What changed in this filing

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Item 1. Business

2024-03-22 compared with 2023-03-31 · 1078 added, 213 removed, 5 unchanged (100% of the section changed)

Item 1 Business.

We are a medical robotics company developing a

fully autonomous medical robotic system using proprietary software which integrates Artificial Intelligence (“ AI ”)

and Deep Learning, or machine learning, (“ DL ”).

By using an AI and DL enhanced software program, we are creating an

intelligent robotic system that we believe can “ robotize ” a wide range of medical procedures currently being performed

by human hands.

We are concentrating our research and development efforts to meet rising expectations of patients and practitioners alike

for the precision, safety and speed offered by an AI enhanced robotics platform system that can be combined with proven medical devices,

end-effectors and surgical instruments.

We believe that progress in mechanical and software

engineering has made possible lightweight and relatively inexpensive robotic devices for difficult procedures in various medical fields.

Medical robots are already being successfully employed in several areas of surgery, including Urology (Prostate), Colo-Rectal, Gynecology,

Thoracic, General Surgery, Orthopedics, and Neuro and Spine Surgery.

Robots are also being used for Telemedicine and assistive robotic

methods are addressing the delivery of healthcare in inaccessible locations, ranging from rural areas lacking specialist expertise to

post-disaster scenarios, and battlefield areas.

With the aging population dominating demographics in the U.S.

across all spectrums of

healthcare, robotic technologies are being developed toward promoting improved function, lower morbidity and improved overall outcomes.

We are developing a treatment-independent autonomous

robotics system utilizing our proprietary AI-driven precision guidance system, applicable to a variety of minimally and non-invasive procedures,

with an initial focus on skin resurfacing aesthetic procedures utilizing several FDA approved skin enhancing techniques robotized for

superior performance and optimal results.

Our medical robotic system is being developed to deliver skin resurfacing treatments, such as

micro-needling and laser therapies with improved efficiency, accuracy and precision over current procedures conducted by human hand, and

only requiring the doctor to input or just confirm treatment parameters.

As a result, use of our medical robotic system is expected to

provide improved quality and safety as well as improve patient throughput and workflow.

Our autonomous medical robotics system is being

developed to be compatible with available FDA approved surgical tools and end-effectors, enabling us to initially penetrate a sizable

and fast-growing aesthetics market, which includes micro-needling and laser solutions.

Our robotics system will allow doctors, and anyone

permitted to treat patients, defined at the State level, such as a licensed aesthetician, to treat damaged skin autonomously by delivering,

for example, micro-needling to the skin.

The micro-needling catalyzes the natural process of collagen remodeling, consisting of formation

of new collagen, elastin, and vascularization in the papillary dermis, similar to the effect of laser treatments.

We expect our robotic system to eliminate

many of the common errors that occur during handheld procedures, such as over- or under- exposure of the needles or energy-based instruments

that can have terrible cosmetic results and even injure the patient.

In addition, our system is being designed to continuously adjust

treatment parameters, such as penetration depth, time, and energy in order to individualize the outcome based on our algorithms.

system has been designed and developed through a seamless collaboration of the surgeon, the engineer and the scientist.

Since the medical

robotic industry has progressed greatly in miniaturization, adaptability and lower costs, we believe that the Avra “ brains ”

technology component can lead to dramatic opportunities in all of medicine.

The advantages of robotizing already FDA approved

aesthetic devices are many.

In contrast to a human using a handheld device, our aesthetics robotic system has the potential to perform

each and every procedure with unsurpassed precision without constraint of age, proficiency, experience or fatigue.

Likewise, in many skin

related treatments the amount of energy delivered, distance and/or depth of the instrument to, or into, the skin, and treating only the

affected area are critical to the outcome.

The robotic system can maintain these parameters with unparalleled accuracy.

The system can

also replicate the same procedure time and again precisely.

Delivery of certain aesthetic treatments by robotic systems is believed to

be the most efficient option, requiring fewer visits per patient while increasing patient throughput — a benefit for patients and

practitioners alike.

Advantages of using our medical robotic approach

to procedures include:

cost per treatment.

treatment accuracy.

treatment outcomes.

patient throughput and revenue generation for the physician.

multi-platform integration.

shortfall of physicians/surgeons.

future integration of medical and technological advancements such as molecular biologics.

We believe that our initial medical robotic system

for the aesthetics market should find rapid acceptance based on the aforementioned advantages of using the attribute of robotics versus

traditional manual applications.

Furthermore, there is general acceptance by consumers for fee-for-service cash payments in the facial

aesthetics market thereby avoiding medical insurance reimbursement issues.

Our medical robotic system utilizes a robotic arm that has

7-degrees of freedom integrated with our proprietary AI-driven control software and algorithms.

The robotic arm was designed and built

under the required medical device standards of the U.S.

Food and Drug Administration (the “ FDA ”).

Our strategy is to

integrate the robotic arm with FDA approved devices, which is expected to allow for a more expedited approval of the integrated system.

We believe that the FDA approval process will primarily focus upon validation of the medical robotic system’s software control.

This could lead to a less onerous, more de-risked regulatory path to approval, particularly if strong preclinical results are achieved.

Subsequent to the completion of the FDA preclinical work, estimated to take six months, we believe that we will be able to additionally

modify and robotize certain non-invasive instruments that do not require FDA approvals and proceed to the cosmetic treatments marketplace.

This action could sharply reduce the time to commercial operations and revenues.

We previously retained the services of The Horizon

Phoenix Group (“ HPG ”), a consulting firm experienced in securing U.S.

and foreign regulatory approvals for medical

devices, in order to initiate the regulatory process.

Working with HPG, we prepared and filed an application with the FDA for our initial

medical robotic system and in August 2019 held an initial pre-collaboration meeting with the FDA.

We believe that this is the first of

a series of meetings where the Avra system and its regulatory requirements will be discussed in ever-increasing specificity.

allow for a more focused regulatory process, saving both resources and time.

The robotic arm that we intend to utilize for our system

has already been granted approval in the EU and received a CE mark.

We have begun implementing a quality and regulatory system that will

serve as the foundation for U.S., Canadian, European, Australian, Japanese, and Brazilian market access for our medical robotic system.

The Medical Device Single Audit Program(“ MDSAP ”), which we plan to employ, is a single inspection that, when completed,

is expected to support market access to these six most important medical device marketplaces.

Since 2016, we had a research partnership with

the University of Central Florida (“ UCF ”) to develop a prototype intelligent medical robotic system.

UCF is recognized

particularly for its work in the area of medical robotic research and design, with a focus on the guidance systems.

Avra has paid UCF

a one-time fee for outright ownership of work developed by UCF in the collaboration.

The Research Agreement was extended several times

and expired on April 30, 2021.

To further the depth of our research and development we also began a partnership in 2021 with Florida Polytechnic

University and are actively working with them on developing our system.

Avra recently brought in two Associate Professors and three graduates

to join Avra’s engineering development team.

Effective October 11th, 2021 Avra executed a Sponsored Student Project Agreement which

includes two payments of $8,030 each covering Fall semester in 2021 and Spring semester in 2022.

Recent Developments

On November 7, 2022, AVRA entered into a definitive

Merger Agreement (the “ Merger Agreement ”), by and among AVRA, AVRA-SSI Merger Corporation, a Delaware corporation

and wholly-owned subsidiary of AVRA (“ Merger Sub ”), CardioVentures, Inc., a Delaware corporation (“ SSI -

Sudhir Srivastava (“ Dr.

Srivastava ”), who, through his holding company, owns a controlling interest

SSI-DE, through a subsidiary, owns a controlling

interest in Sudhir Srivastava Innovations Pvt.

Ltd., an Indian private limited company (“ SSI - India ”).

Based in Haryana,

India, SSI-India is engaged in the development, commercialization, manufacturing and sale of medical and surgical robotic systems utilizing

patents, trademarks and other intellectual property held by Dr.

Srivastava (the “SSI Intellectual Property”).

Pursuant to the Merger Agreement, Merger Sub

will merge with and into SSI – DE (the “ Merger ”).

In the Merger, holders of the outstanding shares of common

stock of SSI – DE at closing (including certain parties providing Interim Financing as described below), will receive in exchange

for their SSI – DE shares, such number of shares of AVRA common stock as will result in such holders owning 95% of the outstanding

post-Merger shares of AVRA common stock, with the current shareholders of AVRA owning 5% of the outstanding post-Merger shares of AVRA

common stock.

In addition to the foregoing, upon completion

of the Merger, the holders of SSI – DE common stock will receive, pro rata, shares of newly designated Series A Non-Convertible

Preferred Stock (the “ Series A Preferred Shares ”).

The Series A Preferred Shares will vote together

with Shares of our common stock as a single class on all matters presented to a vote of stockholders, except as required by law and entitle

the holders of the Series A Preferred Shares to exercise 51.0% of the total voting power of the Company.

The Series A Preferred Shares

are not convertible into common stock, do not have any dividend rights and have a nominal liquidation preference.

