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Item 1. Business

2026-03-10 compared with 2025-04-15 · 924 added, 759 removed, 484 unchanged (78% of the section changed)

Company Background

We are a commercial-stage surgical robotics company

focused on transforming patient lives by democratizing access to advanced surgical robotics technologies.

We design, manufacture and market an advanced,

next-generation and affordable surgical robotic system called the SSi Mantra.

While surgical robotic systems have gained acceptance

globally in the past two decades for providing greater efficiency, better clinical outcomes and reducing healthcare costs, access to such

systems remains largely limited to developed countries such as the United States, the European Union (the “ EU ’) and

With the SSi Mantra, we are breaking down barriers

and accelerating access to surgical robotics technologies in underserved regions of the world.

Developed by a visionary team of surgeons, engineers

and industry veterans, the SSi Mantra includes several innovative features to address shortcomings of the current generation of robotic

surgery systems.

We commenced development of the SSi Mantra in

2014, received regulatory approval by the Central Drugs Standard Control Organization (“ CDSCO ”) India’s equivalent

Food and Drug Administration (“ FDA ”), for its sale and use in India and commercially launched sales in

We also received ISO 13485 (quality management system) approval for the SSi Mantra 3.

The SSi Mantra has been clinically

validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than 80 different

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

As of December 31, 2024, we have installed 62 systems,

of which 58 are located in India and 4 at overseas locations.

We are currently focusing our efforts on marketing our next generation SSi

Mantra 3, which was introduced in June 2024.

Our commercially installed SSi Mantra Surgical Robotic

systems in India have been used to perform more than 3,500 surgical procedures, including cardiovascular, thoracic, head and neck, gynecological,

urological, cancer and general surgeries.

The SSi Mantra 3 has also been granted regulatory approval in Guatemala, Nepal, Ecuador and

Indonesia, although our marketing efforts in those countries have been limited to date.

We have filed a pre-submission application with

FDA, requesting feedback on the SSi Mantra.

We had a feedback meeting with the FDA on April 2, 2024 and the FDA has indicated

that we should pursue the Investigational Device Exemption (“ IDE ”) route to obtain U.S.

approval to market.

we are in the process of preparation of the IDE Application and expect to start our U.S.

IDE study in third quarter of 2025, subject to

FDA IDE and Institutional Review Board (“ IRB ”) approvals.

We have also been in discussions with an EU Notified Body

for the CE certification, which will allow us to market the SSi Mantra in the EU.

There can be no assurance as to when we will secure

such regulatory approvals, if at all.

Our ISO 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.

An additional 79 countries require only minimal registration.

In our journey to make the benefits of robotically

assisted surgeries available to as many people of the world as possible, we reached several milestones in 2024:

● In April 2024, our SSi Mantra surgical robotic system was utilized

to perform the first pyeloplasty procedure on an infant.

● In May 2024, we surpassed more than 1,000 procedures globally and 100 robotic cardiac surgeries done using

our SSi Mantra systems.

● In June 2024 we received regulatory approval for the SSi Mantra from the Indonesian Ministry of Health

for clinical use in the Republic of Indonesia.

● We introduced the new generation SSi Mantra 3 Surgical Robotic System at the Society of Robotic Surgery

(SRS) Annual Meeting, which took place from June 20-23, 2024 in Orlando, Florida.

● On June 15, 2024, we completed the first telesurgery for a urology oncology procedure in India.

involved a complex cysto-prostatectomy case with bilateral lymph node dissection, performed at the Rajiv Gandhi Cancer Institute in Delhi

located at a distance of about 35 kilometers from the telesurgery lab in our manufacturing facility in Gurugram, Delhi NCR, India.

● On June 18, 2024, we announced that our SSi Mantra had been installed at Baidya & Banskota Hospital

in Kathmandu, Nepal marking the first time a surgical robotic system had been installed in Nepal.

From July 23 - 25, 2024, we unveiled our latest generation, SSi Mantra 3 system in the U.S.

during an exclusive demonstration for media, analysts and the investment community at our newly opened showroom located in the New York City financial district.

On August 27, 2024, we had an interactive pre-submission meeting with the U.S.

The pre-submission meeting was organized with the FDA’s Center for Devices and Radiological Health (“ CDRH ”) to seek interactive feedback from them regarding our regulatory strategy, biocompatibility assessment, reprocessing validation, and clinical data.

Based on the feedback received from the FDA, we are proceeding with a de novo pathway through an IDE application for pre-market submission of our SSi Mantra Surgical Robotic System.

2, 2024, marked our entry into Central and South American markets with the installation of our first SSi Mantra system at

Interhospital, a large multi-specialty hospital in Guayaquil City, Ecuador following receipt of Ecuadorian regulatory approvals for

clinical use of SSi Mantra in May 2024 through our distribution partner, Ingemedica Del Ecuador S.A.

● In November 2024 we successfully performed the first-ever robotic cardiac surgery in Indonesia, a bilateral

IMA CABG (Coronary Artery Bypass Graft), and ASD Repair and Beating Heart Totally Endoscopic Coronary Artery Bypass (TECAB).

than 278 million people, and almost 3,000 hospitals, Indonesia is the world’s fourth-most-populous country and has significant potential

for further expansion of its surgical robotic program.

● As of December 31, 2024, a total of 2,759 robotic surgeries had been successfully completed using our

SSi Mantra system globally and the following table demonstrates the capability of our SSi Mantra to perform a wide variety of surgical

procedures of varying complexities:

We design, manufacture and

market an advanced, next-generation and affordable surgical robotic system called the SSi Mantra Surgical Robotic System (the “ SSi

Mantra ”) intended for use in urology, general, gynecology, colorectal, gastroenterology, head and neck, thoracic and cardiac

While surgical robotic systems have gained acceptance globally in the past two decades for providing greater efficiency, better

clinical outcomes and reducing healthcare costs, access to such systems remains largely limited to developed countries such as the United

States (the “ U.S.

”), the European Union (the “ EU ”) and Japan.

With the SSi Mantra, we are breaking

down barriers and accelerating access to surgical robotics technologies in underserved regions of the world.

Led and developed by Dr.

Sudhir P Srivastava,

our founder, Chairman and Chief Executive Officer with a visionary team of engineers, surgeons and industry veterans, the SSi Mantra

includes several innovative features to address shortcomings of the current generation of robotic surgery systems.

The SSi Mantra marks

the realization of Dr.

Srivastava’s vision to develop and commercialize a surgical robotic system which would facilitate making

robotic surgery affordable and accessible to a global population.

We commenced development of the SSi Mantra in 2014, received regulatory

approval by the Central Drugs Standard Control Organization (“ CDSCO ”) India’s equivalent of the U.S.

Drug Administration (“ FDA ”), for its sale and use in India and commercially launched sales in late 2022.

We also received

ISO 13485 (quality management system) approval for the SSi Mantra in November 2021.

The latest generation SSi Mantra 3 was introduced

in India with telesurgery and tele-proctoring capabilities along with advanced energy instrumentation.

The SSi Mantra 3 received CDSCO

approval in November 2024 and has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically

assisted surgeries.

As of December 31, 2025, we have installed 168

systems, of which 154 are located in India, and 14 at overseas locations, including 21 systems installed on pay per use basis, 8 systems

installed for demonstration purposes, and 10 upgraded systems.

Including our strong foundational market of India, the SSi Mantra installed

base currently spans 10 countries.

