What changed in this filing

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Item 1. Business

2026-02-27 compared with 2025-02-19 · 411 added, 468 removed, 222 unchanged (80% of the section changed)

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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.

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

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 of 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.

We have reimagined the way people can correct their

We plan to disrupt the aligner

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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.

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.

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 correction.

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

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.

The name “ZSmile” is intended to communicate that people

can correct their smile while they sleep or colloquially “getting some zzz’s”.

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.

The Platform is a Class II medical device which received 510(k) clearance from the FDA for commercialization

pursuant to the 510(k) notification process in February 2026, being substantially equivalent to the Aerodentis System.

Platform, represents an improvement upon the Aerodentis System, which is also a Class II medical device which received 510(k) clearance

from the FDA in April 2020.

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.

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

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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.

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.

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.

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

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

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.

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

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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.

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.

Building on the Aerodentis System, we developed

a more advanced product called “ZSmile.” This is our next generation, comprehensive enhanced solution to Class 1 and Class

2 malocclusion for which we received 510(k) clearance to market and sell in the U.S.

as of February 2026.

The new ZSmile Platform was

developed over the course of two years 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 refers 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:

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 System”).

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.

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 technology.

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.

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.

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.

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.

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.

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.

Smart Aligner System

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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 device is thus designed to communicate with the patient’s smartphone as well as the ZSmile AI Cloud and the designated

dental professional.

The clear aligner of a patient’s

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second generation device ZSmile

ZSmile depicted

being used while sleeping

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

most prevalent clinical dental conditions in the world, affecting approximately 56% of the global population.

1 This translates

into approximately 4.6 billion people globally with malocclusions who could benefit from straightening their teeth.

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 0.46% 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.

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of their treatments.

Alhammadi, Maged Sultan, et al.

“Global distribution of malocclusion traits:

A systematic review.” Dental press journal of

orthodontics 23 (2018):

Business Insight.

The global clear aligners market is projected to grow from $3.80 billion in 2023 to $17.27 billion by 2030, at a CAGR

of 24.2% during the forecast period, 2023-2030 (June 2023), available at https://www.fortunebusinessinsights.com/industry-reports/clear-aligners-market-101377.

Chen, Healthcare (MDPI) 2024 “Prevalence of Malocclusion Traits in Primary Dentition, A Systematic Review” https://www.mdpi.com/2227-9032/12/13/1321

2 https://www.fortunebusinessinsights.com/industry-reports/clear-aligners-market-101377.Calculation

based on global population of 8.3 billion:

https://www.worldometers.info/demographics/world-demographics/

Global Orthodontic Supplies Market Report 2024 – Improving Oral Health Care, available at https://meditechinsights.com/global-orthodontic-supplies-market/.

According to a 2025 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

conducted by Grand View Research (the “Grand View Research 2025 Study”), the global clear aligners market size was estimated

at $8.3 billion in 2025 and is projected to reach $56.8 billion by 2033, growing at a CAGR of 26.95% from 2026 to 2033.

Grand View Research Study, 2025

Our Platform seeks to address

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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:

Adults, Teenagers;

At-home aligners/Direct-to-consumer (DTC) Aligners, In-office Aligners;

Hard Type, Medium Type, Soft Type;

By Material Type:

Polyurethane, Plastic Polyethylene Terephthalate Glycol, Poly-vinyl

By Distribution Channel:

Direct Sales, Laboratories, Others;

Hospitals, Standalone Practices, Group Practices,

Others) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2022-2030 (October 2022), available at

https://www.precedenceresearch.com/clear-aligners-market.

Precedence Research Study, 2022

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

36% of dentists were already performing orthodontic procedures such as the malocclusion corrections.

5 This is an indication

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 involvement.

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 could benefit from

using ZSmile to correct their smiles.

Based on the Grand View Research 2025 Study, 30% of a $56.8 billion market represents a potential

addressable market of $17 billion.

4 https://www.grandviewresearch.com/industry-analysis/clear-aligners-market

Based on Grand View Research Study,

2025 and the potential of ZSmile to be able to treat 30% of cases

ZSmile targets the General Dentists Market as well as Orthodontists

Our total 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 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 significantly expands our target distribution channel to cover both orthodontists and dentists.

For example, in 2024 there were 10,830 licensed orthodontists in the U.S.

while there were 159,562 general practice dentists, based on American Dental Association (ADA) via Statista.

5 https://www.statista.com/statistics/1114666/number-of-active-dentists-by-practice-area-us/

15 X larger addressable market:

General practice dentists outnumber orthodontists

approximately 15 to 1.

By enabling GP dentists to deliver orthodontic treatment through ZSmile, the Company’s total addressable practitioner

market expands significantly.

American Dental Association (ADA)

via Statista, reporting 2024

Business Model

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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

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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.

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

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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.

The Platform is designed to

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

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

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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.

enable the manufacture of our smart aligner systems in volume.

Part of our development efforts will be focused on the 3D printing of our

smart aligner, which we believe to be feasible within a year and which we expect will greatly increase manufacturing efficiency.

As of December 2025, 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 headed by Avi Kayton, a skilled development manager and systems engineer with 16 years of experience, including extensive experience

in medical device companies.