Company Background

We design, develop, manufacture and market surgical

robotic systems including the SSi Mantra Surgical Robotic System and its associated instruments and accessories.

Our vision is to create

new, technologically advanced systems that will surpass existing surgical robotic systems to provide cost effective surgical solutions

to benefit greater numbers of patients around the world.

Robotic surgical procedures have achieved acceptance

globally over the past two decades because they generally offer a faster recovery period, result in less post-operative pain and discomfort,

provide for greater precision, reduce the risk of infection, result in minimal blood loss and permit the use of smaller incisions.

the global market penetration for surgical robotic systems has in large part been limited to developed countries due to the high costs

and steep learning curve for the existing systems.

The SSi Mantra was specifically developed from the ground up to address these issues

by providing an advanced, affordable and accessible surgical robotic system.

We commenced development of the SSi Mantra

in 2014, received regulatory approval for its sale and use in India and commercially launched sales in August 2022.

The SSi Mantra

has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries

in more than fifty different types of surgical procedures in India without any device related adverse events.

As of December 31,

2023, we have installed 23 systems, of which twenty-one are located in India, one in Dubai and one at the Johns Hopkins Hospital in

Baltimore, Maryland for clinical training and ongoing research and development.

The SSi Mantra system installed in the Minimally

Invasive Lab at Johns Hopkins Hospital in Baltimore, Maryland is being used for training and research purposes only and not for use

in any clinical procedures on human patients and therefore did not require any regulatory approvals.

Following approval by the

Indian regulatory body (CDSCO), the systems commercially installed in India have been used to perform more than seven-hundred

surgical procedures, including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries.

SSi Mantra Surgical Robotic System has additionally been granted regulatory approval in Guatemala.

However, as of the date of this

report, no systems have been installed in Guatemala.

We have initiated the process to obtain regulatory approvals in the United

States from the Food and Drug Administration (the “ FDA ”) and in the European Union.

We have filed a

pre-submission application with the FDA requesting feedback on the SSi Mantra Surgical Robotic System.

We received an

acknowledgement of this pre-submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17,

2024, and we have a feedback meeting scheduled with the FDA on April 2, 2024.

We have also been in discussions with an EU Notified

body for the CE certification.

There can be no assurance as to when we will secure such regulatory approvals, if at all.

13485 (quality management system) approval, CDSCO approval for the manufacture, sale and distribution of our products and our Indian export license allow us to market our products in fifty non-FDA and non-EU countries without further regulatory approvals.

additional seventy-nine countries require only minimal registration.

Corporate Information

The Company was incorporated in the state of Florida

on February 4, 2015, under the name “ Avra Surgical Microsystems, Inc., ” and changed its name to “ Avra Medical

Robotics, Inc.

” on November 5, 2015.

From inception through April 13, 2023, we were

engaged in developing a fully autonomous medical robotic system using proprietary software which integrated Artificial Intelligence and

Deep Learning, or Machine Learning.

Our research and development efforts were based in Orlando, Florida, where we established a research

partnership with the University of Central Florida.

On April 14, 2023, we consummated the acquisition

of CardioVentures, Inc., a Delaware corporation (“ CardioVentures ”), pursuant to a Merger Agreement dated November 7,

2022 (the “ Merger Agreement ”), by and among the Company, a wholly owned subsidiary of the Company (“ Merger

Sub ”), CardioVentures and Dr.

Sudhir Srivastava, who, through his holding company, owned a controlling interest in CardioVentures.

CardioVentures, through a subsidiary, owned a

controlling interest in Sudhir Srivastava Innovations Pvt.

Ltd., an Indian private limited company, which developed and manufactures and

markets the SSi Mantra, which is designed to provide an advanced, yet cost-effective surgical robotic system which make the benefits of

robotic surgery available to a larger part of the global population.

Pursuant to the Merger Agreement, at Closing,

Merger Sub merged with and into CardioVentures (the “ CardioVentures Merger ”).

In the CardioVentures Merger, holders

of the outstanding shares of common stock of CardioVentures (including certain parties who provided interim convertible financing during

the pendency of the Merger Agreement, were issued 135,808,884 shares of SSi common stock, representing approximately 95% of issued and

outstanding shares of SSi common stock post-merger, with the existing shareholders of SSi holding approximately 6,544,344 shares of SSi

common stock representing approximately 5% of issued and outstanding shares of SSi common stock post-merger.

In addition, the holder of CardioVentures common

stock also received shares of newly designated Series A Non-Convertible Preferred Stock (the “ Series A Preferred Shares ”),

which affords the holder 51% of the total voting power of the Company.

As a result of the foregoing, a “ Change in Control ”

of the Company occurred, with Dr.

Sudhir Srivastava becoming the Company’s principal and controlling stockholder.

The Series A Preferred

Shares also have certain protective provisions, such as requiring the vote of a majority of Series A Preferred Shares to change or amend

their rights, powers, privileges, limitations and restrictions.

The Series A Preferred Shares are automatically redeemable by the Company

for nominal consideration at such time as the holder owns less than 50% of the shares of AVRA common stock received in the Merger.

Concurrent with consummation of the Merger, Dr.

Srivastava will assign the SSI Intellectual Property being utilized by SSI – India in the development, manufacture and sale of its

robotic surgical system to a subsidiary of AVRA.

In exchange for such assignment, Dr.

Srivastava will receive a royalty of three percent

(3%) of net revenues (gross revenues less cost of goods sold) generated from the sale or license of products using the SSI Intellectual

In addition, at closing, the current directors

and executive officers will resign, other than Barry Cohen, who will continue as a director and in a new executive capacity, and the designees

of the SSI – DE stockholders will be appointed to AVRA’s board of directors and management.

Post – Merger, AVRA intends

to focus a significant part of its efforts on expanding and further developing the business of SSI-India, which will be an indirect majority-owned

subsidiary of AVRA.

In addition to customary closing conditions, consummation

of the Merger is subject to the following conditions to be satisfied or waived by SSI – DE and Dr.

Srivastava at or prior to consummation

of the Merger:

● AVRA shall have changed its corporate name to “SS Innovations,

● AVRA shall have implemented a one for ten reverse stock split;

● AVRA shall have increased its authorized common stock to

250,000,000 shares.

The Merger Agreement, the Merger and the above

corporate actions have been approved by AVRA’s board of directors and majority stockholders.

They are subject to the final processing

of an Issuer Company – Related Action Notification Form, which we have filed with the Financial Industry Regulatory Authority and

the filing of appropriate amendments to our Articles of Incorporation with the Florida Secretary of State.

Interim Financing

As contemplated by the Merger Agreement, pending

consummation of the Merger, we have provided SSI – DE and its affiliates, a total of $5,000,000 in interim financing as of the date

of this Report (the “ Interim Financing ”).

The Interim Financing is evidenced by one-year promissory Notes made in favor

of the Company by SSI-DE and its affiliates, including Dr.

Srivastava, jointly and severally (the “ SSI Notes ”).

on the SSI Notes accrues at the rate of 7% per annum, payable together with the principal amount at maturity.

The SSI Notes have an original

issue discount of 10% for the first $2,000,000 and 6% for the balance.

If the SSI Notes are not repaid in full on or at maturity, they

will automatically convert into a percentage equity interest in SSI-DE determined by dividing the principal amount of accrued interest

on the SSI Notes divided by $100 million.

The SSI Notes contain customary default provisions and other typical terms and conditions.

Prior to consummation of the Merger, we may make

additional advances to SSI – DE and its affiliates, evidenced by additional SSI Notes.

These SSI Notes will be substantially similar

in form and substance to the initial SSI Notes, provided, however, that SSI Notes issued in excess of an aggregate principal amount of

$2,000,000, will have an original issue discount of 6% as opposed to 10%, and the valuation for determining conversion may be $250 million

as opposed to $100 million.

In order to fund the Interim Financing, the Company

offered and sold to two accredited investors, a total of $3,000,000 and $2,000,000 in principal amount of one-year convertible promissory

notes (the “ Convertible Notes ”), respectively.

The Convertible Notes will have the same interest rate and payment terms

as the SSI Notes and otherwise be substantially similar to the SSI Notes, provided, however, that the Convertible Notes do not have an

original issue discount.

Further, upon consummation of the Merger (if and when it is consummated) the Convertible Notes will automatically

convert into a number of shares of AVRA common stock determined by dividing the principal amount of the Convertible Notes by $100 million

and multiplying such number expressed as a percentage by the number of AVRA shares of common stock issued to the stockholders of SSI-DE

upon consummation of the Merger.

The Convertible Notes were issued in private transactions

pursuant to the exemptions from registration under Section 4(a)2 of the Securities Act of 1933, as amended and the rules and regulations

promulgated thereunder.

Pending the Merger, each of AVRA and SSI–DE

and its affiliates may seek to secure additional equity or debt financing, including, without limitation, further Interim Financing.

