed care programs, government programs including the VA, and worker’s compensation payments.
−Removed: We expect that
−Removed: third-party payors will be an increasingly important source of revenue in the future as we seek to clarify the Medicare coverage category
−Removed: (i.e., benefit category) applicable for personal exoskeletons.
−Removed: In December 2015, the VA issued a national policy for the evaluation, training,
−Removed: and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans across the United States.
−Removed: The VA policy is the first
−Removed: national coverage policy in the United States for qualifying individuals who have suffered spinal cord injury.
−Removed: ReWalk Personal and ReWalk Rehabilitation systems are generally
−Removed: covered by a five-year warranty from the date of purchase, which is included in the purchase price.
−Removed: The warranty covers all elements of
−Removed: the systems, including the batteries, other than normal wear and tear.
+Added: We currently rely, and in the future will rely, on sales and rentals
+Added: of our ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices, sales and rentals of our AlterG Anti-Gravity systems and related
+Added: consumables and services, and sales of our ReStore exo-suit device, additional Distributed Products such as the MyoCycle, and related
+Added: extended service contracts for the SCI Products.
+Added: Our revenue is generated from a combination of third-party payors, including private
+Added: and government employers, institutions, and self-payors.
+Added: Payments for our products by third party payors have been made primarily through
+Added: case-by-case determinations.
+Added: Third-party payors include, without limitation, private insurance plans, workers’ compensation programs,
+Added: managed care organizations, and government programs including the VHA and Medicare.
+Added: We expect that third-party payors will be an increasingly
+Added: important source of revenue in the future as we increase the volume of sales of ReWalk Personal systems to Medicare-eligible beneficiaries
+Added: following establishment of a benefit category and anticipated pricing.
+Added: In December 2015, the VHA issued a national policy for the
+Added: evaluation, training, and procurement of ReWalk Personal Exoskeleton systems for all qualifying veterans across the United States.
+Added: VHA policy is the first national coverage policy in the United States for qualifying individuals who have suffered spinal cord injury.
+Added: ReWalk Personal and ReWalk Rehabilitation Exoskeleton systems are generally covered
+Added: by a five-year warranty from the date of purchase, which is included in the purchase price.
+Added: The warranty covers all elements of the systems,
+Added: including the batteries, other than normal wear and tear.
Our ReStore device is sold with a two-year warranty.
−Removed: for our Distributed Products warranty range between one year to ten years depending on the specific product and part.
+Added: The AlterG Anti-Gravity
+Added: systems are sold with a one-year factory warranty covering parts and services in the U.S.
+Added: and a two-year factory warranty covering parts
+Added: only in the rest of the world.
+Added: Warranties for our Distributed Products range between three years to ten years depending on the specific
+Added: product and part and are the responsibility of the manufacturers.
Cost of Revenue and Gross
−Removed: Cost of revenue consists primarily of systems purchased from our
−Removed: outsourced manufacturer, Sanmina.
−Removed: Cost of revenue also includes internal costs such as salaries and related personnel costs including
−Removed: non-cash share-based compensation, manufacturing and inventory management, training and inspection, warranty and service activities, freight
−Removed: costs, and reserves for excess and obsolete inventory, when necessary.
−Removed: The cost of revenue also includes royalties and expenses related
−Removed: to royalty-bearing research and development grants.
+Added: For ReWalk and ReStore, cost of revenue consists primarily of complete
+Added: systems purchased from our outsourced manufacturer, Sanmina.
+Added: For these products, cost of revenue also includes internal costs such
+Added: as salaries and related personnel costs including non-cash share-based compensation, functions that support manufacturing and inventory
+Added: management, training and inspection, service activities, freight costs, and reserves for warranty and inventory condition.
+Added: revenue also includes royalties and expenses related to royalty-bearing research and development grants.
+Added: For our AlterG systems, which we manufacture ourselves at our facility
+Added: in Fremont, California, cost of revenue consists primarily of raw materials, direct labor, indirect labor, and other factory overhead
+Added: costs such as rent and utilities.
+Added: In addition, cost of revenue also includes field service costs, shipping expenses and reserves
+Added: for warranty and inventory condition.
+Added: For Distributed Products such as the MyoCycle cost of revenue consists
+Added: primarily of complete systems purchased from MYOLYN.
+Added: In addition, the cost of revenue also includes field service costs and shipping expenses.
Our gross profit and gross margin (defined as gross profit as a
−Removed: percentage of revenue) are influenced by a number of factors, including primarily the volume and price of our products sold, fluctuations
−Removed: in the mix of products sold, and variability in our cost of revenue.
−Removed: We expect gross profit and gross margin will expand in the future
−Removed: as we increase our revenue volumes and realize operating efficiencies associated with greater scale which will reduce the cost of revenue
−Removed: as a percentage of revenue.
+Added: percentage of revenue) are influenced by a number of factors, including the volume and price of our products sold, fluctuations in the
+Added: mix of products sold, and variability in our cost of revenue.
+Added: We expect gross profit and gross margin will expand in the future as we
+Added: increase our revenue volumes and realize operating efficiencies associated with greater scale which will reduce the cost of revenue as
+Added: a percentage of revenue.
Operating Expenses
7 unchanged sentences
We previously received grants and other
−Removed: funding from the Israel Innovation Authority, (formerly known as the Office of the Chief Scientist) (“IIA”).
−Removed: Certain of those
−Removed: grants require us to pay royalties on sales of certain systems, which are recorded as cost of revenue.
−Removed: We may receive additional funding
−Removed: from these entities or others in the future.
+Added: funding from the IIA.
+Added: Certain of those grants require us to pay royalties on sales of certain systems, which are recorded as cost of revenue.
+Added: We may receive additional funding from these entities or others in the future.
See “Grants and Other Funding” below.
9 unchanged sentences
Financial income and expenses consist of bank commissions, foreign
−Removed: exchange gains and losses, interest earned on investments in short term deposits, interest expenses related to the Loan Agreement (as
−Removed: defined below) with Kreos (as defined below).
+Added: exchange gains and losses, interest earned on investments in short term deposits and royalty income.
Interest income consists of interest earned on our cash and cash
2 unchanged sentences
currency exchange changes reflect gains or losses related to transactions denominated in currencies other than the U.S.
−Removed: On December 30, 2015, we entered into a Loan Agreement (the
−Removed: “Loan Agreement”) with Kreos Capital V (Expert Fund) Limited (“Kreos”) pursuant to which Kreos extended a line
−Removed: of credit to us in the amount of $20.0 million.