We are currently focusing our efforts on marketing our latest generation SSi Mantra 3 in international

markets and anticipate receiving EU and U.S.

regulatory approvals to market in those regions in 2026, however, there can be no assurance

as to when or if we will secure such regulatory approvals.

Our commercially installed SSi Mantra systems

have been used to perform more than 7,800 surgical procedures including approximately 400 cardiac robotic surgeries across 153 hospitals

as of December 31, 2025.

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

perform robotically assisted surgeries in more than 100 different types of surgical procedures without any device-related adverse events.

These procedures have spanned across the following nine surgical specialties:

Type of Surgical Procedure

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Plastic/Reconstructive

121 pediatric surgeries,

120 telesurgeries and 232 surgeries outside of India

In December 2024, we became the first and only

company in India to receive CDSCO regulatory approval for use of a robotic surgical system in the performance of Telesurgery and Tele-proctoring

Since receiving such approvals, we have performed more than 120 telesurgeries using our SSi Mantra as of December 31, 2025,

including a robotic cardiac surgery over a distance of more than 5,000 miles.

In addition to India, the SSi Mantra has also

been granted regulatory approval in Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the United

Arab Emirates.

Our ISO 13485 (quality management system) approval,

CDSCO approval for the manufacture, sale and distribution of our systems and related devices and our Indian export license allow us to

market our systems and related devices in 50 non-FDA and non-EU countries without further regulatory approvals, including Chile, Nepal

An additional 79 countries require only minimal registration.

Our marketing efforts outside India have been limited to date.

On December 5, 2025, we submitted a 510(k) premarket

notification to the FDA for the SSi Mantra for multiple specialty procedure types, including:

general, urological, colorectal, gynecological,

and cardiac surgery.

We believe that the 510(k) regulatory pathway offers potential speed and cost advantages.

The FDA has stated that

its goal is to complete reviews of 510(k) submissions within 90 days of receipt.

However, time to approval could be longer due to factors

such as the 15-day acceptance review, the submission of additional information, and a submitter’s response time.

We have engaged

RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission.

If approved by the FDA, the SSi Mantra would be cleared to

market in the U.S.

Submission of a 510(k) premarket notification request does not guarantee FDA approval.

We have also submitted our

technical files to Szutest, an EU Notified Body for the CE certification, which if obtained will allow us to market the SSi Mantra in

We believe that we will be able to secure FDA approval and EU certification in 2026.

However, there can be no assurance as to

when or if we will secure such regulatory approvals.

We generate revenues from the sale of the SSi

Mantra Surgical Robotic System.

We offer our SSi Mantra through three selling models:

(i) outright purchase, where revenue is realized

(ii) purchase on a deferred or installment payment basis;

and (iii) purchase on a pay-per-procedure basis, where revenue is recognized

We also earn recurring revenue from the sales of instruments, accessories and services.

We sell our products directly to customers

as well as through distributors.

The SSi Mantra improves patient experience, reduces

variabilities and disruption and lowers per-procedure costs.

We believe that the SSi Mantra benefits patients, physicians and hospitals

by providing access to an advanced and optimized robotic system.

(i) outright purchase, where revenue is realized upfront;

(ii) purchase

on a deferred or installment payment basis;

and (iii) purchase on a pay-per-procedure basis, where revenue is recognized over time.

also earn recurring revenue from the sales of instruments, accessories and services.

We sell our systems and related devices directly

to customers as well as through distributors.

We believe the SSi Mantra improves patient experience,

reduces variabilities and disruption and lowers per-procedure costs.

We believe that the SSi Mantra benefits patients, physicians and

hospitals by providing access to an advanced and optimized robotic system.

Recent Development

On March 6, 2026 (the “ Closing Date ”),

the Company completed a private placement of its common stock which generated gross proceeds of $18,621,498, before deducting offering

In the offering, we offered and sold (shares are

under issuance as on the date of Annual Report) a total of 5,774,839 shares of common stock consisting of:

● an aggregate of 1,300,006 shares of common stock at an average

price of $4.00 per share for a total of $5,197,000 to directors, details of the same are as below:

shares to Dr.

Sudhir Srivastava, our Chairman and Chief Executive Officer at $4.01 per share amounting to $2,000,000;

shares to Dr.

Frederic Moll, our Vice Chairman at $3.99 per share amounting to $2,000,000;

shares to Tim Adams, a director at $3.99 per share amounting to $1,197,000;

of 4,474,833 shares of common stock at $3.00 per share and total consideration of $13,424,498, to existing and new investors, led by

Manipal Global Health Services, an existing shareholder.

SSi intends to use the net proceeds from this

private placement for working capital and other general corporate purposes, which include, but are not limited to advancing the Company’s

our growth initiatives in India and other existing global markets and supporting preparation for entry into the United States and European

Union markets.

In connection with a $2,499,999 investment by

one of the non-affiliated investors in the private placement, the Company will pay a FINRA member firm a cash commission of $175,000 (7%

of the investment) and issue to such firm five-year warrants to purchase 41,667 shares of our common stock at an exercise price of $3.45

The purchase price paid by participating directors

and executive officers, reflects the “Minimum Price” as determined under the applicable rules of the Nasdaq Stock Market LLC.

The Company has advised the non-affiliate investors

in the private placement that within ninety (90) days of the Closing Date, it will file a Registration Statement on Form S-3 (or other

applicable form) under the Securities Act covering the resale of their shares and thereafter will use its commercially reasonable efforts

to have the Registration Statement declared effective by the SEC as soon as practicable.

The securities in the private placement were offered

and sold in in accordance with the exemption from registration afforded by Section 4(a)(2) of and Rule 506(b) of Regulation D under the

Securities Act.

Corporate Information

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” 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 Bahamian holding company, Sushruta Pvt.

(“ Sushruta ”),

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 (“ SSI-India ”), 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 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 of the CardioVentures

Merger on April 14, 2023, the Company changed its name to “ SS Innovations International, Inc., ” effected a one-for-10

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 Sushruta, 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

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 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 Annual Report and is not incorporated by reference herein.

We have included our website address as an inactive textual reference

Information appearing on our corporate website is not part of this Annual Report 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 over 3,500 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 (“ 3D4K ”) 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 the precise dissection and reconstruction of anatomical structures within the body.

are currently focusing our efforts on marketing our next generation SSi Mantra 3, which was introduced in June 2024.

The SSi Mantra 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 100 different types of surgical procedures in India without any device related adverse events.

As of the date of this Annual Report, surgeons have performed over 7,800 surgical procedures 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 (“ 3D

4K ”) 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 the precise dissection and reconstruction of anatomical structures within the body.

We are currently focusing our efforts

on marketing our SSi Mantra 3 in international markets.

The SSi Mantra 3 is comprised of the following

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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 through surgical ports going inside of the patient.

When using the SSi Mantra 3, 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.

view a 3D 4K 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 digital

imaging and communications in medicine (“ DICOM ”) applications.

The surgeon’s fingers grasp extremely precise

ergonomic lightweight magnetic 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

through surgical ports going inside of the patient.

When using the SSi Mantra 3, 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.

The SSi Mantra is also equipped with a head-tracking camera safety feature that detects when

the surgeon looks away from the 3D 4K monitor to help prevent inadvertent instrument movement.

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 .

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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.

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

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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

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.

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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

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 Endo-surgical Instruments .

instruments that we manufacture have endo wrist technology with 7 degrees of freedom for natural dexterity and tips customized for various

surgical procedures.

