What changed in this filing

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Item 1. Business

2025-02-19 compared with 2024-04-01 · 590 added, 518 removed, 100 unchanged (92% of the section changed)

used in this Report, all references to “we,” “our” and “us” for periods prior to the closing of the

Share Exchange refer to Dror Ortho-Design Ltd., a company incorporated under the laws of the State of Israel, and for periods subsequent

to the closing of the Share Exchange refer to Dror Ortho-Design, Inc., a Delaware corporation and its direct and indirect subsidiaries.

We were incorporated as Novint Technologies, Inc.

in the State of New

Mexico in April 1999.

On February 26, 2002, we changed our state of incorporation to Delaware by merging with Novint Technologies, Inc.,

a Delaware corporation.

On July 5, 2023, we entered into a share exchange agreement with the shareholders of Dror Ortho-Design, Ltd.

Dror”), pursuant to which the shareholders of Private Dror agreed to exchange all of their outstanding ordinary shares Private Dror

for shares of our Common Stock and convertible preferred stock (the “Share Exchange”).

On August 14, 2023, the Share

Exchange was consummated and we changed our name from “Novint Technologies, Inc.” to “Dror Ortho-Design, Inc.”

Following the Share Exchange, we succeeded to the business of Private Dror as our sole line of business.

have reimagined the way people can correct their smile.

plan to disrupt the aligner market by offering millions of people a revolutionary alternative.

We believe that people do not need to

change their lifestyle to correct their smile as they are required to do with existing aligner solutions.

aligner solutions generally share the same treatment principles, which are different from our solution.

In most cases, patients seeking

to improve their smile need to undergo a 12-to-15 month process of wearing plastic aligners, which need to be worn the entire day and

should only be removed while eating or drinking.

Patients are prescribed a series of 20 to 30 aligners that are intended to forcefully

move teeth progressively closer to their intended final position.

This process causes pain every time a new aligner is used and restricts

blood circulation, which counterproductively slows down tooth movement.

All-day aligner solutions are also intrusive, as patients need

to conduct their lives at work or school wearing the plastic aligners.

In addition, most existing aligner therapies require multiple

visits to an orthodontist to monitor the progress of treatment plans through intraoral scanning, physical examination and patient testimony.

believe that recent rapid advancements in technology have made traditional aligner solutions no longer the most effective treatment option

for smile correction.

As used in this Report,

all references to “we,” “our” and “us” for periods prior to the closing of the Share Exchange refer

to Dror Ortho-Design Ltd., a company incorporated under the laws of the State of Israel, and for periods subsequent to the closing of

the Share Exchange refer to Dror Ortho-Design, Inc., a Delaware corporation and its direct and indirect subsidiaries.

We were incorporated as Novint

Technologies, Inc.

in the State of New Mexico in April 1999.

On February 26, 2002, we changed our state of incorporation to Delaware

by merging with Novint Technologies, Inc., a Delaware corporation.

On July 5, 2023, we entered into a share exchange agreement with the

shareholders of Dror Ortho-Design, Ltd.

(“Private Dror”), pursuant to which the shareholders of Private Dror agreed to exchange

all of their outstanding ordinary shares Private Dror for shares of our Common Stock and convertible preferred stock (the “Share

On August 14, 2023, the Share Exchange was consummated and we changed our name from “Novint Technologies,

Inc.” to “Dror Ortho-Design, Inc.” Following the Share Exchange, we succeeded to the business of Private Dror as our

sole line of business.

We have reimagined the way people can correct

We plan to disrupt the aligner

market by offering millions of people a revolutionary alternative.

We believe that people do not need to change their lifestyle to correct

their smile as they are required to do with existing aligner solutions.

Existing aligner solutions

generally share the same treatment principles, which are different from our solution.

In most cases, patients seeking to improve their

smile need to undergo a 12-to-15 month process of wearing plastic aligners, which need to be worn the entire day and should only be removed

while eating or drinking.

Patients are prescribed a series of 20 to 30 aligners that are intended to forcefully move teeth progressively

closer to their intended final position.

This process causes pain every time a new aligner is used and restricts blood circulation, which

counterproductively slows down tooth movement.

All-day aligner solutions are also intrusive, as patients need to conduct their lives

at work or school wearing the plastic aligners.

In addition, most existing aligner therapies require multiple visits to an orthodontist

to monitor the progress of treatment plans through intraoral scanning, physical examination and patient testimony.

We believe that recent

rapid advancements in technology have made traditional aligner solutions no longer the most effective treatment option for smile

Our Company has developed a proprietary AI-based platform to correct people’s smiles in a discreet and less

painful manner (the “Platform”).

The Platform uses only one smart aligner to gently move teeth into their optimum position

with pulsating air while the patient is sleeping or at home.

The Company has several patents for the technology used in the Platform

and is currently in the process of preparing the prototype for FDA approval.

predecessor first generation Aerodentis System is a Class II medical device, which was cleared by FDA for commercialization in the U.S.

pursuant to the 510(k) notification process for movement and alignment of teeth during orthodontic treatment of malocclusion in April

The Company is preparing to apply for 510(k) clearance for the Platform as a Class II medical device, which constitutes an updated

version of the currently cleared device.

Such updated Platform contains new and/or different components than the original device, which

is why a new 510(k) clearance is required prior to marketing the Platform in the U.S.

We have not yet filed a 510(k) submission for the

Platform, and it has, thus, not been found by the FDA to be substantially equivalent to the first generation Aerodentis System.

Company currently does not generate revenues to fund operations and anticipates that it will continue to incur significant losses as

it continues to develop the Platform.

Please refer to “Risk Factors - We are in the development stage, are not generating revenues

and have no operating history in the manufacturing and distribution of orthodontic medical devices or platforms for consumer use.”

for additional information.

The Company intends to spend approximately $2.5 million over the next 18 months on software and hardware

development as well as the accompanying regulatory approvals and IP protection associated with such software and hardware projects.

First Generation Aerodentis System

Company was founded in 2005 with the goal of offering millions of people a chance to correct their smile in a more discreet and less

painful manner.

The first generation of our product underwent ten years of development by a team of twelve orthodontists, engineers,

industrial designers and dental technicians.

This team developed a new clinically-proven method for correcting Class 1 and Class 2 malocclusion

using pulsating air.

The team discovered that using pulsating air improved blood circulation in the gums, which is essential to tooth

This first-generation product (the “Aerodentis System”) was composed of a base control unit that contained a pump

and motor that would deliver pulses of air to a micro balloon that was part of a mouthpiece to be used by the patient to deliver the

The use of pulsating air is the base patented technology that distinguishes our Aerodentis System from clear aligner therapies,

which are designed to move teeth using continuous resistant force delivered by the aligner, which impairs blood flow.

Base control unit, containing micro-pump and controls, attached to the smart aligner.

The smart aligner is composed of an outer mouthpiece

structure, which is shaped based on the final position of the teeth for a perfect smile.

Behind the outer mouthpiece structure is a micro

balloon that is attached to the base control unit with a fine and flexible microtube.

The balloon delivers pulsating air by inflating

and deflating.

Behind the balloon is the “push structure,” which provides the balloon with a surface to push against as it

gently moves the teeth.

January 2013, the Aerodentis System composed of the base control unit and custom mouthpiece received the European CE Mark.

received FDA clearance via the 510(k) process as a Class II medical device, with broad indication for use “in movement and alignment

of teeth during orthodontic treatment of malocclusion.” Clinical trials demonstrated that Aerodentis System was suitable for adults

and pediatric patients with Class 1 and Class 2 malocclusion, including crowding, proclination and retroclination.

Further, clinical

trials have demonstrated that the effectiveness of Aerodentis System was consistent with the results achieved by the Invisalign clear

aligners solution provided by Align Technology, Inc.

Close up of smart aligner with (1) outer structure formed based on the final tooth position desired for a perfect smile and (2) micro

balloon inserted between the outer structure and the inner structure to support the balloon’s expansion.

on the Aerodentis System, we have developed a prototype of the Platform, our next generation, comprehensive enhanced solution to Class

1 and Class 2 malocclusion for which we intend to submit a 510(k) application for marketing in the U.S., as the Platform is beyond the

scope of our current FDA clearance.