−Removed: In connection with the Loan Agreement, we issued to Kreos a warrant to purchase up to
−Removed: 4,771 of our ordinary shares at an exercise price of $241.00 as we drew down $12.0 million under the Loan Agreement, which amount was
−Removed: increased to 6,679 ordinary shares upon an additional drawdown of $8.0 million.
−Removed: On June 9, 2017, $3.0 million of the outstanding principal
−Removed: amount was extended by an additional three years with the same interest rate and became subject to repayment in accordance with, and subject
−Removed: to the terms of a secured convertible promissory note (the “Kreos Convertible Note”).
−Removed: On November 20, 2018, we agreed to repay
−Removed: $3.6 million to Kreos in satisfaction of all outstanding indebtedness under the Kreos Convertible Note and other related payments, including
−Removed: prepayment costs and end of loan payments and Kreos agreed to terminate the Kreos Convertible Note.
−Removed: We repaid Kreos the $3.6 million by
−Removed: issuing to Kreos 192,000 units (each unit consisting of one ordinary share and one warrant to purchase one ordinary share) and 288,000
−Removed: pre-funded units (each pre-funded unit consisting of one pre-funded warrant to purchase one ordinary share and one warrant to purchase
−Removed: one ordinary share) at the a public offering price of $0.30 and $0.29, respectively, for an aggregate price of $3.6 million (including
−Removed: the aggregate exercise price for the ordinary shares to be received upon exercise of the pre-funded warrants, assuming Kreos exercises
−Removed: all of the pre-funded warrants it purchased as part of our public offering.
−Removed: We and Kreos also agreed to revise the principal and the repayment
−Removed: schedule under the Kreos Loan Agreement.
−Removed: Additionally, we entered into the Kreos Warrant Amendment with Kreos, which amended the exercise
−Removed: price of the warrant to purchase 6,679 ordinary shares currently held by Kreos from $241.00 to $7.50.
−Removed: On December 29, 2020, we repaid
−Removed: in full the remaining loan principal amount to Kreos including the end of loan payments, and by that discharged all of our obligations
−Removed: For further discussion of the Loan Agreement with Kreos, see “-Liquidity
−Removed: and Capital Resources” below and also Note 6 to our audited consolidated financial statements below.
Taxes on Income
−Removed: As of December 31, 2022, we had not yet generated
−Removed: taxable income in Israel.
−Removed: As of that date, our net operating loss carry forwards for Israeli tax purposes amounted to approximately $220.9
−Removed: After we utilize our net operating loss carryforwards, we are eligible for certain tax benefits in Israel under the Law for the
−Removed: Encouragement of Capital Investments, 1959.
−Removed: Our benefit period currently ends ten years after the year in which we first have taxable
−Removed: income in Israel provided that the benefit period will not extend beyond 2024.
+Added: As of December 31, 2023, we had not yet generated taxable
+Added: income in Israel.
+Added: As of that date, our net operating loss carryforwards for Israeli tax purposes amounted to approximately $242.6 million.
+Added: After we utilize our net operating loss carryforwards, we are eligible for certain tax benefits in Israel under the Law for the Encouragement
+Added: of Capital Investments, 1959.
+Added: Our benefit period currently ends ten years after the year in which we first have taxable income in Israel
+Added: provided that the benefit period will not extend beyond 2024.
+Added: AlterG had federal net operating loss carry forwards totalling $31.4 million
+Added: and state net operating loss carry forwards of $47.2 million, set to expire in 2025 and 2028, respectively.
Our taxable income generated outside of Israel will be subject
28 unchanged sentences
Years Ended December 31,
−Removed: Personal unit revenue
−Removed: Rehabilitation unit revenue
−Removed: Personal unit revenue consists of ReWalk Personal
−Removed: Exoskeleton and Distributed Products sale, rental, service, and warranty revenue for individual use.
−Removed: Rehabilitation unit revenue consist of ReStore, Distributed Products
−Removed: and SCI Products sale, rental, service, and warranty revenue to clinics and hospitals for treating patients with relevant medical conditions
−Removed: or for usage by medical academic centers.
−Removed: Revenue was $5.5 million, a decrease of $0.5 million, or 8%, during
−Removed: 2022 as compared to 2021.
−Removed: The decrease was driven primarily by lower rehabilitation units sold in the United States due to a one time
−Removed: multiple-unit shipment to a medical academic center in 2021, partially offset by a higher number of distributed products units sold in
−Removed: Additionally, we experienced an adverse impact to revenue from currency due to an erosion of the euro-dollar exchange rate.
+Added: Revenues consist of SCI Products, AlterG Anti-Gravity systems,
+Added: ReStore and Distributed Products.
+Added: Revenue was $13.9 million, an increase of $8.3 million, or 51%,
+Added: during 2023 as compared to 2022.
+Added: Of this increase, $7.7 million was attributable to the AlterG business, which was acquired on August
+Added: The remaining increase of $0.7 million was a result of a higher revenues from ReWalk Personal Exoskeletons and MyoCycles.
In the future, we expect our growth to be driven by sales of our
−Removed: ReWalk Personal device through expansion of coverage and reimbursement by commercial and government third-party payors, as well as sales
−Removed: of Distributed Products and the ReStore device to rehabilitation clinics and personal users.
+Added: ReWalk Personal device through expansion of coverage and reimbursement by commercial and government third-party payors, and our AlterG
+Added: Anti-Gravity systems, as well as sales of Distributed Products, and the ReStore device to rehabilitation clinics and personal users.
Our gross profit for 2023 and 2022 were as follows (in thousands):
Years Ended December 31,
−Removed: Gross profit was $1.9 million, or 35% of revenue,
−Removed: for 2022, as compared to a gross profit of $2.9 million, or 49% of revenue for 2021.
−Removed: Our gross profit declined because of a higher inventory
−Removed: reserve of ReStore finished goods and raw materials due to the obsolescence of electronic components.
−Removed: Gross profit decrease is also attributable
−Removed: to a decreased volume of ReWalk Personal Exoskeleton sales, increase of production costs and freight expense.
+Added: Gross profit was $4.5 million, or 32% of revenue, for 2023, as compared to a gross profit
+Added: of $1.9 million, or 35% of revenue for 2022.
+Added: The AlterG business contributed $2.1 million of gross profit for 2023.
+Added: Gross profit for 2023
+Added: also included the impact of $1.5 million for the amortization of intangible assets and purchase accounting inventory adjustments from
+Added: the acquisition of AlterG.