Mudra instruments are offered in an 8.6 mm 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

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

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 our 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.

We recently completed the development of five new 5-millimeter

surgical instruments for clinical use across multiple specialties, including pediatric, cardiac, and head and neck surgery, among other

procedures involving smaller anatomical structures.

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 over 20 cardiac surgery specific instruments.

A variety of instruments may be selected and used

interchangeably during surgery.

All instruments are sterilizable at the hospital, and most have a minimum reusable lifecycle of 10 uses.

A programmed memory chip inside each instrument performs several functions that help determine how the SSi Mantra and our 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 .

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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.

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.

Tele proctoring and Telesurgery.

the only surgical robotic company to have received a regulatory approval from CDSCO for both tele proctoring and telesurgery.

the first surgical robotic company to have received a regulatory approval from CDSCO for both tele proctoring and telesurgery.

the demonstration of our telesurgery capabilities at the SMRSC 2024, a global conference organized by the Company, we began our clinical

trials that were conducted to validate this novel approach towards remote surgery.

We first conducted two animal trials at a leading laparoscopy

hospital in Delhi NCR region located five kilometers away from our telesurgery lab in our facility.

We first conducted two animal trials at a leading

laparoscopy hospital in Delhi NCR region located five kilometers away from our telesurgery lab facility.

Thereafter, we performed a simple

robotic gall bladder removal (Cholecystectomy) to demonstrate safety and efficacy of our SSi Mantra Surgical Robotic System, when utilized

in a remote setting.

After this trial, SSi commenced clinical trials wherein six complex urology, oncology and gynecology procedures were

performed at Rajiv Gandhi Cancer Institute at a distance of approximately 35 kilometers.

Most recently, we have successfully performed

robotic gall bladder removal (Cholecystectomy) to demonstrate safety and efficacy of our SSi Mantra system, when utilized in a remote

After this trial, SSi commenced clinical trials wherein six complex urology, oncology and gynecology procedures were performed

at Rajiv Gandhi Cancer Institute at a distance of approximately 35 kilometers (approximately 22 miles).

We have successfully performed

five robotic cardiac telesurgeries between our telesurgery lab in Gurugram and at a hospital in Jaipur located at a distance of approximately

286 kilometers, marking the world’s first accomplishment in the field of robotic cardiac surgery and in March 2025, we used the

SSi Mantra 3 to perform robotic cardiac telesurgery over a 2,000-kilometer distance between SSi’s headquarters in Gurugram, and

the Aster CMI Hospital in Bengaluru.

286 kilometers (approximately 179 miles), marking the world’s first accomplishment in the field of robotic cardiac surgery.

March 2025, we used the SSi Mantra to perform robotic cardiac telesurgery over a 2,000-kilometer (1,250 mile) distance between SSi’s

headquarters in Gurugram, and the Aster CMI Hospital in Bengaluru.

In July 2025, we successfully completed the world’s first inter-continental

robotic cardiac telesurgery on July 19, 2025, from Strasbourg, France to Indore, India, a distance of over 4,000 miles (2,500 miles),

using the SSi Mantra and the world’s first robotic bariatric telesurgery over a distance of 896 kilometers (560 miles) from Gurugram,

India to Indore, India using the SSi Mantra.

In September 2025, we announced the successful completion of the first robotic telesurgery

performed from our MantraM bus mobile robotic telesurgery unit and the successful completion of the world’s first pediatric pyeloplasty

telesurgery utilizing our SSi Mantra from our headquarters in Gurugram, India to a 16-month-old patient in Hyderabad, India nearly 1,600

kilometers (1,000 miles) away.

As of the date of this Annual Report, more than 120 telesurgeries have been performed, at distances of

up to 9,600 kilometers (6,000 miles), utilizing the SSi Mantra.

Instruments under Development

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Surgery and Oncology Surgery.

Upon completion of this development, SSI would be the second company globally to have a robotic stapler

that is compatible with its robotic surgical platform.

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.

Once development of the SSi Robotic Stapler has been completed, SSI will be the second company globally

with a robotic stapler compatible with its robotic surgical platform.

SSi Maya is an enabling digital

platform that compliments the SSI Mantra system and enhances surgical capabilities with Mixed Reality (XR) and AI enabled technologies

including the following:

SSi Guru is a virtual tele illustration feature used

for tele mentoring with the help of a portable 3D surgery viewer, XR headset and interactive virtual screens .

SSi XR Cognitive Skill Simulator.

SSi XR Cognitive Skill

Simulator is an extended reality (XR) software platform developed to train and educate surgeons and surgical assistants in the application

of the SSi Mantra.

The system combines a console-based interface with VR-driven instructional modules that provide instrument tracking

overlays and guided procedural workflows.

This integrated learning environment is designed to strengthen cognitive understanding,

reinforce muscle memory, and improve motor skills through repetitive, structured practice, supporting immersive and innovative pre-operative

The simulator incorporates SSi’s AR Smart Glasses 3D Visualization System , delivering 3D HD 1080p imaging

with adjustable interpupillary distance, direct endoscope video input, advanced signal processing, and IMU-based head tracking.

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 Holographic

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

education, and offering guidance for surgical procedures.

SSi Holographic Anatomy is being designed to present patients with three-dimensional

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

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

It includes a state-of-the-art AI enabled

application viewer which is seamlessly integrated with the SSi Mantra 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.

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:

Reality Headset is a light-weight set of glasses with a magnified 3D view aimed at improving surgeons’ intraoperative experience

by seamlessly interfacing with the SSi Mantra.

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 collaboration between

the SSi Mixed Reality Headset and SSi Mantra technologies will create a comprehensive surgical platform, setting a new standard for intraoperative

medical advancements and pushing the boundaries of surgical excellence.

Features include:

Peripheral view;

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32-inch image projection which allows for one meter depth perception;

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

Two separate left and right eye video signals projected through an

optical engine onto an opaque micro-LED screen;

Natural reconstruction of the 3D image by the human brain.

In March 2025, we unveiled

our Mobile Tele-Surgical Unit, the “ SSi MantraM ” which is designed to offer access to remote robotically-assisted surgical

procedures, to geographic areas, which have only limited access to that level of healthcare.

our Mobile Tele-Surgical Unit, the “ SSi MantraM ” which is designed to offer access to remote robotically assisted

surgical procedures, to geographic areas, which have only limited access to that level of healthcare.

SSi Mantra Tele Surgeon Console (TSC) .

The SSi Mantra Tele Surgeon Console (TSC) is a compact, self-contained telesurgery workstation designed to enable safe and effective

remote surgical operation in environments with limited space.

The TSC integrates a compact ergonomic chair with inbuilt electronics,

magnetic sensor-based control systems, lightweight 3D viewing glasses, and a magnified three-dimensional view of the surgical field,

while its portable, space-efficient design allows deployment in physician offices and other locations with small physical footprints.is

a compact, self-contained telesurgery workstation designed to enable safe and effective remote surgical operation in environments with

limited space.

The TSC integrates a compact ergonomic chair with inbuilt electronics, magnetic sensor-based control systems, lightweight

3D viewing glasses, and a magnified three-dimensional view of the surgical field, while its portable, space-efficient design allows deployment

in physician offices and other locations with small physical footprints.