The prototype of the Platform was developed over the course of eighteen months and is intended to

advance the proven clinical features of the Aerodentis System while incorporating recent developments in artificial intelligence utilized

in our Aerodentis AI Cloud (as defined below) component of the Platform, secure wireless and Internet communications with Internet of

Things (“IoT”) devices used in our Smart Aligner System component of the Platform and advanced imaging and 3D printing technologies.

IoT devices revers to pieces of hardware, such as sensors, actuators, gadgets, appliances, or machines, that are programmed for certain

applications and can transmit data over the internet or other networks.

is comprised of three primary components:

Aerodentis smartphone application;

AI-based cloud service (“Aerodentis AI Cloud”), which is used to perform analytics and manage patient treatment plans;

smart aligner system used by the patient, which consists of:

(i) a base control unit containing the pump and the IoT components and (ii)

a smart aligner containing the micro-balloon that gently pushes teeth into their intended final position using pulsating air (the “Smart

Aligner System”).

The following

provides a more detailed description of each of the components of our Platform:

Smartphone Application

freely downloadable Aerodentis smartphone application will allow potential patients to make a video of their smile and teeth and upload

the video to the Aerodentis AI Cloud.

This 2D video will be converted into a 3D model using our proprietary patent-pending AI based image

analysis technology.

The underlying algorithms will then perform an initial analysis to determine if the patient can potentially benefit

from our solution.

On July 14, 2024, the Company announced that its next generation solution will be rebranded from Aerodentis to

“ZSmile” (the “Platform”) since the Platform is intended for nighttime use and while sleeping.

“ZSmile” is intended to communicate that people can correct their smile while they sleep or colloquially “getting

ZSmile uses only one smart aligner to gently move teeth into their optimum position with pulsating air

while the patient is sleeping or at home.

The Company has several patents for the technology used in the Platform and is currently

in the process of preparing the prototype for FDA approval.

Our predecessor first generation

Aerodentis System is a Class II medical device, which was cleared by FDA for commercialization in the U.S.

pursuant to the 510(k) notification

process for movement and alignment of teeth during orthodontic treatment of malocclusion in April 2020.

The Company is preparing to apply

for 510(k) clearance for the Platform as a Class II medical device, which constitutes an updated version of the currently cleared device.

Such updated Platform contains new and/or different components than the original device, which is why a new 510(k) clearance is required

prior to marketing the Platform in the U.S.

We have not yet filed a 510(k) submission for the Platform, and it has, thus, not been found

by the FDA to be substantially equivalent to the first generation Aerodentis System.

The Company currently does

not generate revenues to fund operations and anticipates that it will continue to incur significant losses as it continues to develop

the Platform.

Please refer to “Risk Factors - We are in the development stage, are not generating revenues and have no operating

history in the manufacturing and distribution of orthodontic medical devices or platforms for consumer use.” for additional information.

The Company intends to spend approximately $1 million over the next 12 months on software and hardware development as well as the accompanying

regulatory approvals and IP protection associated with such software and hardware projects.

The First Generation Aerodentis System

Our Company was founded in

2005 with the goal of offering millions of people a chance to correct their smile in a more discreet and less painful manner.

generation of our product underwent ten years of development by a team of twelve orthodontists, engineers, industrial designers and dental

This team developed a new clinically-proven method for correcting Class 1 and Class 2 malocclusion using pulsating air.

The team discovered that using pulsating air improved blood circulation in the gums, which is essential to tooth movement.

This first-generation

product (the “Aerodentis System”) was composed of a base control unit that contained a pump and motor that would deliver

pulses of air to a micro balloon that was part of a mouthpiece to be used by the patient to deliver the treatment.

The use of pulsating

air is the base patented technology that distinguishes our Aerodentis System from clear aligner therapies, which are designed to move

teeth using continuous resistant force delivered by the aligner, which impairs blood flow.

unit, containing micro-pump and controls, attached to the smart aligner.

The smart aligner is composed of an outer mouthpiece structure,

which is shaped based on the final position of the teeth for a perfect smile.

Behind the outer mouthpiece structure is a micro balloon

that is attached to the base control unit with a fine and flexible microtube.

The balloon delivers pulsating air by inflating and deflating.

Behind the balloon is the “push structure,” which provides the balloon with a surface to push against as it gently moves

In January 2013, the Aerodentis

System composed of the base control unit and custom mouthpiece received the European CE Mark.

In 2020, it received FDA clearance via

the 510(k) process as a Class II medical device, with broad indication for use “in movement and alignment of teeth during orthodontic

treatment of malocclusion.” Clinical trials demonstrated that Aerodentis System was suitable for adults and pediatric patients

with Class 1 and Class 2 malocclusion, including crowding, proclination and retroclination.

Further, clinical trials have demonstrated

that the effectiveness of Aerodentis System was consistent with the results achieved by the Invisalign clear aligners solution provided

by Align Technology, Inc.

smart aligner with (1) outer structure formed based on the final tooth position desired for a perfect smile and (2) micro balloon

inserted between the outer structure and the inner structure to support the balloon’s expansion.

Building on the Aerodentis

System, we have developed a prototype of the ZSmile, our next generation, comprehensive enhanced solution to Class 1 and Class 2 malocclusion

for which we intend to submit a 510(k) application for marketing in the U.S., as the Platform is beyond the scope of our current FDA

The prototype of the Platform was developed over the course of eighteen months and is intended to advance the proven clinical

features of the Aerodentis System while incorporating recent developments in artificial intelligence utilized in our ZSmile AI Cloud

(as defined below) component of the Platform, secure wireless and Internet communications with Internet of Things (“IoT”)

devices used in our Smart Aligner System component of the Platform and advanced imaging and 3D printing technologies.

IoT devices revers

to pieces of hardware, such as sensors, actuators, gadgets, appliances, or machines, that are programmed for certain applications and

can transmit data over the internet or other networks.

Our Platform is comprised of three primary components:

the ZSmile smartphone application;

our AI-based cloud service

(“ZSmile AI Cloud”), which is used to perform analytics and manage patient treatment plans;

the smart aligner system

used by the patient, which consists of:

(i) a base control unit containing the pump and the IoT components and (ii) a smart aligner

containing the micro-balloon that gently pushes teeth into their intended final position using pulsating air (the “Smart Aligner

The following provides a more detailed description of each of the

components of our Platform:

ZSmile Smartphone Application

Our freely downloadable

ZSmile smartphone application will allow potential patients to make a video of their smile and teeth and upload the video to the

ZSmile AI Cloud.

This 2D video will be converted into a 3D model using our proprietary patent-pending AI based image analysis

The underlying algorithms will then perform an initial analysis to determine if the patient can potentially benefit from

our solution.

This complex analysis will be performed in minutes and will deliver a “Go/No Go” response.

Once a patient

begins treatment, they will use the smartphone application to provide their dental professional with ongoing remote monitoring of their

treatment progress.

The smartphone application can be used to upload additional teeth videos showing progress and to transmit data from

the Smart Aligner System (described below), including the amount of time the patient used the Smart Aligner System and the pressure and

pulse levels administered.

Aerodentis AI Cloud will be used to analyze data uploaded by patients and to facilitate communication between patients and dental professionals.

If the analysis performed on the initial video upload from the Aerodentis smartphone application delivers a “Go” result,

the patient will be invited to have an intraoral scan performed by a dental professional from our network of participating providers.

The results of this intraoral scan will be uploaded to the Aerodentis AI Cloud by the dental professional, and the Aerodentis AI Cloud

will use a machine learning algorithm to compare the scan with the initial model generated from the patient’s initial video upload.

The machine learning algorithm is designed to learn with every scan how to improve the accuracy of the 3D images it generates from smartphone

We believe that the Platform’s image analysis of smartphone videos will eventually approach the level of accuracy observed

in intraoral scans.

If we achieve this, we will be in a position to be able provide highly accurate image analysis of teeth that can

be used throughout the dental industry since it would allow for smartphones to essentially replace the need for intraoral scans for certain

This would dramatically increase the efficiency and treatment delivery cycle in the dental industry and result in a potentially

material economic benefit to our Company in the future.

Aerodentis AI Cloud will also be used for ongoing analysis of patient data and management of a patient’s treatment plan throughout

the treatment.

A dental professional will use our Platform to develop a customized treatment plan, including any interproximal reduction

necessary before treatment begins, based on the Smart Aligner System.

As a patient uploads progress videos from their smartphone, the

Platform will compare tooth positions in previous videos to current positions.