+Added: Excluding the impact of these factors resulting from the acquisition of AlterG, gross profit was $2.4
+Added: million, or 38% of revenue for 2023, as compared to $1.9 million, or 35% of revenue for 2022.
+Added: This increase was a result of a higher average
+Added: selling price in 2023 due to new features in our ReWalk Personal Exoskeleton and MyoCycles.
We expect gross profit and gross margin will increase in the future
1 unchanged sentence
as a percentage of revenue.
−Removed: Improvements may be partially offset by the lower margins we currently expect from ReStore and our Distributed
−Removed: Products as well as due to an increase in material costs.
+Added: Improvements may be partially offset by the lower margins we currently expect from ReStore as well as due
+Added: to an increase in material costs.
Research and Development
−Removed: Our research and development expense, net for 2022 and 2021 was
−Removed: as follows (in thousands):
+Added: Our research and development expense, net for 2023 and 2022 was as follows (in thousands):
Years Ended December 31,
2 unchanged sentences
of $0.1 million, or 3%, during 2023 as compared to 2022.
−Removed: The increase is attributable to increased personnel and personnel related expenses
−Removed: and subcontractors’ expenses primarily due to development projects offset partially with grant received from the IIA.
−Removed: We intend to focus our research and development expenses mainly
−Removed: on our current products maintenance and improvement as well as in support of the FDA submission for clearance of the stair walking capability
−Removed: of the ReWalk 6.0 and in support of the FDA submission for clearance of the ReWalk 7.0 next generation model.
−Removed: Sales and Marketing Expenses
−Removed: Our sales and marketing expense for 2022 and 2021 was as follows
−Removed: (in thousands):
+Added: The AlterG business contributed $0.8 million of research and development spending
+Added: Excluding the impact of the acquisition of AlterG, research and development declined by $0.7 million, or 17% for the year
+Added: ended December 31, 2023.
+Added: The decrease is attributable to the conclusion of the stairs capability project and the gradual reduction of
+Added: spend on the ReWalk 7 development project as it approached conclusion.
+Added: We intend to focus the rest of our research and development expenses
+Added: mainly on our current product support, as well as to advance the FDA submission for clearance of the ReWalk 7 next-generation exoskeleton
+Added: We have ongoing product development activity with our AlterG Anti-Gravity systems, including a program to develop a new entry level
+Added: model of AlterG Anti-Gravity system aimed to improve the affordability to price-conscious customers.
+Added: Sales and Marketing Expense
+Added: Our sales and marketing expense for 2023 and 2022 was as follows (in thousands):
Years Ended December 31,
Sales and marketing expense
−Removed: Sales and marketing expense was $9.8 million in
−Removed: 2022, an increase of $2.8 million, or 41%, during 2022 as compared to 2021.
−Removed: The increase was driven by higher consulting expenses related
−Removed: to CMS reimbursement progress, an increase in tradeshow and travel expenses since Covid-19 restrictions are being lifted and personnel
−Removed: and personnel-related expenses.
+Added: Sales and marketing expense was $13.9 million in 2023, an increase
+Added: of $4.1 million, or 41%, during 2023 as compared to 2022.
+Added: The AlterG business contributed $2.0 million of sales and marketing expenses
+Added: Sales and marketing expenses for 2023 also included $0.6 million of amortization of intangible assets from the acquisition of
+Added: Excluding the impact of these factors resulting from the acquisition of AlterG, sales and marketing expenses increased $1.5 million,
+Added: or 15%, for 2023.
+Added: The remaining increase was primarily driven by higher consulting expenses related to the CMS reimbursement process
+Added: and market access initiatives.
In the near term our sales and marketing expense are expected to
−Removed: be driven by our efforts expand the reimbursement coverage of our ReWalk Personal device and to support our current commercial product
+Added: be driven by our efforts to expand the reimbursement coverage of our ReWalk Personal Exoskeleton device, to integrate and unify the combined
+Added: sales and marketing resources of the ReWalk and AlterG organizations, and to support our current commercial product activities.
General and Administrative
−Removed: Our general and administrative expense for 2022 and 2021 was as
−Removed: follows (in thousands):
+Added: Our general and administrative expense for 2023 and 2022 was as follows (in thousands):
Years Ended December 31,
2 unchanged sentences
of $2.9 million, or 40%, during 2023 as compared to 2022.
−Removed: The increase was mainly driven by increased professional services expenses related
−Removed: to the 2022 proxy process, partially offset by a decrease in insurance costs.
−Removed: Financial Expenses (income),
−Removed: Our financial expense, net for 2022 and 2021 was as follows (in
+Added: The AlterG business contributed $1.1 million of general and administrative expenses
+Added: General and administrative expenses also included $2.5 million of M&A-related expenses, and $0.1 million of amortization
+Added: of intangible assets from the acquisition of AlterG offset partially by $0.3 remeasurement of earn out liability.
+Added: Excluding the impact
+Added: of these factors resulting from the acquisition of AlterG, general and administrative expenses decreased $0.6 million, or 7%, for 2023.
+Added: The decrease was mainly driven by lower professional services expenses.
+Added: Financial income, net
+Added: Our financial income, net for 2023 and 2022 was as follows (in thousands):
Years Ended December 31,
−Removed: Financial expense (income), net
−Removed: Financial expense (income), net, decreased by $13 thousand during
−Removed: 2022 as compared to 2021.
−Removed: The decrease is mainly due to exchange rate fluctuations.
+Added: Financial income, net
+Added: Financial income, net, reflects an increase in financial income
+Added: of $1.5 million during 2023 as compared to 2022.
+Added: The increase in financial income was primarily due to a change in cash management
+Added: practices to move cash balances to accounts that pay a higher interest rate and yield greater interest income, as well as exchange rate
+Added: fluctuations.
*) Represents an amount lower than $1.
1 unchanged sentence
Years Ended December 31,
−Removed: Taxes on income
−Removed: Income tax increased by $373 thousand during 2022 as compared to
−Removed: 2021 due to the application of a valuation allowance to our deferred tax assets.
+Added: Taxes on income (benefit)
+Added: Income tax decreased by $0.5 million during 2023 as compared to 2022, mainly due to
+Added: the utilization of net operation losses forward arising from the acquisition of AlterG.
Year Ended December 31, 2022 Compared to Year Ended December 31,
A discussion of changes in our results of operations in 2022 compared
−Removed: to 2021 has been omitted from this annual report on Form 10-K but may be found in “Item 7.
+Added: to 2021 has been omitted from this annual report on Form 10-K but may be found in “Part I.