As of the date of this report the Company has two full-time and three

part-time employees, including certain executive officers.

We also rely on independent third-party consultants to perform additional services

Shares are automatically redeemed by the Company for nominal consideration at such time as the holder owns less than 50% of the shares

issued to it in connection with the CardioVentures Merger.

Contemporaneously with the Closing on April 14,

2023, the Company changed its name to “ SS Innovations International, Inc., ” effected a one-for-ten reverse stock split

and increased its authorized common stock to 250,000,000 shares.

In connection with the consummation of the CardioVentures

Sudhir Srivastava, through his holding company, assigned all patents, trademarks and other intellectual property used in the

development, commercialization, manufacturing and sale of its medical and surgical robotic systems and products to one or more wholly

owned subsidiaries of SSi.

Our principal executive offices are located at

404-405, 3 rd Floor, iLabs Info Technology Centre, Udyog Vihar, Phase III, Gurugram, Haryana 122016, India.

Our telephone number

is +91 73375 53469.

Our corporate website is https://ssinnovations.com.

Information appearing on our corporate website is not part of

this prospectus and is not incorporated by reference herein.

We have included our website address as an inactive textual reference only.

The SSi Mantra

The SSi Mantra Surgical Robotic System is designed

to enable surgeons to perform a wide range of surgical procedures including cardiovascular, thoracic, head and neck, gynecological, urological,

cancer and general surgeries.

The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use

to perform robotically assisted surgeries in more than fifty different types of surgical procedures in India without any device related

adverse events.

As of the date of this Annual Report, surgeons have performed approximately 800 surgical procedures in India in a wide

array of fields using the SSi Mantra, including many complex surgeries.

The SSi Mantra offers the entire operating room staff three-dimensional,

high definition (“ 3DHD ”) vision, and gives the surgeon a magnified view up to ten times magnification.

Our system uses

specialized instrumentation, including a miniaturized surgical camera (endoscope) and wristed instruments (for example, scissors, scalpels

and forceps) that are designed to help with precise dissection and reconstruction of anatomical structures within the body.

The SSi Mantra is comprised of the following components:

Surgeon Console .

The SSi Mantra allows

surgeons to operate while comfortably seated at an ergonomic open-faced console.

Surgeons use a special pair of passive 3D glasses to

view a 3DHD image of the surgical field on a 32-inch 3D 4K resolution monitor with up to ten (10) times magnification, resulting in significantly

enhanced vision for the surgeon.

The surgeon also has a second large 23-inch 2D touch monitor for system controls and DICOM applications.

The surgeon’s fingers grasp extremely precise ergonomic hand controls, with the surgeon’s hands naturally positioned relative

to his or her eyes, thereby minimizing strain during the surgeon’s movements.

Using electronic hardware, software, algorithms and

mechanics, our technology translates the surgeon’s hand movements into precise and corresponding real-time movements of the SSi

Mantra instruments positioned inside the patient.

When using the SSi Mantra, the surgeon is able to sit in an ergonomic position and can

see both the specific positioning of his or her hands and feet, thereby reducing the learning curve and maintaining comfortable ergonomics

during the surgical procedure.

In addition, the SSi Mantra’s robotic arms hold the camera and instruments steady, offering greater

stability for surgeons and operating room staff.

Patient-Side Robotic Arm Carts .

arm carts are modular in design with robotic arms mounted on individual carts, each with a maximum height of 7.2 feet.

The modular design

offers the flexibility of cart and robotic arm positioning to provide better placement in relation to the procedure and avoid collisions.

Further, there is the option of using three, four or five robotic arm configurations based on the users’ preference and specific

surgical procedures.

Each robotic arm cart includes stability via parking locks, freedom of patient docking and advanced touch-screen

Each robotic arm cart has a built-in auto-leveling feature which allows each individual arm cart to be perfectly horizontally

level with respect to uneven floor surfaces that may be present in an operating room.

The vision cart provides

an additional 32-inch 3D 4K resolution monitor, identical to the surgeon’s console, for the operating room staff.

While wearing

the 3D glasses, the entire operating team can view what the surgeon sees with the same depth perception.

This ability also helps in reducing

the entire team’s learning curve and translates into a safer and more efficient exchange of instruments and introduction of supplies

required in surgery.

The vision cart also houses the control system for the articulating endoscope and camera and pre-operative guidance

It has uninterruptible power supply battery backup, universal safety features and incorporates an Omni 3DHD multimedia recording

and streaming platform.

Tele-Proctoring/Tele-Mentoring Capabilities .

The SSi Mantra

has a built-in live streaming platform, which provides for remote proctoring, thereby resulting in efficient and cost-effective teaching

and training capabilities.

Instruments and Accessories

We offer a comprehensive suite of stapling, energy

and core instrumentation for our surgical systems, under the brand name of SSi Mudra.

Mudra Technology .

The technology employed

in our instruments is designed to transform the surgeon’s natural hand movements outside of the body into corresponding controlled

movements inside the patient’s body, just as would be available to the surgeon in open surgery.

With our technology, a surgeon

can also use “motion scaling,” a feature that translates, for example, a three-centimeter hand movement outside the patient’s

body into a one-centimeter instrument movement in the surgical field inside the patient’s body.

Motion scaling is designed to allow

precision and control for delicate tasks.

In addition, the advanced software technology of the robotic system filters and eliminates

any tremors that may be present in a surgeon’s hands.

Mudra Instruments .

Most of the more than

30 instruments that we manufacture incorporate Mudra technology with wristed joints for natural dexterity and tips customized for

various surgical procedures.

Mudra instruments are offered in an 8mm diameter.

Various Mudra instrument tips include forceps, scissors,

electrocautery tools, scalpels and other surgical tools that are familiar to the surgeon from open surgery and conventional minimally

invasive surgery (“ MIS ”).

We have also developed and made available a variety of cardiac surgery specific instruments.

A variety of instruments may be selected and used interchangeably during surgery.

All instruments are sterilizable at the hospital, and

all are reusable for a defined number of procedures.

A programmed memory chip inside each instrument performs several functions that help

determine how the SSi Mantra and instruments work together.

In addition, the chip generally will not allow the instrument to be used for

more than the prescribed number of procedures to help ensure that its performance meets specifications during each procedure.

Accessory Products .

We sell various accessory

products, which are used in conjunction with the SSi Mantra as surgical procedures are performed.

Accessory products include sterile drapes

used to help ensure a sterile field during surgery, vision products—such as replacement 3D stereo endoscopes, cannulas for the instruments

and camera and special seals to prevent leakage of carbon dioxide gas used during a procedure.

Instruments under Development

We also have a number of additional sophisticated

instruments currently under development.

These include:

NADI – Automated Coronary Anastomotic

This instrument is a micro stapling device intended to join two arteries together in cardiac bypass procedures.

to offer the instrument in both robotic surgery and manual versions.

The manual version is for use by cardiac surgeons who do not have

a robotic system and can be utilized in an open or minimally invasive procedure.

SSi Multi-Fire Clip Applier .

The SSi Multi-Fire

Clip Applier is a cartridge-based clip applicator being developed to be utilized for the hemostasis of blood vessels.

Use of such a device

is a requirement during many surgical procedures.

Currently, the clip applicators traditionally used in surgical procedures require withdrawal

of the instrument after each clip is placed resulting in a time-consuming process.

By providing a cartridge with multiple clips we believe

the SSi Multi-Fire Clip Applier will allow for greater efficiency and time savings during surgical procedures.

SSi Ultrasonic Surgical Device .

scalpel is a surgical instrument being designed to simultaneously cut and cauterize tissue.

Ultrasonic energy is used in the harmonic

scalpel where ultrasonic energy is converted to mechanical energy at the active blade.

SSi Maya - XR Pre-Operative Simulator .

SSi Maya is a Mixed Reality (XR) software application being crafted to transform the educational paradigm for surgeons and surgical assistants.

SSi Maya is specifically being designed to train and educate users on the intricacies of the SSi Mantra Surgical Robotic System.

to offer immersive and innovative pre-operative training.

SSi Holographic Anatomy .

This product is an advanced augmented reality tool being developed for the purpose of visualizing anatomies, providing comprehensive patient

education, and offering guidance for surgical procedures.

This application will potentially present patients with three-dimensional DICOM

data, enabling them to better understand and engage with their own health information.

SSi Yog - Tele Proctor .

SSi Yog introduces a pioneering solution for tele-proctoring.

It is designed for remote surgical proctoring.

This software seamlessly

integrates mixed reality with the SSi Mantra Surgical Robotic System, offering healthcare professionals and surgeons unprecedented access

to real-time guidance over long distances.

Notably, the application is platform-agnostic and caters to both open, laparoscopic and robotic

surgeries making it versatile enough to address diverse surgical scenarios.

SSi Chitrasa - Advanced DICOM Viewer .

Chitrasa is being designed to empower robotic surgeons with unparalleled DICOM visualization capabilities.