Unlike conventional consoles where the surgeon

sits opposing a stationary unit, the TSC features a “surgeon-within-the-console” design, integrating the surgeon directly

into the station and offering extensive ergonomic adjustments, including foot pedal retraction and extension, console height adjustment,

and fully configurable armrests, along with comprehensive back and neck support to maintain optimal posture and minimize fatigue during

prolonged procedures.

In October 2025, the first telesurgery using the TSC was successfully performed by Dr.

Sudhir Srivastava from his

residence in New Delhi, India, demonstrating the system’s portability, ergonomic effectiveness, and feasibility for remote surgical

applications.

5mm Surgical Instruments .

completed the development of five new 5-millimeter surgical instruments for clinical use across multiple specialties, including pediatric,

cardiac, and head and neck surgery, among other procedures involving smaller anatomical structures.

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.

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

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support is operational support to ensure smooth onboarding and the 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 care 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 of our SSi Mantra system.

upgrades and updates enable the latest product innovations, enhancements and reliability improvements.

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 care plan portfolio offers flexible service plans to ensure

reliability of the systems and instruments and help optimize the robotics program.

Our support team consisting of expert field service,

remote technical support and customer care agents assist customers to resolve and prevent any technology issues that could inhibit optimal

utilization of our SSi Mantra system.

Software upgrades and updates enable the latest product innovations, enhancements and reliability

improvements.

Peer Review Papers

The following peer review papers have been published

with respect to the SSi Mantra and our technology:

In a peer review paper entitled, “Initial

experience of SSI Mantra robot-assisted transabdominal pre-peritoneal repair of primary ventral hernias” by Magan Mehrotra and

Chukka Gautam Kumar published on July 30, 2024 in the Journal of Minimal Access Surgery, the authors describe their initial experience

with robot-assisted transabdominal pre-peritoneal (rTAPP) repair of small- and medium-sized primary midline ventral hernias using the

In a peer review paper entitled, “ Robotic

uro-oncology applications of SSI Mantra robot” by Sudhir K.

Rawal, Ashish Khanna, Amitabh Singh, Sarbartha K.

Pratihar, Ishan

Malla, Mujahid Ali, Vivek Vasudeo, Kaushik Jaganthan, Bhuvan Kumar, and Nikhil Saurabh published on April 19, 2024 in the Asian Journal

of Urology , the authors report on their preliminary clinical experience with the SSi Mantra.

In a peer review paper entitled, “ Safety

and Efficacy of Robotic Hysterectomy Using the SSI Mantra Robotic System ” by Gajbhiye et al.

published in 2025 in the Cureus

Journal of Medical Science , the authors evaluate the safety, feasibility, and peri-operative outcomes of robotic hysterectomy performed

using the SSi Mantra.

In a peer review paper entitled, “ Feasibility

of One Anastomosis Gastric Bypass Using the SSI Mantra Robotic Platform ” by Magan Mehrotra, Chukka Gautam Kumar and Nikhil

Mehrotra published on September 16, 2024 in the Journal of Bariatric Surgery , the authors describe the first robotic one anastomosis

gastric bypass (OAGB) performed using the SSI Mantra in a patient with severe obesity.

In a peer review paper entitled, “ Real-world

performance of the SSI Mantra™ robotic system:

a multicentric multi-specialty study evaluating its safety and surgical applications ”

by Somashekhar S.P.

(a director of the Company), Medha Sugara, Kushal Agrawal, Sudhir Kumar Rawal, Amitabh Singh, Magan Mehrotra, Raj

Gajbhiye, Chandramohan Vaddi, Srikarthik Voleti, Leena Mehrotra, Ganesh Gorthi, Manjiri Somashekhar, and Nitin Kumar Rajput on December

23, 2025 in the Journal of Robotic Surgery , the authors evaluate the real-world safety, feasibility, and learning curves of the

SSI Mantra across India.

Macro Healthcare Trends

Advances in surgical technology are

making next-generation robotic systems increasingly versatile across a broad spectrum of procedures, at a time when demographic

shifts, including an aging global population, are driving higher demand for surgical interventions and the disease burden from

chronic and lifestyle-related conditions continues to rise.

These trends are further compounded by workforce challenges, as healthcare

systems face shortages of trained professionals, which robotic and digital technologies help address by reducing labor intensity per

care episode.

From an economic perspective, such systems improve value for both providers and payers through greater efficiency

and optimized resource utilization.

They also deliver meaningful patient benefits, including reduced surgical trauma, shorter recovery

times, and improved clinical outcomes, while offering surgeons significant benefits through enhanced ergonomics, precision,

and reduced fatigue.

In addition, hospitals benefit from increased revenue potential, lower complication rates, shorter lengths of stay,

and overall improved operational efficiency.

Increasing demand for healthcare :

The increasing

demand for healthcare in emerging markets such as India is driven by population growth and a growing middle class, rising per capita incomes,

growing health insurance penetration and changing lifestyles.

These trends are resulting in patients demanding

specialized, higher quality products and services, with improved efficiency and outcomes for an overall better healthcare experience.

India’s healthcare industry is expected to grow from $370 billion in 2022 to $610 billion in 2026.

The proportion of the Indian

population in the working age-group (15–59 years of age) is expected to rise from 60.7% in 2011 to 65.1% in 2036.

This demographic

segment demands, and we believe is willing to spend on high-quality healthcare services.

increasing demand for healthcare in emerging markets such as India is driven by population growth and a growing middle class, rising

per capita incomes, growing health insurance penetration and changing lifestyles.

These trends are increasingly resulting in patients

demanding specialized, higher quality products and services that deliver better clinical outcomes, improved efficiency and an overall

superior healthcare experience.

According to the New Indian Express, India’s healthcare industry is expected to grow from $638 billion

in 2025 to $1.5 trillion by 2030.

This growth is supported by favorable demographics, with India continuing to benefit from a large working-age

The proportion of the Indian population in the working age-group (15–64 years of age) is expected to reach 68.9% by

2030, with a median age of 28.4 years, according to www.dristiias.com.

This demographic represents a sizeable consumer base with rising

purchasing power and we believe is willing to spend on high-quality healthcare services.

Together, these factors create strong long-term

demand fundamentals for advanced healthcare solutions and specialized medical technologies in India.

Growing adoption of technology :

and hospitals are increasingly focused on improving clinical outcomes while enhancing patient experience.

Hospitals aim to achieve these

goals by customizing care, improving provider efficiency by lowering the amount of time required to treat patients and reducing overall

Shorter recovery times with robotic-assisted surgery maximizes the operational efficiency of the bed capacity, along with reduction

in complications.

India has a large and growing unmet need for advanced surgical

The country has an extensive healthcare delivery network with tens of thousands of hospitals (including public, private and multi-specialty

institutions) performing a very high volume of procedures each year.

According to recent industry data, over 30 million surgeries are

performed annually in India across various specialties, reflecting the sheer scale of surgical demand in the country, while robotic

surgery adoption remains a small but rapidly growing segment of this total surgical volume.

Although precise consolidated national figures on total robotic surgeries

in India varies, recent reports indicate that India recorded more than 10,000 robotic assisted procedures in 2024 and industry

associations estimate that up to 60,000 robotic-assisted surgeries are now performed annually by over 1,500 trained surgeons spanning

general surgery, urology, oncology, gynecology, cardiology, and other specialties.

Recent market intelligence also shows that India

has over 950 trained robotic surgeons and more than 180 installed robotic surgical systems across government and private hospitals,

with growth expected to accelerate as more systems and training capacity come online.

Significant unmet need :

India has 70,000

hospitals and approximately 21 million major surgeries are performed in India every year.