A dental professional will be able to use this data to

remotely monitor the treatment progress and modify the treatment plan remotely as needed.

Aligner System

Platform’s Smart Aligner System features a newer, more advanced version of our first generation Aerodentis System, featuring completely

redesigned micropump and motor mechanisms.

The redesign has significantly increased the pump’s pressure capacity, efficiency, and

In addition, the base control unit of Smart Aligner System is now IoT-enabled to allow external secure communication with

the device using Wi-Fi and Bluetooth.

The device will thus be able to communicate with the patient’s smartphone as well as the

Aerodentis AI Cloud and the designated dental professional, subject to FDA clearance.

clear aligner of a patient’s Smart Aligner System will be created using 3D printing based on various 3D images of the patient’s

teeth that are collected and analyzed in the Aerodentis AI Cloud.

This will represent a significant development in our industry since,

today, aligners are not printed but produced using a thermoforming process.

Other companies have implemented 3D printing to produce the

aligner models but not the actual aligners.

Although using 3D printing is a superior method for production due to its level of precision

and customizability, it has not been implemented in the production of aligners in the traditional aligner market because it would be

financially prohibitive to do so, since traditional aligner solutions would need to print multiple aligners for each patient.

solution requires only one smart aligner to be produced for each patient, we will be able to take advantage of this cost-effective production

method that will also have economies of scale.

is one of the most prevalent clinical dental conditions in the world, affecting approximately 60% to 75% of the global population.

It is estimated that there are approximately 500 million people globally with malocclusion who could benefit from straightening

2 However, most people afflicted by malocclusion do not seek orthodontic treatment due to a number of reasons,

including negative perceptions of metal braces, affordability of treatment, and accessibility to doctors in certain markets and geographies.

Annually, only approximately 21 million or 4.2% of the affected individuals elect treatment by orthodontists.

3 Today, most

orthodontic patients continue to have their malocclusions treated with the use of traditional corrective methods such as metal arch wires

and brackets, referred to as braces, augmented with elastics, metal expanders, headgear or functional appliances, and other ancillary

devices as needed.

Upon completion of a patient’s treatment, their dental professional may recommend the patient use a retainer

appliance to preserve the benefits of their treatments.

to a 2022 study conducted by Precedent Research (“Precedence Research 2022 Study”), the global clear aligners market size

was estimated at $6.29 billion in 2022 and is expected to surpass around $46.3 billion by 2030, expanding at a compound annual growth

rate (CAGR) of 28.34% during the period 2022 to 2030.

Precedence Research Study, 2022

Platform seeks to address this large and underserved global market by offering a discreet, less intrusive and less painful treatment

alternative to available clear aligners and traditional orthodontic treatments.

Our Platform is optimized to correct malocclusions that

relate to the “social six,” which are the front upper six and lower six teeth.

We believe that at least 30% of those who

currently seek treatment, or 6.6 million people, could benefit from using Aerodentis to correct their smiles.

According to the Precedence

Research 2022 Study, by 2028, the market for clear aligners will surpass 22 million people, which is our total addressable market.

begins treatment, they will use the smartphone application to provide their dental professional with ongoing remote monitoring of

their treatment progress.

The smartphone application can be used to upload additional teeth videos showing progress and to transmit

data from the Smart Aligner System (described below), including the amount of time the patient used the Smart Aligner System and the

pressure and pulse levels administered.

ZSmile AI Cloud

The ZSmile AI Cloud will

be used to analyze data uploaded by patients and to facilitate communication between patients and dental professionals.

If the analysis

performed on the initial video upload from the ZSmile smartphone application delivers a “Go” result, the patient will be

invited to have an intraoral scan performed by a dental professional from our network of participating providers.

The results of this

intraoral scan will be uploaded to the ZSmile AI Cloud by the dental professional, and the ZSmile AI Cloud will use a machine learning

algorithm to compare the scan with the initial model generated from the patient’s initial video upload.

The machine learning algorithm

is designed to learn with every scan how to improve the accuracy of the 3D images it generates from smartphone videos.

We believe that

the Platform’s image analysis of smartphone videos will eventually approach the level of accuracy observed in intraoral scans.

If we achieve this, we will be in a position to be able provide highly accurate image analysis of teeth that can be used throughout the

dental industry since it would allow for smartphones to essentially replace the need for intraoral scans for certain cases.

dramatically increase the efficiency and treatment delivery cycle in the dental industry and result in a potentially material economic

benefit to our Company in the future.

The ZSmile AI Cloud will

also be used for ongoing analysis of patient data and management of a patient’s treatment plan throughout the treatment.

professional will use our Platform to develop a customized treatment plan, including any interproximal reduction necessary before treatment

begins, based on the Smart Aligner System.

As a patient uploads progress videos from their smartphone, the Platform will compare tooth

positions in previous videos to current positions.

A dental professional will be able to use this data to remotely monitor the treatment

progress and modify the treatment plan remotely as needed.

Smart Aligner System

The Platform’s Smart

Aligner System features a newer, more advanced version of our first generation ZSmile System, featuring completely redesigned micropump

and motor mechanisms.

The redesign has significantly increased the pump’s pressure capacity, efficiency, and durability.

the base control unit of Smart Aligner System is now IoT-enabled to allow external secure communication with the device using Wi-Fi and

The device will thus be able to communicate with the patient’s smartphone as well as the ZSmile AI Cloud and the designated

dental professional, subject to FDA clearance.

The clear aligner of a patient’s

Smart Aligner System will be created using 3D printing based on various 3D images of the patient’s teeth that are collected and

analyzed in the ZSmile AI Cloud.

This will represent a significant development in our industry since, today, aligners are not printed

but produced using a thermoforming process.

Other companies have implemented 3D printing to produce the aligner models but not the actual

Although using 3D printing is a superior method for production due to its level of precision and customizability, it has not

been implemented in the production of aligners in the traditional aligner market because it would be financially prohibitive to do so,

since traditional aligner solutions would need to print multiple aligners for each patient.

Since our solution requires only one smart

aligner to be produced for each patient, we will be able to take advantage of this cost-effective production method that will also have

economies of scale.

The Company’s

second generation device ZSmile

ZSmile depicted

being used while sleeping

Market Opportunity

Malocclusion is one of the

most prevalent clinical dental conditions in the world, affecting approximately 60% to 75% of the global population.

estimated that there are approximately 500 million people globally with malocclusion who could benefit from straightening their teeth.

However, most people afflicted by malocclusion do not seek orthodontic treatment due to a number of reasons, including negative

perceptions of metal braces, affordability of treatment, and accessibility to doctors in certain markets and geographies.

Annually, only

approximately 21 million or 4.2% of the affected individuals elect treatment by orthodontists.

3 Today, most orthodontic patients

continue to have their malocclusions treated with the use of traditional corrective methods such as metal arch wires and brackets, referred to

as braces, augmented with elastics, metal expanders, headgear or functional appliances, and other ancillary devices as needed.

Upon completion

of a patient’s treatment, their dental professional may recommend the patient use a retainer appliance to preserve the benefits

of their treatments.

Alhammadi, Maged Sultan, et al.

6 unchanged sentences

Global Orthodontic Supplies Market Report 2027 – Improving Oral Health Care, available at https://meditechinsights.com/global-orthodontic-supplies-market/.

According to a 2022 study

conducted by Precedent Research (“Precedence Research 2022 Study”), the global clear aligners market size was estimated at

$6.29 billion in 2022 and is expected to surpass around $46.3 billion by 2030, expanding at a compound annual growth rate (CAGR) of 28.34%

during the period 2022 to 2030.

Precedence Research Study, 2022

Our Platform seeks to address

this large and underserved global market by offering a discreet, less intrusive and less painful treatment alternative to available clear

aligners and traditional orthodontic treatments.

Our Platform is optimized to correct malocclusions that relate to the “social

six,” which are the front upper six and lower six teeth.

We believe that at least 30% of those who currently seek treatment, or

6.6 million people, could benefit from using ZSmile to correct their smiles.

According to the Precedence Research 2022 Study, by 2028,

the market for clear aligners will surpass 22 million people, which is our total addressable market.

Clear Aligners Market (By Age:

10 unchanged sentences

Precedence Research Study, 2022

addressable market also stands to benefit from the recent trend toward dentists, rather than orthodontists, delivering orthodontic care

through clear aligners.