It includes a state-of-the-art

AI enabled application viewer which is seamlessly integrated with the SSi Mantra Surgical Robotic System to provide surgeons with comprehensive

tools to enhance their surgical confidence and precision in the operating room.

SSi Mixed Reality Headset -

The SSi Mixed Reality headset is a medical-grade device that we hope will revolutionize intraoperative experiences by seamlessly interfacing

with the SSi Mantra Surgical Robotic System.

This device is being designed to offer surgeons an immersive 3D endoscopic feed visualization,

while interactable augmented objects provide real-time patient vitals and data for enhanced surgical precision.

The potentially seamless

collaboration between these technologies creates a comprehensive surgical platform, setting a new standard for intraoperative medical

advancements and pushing the boundaries of surgical excellence.

Some salient features include:

resolution 3DHD vision

image projection which allows for one meter depth perception

separate left and right eye video signals projected through an optical engine onto an opaque micro-LED screen

reconstruction of the 3D image by the human brain

We have a network of field service engineers in

India and maintain relationships with various distributors around the globe.

This infrastructure of service and support specialists offers

a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system

health monitoring.

Our comprehensive support and program assistance

helps ensure customers and care teams maximize program performance and protect their investment.

Readiness and Maintenance Support .

support is operational support to ensure smooth onboarding and adoption of new systems and technology.

Maintenance support helps to maximize

operational efficiency and reduce unplanned equipment downtime.

It includes services care plans, support teams, monitoring, software upgrades

and updates, as well as a customer portal.

The service plan portfolio offers flexible service plans to ensure reliability of the systems

and instruments and help optimize the robotics program.

The support team of expert field service, remote technical support and customer

care agents resolve and prevent any technology issues that could inhibit optimal utilization.

Software upgrades and updates enable the

latest product innovations, enhancements and reliability improvements.

Our initial strategy is to focus on underserved

markets, such as India, where market penetration for surgical robotic systems has in large part been limited because of the high costs

of and steep learning curve for existing systems.

After validating the SSi Mantra Surgical Robotic System in these markets, which we believe

we are currently accomplishing, we intend to leverage its advanced technology, significantly lower cost (approximately one third of the

cost of existing systems) and ease of training to move into other markets, such as the United States and Europe.

Key elements of this

strategy include:

Focus on underserved markets .

our operations are based and where we have commercially launched the SSi Mantra, has a population of approximately 1.4 billion people

and 70,000 hospitals.

However, only about 0.1% of global robotic surgical procedures.

As a comparison, there are only approximately 6,120

hospitals in the U.S.

By offering our advanced, cost-effective SSi Mantra Surgical Robotic System, we believe that we can significantly

penetrate the Indian market, as well as other underserved markets in Asia, Africa, Europe, Central and South America and elsewhere.

Focus on key institutions .

Our marketing

efforts are focused on large multi-specialty care hospitals where a majority of complex surgical procedures are performed.

Following the

initial placement at a given hospital, we intend to expand the number of physicians who use the SSi Mantra Surgical Robotic System and

work with the hospitals and their surgeons to promote patient education as to the benefits and cost effectiveness of our system.

that these efforts will not only result in both increased usage and additional sales of instruments and systems at hospitals that purchase

the system, but also increased demand from competing hospitals, surgeons and other physicians.

Focus on Leading Surgeons to Drive Rapid and

Broad Adoption .

We place significant emphasis on marketing the SSi Mantra to leading surgeons who are considered to be the “thought

leaders” in their institutions and fields.

In this regard, we have established both an Indian Medical Advisory Board and an International

Advisory Board consisting of leading surgeons in their respective fields.

We believe that the participation of these surgeons in our product

development and their use of the SSi Mantra will generate confidence in many other surgeons to utilize the system for all types of surgical

Continued Development and Marketing .

intend to continue developing and enhancing our technology and products and to communicate the benefits and advantages of the SSi Mantra

System (lower cost, ease of training and improved patient outcomes) in India and the other markets we plan to enter.

Evaluation, Familiarization and Training Agreements

with Major Medical Facilities .

We have and intend to continue entering into agreements with major medical facilities to install the

SSi Mantra Surgical Robotic System for evaluation, familiarization and training purposes.

As of the date of this Annual Report, we had

entered into such agreements with approximately four hospital networks in India and with Johns Hopkins University in Baltimore, Maryland.

Clinical Applications

The SSi Mantra has been clinically

validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than fifty different

types of surgical procedures in India without any device related adverse events.

As of the date of this Annual Report, we have installed

25 systems in India, which have been used to perform close to eight hundred surgical procedures, including cardiovascular, thoracic, head

and neck, gynecological, urological, cancer and general surgeries.

We maintain productive collaborations with leading surgeons to explore

and develop new techniques and applications for robotic-assisted surgery with the SSi Mantra.

We primarily focus our development efforts

on those procedures in which we believe our products bring the highest patient value, surgeon value and hospital value.

Representative

surgical applications are described below.

Cardiovascular Surgery

Internal Mammary Artery Dissection .

a coronary artery bypass graft procedure used in cardiac surgery, a blocked coronary artery is bypassed with a graft.

When available,

an artery from the chest called the internal mammary artery is dissected from its natural position and grafted into place to perform the

Because the internal mammary artery is located inferior to the anterior surface of the chest, dissection of the vessel is challenging

using existing surgical instruments through the three- to five-inch incision commonly used in a non-robotic coronary artery bypass graft

Our products have multiple joints that emulate the surgeon’s shoulders and elbows, allowing exact positioning of the

instruments inside the patient’s chest.

In addition, our Mudra instrument joints is designed to permit the surgeon to reach behind

the tissues for easier dissection of the internal mammary artery.

Thus, we believe that the internal mammary artery can be dissected with

greater ease and precision using the SSi Mantra Surgical Robotic System.

Totally Endoscopic Coronary Artery Bypass Surgery

Coronary artery bypass graft surgery demands that the surgeon delicately dissect and precisely suture very small structures,

which are less than two millimeters in diameter, under significant magnification.

These procedures are difficult when performed in open

They are even more difficult when performed using a limited incision approach and can be challenging to perform when the heart

As a result, this procedure is typically done as open surgery by stopping the heart and using a heart/lung bypass machine.

The technology employed by the SSi Mantra is designed to allow surgeons to perform scaled instrument movements that can be even more precise

than the movements used in open surgery, thus enabling precise suturing of single and multiple coronary vessels on a stopped or beating

Mitral and Aortic Valve Repair/Replacement .

Valve repair and replacement surgeries are challenging even when using open surgical techniques.

Significant exposure of the surgical

field is essential to the identification and precise manipulation of valves and other structures inside the heart and is key to successful

surgical outcomes with minimal complications.

Motion scaling allows a surgeon using the SSi Mantra to maneuver instruments inside the

patient even more precisely than is possible in open surgery.

The SSi Mantra has enabled heart valve repairs to be performed through small

ports in a manner that could not have been accomplished with open surgery.

Thoracic Surgery

Conventional approaches to surgical procedures

in the thorax include both open and video-assisted thoracoscopic approaches.

Procedures performed via these methods include pulmonary

wedge resection, pulmonary lobectomy, thymectomy, mediastinal mass excision and esophagectomy.

Head and Neck Surgery

Transoral Surgery .

Head and neck cancers

are typically treated by either surgical resection or chemo-radiation, or a combination of both.

Surgical resection performed by an open

approach may require a “jaw-splitting” mandibulotomy.

This procedure, while effective in treating cancer, is potentially traumatic

and disfiguring to the patient.

Less invasive approaches via the mouth (transoral surgery) are challenged by line-of-sight limitations

dictated by conventional endoscopic tools.

Chemo-radiation as a primary therapy does allow patients to avoid traumatic surgical incisions;

however, the literature suggests that this modality diminishes patients’ ability to speak and swallow normally.

Robotically assisted

transoral surgery allows them to operate on tumors occurring in the oropharynx (i.e., tonsil and base of tongue) and larynx via the mouth

and to overcome some of the line-of-sight limitations of conventional transoral surgery.

Gynecologic Surgery

Hysterectom y .

Removal of the uterus

is one of the most performed surgeries in gynecology and is performed for a variety of underlying benign and cancerous conditions.

Hysterectomies

can be performed using open surgery or minimally invasive techniques, which include vaginal, laparoscopic, and robotic-assisted approaches.

We believe that robotic-assisted surgery with the SSi Mantra provides patients the opportunity to receive a minimally invasive treatment

as an alternative to an open hysterectomy.

Sacro colpopexy.

The abdominal (open) sacro

colpopexy is one of the operations performed to treat vaginal vault prolapse.

Sacro colpopexy involves suturing a synthetic mesh that

connects and supports the vagina to the sacrum (tailbone).

A sacro colpopexy can be performed using a conventional laparoscopic technique;

however, it is often difficult and cumbersome to perform.

Robotic assisted surgical capabilities enable a larger number of these procedures

to be performed through a minimally invasive technique, conferring the benefits of minimally invasive surgery to a broader range of sacro

colpopexy patients.