However, only 10,000–12,000 robotic surgeries

are done in India annually, representing less than 0.1% of the global volume.

Furthermore, laparoscopy is well established in India, leading

to a large pool of laparoscopic surgeons.

This will facilitate a faster transition from laparoscopy to robotic surgery.

There is a large

unmet need for surgical robotic systems that are affordable, accessible and have aftermarket support.

Despite this growth,

surgical robotic procedures represent only a small fraction of total surgical volumes in India nationwide, highlighting a significant

unmet need for surgical robotic platforms that are affordable, accessible, and supported with strong aftermarket service networks across

urban and non-urban centers.

The established prevalence of laparoscopic surgery in India has created a large base of laparoscopic surgeons,

many of whom are well-positioned to adopt surgical robotic systems as they seek technologies that can facilitate the transition from

traditional laparoscopy to robot-assisted surgery, improve precision, reduce recovery times, and expand the scope of minimally invasive

Increasing health insurance penetration :

Health insurance coverage is an important determinant of access to and demand for healthcare services.

Health insurance coverage in India

has steadily grown in recent years, covering 70% of the population with nearly 950 million people with either private health insurance

or government subsidized schemes such as Ayushman Bharat.

Currently, Indians spend approximately 20% of their health spending as an out-of-pocket

expenditure compared to 55% in 2019.

Key elements of the positive transformation of India’s healthcare system are the National Health

Mission, Ayushman Bharat, and medical tourism.

Health insurance coverage is a critical determinant of access to and demand for healthcare services in India.

Insurance penetration has

expanded steadily over the last decade, primarily driven by public schemes and growing private insurance adoption.

As of 2025, government-backed

schemes led by Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (PM-JAY) have issued over 420 million health cards,

making it the world’s largest public health insurance program.

When combined with state government schemes and private insurance,

a significant share of the population has some form of financial health protection, although household-level surveys indicate that

coverage is not yet universal and remains uneven across income groups and states.

India has also made progress in reducing the financial burden on patients.

Out-of-pocket

expenditure (“ OOPE ”), which exceeded 60% of total health spending in 2014-2015, declined to approximately 39.4%

in 2021-2022.

This improvement reflects increased public health spending, wider insurance penetration, and expanded access to empaneled

Key enablers of this transformation include the National Health Mission, Ayushman Bharat, and the continued growth of

medical value travel.

Medical value travel :

India has emerged

as a leading destination for medical tourism, attracting patients from around the world.

The Indian medical tourism market was valued

at $2.89 billion in 2020 and is expected to reach $13.42 billion by 2026.

The medical tourism sector has emerged as a key growth driver

for surgical procedures in India.

The factors contributing to the growth of medical tourism include availability of advanced treatments

at relatively lower costs, the availability of skilled doctors, advanced technology in private hospitals, English language proficiency

and ease of travel.

The Indian Government has played a pivotal role in paving the way for these international patients to enter the country

and avail their desired medical treatments.

It has implemented a number of policies, including the introduction of an e-Medical visa,

multiple entry visas and longer stays as needed for treatment.

as one of the world’s leading destinations for medical value travel, attracting patients from Asia, Africa, the Middle East,

and other markets.

According to Mordor Intelligence, the Indian medical tourism market estimated at approximately $12.32 billion in 2026,

is projected to grow to $22.1 billion by 2031, at a CAGR of 12.42% during the forecast period (2026-2031), supported by a strong pipeline

of complex surgical procedures.

Medical tourism has become an important growth driver for surgical volumes, including advanced minimally

invasive and robotic procedures.

Key factors underpinning this growth include significantly lower treatment costs compared to developed

markets, availability of highly skilled doctors, advanced infrastructure in private hospitals, English language proficiency, and improving

ease of travel.

The Government of India has actively supported this segment through policy initiatives such as e-Medical visas,

multiple-entry visas, and extended stay provisions for patients and caregivers.

Favorable regulatory environment :

several policy measures were implemented to drive the growth of India’s healthcare sector.

These include increase in public health

expenditure to 2.5% of GDP by 2025;

an implementation of several large-scale and ambitious initiatives like Ayushman Bharat—the

world’s largest universal health coverage scheme covering 500 million people;

commitment from the Government to invest $200 billion

in medical infrastructure by 2024, as well as the roll out of various schemes under the Aatma Nirbhar Bharat Abhiyaan.

In particular,

the Performance-Linked Incentive (PLI) Scheme and the Scheme for Promotion of Medical Device Parks offers significant financial incentives

for investors to manufacture in India.

A new PLI 2.0 scheme is also being prepared for promotion of the in-vitro diagnostics market.

healthcare sector continues to benefit from a supportive and evolving regulatory environment.

Public health expenditure has increased

steadily, with government policy reiterating a long-term target of raising public health spending toward 2.5% of GDP.

The government

has also committed substantial investments in healthcare and medical infrastructure over the past decade, alongside structural reforms

under the Aatma Nirbhar Bharat Abhiyaan.

To strengthen domestic manufacturing, the government introduced the Production-Linked

Incentive (PLI) Scheme for Medical Devices, the Scheme for Promotion of Medical Device Parks, and is progressing toward PLI

2.0, including support for in-vitro diagnostics.

These initiatives offer capital incentives, infrastructure support, and scale advantages,

positioning India as an increasingly attractive hub for medical technology manufacturing and innovation.

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 and ease of training to move into

other markets, such as the United States and Europe.

Key elements of this strategy include:

and steep learning curve for existing systems.

After validating the SSi Mantra in these markets, we intend to leverage our advanced technology,

significantly lower cost and ease of training to move into other markets, such as the U.S.

Key elements of this strategy

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.

As a comparison, there are only approximately 6,120 hospitals in the U.S.

However, only about 0.1% of global robotic

surgical procedures are done in India.

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.

supported by an extensive network of roughly 70,000 hospitals providing diverse care across urban and rural regions.

to the United States, which has approximately 6,000 hospitals, India’s healthcare infrastructure is far larger in scale but

still developing in advanced surgical capabilities.

Despite this scale, the adoption of robotic surgery in India remains relatively low.

As of 2024, India accounted for approximately 6% of the Asia-Pacific robotic surgical systems market and reported over

10,000 robotic-assisted surgeries in 2024 alone, with over 180 installed systems and more than 950 trained robotic surgeons supporting

growth in major specialty centers.

Given this under-penetration—surgical robotic

procedures comprise only a small fraction of overall surgical volumes in India despite millions of annual operations.

We believe there

is significant opportunity for affordable, high-performance systems like the SSi Mantra to expand access in underserved domestic

markets and globally across Asia, Africa, Europe, Central and South America, and other regions.

The surgical robotics market

in India is projected to grow robustly over the coming decade, driven by increasing demand for minimally invasive procedures, rising

chronic disease prevalence, and broader capability adoption in tertiary care centers, yet accessibility outside of premier institutions

remains limited.

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.

efforts are focused on large multi-specialty care hospitals where most 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 and work with the hospitals and their

surgeons to promote patient education as to the benefits and cost effectiveness of our system.

We believe 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

We place significant emphasis on marketing the SSi Mantra to leading surgeons who are “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 procedures.

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.

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

Evaluation, Familiarization and Training Agreements

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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.

SSi Mantra for evaluation, familiarization and training purposes.

As of the date of this Annual Report, we had entered into such agreements

with approximately ten hospital networks in India and with Johns Hopkins University in Baltimore, Maryland.