Management's Discussion and Analysis
of Financial Condition and Results of Operations” of our Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC
−Removed: on February 24, 2022, which is available free of charge on the SEC's website at www.sec.gov and at www.rewalk.com, and is incorporated
+Added: on February 23, 2023, which is available free of charge on the SEC's website at www.sec.gov and at golifeward.com, and is incorporated
by reference herein.
10 unchanged sentences
are considered critical, we make many other accounting estimates in preparing our financial statements and related disclosures.
−Removed: to our audited consolidated financial statements presented elsewhere in this annual report for a description of the significant accounting
−Removed: policies that we used to prepare our consolidated financial statements.
−Removed: The critical accounting policies that were impacted by the estimates,
−Removed: judgments and assumptions used in the preparation of our consolidated financial statements are discussed below.
+Added: to our consolidated financial statements presented elsewhere in this annual report for a description of the significant accounting policies
+Added: that we used to prepare our consolidated financial statements.
+Added: The critical accounting policies that were impacted by the estimates, judgments
+Added: and assumptions used in the preparation of our consolidated financial statements are discussed below.
Revenue Recognition
−Removed: Our revenue is recognized in accordance with ASC
−Removed: Topic 606 when obligations under the terms of a contract with our customer are satisfied;
−Removed: generally, this occurs with the transfer of
−Removed: control of our products or services.
−Removed: Revenue is measured as the amount of consideration to which we expect to be entitled in exchange
−Removed: for transferring products or providing services.
−Removed: To achieve this core principle, the Company applies the following five steps:
+Added: Our revenue is recognized in accordance with ASC Topic 606 when
+Added: obligations under the terms of a contract with our customer are satisfied;
+Added: generally, this occurs with the transfer of control of our
+Added: products or services.
+Added: Revenue is measured as the amount of consideration to which we expect to be entitled in exchange for transferring
+Added: products or providing services.
+Added: To achieve this core principle, we apply the following five steps:
identify the contract with a customer;
2 unchanged sentences
allocate the transaction price to performance obligations in
−Removed: Recognize revenue when or as the Company satisfies a performance
+Added: the contract;
+Added: recognize revenue when or as we satisfy a performance obligation.
Provisions are made at the time of revenue recognition for any
9 unchanged sentences
Accordingly, we consider all the distributors as end-users.
−Removed: generally does not grant a right of return for its products.
−Removed: In rare circumstances the Company provides a right of return of its products.
−Removed: In those cases, the Company records reductions to revenue for expected future product returns based on the Company’s historical
−Removed: experience and estimates.
−Removed: For the majority of sales of Rehabilitation systems,
−Removed: we include insignificant training and consider the elements in the arrangement to be a single performance obligation.
−Removed: In accordance
−Removed: with ASC 606, we have concluded that the training is essential to the functionality of our systems.
−Removed: Therefore, we recognize revenue for
−Removed: the system and training only after delivery, in accordance with the agreement delivery terms, to the customer and after the training has
−Removed: been completed, once all other revenue recognition criteria have been met.
−Removed: For sales of Personal systems to end users, and for sales of
−Removed: Personal or Rehabilitation systems to third party distributors, we do not provide training to the end user as this training is completed
−Removed: by the rehabilitation centers or by the distributor that have previously completed the ReWalk Training program.
+Added: do not grant a right of return for our products except in rare circumstances, and in those cases we record reductions to revenue for expected
+Added: future product returns based on our historical experience and estimates.
+Added: For the majority of sales of ReWalk Rehabilitation Exoskeleton systems, we include insignificant training
+Added: and consider the elements in the arrangement to be a single performance obligation.
+Added: Therefore, the Company recognizes revenue for the
+Added: system only when control is transferred after delivery and when the training has been completed, in accordance with the agreement terms
+Added: with the customer, once all other revenue recognition criteria have been met.
+Added: For sales of ReWalk Personal Exoskeleton systems to end
+Added: users, and for sales of ReWalk Personal Exoskeleton or ReWalk Rehabilitation Exoskeleton systems to third party distributors, we do not
+Added: provide training to the end user as this training is completed by the rehabilitation centers or by the distributor that have previously
+Added: completed the ReWalk Training program.
Warranties are classified as either assurance type or service type
2 unchanged sentences
SCI Products include a five-year warranty.
−Removed: first two years are considered as an assurance type warranty and the additional period is considered an extended service arrangement,
−Removed: which is a service type warranty.
−Removed: A service type warranty is either sold with a unit or separately for a unit for which the warranty has
−Removed: A service type warranty is accounted as a separate performance obligation and revenue is recognized ratably over the life of
−Removed: the warranty.
−Removed: The ReStore device is sold with a two-year warranty
−Removed: which is considered as assurance type warranty.
−Removed: The Distributed Products are sold with assurance type warranty ranging
−Removed: from between one year to ten years, depending on the specific product and part.
−Removed: The Company also offers a rent-to-purchase option for its ReWalk
−Removed: Personal device.
−Removed: Those transactions provide potential customers the option to use the device for a short term, after which they can choose
−Removed: whether to purchase it.
−Removed: In such cases we recognize revenue ratably according to the agreed rental monthly fee.
−Removed: For units placed, we transfer
−Removed: control and recognize a sale when title has passed to our customer and rental revenue ratably according to the agreed rental monthly fee.
−Removed: Each unit placed is considered an independent, unbundled performance obligation.
−Removed: Share-Based Compensation
−Removed: – Option and Restricted Stock Units (“RSUs”) Valuations
−Removed: We account for share-based compensation in accordance with ASC
−Removed: 718, “Compensation-Stock Compensation.” ASC No.
−Removed: 718 requires companies to estimate the fair value of equity-based
−Removed: payment awards on the date of grant using an Option-Pricing Model, or OPM.
−Removed: The value of the portion of the award that is ultimately expected
−Removed: to vest is recognized as an expense over the requisite service periods in our consolidated statements of operations.
−Removed: We selected the Black-Scholes-Merton option pricing model as the
−Removed: most appropriate method for determining the estimated fair value of options.
−Removed: The resulting cost of an equity incentive award is recognized
−Removed: as an expense over the requisite service period of the award, which is usually the vesting period.
−Removed: We recognize compensation expense over
−Removed: the vesting period using the straight-line method and classify these amounts in the consolidated financial statements based on the department
−Removed: to which the related employee reports.
−Removed: The determination of the grant date fair value of options using
−Removed: the Black-Scholes-Merton option pricing model is affected by estimates and assumptions regarding a number of complex and subjective variables.