Urologic Surgery

Prostatectomy .

Radical prostatectomy is

the removal of the prostate gland and accompanying lymph nodes in patients diagnosed with clinically localized prostate cancer.

approach to the removal of the prostate was via an open surgical procedure.

The conventional laparoscopic approach is an option, but it

is difficult and poses challenges to even the most skilled urologist.

The SSi Mantra will enable a larger number of surgeons to convert

from using an open surgical technique to a minimally invasive robotic surgical technique.

Partial Nephrectomy .

Partial nephrectomy

is the removal of a small portion of a kidney (typically, an area of the kidney containing a tumor).

Partial nephrectomies are most commonly

performed in patients diagnosed with clinically localized renal cancer.

Excluding robotic-assisted surgery, there are three common surgical

approaches to performing partial nephrectomies:

open surgical technique, laparoscopy, and hand-assisted laparoscopy, which is a hybrid

of open surgery and laparoscopic techniques.

Robotic assisted surgical capabilities may enable a large number of these procedures to be

performed through a minimally invasive technique, conferring the benefits of minimally invasive surgery to a broader range of partial

nephrectomy patients.

Radical Nephrectomy .

A radical nephrectomy

is a surgery to remove the entire kidney, typically done to treat kidney cancers and occasionally or other reasons.

In some instances,

the adrenal gland and lymph nodes may be removed as well.

Robotic-assisted cystectomy

is a minimally invasive bladder surgery with the same cancer removal success as open surgery.

During a robotic cystectomy, robotically

trained urology surgeons remove the bladder and redirect the urinary tract using a surgical robot.

A robotic cystectomy is performed through

a series of small keyhole-sized incisions across the abdomen, which is less painful, heals faster, and produces significantly less surface

scarring than the larger incision associated with open surgery.

General Surgery

Hernia Repair .

A hernia occurs when an

organ or other tissue squeezes through a weak spot in a surrounding muscle or connective tissue.

During a hernia repair surgery, the weakened

tissue is secured, and defects are repaired.

Common types of hernias are ventral and inguinal.

Ventral, or abdominal hernia, may occur

through a scar after surgery in the abdomen.

Inguinal hernia is a bulge in the groin and is more common in men.

Colorectal Surgery .

These procedures typically

involve benign or cancerous conditions of the lower digestive system, in particular the rectum or colon.

Common procedures in this area

include hemicolectomy, sigmoidoscopy, low anterior resection and abdominoperineal resection.

Cholecystectom y .

Cholecystectomy,

or the surgical removal of the gall bladder, is a commonly performed general surgery procedure.

Cholecystectomy is the primary method

for the treatment of gallstones and other gall bladder diseases.

Most cholecystectomies are performed using multi-port MIS techniques,

although some surgeons choose to perform cholecystectomies using manual single-port instrumentation.

The Global Robotic Surgery Market

The global surgical robotics market was

valued at $8.78 billion in 2023, and is projected to reach $37.5 billion by 2032, growing at a compound annual growth rate

(“ CAGR ”) of 17.5% from 2023 to 2032.

Surgical robots offer significant advantages in minimally invasive surgery

by enabling exceptionally precise manipulation of surgical instruments within constrained operation spaces, surpassing human

capabilities.

Robotic surgery is a procedure which involves a minimally invasive spectrum and represents an evolution in practice

across numerous medical disciplines.

Surgical robotics technology is used across various medical specialties, enabling surgeons to

perform complex procedures through small incisions, resulting in reduced patient trauma, shorter recovery times, and enhanced

patient outcomes .

Surgeries conducted utilizing robotic systems are expected to grow by approximately 400%, from 1.6 million

surgeries in 2020 to 6.2 million surgeries by 2030.

Market Dynamics

Increase in demand and acceptance of laparoscopic

or minimally invasive surgery (“ MIS ”) due to the benefits to patients and surgeons, such as better screening, greater

precision, shorter hospitalization, reduced pain and discomfort has fueled the growth in the global surgical robotics market.

the surge in the number of gynecological, neurological and urological diseases is a primary factor driving the surgical robotics market

In addition, surgical robotics enable minimally

invasive procedures, which involve smaller incisions, reduced trauma to surrounding tissues, and quicker recovery times.

increasingly seeking procedures that result in less pain and shorter hospital stays, and surgical robots fulfill these demands and the

rise in adoption of minimally invasive procedures has fueled market growth.

Many surgical robotic systems incorporate advanced

visualization technologies, such as high-definition 3D imaging and augmented reality.

These technologies grant surgeons a clearer view

of the surgical site, enhancing their ability to visualize complex anatomical structures and perform intricate tasks.

The growth of the

surgical robotics market is expected to be driven by the availability of improved healthcare infrastructure, increase in unmet healthcare

needs, rise in prevalence of chronic diseases, and surge in demand for advanced surgical robotics products.

Furthermore, the increase in need for automation

in the healthcare industry and the shifting trend towards advanced robotic surgeries fuels market growth.

Moreover, untapped economies

such as Brazil, India, China and other developing economies create a lucrative surgical robotics market opportunity.

The demand for surgical robotics is not only limited

to developed countries such as the U.S.

but is also being witnessed in the developing countries, such as China, and India, which fuel

the growth of the market.

Factors such as the rise in the number of surgeries drive the adoption of robotic technologies across different

specialties, contributing to the robust growth of the surgical robotics market.

For instance, according to the National Center for Biotechnology

and Information (NCBI), in 2022, around 1,918,030 new cancer cases are projected to occur in the United States.

In light of this projection,

the number of cancer surgeries performed by the subspecialty of robotic oncology surgeons is also expected to increase drastically as

Furthermore, as the global population ages, we

expect that there will be a greater need for surgical interventions to address age-related health conditions which boosts market growth.

Surgical robots assist surgeons in handling the complexities of these procedures, allowing for safer and more effective outcomes in elderly

Moreover, initially limited to specific procedures, robotic technologies are now being adapted for a broader spectrum of surgeries

across various medical fields, including cardiac, neurology, urology, gynecology, and more.

This versatility attracts hospitals and clinics

aiming to offer comprehensive robotic surgical services which is expected to drive the market growth.

High initial costs associated with acquiring

and implementing robotic systems, including infrastructure and training, pose a financial challenge for many healthcare facilities which

may impede market growth.

Regulatory complexities and concerns regarding patient safety, as well as the need for rigorous clinical validation

of robotic procedures, slow down the adoption process.

In addition, the intricate nature of surgical robotics necessitates specialized

training for surgeons, potentially leading to a shortage of skilled professionals.

These factors collectively hinder the rapid expansion

of the surgical robotics market.

Segmental Overview

The surgical robotics industry is segmented into

components, surgery type, and region.

By component, the market is categorized into systems, accessories, and services.

On the basis of

surgery type, the market is segregated into gynecology surgery, urology surgery, neurosurgery, orthopedic surgery, general surgery, and

other surgeries.

Region wise, the market is analyzed across North America, Europe, Asia-Pacific, Latin America, the Middle East and Africa

With a consistently expanding installed base of

surgical robotic systems globally and increasing utilization thereof, the accessories and services segment dominated the global surgical

robotics market in 2022 and is expected to remain dominant throughout the forecast period, due to a further rise in the number of surgical

robotics procedures performed with precision, accuracy, and improved patient outcomes, coupled with the increased adoption of surgical

robotics technology.

However, the systems segment is expected to register the highest CAGR during the forecast period, owing to a rise

in technological advancements and an increase in demand for advanced robotic surgical systems.

By Surgery Type

The general surgery segment dominated the global

surgical robotics market share in 2022 and is anticipated to continue this trend during the forecast period.

This is attributed to versatility

and effectiveness of surgical robotics in a wide range of general surgery procedures, increase in patient demand for minimally invasive

surgeries, and ongoing advancements in technology.

The surgical robotics market size is analyzed

across North America, Europe, Asia-Pacific, and LAMEA.

North America accounted for a major share of the surgical robotics industry in

2022 in terms of number of surgical robotic systems installed and is expected to maintain its dominance during the forecast period.

addition, the presence of well-established healthcare infrastructure, high purchasing power, and rise in adoption rate of advanced surgical

robotics products are expected to drive the market growth.

Furthermore, product launch, collaborations, and acquisitions adopted by the

key players in this region boost the growth of the market.

Asia-Pacific is expected to grow at the highest

rate during the surgical robotics market forecast period.

The market growth in this region is attributable to the growing industrial infrastructure,

the rise in prevalence of chronic diseases, such as cancer and cardiovascular conditions which has driven the need for sophisticated surgical

interventions, which surgical robotic systems can provide.

Moreover, the increase in awareness and acceptance of minimally invasive procedures

among patients in the Asia-Pacific region along with the benefits offered by surgical robotics further propels the market growth in this

Within the Asia-Pacific region, India, being the

fastest growing economy, rising incomes and significant unmet need for high-quality healthcare services is potentially a key driver for

the growth of surgical robotics in the country.