In order for a smile correction solution to work properly, a treatment plan and monitoring needs to be executed

by a dental professional, such as dentists and orthodontists.

Since the Aerodentis Platform provides the necessary information to develop

and administer a treatment plan using our solution, it may be used by dentists as well as orthodontists, which expands our target distribution

channel to cover both orthodontists and dentists.

Our total addressable market

also stands to benefit from the recent trend toward dentists, rather than orthodontists, delivering orthodontic care through clear

In order for a smile correction solution to work properly, a treatment plan and monitoring needs to be executed by a dental

professional, such as dentists and orthodontists.

Since the ZSmile Platform provides the necessary information to develop and administer

a treatment plan using our solution, it may be used by dentists as well as orthodontists, which expands our target distribution channel

to cover both orthodontists and dentists.

According to a 2019 Journal of Family Medicine and Primary Care article, approximately

2 unchanged sentences

of an ongoing trend of dentists assuming more orthodontic treatment offerings in their practices.

We believe that the ease of use of

our Platform will also facilitate eventually selling our solution directly to the consumer in qualified cases with remote dental professional

business model is focused on engaging the customer throughout their smile correction journey and beyond.

Our solution provides an innovative,

proprietary end-to-end platform that spans all stages of customer engagement, from initial acquisition to treatment and ongoing maintenance—all

with minimal need for office visits and lifestyle inconvenience.

Initiated Dentist-Controlled Treatment

other solutions in the market, such as traditional clear aligners, we believe our Platform will provide greater access and interaction

with the customers and allow customers to feel more involved in their own treatment process.

We hope to engage the power of social media

and other digital outlets to initiate initial demand for our Platform by the customers.

5 See Jayaprakash, Poonam K., et al.

“A survey on orthodontic

services provided by general dental practitioners.” Journal of family medicine and primary care 8.7 (2019):

Engagement – Value Creation

Platform is designed to have a high level of engagement with customers, if cleared for marketing in the U.S., as users will be able to

scan their teeth with any smartphone and see how our solution can improve their smile.

We intend to engage the customer from their first

interest in correcting their smile and guide them throughout our convenient process.

of Dental Professionals

cleared by FDA, the Platform will generally function via the following process:

if the customer can benefit from our Platform, based

on the severity of their tooth alignment and malocclusions, they will be referred to a dental professional in our network for an intraoral

Once the results of the scan are uploaded to our Aerodentis AI Cloud, a remote dental professional will develop a treatment plan

for that patient using our Platform.

If the patient requires any tooth preparation before initiating treatment with the smart aligner,

the patient will again be referred to a dental professional in our network.

The Company currently does not have any written agreements

or arrangements with any dental professionals governing provision of orthodontic services using our Platform.

– Value Capture

intend to generate revenues by:

our solution through a professional dental network;

ongoing monitoring and treatment plans for those who have completed their smile correction and may require smile maintenance throughout

selling directly to the consumer in qualified cases with remote dental professional involvement

and Marketing

intend to market our Platform in Israel, the European Union (“E.U.”), United Kingdom, United States, and Canada, subject

to each country’s requisite regulatory authorization.

We intend to utilize social media to promote our Platform to our targeted

The Platform has a potentially viral social media message that we hope will drive demand by placing user-generated content

on all major social medial platforms.

Our marketing strategy themes and promotional messages will emphasize the ease and convenience

offered by our Platform as compared to other available treatments.

and Development

have a research and development team with software development, medical device development, dental/orthodontic, data science and other

innovation focused backgrounds.

Our current research and development efforts are primarily focused on enhancing the Platform and developing

software and processes to enable the manufacture of our smart aligner systems in volume as well as productizing the prototype through

the development of UI/UX and system integration with existing patent systems.

of March 2023, our outsourced software development team is composed of eight professionals with years of experience in artificial intelligence

development, data science, application and software engineering.

Members of the team come from the elite intelligence units of the Israeli

Defense Force and have a breadth of experience in computer vision, imaging and targeting systems development.

Our software development

team is headed by Yossi Avni, who has 25 years of experience in developing advanced artificial intelligence applications, behavioral

biometrics, behavioral profiling and advanced security systems and holds over 100 patents in these areas.

hardware and systems development team is composed of six professionals with years of experience in FDA-compliant medical device development.

They are a part of Aran Research Development Prototypes Ltd.

(“Aran”), a leading Israeli product design and development firm

and our third-party hardware development partner.

Aran is ISO 13485 certified and maintains a ISO 7 cleanroom for testing and assembly.

Aran also has manufacturing facilities and a full suite of 3D printing capabilities, which are compliant with FDA guidelines.

and systems development team is headed by Avi Kayton, a skilled development manager and systems engineer with 16 years of experience,

including extensive experience in medical device companies.

have three issued U.S.

We believe that the ease of use

of our Platform will also facilitate eventually selling our solution directly to the consumer in qualified cases with remote dental

professional involvement.

Business Model

Our business model is focused

on engaging the customer throughout their smile correction journey and beyond.

Our solution provides an innovative, proprietary end-to-end

platform that spans all stages of customer engagement, from initial acquisition to treatment and ongoing maintenance — all with

minimal need for office visits and lifestyle inconvenience.

Jayaprakash, Poonam K., et al.

“A survey on orthodontic services provided by general dental practitioners.” Journal of family

medicine and primary care 8.7 (2019):

Customer Initiated Dentist-Controlled Treatment

Unlike other solutions in

the market, such as traditional clear aligners, we believe our Platform will provide greater access and interaction with the customers

and allow customers to feel more involved in their own treatment process.

We hope to engage the power of social media and other digital

outlets to initiate initial demand for our Platform by the customers.

Customer Engagement – Value Creation

Our Platform is designed

to have a high level of engagement with customers, if cleared for marketing in the U.S., as users will be able to scan their teeth with

any smartphone and see how our solution can improve their smile.

We intend to engage the customer from their first interest in correcting

their smile and guide them throughout our convenient process.

Network of Dental Professionals

If cleared by FDA, the Platform

will generally function via the following process:

if the customer can benefit from our Platform, based on the severity of their tooth

alignment and malocclusions, they will be referred to a dental professional in our network for an intraoral scan.

Once the results of

the scan are uploaded to our ZSmile AI Cloud, a remote dental professional will develop a treatment plan for that patient using our Platform.

If the patient requires any tooth preparation before initiating treatment with the smart aligner, the patient will again be referred

to a dental professional in our network.

The Company currently does not have any written agreements or arrangements with any dental professionals

governing provision of orthodontic services using our Platform.

Monetization – Value Capture

We intend to generate revenues

reselling our solution

through a professional dental network;

providing ongoing monitoring

and treatment plans for those who have completed their smile correction and may require smile maintenance throughout their life;

eventually selling directly

to the consumer in qualified cases with remote dental professional involvement

Sales and Marketing

We intend to market our Platform

in Israel, the European Union (“E.U.”), United Kingdom, United States, and Canada, subject to each country’s requisite

regulatory authorization.

We intend to utilize social media to promote our Platform to our targeted audience.

The Platform has a potentially

viral social media message that we hope will drive demand by placing user-generated content on all major social medial platforms.

marketing strategy themes and promotional messages will emphasize the ease and convenience offered by our Platform as compared to other

available treatments.

Research and Development

We have a research and development

team with software development, medical device development, dental/orthodontic, data science and other innovation focused backgrounds.

Our current research and development efforts are primarily focused on enhancing the Platform and developing software and processes to

enable the manufacture of our smart aligner systems in volume as well as productizing the prototype through the development of UI/UX

and system integration with existing patent systems.

As of December 2024, our

outsourced software development team is composed of eight professionals with years of experience in artificial intelligence development,

data science, application and software engineering.

Members of the team come from the elite intelligence units of the Israeli Defense

Force and have a breadth of experience in computer vision, imaging and targeting systems development.

Our software development team is

headed by Yossi Avni, who has 25 years of experience in developing advanced artificial intelligence applications, behavioral biometrics,

behavioral profiling and advanced security systems and holds over 100 patents in these areas.

Our hardware and systems

development team is composed of six professionals with years of experience in FDA-compliant medical device development.

They are a part

of Aran Research Development Prototypes Ltd.

(“Aran”), a leading Israeli product design and development firm and our third-party

hardware development partner.

Aran is ISO 13485 certified and maintains an ISO 7 cleanroom for testing and assembly.