−Removed: These variables include the expected volatility of our share price over the expected term of the options, share option exercise and cancellation
−Removed: behaviors, risk-free interest rates and expected dividends, which are estimated as follows:
−Removed: Risk-free Interest Rate.
−Removed: The risk-free interest rate is based on the yield from U.S.
−Removed: Treasury zero-coupon bonds with a term equivalent to the contractual life
−Removed: of the options.
−Removed: Dividend Yield.
−Removed: never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future.
−Removed: Consequently, we
−Removed: used an expected dividend yield of zero.
−Removed: Expected Volatility.
−Removed: Expected volatility is calculated based on actual historical stock price movements over the most recent periods ending on the grant
−Removed: date, equal to the expected term of the options, or based on certain peer companies that the Company considered to be comparable, in case
−Removed: there is no sufficient trading volume to rely on market volatility.
−Removed: Expected Term .
−Removed: term of options granted represents the period of time that options granted are expected to be outstanding and is determined based on the
−Removed: simplified method in accordance with ASC No.
−Removed: 718-10-S99-1 (SAB No.
−Removed: 110), as adequate historical experience is not available
−Removed: to provide a reasonable estimate.
−Removed: 718 requires forfeitures to be estimated at the time of grant and revised, if necessary,
−Removed: in subsequent periods if actual forfeitures differ from those estimates.
−Removed: The fair value of RSUs granted is determined based on the price
−Removed: of the Company’s ordinary shares on the date of grant.
+Added: The first two years
+Added: are considered as an assurance type warranty and the additional period is considered an extended service arrangement, which is a service
+Added: type warranty.
+Added: A service type warranty is either sold with a unit or separately for a unit for which the warranty has expired.
+Added: type warranty is accounted as a separate performance obligation and revenue is recognized ratably over the life of the warranty.
+Added: The ReStore device is sold with a two-year warranty which is considered as assurance
+Added: type warranty.
+Added: The Distributed Products are sold with an assurance type warranty
+Added: ranging from between three years to ten years, depending on the specific part.
+Added: The AlterG Anti-Gravity systems are sold with a one-year assurance type warranty for
+Added: parts and labor in the US and with a two-year assurance type warranty for parts for distributors.
+Added: We also sell extended warranties
+Added: for AlterG Anti-Gravity systems for the periods after the expiration of the original warranty.
+Added: These are accounted for as separate
+Added: performance obligations from the AlterG Anti-Gravity system.
+Added: We rent our AlterG Anti-Gravity systems to customers for a fixed monthly fee over
+Added: the rental term, which typically ranges from 2 to 3 years.
+Added: Rental revenues accounted for under ASC Topic 842 and are recorded as earned
+Added: on a monthly basis.
+Added: We also offer for the SCI Products a rent-to-purchase model in which we recognize revenue ratably according to the
+Added: agreed rental monthly fee for a limited period prior to selling its products.
+Added: For units placed, we transfer control and recognize a sale
+Added: when title has passed to our customer and rental revenue ratably according to the agreed rental monthly fee.
+Added: Each unit placed is considered
+Added: an independent, unbundled performance obligation.
As part of the process of preparing our consolidated financial
23 unchanged sentences
A discussion of recent accounting pronouncements is included in
−Removed: Note 2w, New Accounting Pronouncements to our consolidated financial statements in this annual report.
+Added: Note 2w, New Accounting Pronouncements, to our consolidated financial statements included elsewhere in this annual report.
Liquidity and Capital Resources
3 unchanged sentences
offerings, cash exercises of outstanding warrants and the incurrence of bank debt.
−Removed: For the full year ended December 31, 2022, the Company incurred
−Removed: a consolidated net loss of $19.6 million and has an accumulated deficit in the total amount of $213.8 million.
−Removed: Our cash and cash equivalent
−Removed: on December 31, 2022, totaled $67.9 million.
−Removed: The Company’s negative operating cash flow for the full year ended December 31, 2022,
−Removed: was $17.9 million.
−Removed: The Company has sufficient funds to support its operation for more than 12 months following the approval of our consolidated
−Removed: financial statements for the fiscal year ended December 31, 2022.
+Added: For the full year ended December 31, 2023, we incurred a consolidated
+Added: net loss of $22.1 million and had an accumulated deficit in the total amount of $235.9 million.
+Added: Our cash and cash equivalents on December
+Added: 31, 2023, totalled $28.1 million.
+Added: Our negative operating cash flow for the full year ended December 31, 2023, was $20.7 million.
+Added: sufficient funds to support our operation for more than 12 months following the approval of our consolidated financial statements for
+Added: the fiscal year ended December 31, 2023.
We expect to incur future net losses and our transition to profitability
−Removed: is dependent upon, among other things, the successful development and commercialization of our products and product candidates, the achievement
−Removed: of a level of revenue adequate to support our cost structure.
−Removed: Until we achieve profitability or generate positive cash flows,
−Removed: we will continue to need to raise additional cash.
−Removed: We intend to fund future operations through cash on hand, additional private and/or
−Removed: public offerings of debt or equity securities, cash exercises of outstanding warrants or a combination of the foregoing.
−Removed: we may seek additional capital through arrangements with strategic partners or from other sources and we will continue to address our
−Removed: cost structure.
−Removed: Notwithstanding, there can be no assurance that we will be able to raise additional funds or achieve or sustain profitability
−Removed: or positive cash flows from operations.
+Added: is dependent upon, among other things, the successful development and commercialization of our products and product candidates, the establishment
+Added: of contracts for the distribution of new product lines, or the acquisition of additional product lines, any of which, or in combination,
+Added: would contribute to the achievement of a level of revenue adequate to support our cost structure.
+Added: Until we achieve profitability
+Added: or generate positive cash flows, we will continue to need to raise additional cash from time to time.
+Added: We intend to fund future operations through cash on hand, additional
+Added: private and/or public offerings of debt or equity securities, cash exercises of outstanding warrants or a combination of the foregoing.
+Added: In addition, we may seek additional capital through arrangements with strategic partners or from other sources and we will continue to
+Added: address our cost structure.
+Added: Notwithstanding, there can be no assurance that we will be able to raise additional funds or achieve or sustain
+Added: profitability or positive cash flows from operations.
Our anticipated primary uses of cash are funding (i) sales, marketing,
−Removed: and promotion activities related to market development for our ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices and
−Removed: other product lines added through distribution agreements;
−Removed: (ii) payor education activities to establish or broaden coverage by third-party
−Removed: payors and CMS for our ReWalk Personal Exoskeleton device;
−Removed: (iii) development of our lightweight exo-suit technology for potential home
−Removed: personal health utilization for multiple indications and future generation designs for our exoskeleton device;
−Removed: (iv) routine product updates;
−Removed: (v) general corporate purposes, including working capital needs;
−Removed: (vi) share repurchase programs;
−Removed: and (vii) potential acquisitions of businesses.