While India’s healthcare sector is poised to grow from $110 billion in 2016 to $610

billion in 2026, its healthcare spending as a percentage of GDP is expected to grow from 3% to 6% and the ratio of insured households

is expected to grow from 37% to 69% between 2023 and 2030.

Similarly, India’s ratio of out-of-pocket healthcare spending is also

expected to decline from 55% in 2023 to 36% in 2030, as the result of increased insurance penetration.

Historically, the lack of investment in healthcare

infrastructure in India, has led it to lag behind World Health Organization (WHO) standards in terms of the number of hospital beds and

physicians per 1,000 population.

In the last several years, with the increasing burden of lifestyle diseases and additional factors such

as increasing medical value travel, a systemic shift has occurred in India with a renewed focus on increasing healthcare spending.

trend is reflected in a 19.7% increase in hospital industry revenue from 2020 to 2023 and a 34.8% increase in hospital industry EBIDTA

during the same period.

Sales, Marketing and Customer Support

We provide our products through a direct sales

organization in India and, outside of India, through an expanding distributor network that, as of December 31, 2023, included distributors

in Guatemala, the United Arab Emirates and ten other countries.

We are further expanding our domestic Indian and

foreign distribution capabilities through the establishment of strategic partnerships.

In December 2023, we entered into a memorandum

of understanding with Surgical Lab, Ltd., a Cairo-based medical device distributor, to provide accessibility our SSi Mantra Surgical Robotic

System for the entire African continent.

In January 2024, we reached an agreement in principle for a strategic partnership with India’s

leading medical equipment supplier, Medikabazaar, to facilitate sales and distribution (including after sales support services) of the

SSi Mantra Surgical Robotic System to hospitals and medical facilities across India.

Our direct sales organization is composed of a

capital sales team of six individuals, which is responsible for selling systems, and a clinical support team of twenty individuals, which

is responsible for supporting the systems used in procedures performed at our hospital accounts.

Our hospital accounts include both individual

hospitals and healthcare facilities as well as hospitals and healthcare facilities that are part of an integrated chain.

The initial system

sale into an account is a major capital equipment purchase by our customers and typically has a lengthy sales cycle that can be affected

by evaluation periods, macroeconomic factors, capital spending prioritization, the timing of budgeting cycles and competitive bidding

Capital sales activities include educating surgeons, physicians and other hospital staff across multiple specialties on the

benefits of robotic-assisted surgery with the SSi Mantra, total treatment costs and the clinical applications that our technology enables.

We also train our sales organization to educate hospital management on the potential benefits of adopting our system, including the clinical

benefits of robotic-assisted surgery with the SSi Mantra, such as improved patient outcomes.

Our clinical sales team works onsite at hospitals,

interacting with surgeons and physicians, operating room staff and hospital administrators to develop and sustain successful robotic-assisted

They assist the hospital in identifying surgeons or physicians who have an interest in robotic-assisted surgery and the potential

benefits provided by the SSi Mantra.

Our clinical sales team provides current clinical information on robotic-assisted surgery and new

product applications to the hospital teams.

We offer our SSi Mantra through three selling

models— outright purchase, purchase on a deferred or installment payment basis, and purchase on a pay per procedure basis.

Our customers place orders to replenish their

supplies of instruments and accessories on a regular basis.

New direct customers who purchase a system typically place an initial stocking

order of instruments and accessories soon after they receive their system.

To date, substantially all of our sales have been

in India, with one initial sale in the United Arab Emirates, where the SSi Mantra system is being utilized for surgical team training

prior to the commencement of clinical procedures.

Our strategic collaboration agreement with Medikabazaar,

will enable our sales, clinical and field service support teams to integrate into Medikabazaar’s existing network of approximately

1,000 professionals and the distribution of our product portfolio will be facilitated through Medikabazaar’s more than 40 fulfilment

centers across India.

Training and Customer

We also provide training for surgeons, physicians

and staff on the operation and use of the SSi Mantra using a variety of training approaches.

These include didactic modules training,

hands on training, dry runs with the surgeons and their entire team, in-person proctored initial cases, on-site support for additional

cases and remote proctoring support for complex cases.

We have a network of field service and technical

support engineers in India and are establishing relationships with various distributors around the globe where we intend to market and

sell the SSi Mantra.

This infrastructure of service and support specialists, along with advanced service tools and solutions, offers a

full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system

health monitoring.

Research and Development

We focus our research and development efforts

on enhancing and improving our products and services with a view to fulfilling our vision that the benefits of advanced robotic surgery

should be cost-effective and available to everyone.

Through ingenuity and intelligent technology, we believe that we can expand the potential

of physicians to heal without constraints due to both cost and accessibility of these technologies.

We employ engineering and research

and development staff to focus on delivering future innovations and sustaining improvements that advance our mission.

In certain instances,

we complement our research and development effort through collaborations with other companies or organizations such as our arrangement

with Johns Hopkins University.

Manufacturing

Our systems and instruments are manufactured by

our employees at our 51,100 square-foot facility in Gurgaon, Delhi NCR, India.

The manufacturing of our products is a complex operation

involving a number of separate processes and components.

We purchase both custom and off-the-shelf components

from a large number of suppliers and subject them to stringent quality specifications, inspections, and processes.

Some of the components

necessary for the assembly of our products are currently provided to us by sole-sourced suppliers (the only recognized supply source available

to us) or single-sourced suppliers (the only approved supply source for us among other sources).

We believe, however, that alternative

suppliers are available if it should become necessary, although no assurance can be given that we could secure such alternative sources

of supply, if required, on commercially reasonable terms or without undue operational disruption.

We purchase the majority of our components and

major assemblies through purchase orders rather than long-term supply agreements and generally do not maintain large volumes of finished

goods relative to our anticipated demand.

Subject to receipt of necessary financing, we

plan to expand our in-house manufacturing capacity in order to meet anticipated increases in demand and to reduce our reliance on third-party

We face competition in the forms of existing open

surgery, conventional MIS, drug therapies, radiation treatment and other emerging diagnostic and interventional surgical approaches.

success depends on continued clinical and technical innovation, quality and reliability, as well as educating hospitals, surgeons and

patients on the demonstrated results associated with robotic-assisted medical procedures using our SSi Mantra Surgical Robotic System

and its efficacy and cost-effectiveness relative to other techniques.

We compete with a number of U.S.

and foreign companies

that have developed and currently manufacture and market products in the field of robotic-assisted medical procedures, including but not

Intuitive Surgical, Inc.;

Asensus Surgical, Inc.;

avateramedical GmbH;

CMR Surgical Ltd.;

Johnson & Johnson;

Medrobotics Corporation;

Medtronic plc;

meerecompany Inc.;

Olympus Corporation;

Samsung Electronics Co., Ltd;

Shandong Weigao

Group Medical Polymer Company Ltd.;

Shanghai Microport Medbot (Group) Co., Ltd.;

and Titan Medical Inc.

Most, if not all of these companies

have longer operating histories and greater financial resources than SSi.

In addition, other companies with substantial experience in

industrial robotics could potentially expand into the field of medical robotics and become competitors.

Our failure to compete effectively with these

existing and potential competitors could adversely affect our results of operations, business and prospects.

Intellectual Property

We place considerable importance on obtaining

and maintaining patent, copyright, and trademark protection for our technologies, products and processes.

We generally rely upon a combination of intellectual

property laws, confidentiality procedures and contractual provisions to protect our proprietary technology.

For example, we have patents

and trademarks, both registered and unregistered, that provide distinctive identification of our products in the marketplace.

As of the date of this Annual Report, our intellectual

property portfolio consists of 33 granted utility patents and 63 pending utility patent applications as follows:

Earliest Expiration

Latest Expiration

Earliest Expiration

Latest Expiration

October 6, 2034

October 31, 2038

June 20, 2039

November 21, 2034

December 25, 2039

December 26, 2034

February 8, 2043

December 1, 2043

October 9, 2043

January 12, 2038

October 31, 2038

October 7, 2033

March 29, 2042

October 6, 2034

March 11, 2044

November 10, 2043

MANTRA & MAYA

June 10, 2042

July 27, 2043

November 22, 2033

June 10, 2042

October 10, 2042

January 12, 2038

October 31, 2038

June 20, 2039

January 12, 2038

October 31, 2038

October 6, 2034

June 20, 2039

February 8, 2043

December 1, 2043

November 21, 2034

November 4, 2042

October 9, 2043

August 28, 2024

January 10, 2025

Further, our intellectual property portfolio

also consists of 44 granted design patents and one pending design patent application as follows:

Earliest Expiration

Latest Expiration

Earliest Expiration

Latest Expiration

December 1, 2027

April 17, 2028

December 1, 2027

January 25, 2034

December 20, 2033

August 29, 2033

October 12, 2033

April 17, 2028

In addition, we have filed 53 applications for

trademark registrations in India of which 29 have been granted.