Aran also has manufacturing

facilities and a full suite of 3D printing capabilities, which are compliant with FDA guidelines.

Our hardware and systems development

team is headed by Avi Kayton, a skilled development manager and systems engineer with 16 years of experience, including extensive experience

in medical device companies.

Intellectual Property

We have three issued U.S.

patents, four pending U.S.

patents and numerous global patent applications.

These patents and applications cover

critical aspects of our Platform, including the movement of teeth using pulsating air, our diagnostic process, Platform technology, and

Our issued U.S.

These patents and applications cover critical aspects of

our Platform, including the movement of teeth using pulsating air, our diagnostic process, Platform technology, and 3D printing.

patents 7819661, 10806376, and 10820965 expire in 2030, 2040, and 2040 respectively.

We currently do not

own any trademarks.

intend to continue to pursue further intellectual property protection through U.S.

patent applications, trademark applications,

and non-disclosure and non-compete agreements.

We also intend to seek to protect our software, documentation and other written materials

under trade secret and copyright laws.

There can be no assurance that patents will be issued as a result of any patent application or

that patents that have been issued to us or may issue in the future will be found to be valid and enforceable and sufficient to protect

our technology or products.

business is generally not seasonal.

However, we may experience moderate sales fluctuations, at certain periods of the year, such as January,

due to renewed consumer focus on health improvement and aesthetics.

dental industry is in a period of immense and rapid digital transformation involving products, technologies, distribution channels and

business models.

We face competition in the market for our Platform from the clear aligners market and we expect competition from existing

competitors and new companies that may enter the market or introduce new technologies in the future.

We compete with several well-established

companies both in the traditional orthodontic industry and the direct-to-consumer clear aligner industry, including Align Technologies,

Smile Direct Club, Dentsply Sirona (Byte), 3M Clarity Aligners, and Straumann Group.

Although these companies offer clear aligner solutions,

and thus do not use technologies similar to the Platform, we expect that potential patients will view clear aligner products as alternatives

to the Platform.

We currently do not own any trademarks.

We intend to continue to

pursue further intellectual property protection through U.S.

patent applications, trademark applications, and non-disclosure

and non-compete agreements.

We also intend to seek to protect our software, documentation and other written materials under trade secret

and copyright laws.

There can be no assurance that patents will be issued as a result of any patent application or that patents that

have been issued to us or may issue in the future will be found to be valid and enforceable and sufficient to protect our technology

Our business is generally

not seasonal.

However, we may experience moderate sales fluctuations, at certain periods of the year, such as January, due to renewed

consumer focus on health improvement and aesthetics.

The dental industry is in

a period of immense and rapid digital transformation involving products, technologies, distribution channels and business models.

face competition in the market for our Platform from the clear aligners market and we expect competition from existing competitors and

new companies that may enter the market or introduce new technologies in the future.

We compete with several well-established companies

both in the traditional orthodontic industry and the direct-to-consumer clear aligner industry, including Align Technologies, Dentsply

Sirona (Byte), 3M Clarity Aligners, and Straumann Group.

Although these companies offer clear aligner solutions, and thus do not use

technologies similar to the Platform, we expect that potential patients will view clear aligner products as alternatives to the Platform.

For this reason, we view any company in the clear aligners market as a potential competitor.

that the principal competitive factors in the market for orthodontic appliances include:

We believe that the principal

competitive factors in the market for orthodontic appliances include:

and financing options;

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● orthodontist

believe that our Platform will compare favorably with respect to each of these factors.

products (including the currently cleared version, as well as the next generation Platform for which we have not yet submitted the requisite

510(k) application to FDA) are considered medical devices, and, accordingly, are subject to rigorous regulation by government agencies

in the United States and other countries in which we intend to sell our products.

These regulations vary from country to country but

cover, among other things, the following activities with respect to medical devices:

We believe that our Platform

will compare favorably with respect to each of these factors.

Government Regulation

Our products (including the

currently cleared version, as well as the next generation Platform for which we have not yet submitted the requisite 510(k) application

to FDA) are considered medical devices, and, accordingly, are subject to rigorous regulation by government agencies in the United States

and other countries in which we intend to sell our products.

These regulations vary from country to country but cover, among other things,

the following activities with respect to medical devices:

development and manufacturing;

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import and export

the U.S., numerous laws and regulations govern the processes by which medical devices are developed, manufactured, brought to market

and marketed.

These include the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and its implementing regulations issued

by FDA, among others.

Unless an exemption applies, each medical device commercially distributed in the United States requires FDA clearance

of a 510(k) premarket notification (“510(k) clearance”), granting of a de novo request, or approval of an application

for premarket approval (“PMA”).

In general, under the FD&C Act, medical devices are classified in one of three classes

on the basis of the controls necessary to reasonably assure their safety and effectiveness.

A medical device’s classification determines

the level of FDA review and approval to which the device is subject before it can be marketed to consumers:

FDA Regulation

In the U.S., numerous laws

and regulations govern the processes by which medical devices are developed, manufactured, brought to market and marketed.

These include

the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and its implementing regulations issued by FDA, among others.

an exemption applies, each medical device commercially distributed in the United States requires FDA clearance of a 510(k) premarket

notification (“510(k) clearance”), granting of a de novo request, or approval of an application for premarket approval

In general, under the FD&C Act, medical devices are classified in one of three classes on the basis of the controls

necessary to reasonably assure their safety and effectiveness.

A medical device’s classification determines the level of FDA review

and approval to which the device is subject before it can be marketed to consumers:

I devices, the lowest-risk FDA device classification, include devices with the lowest risk to the patient and are those for which safety

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manufacturing practices for devices.

III devices, high-risk devices that are often implantable or life-sustaining, also require compliance with the medical device general

controls and Quality System Regulations, and generally must be approved by FDA before entering the market through a PMA application.

Approved PMAs can include post-approval conditions and post-market surveillance requirements, analogous to some of the special controls

that may be imposed on Class II devices.

manufacturing quality system is required to be in compliance with the Quality System Regulations enforced by FDA and similar regulations

enforced by other worldwide regulatory authorities.

FDA’s Quality System Regulations require manufacturers to follow stringent

design, testing, process control, documentation, and other quality assurance procedures.

first generation Aerodentis System is a Class II medical device, which was cleared by FDA for commercialization in the U.S.

to the 510(k) notification process for movement and alignment of teeth during orthodontic treatment of malocclusion in April 2020.

are preparing to apply for 510(k) clearance for the updated version of the currently cleared device.

Such updated Platform contains new

and/or different components than the original device, which is why a new 510(k) clearance is required prior to marketing the Platform

We have not yet filed a 510(k) submission for the Platform, and it has, thus, not been found by the FDA to be substantially

equivalent to the first generation Aerodentis System.

The manufacture, marketing and distribution of the Aerodentis System, as well as

our next-generation Platform once cleared by FDA, if ever, is subject to continuing regulation and enforcement by FDA and other government

authorities, which includes routine FDA inspections of our facilities to determine compliance with facility registration requirements,

product listing requirements, medical device reporting regulations, and Quality System Regulations, among others.

If FDA finds that we

have failed to comply with Quality System Regulations or other legal or regulatory requirements, it or other government agencies may

institute a wide variety of enforcement actions against us, ranging from Warning Letters to more severe sanctions, including but not

limited to financial penalties, withdrawal of 510(k) clearances already granted, and criminal prosecution.

We have passed our International

Organization for Standardization (“ISO”) and Medical Device Single Audit Program (“MDSAP”) certification process

and have added the U.S.

to our ISO/MDSAP certification in 2019

510(k) Process

the 510(k) process, the manufacturer must submit to FDA a premarket notification demonstrating that the device is “substantially

equivalent” to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments

of 1976 were enacted, and for which a PMA is not required, a device that has been reclassified from Class III to Class II or Class I,

or another commercially available device that was cleared through the 510(k) process.

To be “substantially equivalent,” the

proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the

predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the

predicate device.

Class III devices, high-risk

devices that are often implantable or life-sustaining, also require compliance with the medical device general controls and Quality

System Regulations, and generally must be approved by FDA before entering the market through a PMA application.

Approved PMAs can

include post-approval conditions and post-market surveillance requirements, analogous to some of the special controls that may be

imposed on Class II devices.