National and International Medical Conferences.

We participated in many International and National Conferences during 2024 hosted by nationally accredited and internationally acclaimed

bodies to help both raise awareness about the SSI Mantra surgical robotic platform and provide hundreds of surgeons with the opportunity

to have an insight of our SSi Mantra system.

Our first Global SMRSC (SSI Mantra Robotic Surgery Conference) that was hosted in January

2024, was attended by over 700 national and international faculty who participated over the course of the two day event and our second

Global SMRSC that was hosted in March 2025, was attended by over 1,200 participants and displayed the increased capabilities of the SSi

Mantra 3, including the performance of telesurgery and the introduction of our mobile robotic surgical system.

At both conferences, key

opinion leaders from India and abroad were given the platform to discuss not only their experience with the SSi Mantra but to foster discussions

on the global potential of a very disruptive yet cost-effective surgical robotic system.

We have and intend to continue to participate in International and National Conferences hosted by nationally accredited and internationally

acclaimed bodies to help raise awareness about the SSi Mantra platform and provide surgeons with the opportunity to view our SSi Mantra

Our first Global SMRSC (SSi Mantra Robotic Surgery Conference) that was hosted in January 2024, was attended by over 700 national

and international faculty and our second Global SMRSC that was hosted in March 2025, was attended by over 1,400 participants and displayed

the increased capabilities of the SSi Mantra 3, including the performance of telesurgery and the introduction of our mobile robotic surgical

At both conferences, key opinion leaders from India and abroad were given a platform to discuss their experience with the SSi

Mantra and foster discussions regarding the global potential of our cost-effective surgical robotic system, we have plans to host the

next Global SMRSC in April 2026 as part of our market outreach plans.

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 ninety different types

safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than one hundred different types

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

As of the date of this Annual Report, we have installed 75

systems in India and overseas, which have been used to perform more than three thousand 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

As of December 31, 2025, we have installed 168 systems, of

which 154 are located in India, and 14 at overseas locations, including 21 systems installed on pay per use basis, 8 systems installed

for demonstration purposes, and 10 upgraded systems which have been used to perform more than 7,800 surgical procedures (compared to 2,759

cumulative surgical procedures as of December 31, 2024), 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 .

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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 are 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

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

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 procedure.

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 are 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.

Totally Endoscopic Coronary Artery Bypass

Surgery (TECAB).

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 surgery.

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

the heart is beating.

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

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 heart.

Mitral and Aortic Valve Repair/Replacement .

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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.

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

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

Head and Neck Surgery

Transoral Surgery .

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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.

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 allows patients to avoid traumatic surgical

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

assisted transoral surgery allows surgeons 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 with the opportunity to receive a minimally invasive treatment

as an alternative to an open hysterectomy.

is one of the most commonly 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

We believe that robotic-assisted surgery with the SSi Mantra provides patients with 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;

The abdominal (open)

Sacro colpopexy is a type of operation 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

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.

Robotic assisted surgical capabilities enable a larger number of

these procedures to be performed through a minimally invasive technique, conferring the benefits of MIS to a broader range of Sacro colpopexy

Urologic Surgery

Prostatectomy .

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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.

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

The conventional laparoscopic approach is difficult and poses

challenges to even the most skilled urologist.

The SSi Mantra will enable a larger number of surgeons to transition from open surgical

techniques to a minimally invasive robotic surgical technique.

Partial Nephrectomy .

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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.

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

be performed through a minimally invasive technique, conferring the benefits of MIS to a broader range of partial nephrectomy patients.

Radical Nephrectomy .

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

During 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.

During 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 .

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The Global Robotic Surgery Market

The global surgical robotics market valued at

9.6 billion in 2023 is forecasted to grow at a robust CAGR of 16.5% reaching US$23.7 billion by 2029*.

Surgical robots offer significant

advantages in minimally invasive surgery by enabling exceptionally precise manipulation of surgical instruments within constrained operation

According to Markets and Markets research, the global surgical robotics

market is projected to reach $27.14 billion by 2030 from $11.98 billion in 2024, at a CAGR of 14.7% during the forecast period.

robots offer significant advantages in MIS by enabling exceptionally precise manipulation of surgical instruments within constrained operation

spaces, surpassing human capabilities.

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

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.

https://www.marketsandmarkets.com/Market-Reports/surgical-robots-market-256618532.html)

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

or 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.

In addition, the surge in the number of gynecological, neurological

and urological diseases is a primary factor driving the surgical robotics market growth.

In addition, surgical robotics enable minimally

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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

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.

Furthermore, as the global population ages, we

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to aim 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.

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

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

These factors collectively hinder the rapid expansion

These factors collectively have hindered expansion

of the surgical robotics market.

Segmental Overview

The surgical robotics industry is segmented into

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

Region wise, the market is analyzed across North America, Europe, Asia-Pacific, Latin America, the Middle East and Africa (“ LAMEA ”).

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.

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 (i.e., Colombia, Ecuador, India, Indonesia, Iraq, Nepal, Oman, Philippines and the United Arab Emirates)

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 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.

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

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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.

Furthermore, product launches, collaborations, and acquisitions adopted

by the key players in this region help to 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 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.

This 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.

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 region.

Within the Asia-Pacific region, India stands out as the fastest-growing

large economy and a critical growth engine for advanced healthcare technologies, including surgical robotics.

Rising incomes, rapid urbanization,

demographic shifts, and a significant unmet need for high-quality tertiary care position India as a pivotal driver of regional healthcare

India’s healthcare sector has expanded

rapidly over the past decade, growing from approximately $110 billion in 2016 to about $372 billion in 2023.

longer term, industry and policy projections indicate India’s healthcare market could approach $1.5 trillion by 2030, supported

by sustained demand and structural reforms.

Healthcare spending in India, while increasing,

remains below global averages.

Over the next five years, healthcare spending as a percentage of GDP is expected to trend upward

toward 5%, though it may still remain below many OECD and emerging-market peers.

According to Niti Aayog, it is estimated that 70%

of the Indian population is covered under public or voluntary private health insurance.

while the remaining 30% (approximately 400 million

people) remain uninsured.

The India health insurance market in terms of gross written premiums was estimated at $15.06 billion in

2024 and is projected to grow at a CAGR of 20.9% from 2025 to 2030.

Despite strong growth, India continues to face

structural gaps in healthcare infrastructure.

The doctor-to-population ratio has improved to roughly 1:811, yet regional disparities

persist, particularly in non-urban areas.

These gaps are driving both public and private investment in hospital capacity, medical colleges,

and advanced care facilities.

In 2026, hospital revenue growth of 16–18%

is projected, supported by higher insurance-funded procedures, medical value travel, and increasing adoption of advanced technologies.

India’s healthcare ecosystem in 2025 was characterized by rapid

market expansion, rising insurance penetration, declining out-of-pocket spending, and accelerating investment in infrastructure and technology.

While capacity constraints remain, these structural trends strongly support the long-term growth of advanced healthcare solutions, including

surgical robotics, positioning India as a central pillar of healthcare growth in the Asia-Pacific region.

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, 2024, included distributors

in Colombia, Ecuador, Guatemala, Indonesia, the Philippines, the United Arab Emirates, CIS Countries, the Baltic Region, Greece, Cyprus,

Sri Lanka, Bangladesh, Nepal, Oman, and Australia.