We have also filed two copyright applications, both of which have been

We intend to apply for additional patents in various

jurisdictions.

Notwithstanding the foregoing, we cannot be certain

as to the scope of protection that the patents granted will afford our technology and products, nor can we be certain that any pending

or future patent applications will be granted.

Furthermore, if any protection we obtain is reduced or eliminated, others could use our

intellectual property without compensating us, resulting in harm to our business.

In addition, others may assert that our products infringe

on their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves,

could also cause us to pay substantial damages and prohibit us from selling our products.

None of our patents and patent applications are licensed to or from

third parties.

Government Regulation

Our products and operations are subject to regulation

in India by the Central Drugs Standard Control Organization (the “ CDSCO ”), by the Food and Drug Administration (the

“ FDA ”) in the U.S.

and by similar agencies in other countries and regions in which we market or plan to market our

In addition, our products must meet the requirements of a large and growing body of international standards, which govern the

design, manufacture, materials content and sourcing, testing, certification, packaging, installation, use and disposal of our products.

We must continually keep abreast of these regulations, standards and requirements and integrate our compliance into the development and

regulatory documentation for our products.

Failure to meet these standards could limit our ability to market our products in those regions

that require compliance with such standards.

Examples of standards to which we are subject include ISO 13485, an internationally recognized

quality management system for the design, development and manufacture of medical devices.

ISO 13485 Quality Management

ISO 13485 is an internationally recognized quality

management system for the design, development and manufacture of medical devices.

It sets out the requirements for a quality management

system specific to the medical device industry.

This standard is designed to be used by manufacturers and end-users throughout the life

cycle of a medical device.

We are required to meet this standard to register our products for sale globally and are subject to rigorous

annual reassessment and audit procedures.

Our Company has developed an ISO 13485 QMS system

in line with EN ISO 13485 and 21 CFR 820, for compliance with U.S.

and European Union (“ EU ”) quality management systems

requirements.

We received ISO 13485 certifications in 2021 and

have successfully completed two surveillance audits.

India Regulation

Medical devices in India had been mostly unregulated

for a long time but that has changed in recent years, with the adoption of rules and regulations designed to improve and enhance patient

Our products are primarily regulated under the Indian Medical Device Rules, 2017, as amended by the Medical Device (Amendment)

Rules, 2020 (as amended, the “ IMDR ”) promulgated and administered by the CDSCO.

These rules cover various aspects of

medical device related regulations, including classification, registration, manufacturing and import, labeling, sales, and post-market

requirements.

Similar to rules in the EU, they mandate that devices are safe and perform their intended function.

Based on intended use of the device, the risks

associated with the device and other parameters referred to in the IMDR, the Central Licensing Authority of India classifies Medical Devices

into four risk classes:

A (low risk);

B (low moderate risk);

C (moderate high risk);

and D (high risk).

The CDSCO has further divided the device classifications

into 24 panels, where our surgical robotic system is classified as a Class B device pertaining to operating room procedures.

We currently have CDSCO approval for the manufacture,

sale and distribution of our products and a license to export our products from India.

Our products will be subject to regulation as

medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (“ FFDCA ”), as implemented and enforced

The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling,

packaging, storage, installation, recordkeeping, complaint and adverse event reporting, clearance, approval, certification, promotion,

marketing, export, import, distribution and service of medical devices in the U.S.

to ensure that medical devices distributed domestically

are safe and effective for their intended uses.

We have filed a pre-submission application with

the FDA requesting feedback on the SSi Mantra Surgical Robotic System and we received acknowledgment of the filing on January 17, 2024.

Under the FFDCA, medical devices are classified

into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device

and the extent of control needed to ensure safety and effectiveness.

We believe that our current SSi Mantra Surgical Robotic System and

other products will be classified as Class II medical devices.

Class II medical devices are those that are subject

to general controls, and most require premarket demonstration of adherence to certain performance standards, as specified by the FDA,

and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

These special controls can include

performance standards, post-market surveillance, patient registries and FDA guidance documents.

Manufacturers of most Class II devices are required

to submit to the FDA a premarket notification under Section 510(k) of the FFDCA requesting authorization to commercially distribute the

The FDA’s authorization to commercially distribute a device subject to a 510(k) premarket notification is generally known

as 510(k) clearance.

Our current products are expected to be subject to premarket notification and clearance under section 510(k) of the

To obtain 510(k) clearance, we must submit to the FDA a premarket notification submission demonstrating that the proposed device

is “substantially equivalent” to a legally marketed predicate device.

The FDA may require additional information, including

clinical data, to make a determination regarding substantial equivalence.

In addition, the FDA collects user fees for certain medical

device submissions and annual fees for medical device establishments.

If the FDA agrees that the device is substantially

equivalent to a predicate device, it will grant clearance to commercially market the device in the U.S.

The FDA has a statutory ninety-day

(90-day) period to respond to a 510(k) submission;

however, as a practical matter, clearance often takes longer.

The FDA may require further

information, including clinical data, to make a determination regarding substantial equivalence.

If the FDA determines that the device,

or its intended use, is not “substantially equivalent” to a predicate device, the device may be designated as a Class III

The device sponsor must proceed with and fulfill the requirements of the more rigorous requirements of the premarket approval

(“ PMA ”) process or can request a risk-based classification determination for the device in accordance with the de novo

classification pathway, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent

to a predicate device.

The PMA process is more demanding than the 510(k)

premarket notification process.

In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the

PMA application must be supported by extensive data, including data from preclinical studies and human clinical trials.

The FDA, by statute

and regulation, has 180 days to review a PMA application, although the review more often occurs over a significantly longer period of

time and can take up to several years.

In approving a PMA application or clearing a 510(k) submission, the FDA may also require some additional

manufacturing controls, design control activities and approvals, as well as specific post-market surveillance requirements when necessary

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

In such cases, the manufacturer might

be required to follow certain patient groups for a number of years and make periodic reports to the FDA on the clinical status of those

Clinical trials are almost always required to

support a PMA and are sometimes required to support a 510(k) submission.

All clinical investigations designed to determine the safety

and effectiveness of a medical device must be conducted in accordance with the FDA’s investigational device exemption (“ IDE ”)

regulations, which govern investigational device labeling, prohibit the promotion of the investigational device and specify an array of

recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

Regardless of the degree of risk presented

by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional Review Board (“ IRB ”)

for each clinical site.

During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example,

trial monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event

reporting, record keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for

The clinical investigators in the clinical study are also subject to the FDA’s regulations and must obtain patient informed

consent, rigorously follow the investigational plan and study protocol, control the disposition of the investigational device and comply

with all reporting and recordkeeping requirements.

Additionally, after a trial begins, we, the FDA, or the IRB could suspend or terminate

a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.

After a device receives 510(k) clearance, any

modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its

intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novo classification.

The FDA requires

each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo classification or a PMA in the first

instance, but the FDA can review any such decision and disagree with a manufacturer’s determination.

If the FDA disagrees with a

manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified

device until 510(k) marketing clearance, approval of a PMA or issuance of a de novo classification.

Also, in these circumstances, the

manufacturer may be subject to significant regulatory fines or penalties.

In addition, the FDA may place significant limitations

upon the intended use of our products as a condition of granting marketing authorization.

Moreover, after a device is placed on the market,

numerous FDA and other regulatory requirements continue to apply.

These requirements include establishment registration and device listing

with the FDA;

compliance with medical device reporting regulations, which require that manufacturers report to the FDA if their device

caused or contributed, or may have caused or contributed, to a death or serious injury or malfunctioned in a way that would likely cause

or contribute to a death or serious injury if it were to recur;

compliance with corrections and removal reporting regulations, which require

that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed

by the device or to remedy a violation of the FFDCA that may present a risk to health;

the FDA’s recall authority, whereby the agency

can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations;

and post-market

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

additional safety and effectiveness data for the device.

In addition, the FDA and the Federal Trade Commission also regulate the advertising

and promotion of our products to ensure that the claims we make are consistent with our regulatory clearances, that there is scientific

data to substantiate the claims and that our advertising is neither false nor misleading.

In general, we may not promote or advertise

our products for uses not within the scope of our intended use statement in our clearances or make unsupported safety and effectiveness

In the U.S., our manufacturing processes will

be required to comply with the Quality System Regulation (“ QSR ”).

The QSR covers, among other things, the methods used

in, and the facilities and controls used for, the design, testing, controlling, documenting, manufacture, packaging, labeling, storage,

installation and servicing of all medical devices intended for human use.

The QSR also requires maintenance of extensive records, which

demonstrate compliance with the FDA regulations, the manufacturer’s own procedures, specifications and testing, as well as distribution

and post-market experience.

Compliance with the QSR is necessary for a manufacturer to be able to continue to market cleared or approved

product offerings in the U.S.

A company’s facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled

inspections by the FDA.