Our manufacturing quality

system is required to be in compliance with the Quality System Regulations enforced by FDA and similar regulations enforced by other

worldwide regulatory authorities.

FDA’s Quality System Regulations require manufacturers to follow stringent design, testing, process

control, documentation, and other quality assurance procedures.

Our first generation Aerodentis

System is a Class II medical device, which was cleared by FDA for commercialization in the U.S.

pursuant to the 510(k) notification process

for movement and alignment of teeth during orthodontic treatment of malocclusion in April 2020.

We are preparing to apply for 510(k)

clearance for the updated version of the currently cleared device.

Such updated Platform contains new and/or different components than

the original device, which is why a new 510(k) clearance is required prior to marketing the Platform in the U.S.

We have not yet filed

a 510(k) submission for the Platform, and it has, thus, not been found by the FDA to be substantially equivalent to the first generation

Aerodentis System.

The manufacture, marketing and distribution of the Aerodentis System, as well as our next-generation Platform once

cleared by FDA, if ever, is subject to continuing regulation and enforcement by FDA and other government authorities, which includes

routine FDA inspections of our facilities to determine compliance with facility registration requirements, product listing requirements,

medical device reporting regulations, and Quality System Regulations, among others.

If FDA finds that we have failed to comply with Quality

System Regulations or other legal or regulatory requirements, it or other government agencies may institute a wide variety of enforcement

actions against us, ranging from Warning Letters to more severe sanctions, including but not limited to financial penalties, withdrawal

of 510(k) clearances already granted, and criminal prosecution.

We have passed our International Organization for Standardization (“ISO”)

and Medical Device Single Audit Program (“MDSAP”) certification process and have added the U.S.

to our ISO/MDSAP certification

The 510(k) Process

Under the 510(k) process,

the manufacturer must submit to FDA a premarket notification demonstrating that the device is “substantially equivalent”

to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted,

and for which a PMA is not required, a device that has been reclassified from Class III to Class II or Class I, or another commercially

available device that was cleared through the 510(k) process.

To be “substantially equivalent,” the proposed device must

have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or

have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device.

Clinical data is sometimes required to support substantial equivalence.

a 510(k) premarket notification is submitted, FDA determines whether to accept it for substantive review.

If it lacks necessary information

for substantive review, FDA will refuse to accept the 510(k) notification.

After a 510(k) premarket

notification is submitted, FDA determines whether to accept it for substantive review.

If it lacks necessary information for substantive

review, FDA will refuse to accept the 510(k) notification.

If it is accepted for filing, FDA begins a substantive review.

By statute, FDA is required to complete its review of a 510(k) notification within 90 days of receiving the 510(k) notification.

practical matter, clearance often takes longer, and clearance is never assured.

FDA may require further information, including clinical

data, to make a determination regarding substantial equivalence, which may significantly prolong the review process.

If 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.

a device is cleared or approved for marketing, numerous and extensive regulatory requirements may continue to apply.

These include but

are not limited to:

FDA is required to complete its review of a 510(k) notification within 90 days of receiving the 510(k) notification.

As a practical matter,

clearance often takes longer, and clearance is never assured.

FDA may require further information, including clinical data, to make a

determination regarding substantial equivalence, which may significantly prolong the review process.

If 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.

Post-Market Regulation

After a device is cleared

or approved for marketing, numerous and extensive regulatory requirements may continue to apply.

These include but are not limited to:

and updated establishment registration and device listing with FDA;

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on sale, distribution, or use of a device;

advertising, promotion, and marketing regulations, which require that promotion is truthful,

not misleading, and provide adequate directions for use and that all claims are substantiated,

and also prohibit the promotion of products for unapproved or “off-label” uses

(i.e., indications that are inconsistent with or beyond the scope of the applicable FDA approval

or clearance) and impose other restrictions on labeling;

or approval of product modifications to legally marketed devices that could significantly

affect safety or effectiveness or that would constitute a major change in intended use;

device reporting regulations, which require that a manufacturer report to FDA if a device

it markets may have caused or contributed to a death or serious injury, or has malfunctioned

and the device or a similar device that it markets would be likely to cause or contribute

advertising, promotion, and marketing regulations, which require that promotion is truthful, not misleading, and provide adequate directions

for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label”

uses (i.e., indications that are inconsistent with or beyond the scope of the applicable FDA approval or clearance) and impose other

restrictions on labeling;

or approval of product modifications to legally marketed devices that could significantly affect safety or effectiveness or that would

constitute a major change in intended use;

device reporting regulations, which require that a manufacturer report to FDA if a device it markets may have caused or contributed to

a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute

to a death or serious injury if the malfunction were to recur;

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● post-market

surveillance activities and regulations, which apply when deemed by FDA to be necessary to

protect the public health or to provide additional safety and effectiveness data for the

has broad regulatory compliance and enforcement powers.

If 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:

surveillance activities and regulations, which apply when deemed by FDA to be necessary to protect the public health or to provide additional

safety and effectiveness data for the device.

FDA has broad regulatory

compliance and enforcement powers.

If 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:

letters, untitled letters, fines, injunctions, consent decrees, and civil penalties;

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restrictions or partial suspension or total shutdown of production;

or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified

or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;

● withdrawing

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to grant export or import approvals for our products;

International

countries throughout the world have established regulatory frameworks for marketing and commercialization of medical devices.

As a designer,

manufacturer, and marketer of medical devices, we are obligated to comply with the respective frameworks of these countries to obtain

and maintain access to these global markets.

International Regulation

Many countries throughout

the world have established regulatory frameworks for marketing and commercialization of medical devices.

As a designer, manufacturer,

and marketer of medical devices, we are obligated to comply with the respective frameworks of these countries to obtain and maintain

access to these global markets.

The frameworks often define requirements for marketing authorizations which vary by country.

Failure to obtain appropriate marketing authorization and to meet all local requirements, including specific quality and safety standards

in any country in which we currently market our products, could cause commercial disruption and/or subject us to sanctions and fines.

Delays in receipt of, or a failure to receive, such marketing authorizations, or the loss of any previously received authorizations,

could have a material adverse effect on our business, financial condition and results of operations.

is currently no premarket government review of medical devices in the European Economic Area (“EEA”).

However, all medical

devices placed on the market in the EEA must meet the relevant essential requirements laid down in Annex I of Directive 93/42/EEC concerning

to obtain appropriate marketing authorization and to meet all local requirements, including specific quality and safety standards in

any country in which we currently market our products, could cause commercial disruption and/or subject us to sanctions and fines.

in receipt of, or a failure to receive, such marketing authorizations, or the loss of any previously received authorizations, could have

a material adverse effect on our business, financial condition and results of operations.

There is currently no

premarket government review of medical devices in the European Economic Area (“EEA”).

However, all medical devices

placed on the market in the EEA must meet the relevant essential requirements laid down in Annex I of Directive 93/42/EEC concerning

medical devices, or the Medical Devices Directive.

The most fundamental essential requirement is that a medical device must be designed

and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of

users and others.

In addition, the device must achieve the performances intended by the manufacturer and be designed, manufactured, and

packaged in a suitable manner.

The European Commission has adopted various standards applicable to medical devices.

These include standards

governing common requirements, such as sterilization and safety of medical electrical equipment, and product standards for certain types

of medical devices.

The most fundamental essential requirement is that a medical device must be

designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and

health of users and others.

In addition, the device must achieve the performances intended by the manufacturer and be designed,

manufactured, and packaged in a suitable manner.

The European Commission has adopted various standards applicable to medical

These include standards governing common requirements, such as sterilization and safety of medical electrical equipment,

and product standards for certain types of medical devices.

There are also harmonized standards relating to design and manufacture.

While not mandatory, compliance with these

standards is viewed as the easiest way to satisfy the essential requirements as a practical matter.

Compliance with a standard developed

to implement an essential requirement also creates a rebuttable presumption that the device satisfies that essential requirement.

April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the E.U.

Medical Device Directive and became effective on May 26, 2021.

The Medical Devices Regulation, among other things, is intended to establish

a uniform, transparent, predictable, and sustainable regulatory framework across the EEA for medical devices and ensure a high level

of safety and health while supporting innovation.

While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the essential requirements as a

practical matter.

Compliance with a standard developed to implement an essential requirement also creates a rebuttable presumption

that the device satisfies that essential requirement.

On April 5, 2017, the European

Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the E.U.