−Removed: Our future cash requirements will depend on many factors, including our rate of revenue growth, the expansion of our sales and marketing
−Removed: activities, the timing and extent of our spending on research and development efforts and international expansion.
−Removed: If our current estimates
−Removed: of revenue, expenses or capital or liquidity requirements change or are inaccurate, we may seek to sell additional equity or debt securities,
−Removed: arrange for additional bank debt financing, or refinance our indebtedness.
−Removed: There can be no assurance that we will be able to raise such
−Removed: funds on acceptable terms.
−Removed: Loan Agreement with Kreos and Related Warrant to Purchase Ordinary
−Removed: Loan Agreement
−Removed: On December 30, 2015, we entered into the Loan Agreement with Kreos
−Removed: pursuant to which Kreos extended a line of credit to us in the amount of $20.0 million, which was subsequently amended on June 9, 2017
−Removed: whereby $3.0 million of the outstanding principal under the Loan Agreement became subject to repayment pursuant to the senior secured
−Removed: Kreos Convertible Note issued on that date.
−Removed: On November 20, 2018 we and Kreos entered into the Second Amendment to the Loan Agreement,
−Removed: in which we repaid Kreos the $3.6 million other related payments, including prepayment costs and end of loan payments, terminating the
−Removed: Kreos Note, by issuing to Kreos 192,000 units and 288,000 pre-funded units as part of an underwritten public offering at the public offering
−Removed: prices, and the parties agreed to revise the principal and the repayment schedule under the Kreos Loan.
−Removed: On December 29, 2020, we repaid
−Removed: in full the remaining loan principal amount to Kreos including end of loan payments and by that discharged all of its obligation to Kreos
−Removed: Accordingly, as of December 31, 2020 the outstanding principal amount under the Kreos Loan Agreement was zero.
−Removed: Purchase Ordinary Shares
−Removed: Pursuant to the terms of the Loan Agreement, on January 4, 2016,
−Removed: we issued to Kreos a warrant to purchase up to 4,771 of our ordinary shares at an exercise price of $241.0 per share, increased to 6,679
−Removed: ordinary shares on December 28, 2016.
−Removed: Subject to the terms of the warrant, the warrant is exercisable, in whole or in part, at any time
−Removed: prior to the earlier of (i) December 30, 2025, or (ii) immediately prior to the consummation of a merger, consolidation, or reorganization
−Removed: of us with or into, or the sale or license of all or substantially all our assets or shares to, any other entity or person, other than
−Removed: a wholly-owned subsidiary of us, excluding any transaction in which our shareholders prior to the transaction will hold more than 50%
−Removed: of the voting and economic rights of the surviving entity after the transaction.
−Removed: On June 5, 2019 and June 6, 2019, we entered into warrant
−Removed: exercise agreements with certain institutional investors of warrants to purchase our ordinary shares, pursuant to which, Kreos agreed
−Removed: to exercise in cash their November 2018 warrants at the then-effective exercise price of $7.50 per share.
−Removed: Under the exercise agreements,
−Removed: we also agreed to issue to Kreos new warrants to purchase up to 480,000 ordinary shares at an exercise price of $7.50 per share with an
−Removed: exercise period of five years.
−Removed: Additionally, Kreos and we entered into the Kreos Warrant Amendment, which amended the exercise price of
−Removed: the warrant to purchase 6,679 ordinary shares currently held by Kreos from $241 to $7.5.
−Removed: Paycheck Protection Program Loan Agreement
−Removed: On April 21, 2020, ReWalk Robotics Inc (“RRI”) entered
−Removed: into a Note agreement evidencing an unsecured loan in the amount of $392 thousand under the PPP as part of the CARES Act enacted
−Removed: on March 27, 2020.
−Removed: The Note provides for an interest rate of 1.00% per year and matures two years after the date of initial
−Removed: disbursement.
−Removed: Beginning on the seventh month following the date of initial disbursement, RRI is required to make 18 monthly
−Removed: payments of principal and interest.
−Removed: The Note may be used for payroll costs, costs related to certain group health care benefits and insurance
−Removed: premiums, rent payments, utility payments, mortgage interest payments and interest payments on any other debt obligation that were incurred
−Removed: before February 15, 2020.
−Removed: Under the terms of the CARES Act, PPP loan recipients can apply for and be granted forgiveness for all or a
−Removed: portion of loan granted under the PPP, with such forgiveness to be determined, subject to limitations, based on the use of the loan proceeds
−Removed: for payment of payroll costs and any payments of mortgage interest, rent, and utilities.
−Removed: The terms of any forgiveness may also be subject
−Removed: to further requirements in any regulations and guidelines the Small Business Administration may adopt.
−Removed: On September 29, 2020, the Company submitted an application for
−Removed: loan forgiveness and on November 6, 2020 the Company received confirmation of its PPP Note forgiveness.
−Removed: For more information see Note
−Removed: 10 to our consolidated financial statements set forth in “Part II.
−Removed: Financial Statements and Supplementary Data” of
−Removed: this annual report.
+Added: and promotion activities related to market development for our ReWalk Personal Exoskeleton device and AlterG Anti-Gravity system,
+Added: broadening third-party payor and CMS coverage for our ReWalk Personal Exoskeleton device and commercializing our new product lines added
+Added: through distribution agreements;
+Added: (ii) development of future generation designs for our ReWalk device, new AlterG products utilizing DAP
+Added: technology, and our lightweight exo-suit technology for potential home personal health utilization for multiple indications;
+Added: (iii) routine
+Added: product updates;
+Added: (iv) potential acquisitions of businesses, such as our recent acquisition of AlterG, and (v) general corporate purposes,
+Added: including working capital needs.
+Added: Our future cash requirements will depend on many factors, including our rate of revenue growth,
+Added: the expansion of our sales and marketing activities, the timing and extent of our spending on research and development efforts, the attractiveness
+Added: of potential acquisition candidates and international expansion.
+Added: If our current estimates of revenue, expenses or capital or liquidity
+Added: requirements change or are inaccurate, we may seek to sell additional equity or debt securities, arrange for additional bank debt financing,
+Added: or refinance our indebtedness.
+Added: There can be no assurance that we will be able to raise such funds on acceptable terms.