Our direct sales organization is composed of a

capital sales team of ten individuals, who are responsible for selling systems, and a clinical support team of thirty 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.

We provide our systems and related devices through

a direct sales organization in India and, outside of India, through an expanding distributor network that, as of December 31, 2025, included

distributors in Colombia, Ecuador, Guatemala, Indonesia, the Philippines, the United Arab Emirates, CIS Countries, the Baltic Region,

Greece, Cyprus, Sri Lanka, Bangladesh, Nepal, Oman, Iraq, the West Indies, Mauritius, Madagascar, Seychelles, and Australia .

Our direct sales organization is composed of

a capital sales team of ten individuals, who are responsible for selling systems, and a clinical support team of thirty 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 processes.

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,

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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.

In cases where the systems are installed on pay per procedure basis,

the Company earns revenue share which is a mix of fixed and variable components.

Variable components consist of revenue share which is

agreed based on the number and type of procedures performed by the customer, while the fixed component involves an agreed amount which

the customer is obliged to pay over the lease term.

Accordingly, the fixed component is recognized on a straight-line basis as lease income.

Since title for the system is not getting transferred to the customer, the cost relating to those systems is capitalized under property,

plant and equipment and accordingly depreciation is charged over its period of useful life.

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.

In cases where the systems are installed on a

pay-per-procedure basis, the Company earns revenue share which is a mix of fixed and variable components.

Variable components consist

of revenue share which is agreed based on the number and type of procedures performed by the customer, while the fixed component involves

an agreed amount which the customer is obliged to pay over the lease term.

Accordingly, the fixed component is recognized on a straight-line

basis as lease income.

Since title for the system is not getting transferred to the customer, the cost relating to those systems is capitalized

under property, plant and equipment and accordingly depreciation is charged over its period of useful life.

Our customers place orders to replenish their

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

To date, substantially all of our sales have been

in India, with one sale each in the United Arab Emirates, Ecuador, Nepal and Indonesia.

Training and Customer

To date, substantially all of our sales have

been in India, with one sale each in the United Arab Emirates, Ecuador, Iraq and Nepal, and two sales in Colombia, Indonesia and the

Training and Customer Support

We also provide training for surgeons, physicians

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cases and remote proctoring support for complex cases.

With respect to sale of surgical robotic systems, training is provided at the time

of delivery to the end customer, however the effort involved is considered negligible.

With respect to the sale of surgical robotic systems, training is provided at

the time of delivery to the end customer, however the effort involved is considered negligible.

We have a network of field service and technical

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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

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 and currently have a research and development team of 65 employees to focus on delivering future innovations and

sustaining improvements that advance our mission.

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 and currently have a research and development team of 81 employees to focus on delivering future innovations and sustaining improvements

that advance our mission.

Manufacturing

Our systems and instruments are manufactured by

our employees at our approximately 70,000 square-feet facility in Gurugram, Delhi NCR, India.

The manufacturing of our products is a complex

operation involving a number of separate processes and components.

Our systems and instruments are manufactured

by our employees at our approximately 75,000 square-foot facility in Gurugram, Delhi NCR, India.

Our facility currently operates with

a production capacity of 20 systems per month across multiple shifts.

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

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(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 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

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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 face competition in the forms of existing

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

Our 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 the SSi Mantra 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

companies that have developed and currently manufacture and market products in the field of robotic-assisted medical procedures, including

but not limited to:

Intuitive Surgical, Inc.;

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Johnson & Johnson;

Medicaroid Corporation;

Medrobotics Corporation;

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Samsung Electronics Co., Ltd.;

Shandong Weigao

Group Medical Polymer Company 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.

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

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January 28, 2042

June 28, 2042

March 3, 2042

October 11, 2044

February 17, 2042

November 10, 2043

March 31, 2043

December 1, 2043

March 31, 2043

MANTRA & MAYA

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July 27, 2043

September 28, 2041

March 17, 2045

October 05, 2041

August 23, 2045

June 10, 2043

January 28, 2043

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MANTRA & MAYA

June 27, 2044

November 4, 2042

September 19, 2044

November 09, 2043

December 27, 2044

August 2, 2044

July 15, 2044

MANTRA & MAYA

September 19, 2044

November 09, 2043

December 27, 2044

August 2, 2044

July 15, 2044

MANTRA & MAYA

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December 27, 2044

August 2, 2044

July 15, 2044

MANTRA & MAYA

September 19, 2044

October 20, 2043

December 27, 2044

August 2, 2044

July 15, 2044

MANTRA & MAYA

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December 27, 2044

August 2, 2044

July 15, 2024

MANTRA & MAYA

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October 20, 2043

November 09, 2043

June 09, 2043

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consists of 8 PCT international WIPO applications as follows:

December 9, 2026

February 27, 2026

October 31, 2025

August 18, 2026

June 27, 2027

June 10, 2026

MANTRA & MAYA

Further, our intellectual property portfolio also

consists of 30 granted design patents and 4 pending design patent application as follows:

Further, our intellectual property portfolio

also consists of 32 granted design patents and 4 pending design patent application as follows:

January 31, 2038

September 27, 2039

December 20, 2038

October 28, 2040

October 31, 2040

August 29, 2038

December 23, 2039

January 20, 2040

October 25, 2039

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through both Madrid and direct foreign filings of which 10 have been registered.

We have also filed two copyright applications,

both of which have been granted.

We intend to apply for additional utility patents,

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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.

Quality Management System

Our systems and related devices and operations

are subject to regulation in India by the CDSCO, by the FDA in the U.S.

and by similar agencies in other countries and regions in which

we market or plan to market our products.

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 systems and related devices.

We must continually keep abreast of these regulations, standards and requirements and

integrate our compliance into the development and regulatory documentation for our systems and related devices.

Failure to meet these

standards could limit our ability to market our systems and related devices 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 System

ISO 13485 is an internationally recognized quality

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system specific to the medical device industry.

This standard is designed to be used by manufacturers throughout the life cycle of a medical

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

and audit procedures.

This standard is designed to be used by manufacturers throughout the life cycle of a

medical device.

We are required to meet this standard to register our systems and related devices for sale globally and are subject to

rigorous annual reassessment and audit procedures.

Our Company has developed a Harmonized 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.

and EU quality management systems requirements.

We received ISO 13485 certifications in 2021.

During the course of 2024, we conducted recertification audit from EU Notified Body for EN ISO 13485 and ISO 13485 and we received the

certification in Q4 of 2024.

During the course of 2024, we conducted a recertification audit from EU Notified Body for EN ISO 13485 and ISO 13485 and we received

the certification in Q4 of 2024.

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.

In the past medical devices in India had been

mostly unregulated, but that has changed in recent years, with the adoption of rules and regulations designed to improve and enhance patient

Our systems and related devices are primarily regulated under the IMDR promulgated and administered by the CDSCO.

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, these regulations mandate that devices be safe and perform their intended

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:

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);

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We currently have CDSCO approval for the manufacture,

sale and distribution of our products under Class C including the Telesurgery approvals and a license to export our products from India.

In December 2024 we became the first and only

company in India to receive CDSCO regulatory approval for telesurgery and tele proctoring capabilities of a surgical robotic system.

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 U.S.

sale and distribution of our systems and related devices under Class C including the Telesurgery approvals and a license to export our

systems and related devices from India.

In December 2024 we became the first company

in India to receive CDSCO regulatory approval for telesurgery and tele proctoring capabilities of a surgical robotic system.