Medical Device Directive

and became effective on May 26, 2021.

The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent,

predictable, and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while

supporting innovation.

The new regulations, among other things:

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they are placed on the market.

received our European CE mark and ISO/MDSAP certification in 2019.

In light of our ISO/MDSAP certification, we believe that we are in

substantial compliance with applicable E.U.

regulations and do not anticipate having to make any material expenditures as a result of

or other currently applicable regulatory requirements.

Under Medical Devices Regulation, manufacturing facilities are subject to

periodic inspections by regulatory authorities and must comply with device safety and effectiveness requirements as set forth therein.

To that end, we have implemented controls and procedures intended to ensure that our Access Dental Lab Quality System meets FDA’s

and ISO requirements.

We passed our audit to renew our ISO/MDSAP certification in April 2023.

System Regulations

manufacturing quality system is required to be in compliance with the Quality System Regulations enforced by FDA and similar regulations

enforced by other worldwide regulatory authorities.

FDA’s Quality System Regulations require manufacturers to follow stringent

design, testing, process control, documentation, and other quality assurance procedures.

If FDA finds that we have failed to comply with

Quality System Regulations or other legal or regulatory requirements, it or other government agencies may institute a wide variety of

enforcement actions against us, ranging from Warning Letters to more severe sanctions, including but not limited to financial penalties,

withdrawal of 510(k) clearances already granted, and criminal prosecution.

In addition, under Canadian regulation, manufacturing facilities

are subject to periodic inspections by regulatory authorities and must comply with device safety and effectiveness requirements as required

by the Medical Devices Regulation.

Professional Regulation

ability to conduct business in each state is dependent in part upon that particular state’s treatment of remote healthcare delivery

under such state’s laws, rules and policies governing the practice of dentistry, which are subject to changing political, regulatory

and other influences.

Orthodontists and dentists who provide professional services to a patient via teledentistry must, in most instances,

hold a valid license to practice or to provide treatment in the state in which the patient is located.

In addition, certain states require

an orthodontist or dentist providing telehealth services to be physically located in the same state as the patient.

Failure to comply

with these laws and regulations can give rise to civil or criminal penalties.

We received our European

CE mark and ISO/MDSAP certification in 2019.

In light of our ISO/MDSAP certification, we believe that we are in substantial compliance

with applicable E.U.

regulations and do not anticipate having to make any material expenditures as a result of E.U.

or other currently

applicable regulatory requirements.

Under Medical Devices Regulation, manufacturing facilities are subject to periodic inspections by

regulatory authorities and must comply with device safety and effectiveness requirements as set forth therein.

To that end, we have implemented

controls and procedures intended to ensure that our Access Dental Lab Quality System meets FDA’s and ISO requirements.

our audit to renew our ISO/MDSAP certification in April 2023.

Quality System Regulations

Our manufacturing quality

system is required to be in compliance with the Quality System Regulations enforced by FDA and similar regulations enforced by other

worldwide regulatory authorities.

FDA’s Quality System Regulations require manufacturers to follow stringent design, testing, process

control, documentation, and other quality assurance procedures.

If FDA finds that we have failed to comply with Quality System Regulations

or other legal or regulatory requirements, it or other government agencies may institute a wide variety of enforcement actions against

us, ranging from Warning Letters to more severe sanctions, including but not limited to financial penalties, withdrawal of 510(k) clearances

already granted, and criminal prosecution.

In addition, under Canadian regulation, manufacturing facilities are subject to periodic inspections

by regulatory authorities and must comply with device safety and effectiveness requirements as required by the Medical Devices Regulation.

State Professional Regulation

Our ability to conduct

business in each state is dependent in part upon that particular state’s treatment of remote healthcare delivery under such

state’s laws, rules and policies governing the practice of dentistry, which are subject to changing political, regulatory and

other influences.

Orthodontists and dentists who provide professional services to a patient via teledentistry must, in most

instances, hold a valid license to practice or to provide treatment in the state in which the patient is located.

certain states require an orthodontist or dentist providing telehealth services to be physically located in the same state as the

Failure to comply with these laws and regulations can give rise to civil or criminal penalties.

Federal and State Laws

are also subject to various laws inside and outside the U.S.

concerning our relationships with healthcare professionals and government

officials, price reporting and regulation, the promotion, sales and marketing of our products and services, the importation and exportation

of our products, reimbursement for our products and services, the operation of our facilities, and the distribution of our products.

Initiatives sponsored by government agencies, legislative bodies, and the private sector regarding these matters, including efforts to

limit the growth of healthcare expenses generally, are ongoing in markets where we do business.

It is not possible to predict at this

time the long-term impact of such cost containment and other measures on our future business.

intend to enter into contracts with orthodontists, dentists, or professional corporations to deliver our products and services to their

Such contractual relationships will be subject to various state laws that prohibit the practice of dentistry by lay entities

or persons and are intended to prevent unlicensed persons from interfering with or influencing the orthodontist’s or dentist’s

professional judgment.

In addition, laws in various states also generally prohibit the sharing of professional services income with nonprofessional

or business interests.

Activities other than those directly related to the delivery of healthcare may be considered an element of the

practice of dentistry in many states.

Under the corporate practice of dentistry restrictions of certain states, non-clinical decisions

and activities may implicate the restrictions on the corporate practice of dentistry.

We will continually monitor state requirements

as to what constitutes the practice of dentistry and take steps to ensure that the orthodontists and dentists who utilize our services

and teledentistry platform handle all clinical aspects of their patients’ care to ensure we do not violate those laws and regulations.

a participant in the health care industry we are subject to extensive and frequently changing regulation under many other laws administered

by governmental entities at the federal, state, and local levels, some of which are, and others of which may be, applicable to our business.

Laws regulating medical device manufacturers and health care providers cover a broad array of subjects.

states have fraud and abuse and consumer protection laws that apply to healthcare items or services reimbursed by any third-party payor,

including commercial insurers, not just those reimbursed by a federally funded healthcare program, or apply regardless of payor.

scope of these laws and the interpretations of them vary from state to state and are enforced by state courts and regulatory authorities,

each with broad discretion.

A determination of liability under such laws could result in fines and penalties and restrictions on our

ability to operate in these jurisdictions.

Information Privacy and Security Laws

are numerous U.S.

federal and state laws and regulations related to the privacy and security of PII, including health information.

others, the federal Health Insurance Portability and Accountability Act of 1996, as amended by HITECH, and their implementing regulations,

which we collectively refer to as HIPAA, establish privacy and security standards that limit the use and disclosure of PHI and require

covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality,

integrity, and availability of individually identifiable health information in electronic form, among other requirements.

of HIPAA may result in civil and criminal penalties.

We are also subject to various

laws inside and outside the U.S.

concerning our relationships with healthcare professionals and government officials, price reporting

and regulation, the promotion, sales and marketing of our products and services, the importation and exportation of our products, reimbursement

for our products and services, the operation of our facilities, and the distribution of our products.

Initiatives sponsored by government

agencies, legislative bodies, and the private sector regarding these matters, including efforts to limit the growth of healthcare expenses

generally, are ongoing in markets where we do business.

It is not possible to predict at this time the long-term impact of such cost

containment and other measures on our future business.

We intend to enter into contracts

with orthodontists, dentists, or professional corporations to deliver our products and services to their patients.

Such contractual relationships

will be subject to various state laws that prohibit the practice of dentistry by lay entities or persons and are intended to prevent

unlicensed persons from interfering with or influencing the orthodontist’s or dentist’s professional judgment.

laws in various states also generally prohibit the sharing of professional services income with nonprofessional or business interests.

Activities other than those directly related to the delivery of healthcare may be considered an element of the practice of dentistry

in many states.

Under the corporate practice of dentistry restrictions of certain states, non-clinical decisions and activities may implicate

the restrictions on the corporate practice of dentistry.

We will continually monitor state requirements as to what constitutes the practice

of dentistry and take steps to ensure that the orthodontists and dentists who utilize our services and teledentistry platform handle

all clinical aspects of their patients’ care to ensure we do not violate those laws and regulations.

As a participant in the health

care industry we are subject to extensive and frequently changing regulation under many other laws administered by governmental entities

at the federal, state, and local levels, some of which are, and others of which may be, applicable to our business.

Laws regulating medical

device manufacturers and health care providers cover a broad array of subjects.