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

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

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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 3D printing.

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.

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

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

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.

Our business is generally

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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.

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.

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

We believe that the principal

competitive factors in the market for orthodontic appliances include:

and financing options;

and convenience;

appeal of the treatment method;

associated with the treatment method;

and effectiveness of treatment;

● orthodontist

price and financing options;

access and convenience;

aesthetic appeal of the treatment method;

comfort associated with the treatment method;

duration and effectiveness of treatment;

orthodontist chair time.

We believe that our Platform

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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;

labeling, content and language of instructions for use and storage;

storage and safety;

sales and distribution;

clearance and approval;

keeping procedures;

● advertising

and promotion;

and field safety corrective actions;

● post-market

surveillance;

● post-market

approval studies;

import and export

Our products (both the first

generation Aerodentis system and the ZSmile Platform) 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:

design, development and manufacturing;

testing, labeling, content and language of instructions for use and storage;

product storage and safety;

marketing, sales and distribution;

pre-market clearance and approval;

record keeping procedures;

advertising and promotion;

recalls and field safety corrective actions;

post-market surveillance;

post-market approval studies;

product import and export

FDA Regulation

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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

and effectiveness can be assured by adherence to FDA’s medical device general controls, including labeling, establishment registration,

device product listing, adverse event reporting, and, for some products, adherence to good manufacturing practices through FDA’s

Quality System Regulations.

II devices, moderate-risk devices, also require compliance with general controls and in some cases, special controls as deemed necessary

by FDA to ensure the safety and effectiveness of the device.

These special controls may include performance standards, particular labeling

requirements, or post-market surveillance obligations.

While most Class I devices are exempt from the 510(k) premarket notification requirement,

typically a Class II device also requires pre-market review and 510(k) clearance as well as adherence to the Quality System Regulations/good

manufacturing practices for devices.

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.

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:

Class I devices, the lowest-risk FDA device classification, include devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to FDA’s medical device general controls, including labeling, establishment registration, device product listing, adverse event reporting, and, for some products, adherence to good manufacturing practices through FDA’s Quality System Regulations.

Class II devices, moderate-risk devices, also require compliance with general controls and in some cases, special controls as deemed necessary by FDA to ensure the safety and effectiveness of the device.

These special controls may include performance standards, particular labeling requirements, or post-market surveillance obligations.

While most Class I devices are exempt from the 510(k) premarket notification requirement, typically a Class II device also requires pre-market review and 510(k) clearance as well as adherence to the Quality System Regulations/good manufacturing practices for devices.

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.

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

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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

Our updated Platform, which contains new

and/or different components than the original device, received 510(k) clearance in February 2026, qualifying it to be marketed in the

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

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,

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.

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.

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.

data is sometimes required to support substantial equivalence.

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.

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.

By statute, 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

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These include but are not limited to:

and updated establishment registration and device listing with FDA;

System Regulation requirements, which require manufacturers to follow stringent quality assurance procedures during all aspects of the

design and manufacturing process;

● restrictions

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

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

● correction,

removal, and recall reporting regulations, and FDA’s recall authority;

with the federal law and regulations requiring Unique Device Identifiers on devices;

● 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 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;

withdrawals, or administrative detention, or seizure of our products;

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 products;

● withdrawing

510(k) clearances or PMA approvals that have already been granted;

to grant export or import approvals for our products;

annual and updated establishment registration and device listing with FDA;

Quality System Regulation requirements, which require manufacturers to follow stringent quality assurance procedures during all aspects of the design and manufacturing process;

restrictions on sale, distribution, or use of a device;

labeling, 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;

clearance 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;

medical 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;

correction, removal, and recall reporting regulations, and FDA’s recall authority;

complying with the federal law and regulations requiring Unique Device Identifiers on devices;

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 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:

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

recalls, withdrawals, or administrative detention, or seizure of our products;

operating restrictions or partial suspension or total shutdown of production;

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

withdrawing 510(k) clearances or PMA approvals that have already been granted;

refusal to grant export or import approvals for our products;

criminal prosecution.

International Regulation

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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.

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.

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

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.

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.

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.

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.

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.

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.

Medical Device Directive and

became effective on May 26, 2021.

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

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The new regulations, among other things:

the rules on placing devices on the market and reinforce surveillance once they are available;

explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance, and safety of devices placed

on the market;

the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

up a central database to provide patients, healthcare professionals, and the public with comprehensive information on products available

rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before

they are placed on the market.

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.

strengthen the rules on placing devices on the market and reinforce surveillance once they are available;

establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance, and safety of devices placed on the market;

improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

set up a central database to provide patients, healthcare professionals, and the public with comprehensive information on products available in the E.U.;

strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

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.

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.

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.

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

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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.

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.

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.

Federal and State Laws

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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.

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

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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.

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.

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

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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.

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

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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.

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.

State attorneys general also

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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.

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

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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.

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.

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.

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

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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.

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.

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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.

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

2 unchanged sentences

to the protection of the environment.

As of December 31, 2024,

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

As of December 31, 2025, we

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

What changed 10-K

Item 1. Business