Equity Raises
6 unchanged sentences
At the time of filing
−Removed: our annual report for the year ended December 31, 2022, on February 23, 2023, we were subject to these limitations, because our public
−Removed: float did not reach at least $75 million in the 60 days preceding the filing of this annual report.
−Removed: We will continue to be subject to
−Removed: these limitations for the remainder of the 2023 fiscal year and until the earlier of such time as our public float reaches at least $75
−Removed: million or when we file our next annual report for the year ended December 31, 2023, at which time we will be required to re-test our
−Removed: status under these rules.
−Removed: If our public float is below $75 million as of the filing of our next annual report on Form 10-K, or at the
−Removed: time we file a new Form S-3, we will continue to be subject to these limitations, until the date that our public float again reaches $75
−Removed: These limitations do not apply to secondary offerings for the resale of our ordinary shares or other securities by selling shareholders
−Removed: or to the issuance of ordinary shares upon conversion by holders of convertible securities, such as warrants.
−Removed: We have registered up to
−Removed: $100 million of ordinary shares warrants and/or debt securities and certain other outstanding securities with registration rights on our
−Removed: registration statement on Form S-3, which was declared effective by the SEC in May 2022.
+Added: this annual report, we were subject to these limitations because our public float did not reach at least $75 million in the 60 days preceding
+Added: the filing of this annual report.
+Added: We will continue to be subject to these limitations for the remainder of the 2024 fiscal year and until
+Added: the earlier of such time as our public float reaches at least $75 million or when we file our next annual report for the year ended December
+Added: 31, 2024, at which time we will be required to re-test our status under these rules.
+Added: If our public float is below $75 million as of the
+Added: filing of our next annual report on Form 10-K, or at the time we file a new Form S-3, we will continue to be subject to these limitations,
+Added: until the date that our public float again reaches $75 million.
+Added: These limitations do not apply to secondary offerings for the resale of
+Added: our ordinary shares or other securities by selling shareholders or to the issuance of ordinary shares upon conversion by holders of convertible
+Added: securities, such as warrants.
+Added: We have registered up to $100 million of ordinary shares warrants and/or debt securities and certain other
+Added: outstanding securities with registration rights on our registration statement on Form S-3, which was declared effective by the SEC in
Equity Offerings and
Warrant Exercises
−Removed: On February 10, 2020, the Company closed a “best efforts”
−Removed: public offering whereby the Company issued an aggregate of 5,600,000 of common units and pre-funded units at a public offering price of
−Removed: $1.25 per common unit and $1.249 per pre-funded unit.
−Removed: As part of the public offering, the Company entered into a securities purchase agreement
−Removed: with certain institutional purchasers.
−Removed: Each common unit consisted of one ordinary share, par value NIS 0.25 per share, and one common
−Removed: warrant to purchase one ordinary share.
−Removed: Each pre-funded unit consisted of one pre-funded warrant to purchase one ordinary share and one
−Removed: common warrant.
−Removed: Additionally, the Company issued warrants to purchase up to 336,000 ordinary shares, with an exercise price of $1.5625
−Removed: per share, to representatives of H.C.
−Removed: Wainwright as compensation for its role as the placement agent in the Company’s February 2020
−Removed: As of December 31, 2020, all pre-funded warrants to purchase ordinary shares had been exercised and 1,831,500 common warrants
−Removed: to purchase ordinary shares had been exercised.
−Removed: On July 6, 2020, the Company entered into a purchase agreement
−Removed: with certain institutional investors for the issuance and sale of 4,938,278 ordinary shares, par value NIS 0.25 per share, at $1.8225
−Removed: per ordinary share and warrants to purchase up to 2,469,139 ordinary shares with an exercise price of $1.76 per share, exercisable from
−Removed: July 6, 2020, until January 6, 2026.
−Removed: Additionally, the Company issued warrants to purchase up to 296,297 ordinary shares, with an exercise
−Removed: price of $2.2781 per share, exercisable from July 6, 2020, until July 2, 2025, to certain representatives of H.C.
−Removed: Wainwright as compensation
−Removed: for its role as the placement agent in our July 2020 registered direct offering.
−Removed: On December 3, 2020, the Company entered into a
−Removed: private placement with certain institutional investors for the issuance and sale of 5,579,776 ordinary shares, par value NIS 0.25 per
−Removed: share, at $1.43375 per ordinary shares and warrants to purchase up to 4,184,832 ordinary shares with exercise price of $1.34 per share,
−Removed: exercisable from December 8, 2020 until June 8, 2026.
−Removed: Additionally, the Company issued warrants to purchase up to 334,787 ordinary shares,
−Removed: with an exercise price of $1.7922 per share, exercisable from December 8, 2020, until June 8, 2026, to certain representatives of H.C.
−Removed: Wainwright as compensation for its role as the placement agent in our December 2020 private placement.
On February 19, 2021, the Company entered into a purchase agreement
25 unchanged sentences
Wainwright as compensation for its role as the placement agent in our September 2021 private placement offering.
−Removed: As of December 31, 2022, we received a total of 9,814,754 outstanding
−Removed: warrants exercises with exercise prices ranging from $1.25 to $1.79 were exercised, for total gross proceeds of approximately $13.8 million.
+Added: As of December 31, 2023, warrants to purchase a total of 9,814,754
+Added: ordinary shares with exercise prices ranging from $1.25 to $1.79 were exercised, for total gross proceeds of approximately $13.8 million.
During the twelve months that ended December 31, 2023, no warrants were exercised.
Share Repurchase Program
−Removed: In June 2022, we announced that our Board approved a program to
−Removed: repurchase up to $8.0 million of our ordinary shares, par value NIS 0.25 per share, subject to receipt of Israeli court approval.
−Removed: 2022, we announced that we had received approval from an Israeli court for the share repurchase program, valid through January 20, 2023.
−Removed: On December 19, 2022, our board of directors approved the extension
−Removed: of our on-going share repurchase program, with such extension to be in the aggregate amount of up to $5.8 million.
−Removed: The extension was approved
−Removed: by an Israeli court on February 9, 2023, and will expire on the earlier of August 9, 2023, or reaching the additional $5.8 million of
−Removed: repurchases of our ordinary shares .
−Removed: Under the program, share repurchases may be made from time to time
−Removed: using a variety of methods, including open market transactions or in privately negotiated transactions.
−Removed: Such repurchases will be made
−Removed: in accordance with all applicable securities laws and regulations, including restrictions relating to volume, price and timing under applicable
−Removed: law, including Rule 10b-18 under the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”).