Several states have fraud

and abuse and consumer protection laws that apply to healthcare items or services reimbursed by any third-party payor, including commercial

insurers, not just those reimbursed by a federally funded healthcare program, or apply regardless of payor.

The scope of these laws and

the interpretations of them vary from state to state and are enforced by state courts and regulatory authorities, each with broad discretion.

A determination of liability under such laws could result in fines and penalties and restrictions on our ability to operate in these

jurisdictions.

Health Information Privacy and Security

There are numerous U.S.

and state laws and regulations related to the privacy and security of PII, including health information.

Among others, the federal Health

Insurance Portability and Accountability Act of 1996, as amended by HITECH, and their implementing regulations, which we collectively

refer to as HIPAA, establish privacy and security standards that limit the use and disclosure of PHI and require covered entities and

business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability

of individually identifiable health information in electronic form, among other requirements.

Violations of HIPAA may

result in civil and criminal penalties.

We must also comply with HIPAA’s breach notification rule which requires notification

to affected individuals and HHS, and in certain cases to media outlets, in the case of a breach of unsecured PHI.

The regulations also

require business associates of covered entities to notify the covered entity of breaches by the business associate.

attorneys general also have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA standards

have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal

In addition, HIPAA mandates that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates

for compliance.

states also have laws that protect the privacy and security of sensitive and personal information, including health information.

laws may be similar to or even more protective than HIPAA and other federal privacy laws.

For example, the laws of the State of California,

are more restrictive than HIPAA.

Where state laws are more protective than HIPAA, we must comply with the state laws we are subject to,

in addition to HIPAA.

The regulations

also require business associates of covered entities to notify the covered entity of breaches by the business associate.

State attorneys general also

have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA standards have been used as the basis

for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information.

HIPAA mandates that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance.

Many states also have laws

that protect the privacy and security of sensitive and personal information, including health information.

These laws may be similar

to or even more protective than HIPAA and other federal privacy laws.

For example, the laws of the State of California, are more restrictive

Where state laws are more protective than HIPAA, we must comply with the state laws we are subject to, in addition to HIPAA.

California passed the California Consumer Privacy Act or CCPA on June 28, 2018, which went into effect January 1, 2020.

On November 3, 2020, the California Privacy Rights Act of 2020 (“CPRA”), which amends the CCPA and adds new privacy

protections that became effective on January 1, 2023, was enacted through a ballot initiative.

While information we maintain that is

covered by HIPAA may be exempt from the CCPA, other records and information we maintain on our patients may be subject to the CCPA.

certain cases, it may be necessary to modify our planned operations and procedures to comply with these more stringent state laws.

only may some of these state laws impose fines and penalties upon violators, but also some, unlike HIPAA, may afford private rights of

action to individuals who believe their personal information has been misused.

In addition, state and federal privacy laws subject to

frequent change.

addition to HIPAA and state health information privacy laws, we may be subject to other state and federal privacy laws, including laws

that prohibit unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements

on certain types of activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards

and to take certain actions in response to a data breach.

data protection, privacy, and other laws and regulations are often more restrictive than those in the U.S.

The E.U., for example, traditionally

has imposed stricter obligations under its laws and regulations relating to privacy, data protection and consumer protection than the

In May 2018, the General Data Protection Regulation (the “GDPR”), which governs data practices and privacy in the E.U.,

became effective and replaced the data protection laws of the individual member states.

GDPR requires companies to meet stringent requirements

regarding the handling of personal data of individuals in the E.U.

These more stringent requirements include expanded disclosures to

inform members about how we may use their personal data, increased controls on profiling members, and increased rights for members to

access, control and delete their personal data.

On November 3,

2020, the California Privacy Rights Act of 2020 (“CPRA”), which amends the CCPA and adds new privacy protections that became

effective on January 1, 2023, was enacted through a ballot initiative.

While information we maintain that is covered by HIPAA may be

exempt from the CCPA, other records and information we maintain on our patients may be subject to the CCPA.

In certain cases, it may

be necessary to modify our planned operations and procedures to comply with these more stringent state laws.

Not only may some of these

state laws impose fines and penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals

who believe their personal information has been misused.

In addition, state and federal privacy laws subject to frequent change.

In addition to HIPAA and

state health information privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit unfair

privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain

types of activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and

to take certain actions in response to a data breach.

Foreign data protection,

privacy, and other laws and regulations are often more restrictive than those in the U.S.

The E.U., for example, traditionally has imposed

stricter obligations under its laws and regulations relating to privacy, data protection and consumer protection than the U.S.

2018, the General Data Protection Regulation (the “GDPR”), which governs data practices and privacy in the E.U., became effective

and replaced the data protection laws of the individual member states.

GDPR requires companies to meet stringent requirements regarding

the handling of personal data of individuals in the E.U.

These more stringent requirements include expanded disclosures to inform members

about how we may use their personal data, increased controls on profiling members, and increased rights for members to access, control

and delete their personal data.

In addition, there are mandatory data breach notification requirements.

includes significant penalties for non-compliance, which may result in monetary penalties of up to 20 million Euros or 4% of a company’s

worldwide turnover, whichever is higher.

GDPR and other similar regulations require companies to give specific types of notice and informed

consent is required for the placement of a cookie or similar technologies on a user’s device for online tracking for behavioral

advertising and other purposes and for direct electronic marketing, and the GDPR also imposes additional conditions in order to satisfy

such consent, such as a prohibition on pre-checked consents.

The law also includes significant

penalties for non-compliance, which may result in monetary penalties of up to 20 million Euros or 4% of a company’s worldwide turnover,

whichever is higher.

GDPR and other similar regulations require companies to give specific types of notice and informed consent is required

for the placement of a cookie or similar technologies on a user’s device for online tracking for behavioral advertising and other

purposes and for direct electronic marketing, and the GDPR also imposes additional conditions in order to satisfy such consent, such

as a prohibition on pre-checked consents.

It remains unclear how the U.K.

data protection laws or regulations will

develop in the medium to longer term and how data transfer to the U.K.

data protection laws or regulations will develop in the medium

to longer term and how data transfer to the U.K.

from the E.U.

will be regulated.

Outside of the E.U., there are

many other countries with data protection laws, and new countries are adopting data protection legislation with increasing frequency.

Many of these laws may require consent from individuals for the use of data for various purposes, including marketing, which may reduce

our ability to market our products.

is no harmonized approach to these laws and regulations globally.

Consequently, we increase our risk of non-compliance with applicable

foreign data protection laws and regulations when we expand internationally.

We may need to change and limit the way we use personal

information in operating our business and may have difficulty maintaining a single operating model that is compliant.

Compliance with

such laws and regulations will result in additional costs and may necessitate changes to our business practices and divergent operating

models, limit the effectiveness of our marketing activities, adversely affect our business, results of operations, and financial condition,

and subject us to additional liabilities.

Environmental

have no material expenditures for compliance with Federal, State or local provisions regulating the discharge of materials into the environment,

or otherwise relating to the protection of the environment.

of August 14, 2023, we had 3 full-time employees and 1 part-time employee.

principal executive offices are located at Shatner Street 3, Jerusalem, Israel, and our telephone number is +972 (0)74-700-6700.

web page address is www.aerodentis.com.

References to our website address do not constitute incorporation by reference of the information

contained on the website, and the information contained on the website is not part of this document or any other document that we file

with or furnish to the SEC.

Outside of the E.U., there are many other countries

with data protection laws, and new countries are adopting data protection legislation with increasing frequency.

Many of these laws may

require consent from individuals for the use of data for various purposes, including marketing, which may reduce our ability to market

our products.

There is no harmonized

approach to these laws and regulations globally.

Consequently, we increase our risk of non-compliance with applicable foreign data

protection laws and regulations when we expand internationally.

We may need to change and limit the way we use personal information

in operating our business and may have difficulty maintaining a single operating model that is compliant.

Compliance with such laws

and regulations will result in additional costs and may necessitate changes to our business practices and divergent operating

models, limit the effectiveness of our marketing activities, adversely affect our business, results of operations, and financial

condition, and subject us to additional liabilities.

Environmental Matters

We have no material expenditures

for compliance with Federal, State or local provisions regulating the discharge of materials into the environment, or otherwise relating

to the protection of the environment.

As of December 31, 2024,

we had 3 full-time employees and 1 part-time employee.

What changed 10-K

Item 1. Business