Failure to maintain compliance with applicable QSR requirements could result in the shut-down of, or restrictions

on, manufacturing operations and the recall or seizure of marketed products.

If the FDA determines that a manufacturer has 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

warning letters, untitled letters, fines, injunctions, consent decrees, administrative penalties, and civil or criminal 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 approvals for our products;

criminal prosecution.

In addition, the discovery of previously unknown

problems with any marketed products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether

resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could

result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

Products manufactured outside of the U.S.

for us are subject to U.S.

Customs and FDA inspection upon entry into the U.S.

We must demonstrate compliance of such products with U.S.

regulations and carefully document the eventual distribution or re-exportation of such products.

Failure to comply with all applicable

regulations could prevent us from having access to products or components critical to the manufacture of finished products and lead to

shortages and delays.

European Union Regulation

In the European Union (the “ EU ”),

all medical devices placed on the EU market must meet the essential requirements (“ Essential Requirements ”), including

the requirement 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 performance intended by the

manufacturer and be designed, manufactured and packaged in a suitable manner.

All medical devices are currently regulated by

Regulation (EU) No 2017/745 (the “ EU Medical Devices Regulation ” or the “ MDR ”), which became

effective on May 26, 2021 and replaced the former regulatory framework set forth in Council Directive 93/42/EEC (the “ MDD ”).

The MDR was adopted with the aim of ensuring better

protection of public health and patient safety.

The MDR establishes a uniform, transparent, predictable and sustainable regulatory framework

across the EU for medical devices and ensures a high level of safety and health while supporting innovation.

Unlike directives, regulations

are directly applicable in EU member states without the need for member states to implement them into national law.

This aims to increase

harmonization across the EU member states.

The MDR requires that, before placing a device

on the market, other than a custom-made device, manufacturers (as well as other economic operators, such as authorized representatives

and importers) must register by submitting identification information to the EUDAMED electronic system, which is in the process of being

The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact

details of the person or persons responsible for regulatory compliance.

The MDR also requires that, before placing a device on the market,

other than a custom-made device, manufacturers must assign a unique identifier to the device and provide it along with other core data

to the unique device identifier (“ UDI ”) database.

All manufacturers placing medical devices on the

market in the EU must comply with the EU medical device vigilance system.

Under this system, serious incidents and Field Safety Corrective

Actions (“ FSCAs ”) must be reported to the relevant authorities of EU member states.

These reports are to be submitted

through EUDAMED (once fully functional) and aim to ensure that, in addition to reporting to the relevant authorities of the EU member

states, other actors, such as the economic operators in the supply chain, will also be informed.

Until EUDAMED is fully functional, the

corresponding provisions of the MDD continue to apply.

Manufacturers are required to take FSCAs, which are defined as any corrective action

for technical or medical reasons to prevent or reduce a risk of a serious incident associated with the use of a medical device that is

made available on the market.

The advertising and promotion of medical devices

is subject to some general principles set forth in EU legislation.

According to the MDR, only devices that are CE (Conformité Européene)

marked may be marketed and advertised in the EU in accordance with their intended purpose.

Directive 2006/114/EC concerning misleading

and comparative advertising and Directive 2005/29/EC on unfair commercial practices, while not specific to the advertising of medical

devices, also apply to the advertising thereof and contain general rules, such as, for example, requiring that advertisements are evidenced,

balanced and not misleading.

Specific requirements are defined at a national level.

EU member states’ laws related to the advertising

and promotion of medical devices, which vary between jurisdictions, may limit or restrict the advertising and promotion of products to

the general public and may impose limitations on promotional activities with healthcare professionals.

Many EU member states have adopted specific anti-gift

statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations.

Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals

or entities and many EU member states have adopted national “Sunshine Acts,” which impose reporting and transparency requirements

(often on an annual basis), similar to the requirements in the United States, on medical device manufacturers.

Certain EU member states

also mandate implementation of commercial compliance programs.

In the EU, regulatory authorities have the power

to carry out announced and, if necessary, unannounced inspections of companies, as well as of suppliers and/or sub-contractors and, where

necessary, the facilities of professional users.

Failure to comply with the applicable regulatory requirements could require time and

resources to respond to the regulatory authorities’ observations and to implement corrective and preventive actions, as appropriate.

Regulatory authorities have broad compliance and enforcement powers and, if such issues cannot be resolved to their satisfaction, can

take a variety of actions, including untitled or warning letters, fines, consent decrees, injunctions, or civil or criminal penalties.

The aforementioned EU rules are generally applicable

in the European Economic Area (“ EEA ”), which consists of the twenty-seven EU member states, as well as Iceland, Liechtenstein

Other countries

Regulations in other countries, including the

requirements for approvals, certification or clearance and the time required for regulatory review, vary from country to country.

countries, such as South Korea, Brazil, Australia and Canada, have their own regulatory agencies.

These countries typically require regulatory

approvals and compliance with extensive safety and quality system regulations included in the Medical Device Single Audit Program that

we will be required to comply with on an ongoing basis.

Failure to obtain regulatory approval in any foreign country in which we plan

to market our products or failure to comply with any regulation in any foreign country in which we market our products may negatively

impact our ability to generate revenue and harm our business.

In addition, local regulations may apply, which

govern the use of our products, and which could have an adverse effect on our product utilization if they are unfavorable.

All such regulations

are revised from time to time and, in general, are increasing in complexity and in the scope and degree of documentation and testing required.

There can be no assurance that the outcomes from such documentation and testing will be acceptable to any particular regulatory agency

or will continue to be acceptable over time.

There are further regulations governing the importation, marketing, sale, distribution, use,

and service as well as the removal and disposal of medical devices in the regions in which we operate and market our products.

to comply with any of these regulations could result in sanctions or fines and could prevent us from marketing our products in these regions.

Our ISO 13485

(quality management system) approval, CDSCO approval for the manufacture, sale and distribution of our products and our Indian

export license allows us to market our products in fifty (50) non-FDA and non-CE (EU) countries without further regulatory approvals

and in an additional seventy-nine (79) countries require only minimal registration.

We have received regulatory approval to market

and sell our products in the United Arab Emirates and Guatemala and have initiated the regulatory approval process, which if

successful, will allow us to market our products in more than fifty (50) countries within approximately one year.

However, there can

be no assurance as to when we will secure any such regulatory approvals, if at all.

Data Privacy and Security

Numerous state, federal, and foreign laws, regulations,

and standards govern the collection, use, access to, confidentiality, and security of health-related and other personal information and

could apply now or in the future to our operations or the operations of our partners.

In the U.S., numerous federal and state laws and

regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations

govern the collection, use, disclosure, and protection of health-related and other personal information.

In addition, certain foreign

laws govern the privacy and security of personal data, including health-related data.

Privacy and security laws, regulations, and other

obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations,

proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

We collect, process, share, disclose, transfer,

and otherwise use data, some of which contains personal information about identifiable individuals including, but not limited to, our

employees, clinical trial participants, partners, and vendors.

Therefore, if we commence marketing our products in the U.S., the EU and

other countries, we will be subject to U.S.

(federal, state and local) and international laws and regulations, including those in the

EEA regarding data privacy and security and our use of such data.

If we market our products in the EU, we will be

subject to the European Union General Data Protection Regulation 2016/679 and applicable national supplementing laws (collectively, the

The GDPR imposes comprehensive data privacy compliance obligations in relation to our collection, processing,

sharing, disclosure, transfer and other use of data relating to an identifiable living individual or “ personal data ,”

including a principle of accountability and the obligation to demonstrate compliance through policies, procedures, training, and audits.

The GDPR also regulates cross-border transfers

of personal data out of the EEA.

Recent legal developments in Europe have created complexity and uncertainty regarding such transfers,

in particular in relation to transfers to the United States.

Cybersecurity

In the normal course of business, we may collect

and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets,

intellectual property, patient information, sensitive third-party information and employee information.

To protect this information, our

existing cybersecurity policies require continuous monitoring and detection programs, network security precautions, encryption of critical

data and in-depth security assessments of vendors.

We maintain various protections designed to safeguard against cyberattacks, including

firewalls and virus detection software.

We have established and regularly test our disaster recovery plan, and we protect against business

interruption by backing up our major systems.

In addition, we periodically scan our environment for any vulnerabilities, perform penetration

testing and engage third parties to assess the effectiveness of our data security practices.

As of the date of this Annual Report, we had 239 employees, 102 of

whom were engaged in manufacturing and service, 38 in marketing and sales, 50 in research and development, 4 in quality control and 45

in administration.

Most of our employees are based at our facility in Gurgaon, Delhi NCR, India.

We generally consider our relationship

with our employees to be good.

Risk Factors.

2 unchanged sentences

to provide the information required by this Item.

Unresolved Staff Comments.

Not applicable.

The Company currently does not own any properties but leases an office

from UCF at 3259 Progress Drive, Orlando, FL 32826 under a lease expiring July 31, 2023, at a rental of $404.68 per month.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business