−Removed: and amount of shares repurchased will be determined by our management, within guidelines to be established by the Board or a committee
−Removed: thereof, based on its ongoing evaluation of our capital needs, market conditions, the trading price of our ordinary shares, trading volume
−Removed: and other factors, subject to applicable law.
−Removed: For all or a portion of the authorized repurchase amount, we may enter into a plan compliant
−Removed: with Rule 10b5-1 under the Exchange Act that is designed to facilitate these repurchases.
−Removed: The repurchase program does not require us to acquire a specific
−Removed: number of shares and may be suspended or discontinued at any time.
−Removed: There can be no assurance as to the timing or number of shares of any
−Removed: repurchases in the future, and any such share repurchases will be funded from available working capital.
−Removed: As of December 31, 2022, we have
−Removed: repurchased approximately 2.9 million of our ordinary shares at an aggregate amount of $2.6 million under the repurchase program.
+Added: On June 2, 2022, our board of directors approved a share repurchase program to repurchase
+Added: up to $8.0 million of our ordinary shares .
+Added: On July 21, 2022, we received approval from an Israeli court for the share repurchase program.
+Added: The program was scheduled to expire on the earlier of January 20, 2023, or reaching $8.0 million of repurchases.
+Added: On December 22, 2022,
+Added: our board of directors approved an extension of the repurchase program, with such extension to be in the aggregate amount of up to $5.8
+Added: The extension was approved by an Israeli court on February 9, 2023, and it expired on August 9, 2023.
+Added: As of December 31, 2023, pursuant to the share repurchase program, we had repurchased
+Added: a total of 4,022,607 of our outstanding ordinary shares at a total cost of $3.5 million.
Years Ended December 31,
2 unchanged sentences
Net cash (used in) provided by financing activities
−Removed: Effect of Exchange rate changes on Cash, Cash Equivalents and Restricted Cash
+Added: Effect of Exchange rate changes on Cash, Cash Equivalents and
+Added: Restricted Cash
Net cash flow
2 unchanged sentences
Net cash used in operating activities was $20.7 million in 2023,
−Removed: an increase of $6.4 million as compared to 2021 mainly due to lower revenue collection, higher consulting, professional services expenses
−Removed: and personnel and personnel related expenses.
+Added: an increase of $2.8 million as compared to 2022 mainly due to higher consulting and professional services fees primarily associated with
+Added: the acquisition of AlterG and the CMS reimbursement process, as well as increased inventory purchases.
Net Cash Used in Investing Activities
−Removed: Net cash used in investing activities decreased to $25 thousand
−Removed: in 2022 as compared to $47 thousand in 2021, primarily as a result of decreased use of cash for the purchase of property and equipment.
−Removed: Net Cash Provided by Financing Activities
−Removed: Net cash (used in) provided by financing activities
−Removed: was a cash use of $2.5 million in 2022, a decrease of $82 million, as compared to cash provided of $79.5 million in 2021.
−Removed: was a result of a share repurchase plan that was initiated in the second half of 2022, while in 2021 the source of cash consisted primarily
−Removed: of proceeds from the issuance of common stock and warrants, as well as the exercise of warrants issued in prior years.
+Added: Net cash used in investing activities increased to $18.1 million in 2023 as compared
+Added: to $0.03 million in 2022, primarily due to the acquisition of AlterG.
+Added: Net Cash Used in Financing Activities
+Added: Net cash used in financing activities was $0.9 million in 2023,
+Added: a decrease of $1.5 million, as compared to 2022.
+Added: The decrease was due to the repurchase of our ordinary shares under our share repurchase
+Added: program, which expired on August 9, 2023.
Year Ended December 31, 2022 Compared to Year
1 unchanged sentence
A discussion of changes in our cash flows in 2022 compared to 2021
−Removed: has been omitted from this annual report on Form 10-K but may be found in “Item 7.
−Removed: Management's Discussion and Analysis of Financial
−Removed: Condition and Results of Operations” of our Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on February
−Removed: 24, 2022, which is available free of charge on the SECs website at www.sec.gov and at www.rewalk.com, and is incorporated by reference
+Added: has been omitted from this annual report on Form 10-K but may be found in “Part I.
+Added: Management's Discussion and Analysis
+Added: of Financial Condition and Results of Operations” of our Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC
+Added: on February 23, 2023, which is available free of charge on the SECs website at www.sec.gov and at golifeward.com, and is incorporated
+Added: by reference herein.
Obligations and Commercial Commitments
5 unchanged sentences
Operating lease obligations (3)
−Removed: The Company depends on one contract manufacturer, Sanmina Corporation, for both the ReStore products and the SCI Products.
−Removed: our manufacturing orders with Sanmina pursuant to purchase orders or by providing forecasts for future requirements.
−Removed: Our Collaboration Agreement with Harvard was originally for a term of five years, commencing in May 2016,
−Removed: and was subsequently amended in April 2018 to extend the term by one additional year.
−Removed: The Collaboration Agreement concluded as of March
+Added: Earnout liability (4)
+Added: We depend on one contract manufacturer, Sanmina Corporation, for both the SCI products and the ReStore Products.
+Added: We place our manufacturing
+Added: orders with Sanmina pursuant to purchase orders or by providing forecasts for future requirements.
+Added: The AlterG Anti-Gravity systems are
+Added: produced in Fremont, California by us.
+Added: Purchase orders are executed with suppliers based on our sales forecast.
Under the Collaboration Agreement, we were required to pay in quarterly installments the funding of our joint research collaboration
8 unchanged sentences
which may not occur.
−Removed: Our operating leases consist of leases for our facilities and motor vehicles.
+Added: Our Collaboration Agreement with Harvard was concluded on March 31, 2022.
+Added: Our operating leases consist of leases for our facilities in the United States, Israel and Germany and motor vehicles in Israel.
+Added: Earnout payments based on AlterG’s revenue growth during the two consecutive trailing twelve-month periods following closing
+Added: of the acquisition.
We calculated the payments due under our operating lease obligation
−Removed: for our Israeli office that are to be paid in NIS at a rate of exchange of NIS 3.519:$1.00, and the payments due under our operating lease
−Removed: obligation for our German subsidiary that are to be paid in euros at a rate of exchange of €1.00:$1.07, both of which were the applicable
−Removed: exchange rates as of December 31, 2022.
+Added: for our Israeli office that are to be paid in NIS at a rate of exchange of NIS 3.627:$1.00, of which were the applicable exchange rate
+Added: as of December 31, 2023.
Off-Balance Sheet Arrangements
5 unchanged sentences
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.