Our systems and related devices will be subject

to regulation as medical devices in the U.S.

under the FFDCA, as implemented and enforced by the FDA.

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 filed a pre-submission application with the

FDA, requesting feedback on the SSi Mantra.

We had a feedback meeting with the FDA on April 2, 2024, and the

FDA has indicated that we should pursue the Investigational Device Exemption (“ IDE ”) route to obtain U.S.

Currently, we are in the process of preparation of the IDE Application and expect to start our U.S.

IDE study in third quarter

of 2025, subject to FDA IDE and Institutional Review Board (“ IRB ”) approvals There can be no assurance that we will

receive FDA approval to market the SSi Mantra through the IDE route, that we will need to undertake a different path as set forth below

or that we will ever receive FDA approval to market.

We had a feedback meeting with the FDA on April 2, 2024.

The pre-submission meeting

(Reference number Q240119) was organized with the FDA to seek interactive feedback from the FDA regarding the regulatory strategy, biocompatibility

assessment, reprocessing validation, and clinical data.

While FDA acknowledged that certain similarities exist between the SSi Mantra

and the proposed predicate device(s), the recommendation was to proceed with a de novo review instead of the 510(k) route.

Under the FDA’s regulatory scheme, medical

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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.

We believe that our current SSi Mantra system

and related devices will be classified as Class II medical devices.

The de novo classification process under the FFDCA

provides a pathway for certain new types of devices to obtain marketing authorization as Class I or Class II devices, rather than remaining

automatically designated as a Class III device, which would require premarket approval.

Class II medical devices are those that are subject

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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

These special controls can

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

Based on further discussions with the FDA, in

August 2025, the Company pivoted from filing a de novo request for the SSi Mantra to pursuing the 510(k) regulatory pathway which offers

potential speed and cost advantages We successfully completed a human factors validation study for our SSi Mantra system at Johns

Hopkins Hospital in September 2025.

On December 5, 2025, we submitted a 510(k) premarket notification to the FDA for the SSi Mantra surgical

robotic system for multiple specialty procedure types, including:

general, urological, colorectal, gynecological, and cardiac surgery.

We have engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission.

If approved by the FDA, the SSi Mantra would

be cleared to market in the U.S.

Submission of a 510(k) premarket notification request does not guarantee FDA approval.

We believe that

we will be able to secure FDA certification in 2026.

However, there can be no assurance as to when or if we will secure such regulatory

The FDA generally reviews a 510(k) premarket

notification submission within 90 calendar days of receipt;

however, in practice, review timelines may extend if additional information

is requested.

During the review, the FDA may issue requests for additional data or clarification to determine whether the subject 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

If the FDA determines that the device is not substantially equivalent

(NSE) to a predicate device, the product may be considered a novel device that does not qualify for the 510(k) pathway.

In such cases,

the sponsor may pursue the de novo classification process for low-to-moderate-risk devices or, if the device presents a higher risk,

proceed with a PMA application.

The PMA process is more demanding and requires

a full evaluation of clinical trial data and extensive documentation.

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 de novo classification

request under Class II, the FDA may also require 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 patients.

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 investigation devices or on making safety or effectiveness claims for them.

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 studying 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 the 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.

support a PMA and are sometimes required to support a de novo classification request.

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.

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 investigation

devices or on making safety or effectiveness claims for them.

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 studying subjects outweigh the anticipated benefits.

After a device receives premarket authorization

from the FDA, 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 the manufacturer’s determination.

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

upon the intended use of our systems and related devices 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 has 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 systems and related devices to ensure that any 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 systems and related devices for uses not within the scope of our intended use statement

in our clearances or make unsupported safety and effectiveness claims.

In addition, the FDA collects user fees for certain

medical device submissions and annual fees for medical device establishments.

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,

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.

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or unscheduled inspections by the FDA.

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

Failure to maintain compliance with applicable QSR requirements could result in the shutdown of,

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

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● recalls, withdrawals, or administrative

detention or seizure of our products;

detention or seizure of our systems and related devices;

● 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;

refusing or delaying requests for 510(k) marketing clearance or PMA

approvals of new or modified systems or devices;

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

refusal to grant export approvals for our systems and related devices;

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.

problems with any marketed systems and related devices, 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.

or 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.

We must demonstrate compliance of such products with

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

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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.

In 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

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

We have been in discussions with an EU Notified

body for CE certification, which will allow us to market the SSi Mantra in the EU.

We expect to submit our CE application submission in

the second quarter of 2025.

There can be no assurance that we will receive CE certification.

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.

We have submitted our technical file to Szutest,

an EU Notified body for CE certification, which if approved will allow us to market the SSi Mantra in the EU.

We expect to receive a

scheduled audit in the second quarter of 2025 and CE marking by the end of 2025.

Szutest may require us to perform additional clinical

trials, which if required will be conducted under the guidance of EU MDR regulation.

There can be no assurance that we will receive CE

certification.

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.

aims to increase harmonization across the EU member states.

The MDR requires that, before placing a device

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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.

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

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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 the risk of a serious incident associated with the use of a medical device that

is made available on the market.

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

action for technical or medical reasons to prevent or reduce the 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.

According to the MDR, only devices that are Conformité Européene

(“ CE ”) 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 be 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.

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

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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.

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

Certain EU member states also mandate

implementation of commercial compliance programs.

In the EU, regulatory authorities have the power

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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

in the EEA, which consists of the twenty-seven EU member states, as well as Iceland, Liechtenstein and Norway.

Other countries

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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 on our ability to generate revenue and harm our business.

We have partnered with a MDSAP-Recognized Auditing Organization, TUV-SUD to obtain

MDSAP certification.

Failure to obtain regulatory approval in any

foreign country in which we plan to market our systems and related devices or failure to comply with any regulation in any foreign country

in which we market our systems and related devices may negatively impact on 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.

govern the use of our systems and related devices, 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

systems and related devices.

Failure to comply with any of these regulations could result in sanctions or fines and could prevent us

from marketing our systems and related devices 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, Nepal,

Indonesia, Guatemala Philippines, Ukraine and Sri Lanka and have initiated the regulatory approval process, in many other countries, 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.

and Security Laws

CDSCO approval for the manufacture, sale and distribution of our systems and related devices and our Indian export license allows us

to market our systems and related devices in fifty (50) non-FDA and non-CE (EU) countries without further regulatory approvals and in

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

We have received regulatory approval to market and

sell our systems and related devices in Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the

United Arab Emirates and have initiated the regulatory approval process, in many other countries, which if successful, will allow us

to market our systems and related devices in more than fifty (50) countries within approximately one year.

However, there can be no assurance

as to when or if we will secure any such regulatory approvals.

Data Privacy and Security Laws

Numerous state, federal, and foreign laws, regulations,

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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

Therefore, if we commence marketing our systems and related devices 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 GDPR.

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

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

in particular in relation to transfers to the United States.

in particular in relation to transfers to the U.S.

Cybersecurity

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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 378

employees, 175 of whom were engaged in manufacturing, 76 in marketing, sales, clinical support and field service, 61 in research and development,

26 in sourcing, 5 in quality control and 35 in administration.

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

We generally consider our relationship with our employees to be good.

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.

Cybersecurity Governance

We are in the process of implementing a cybersecurity

governance and risk management framework.

We consider cybersecurity risk as part of our overall enterprise risk management and are developing

policies, procedures, and controls to identify, assess, and manage cybersecurity and information technology risks.

Our management team, including IT leadership,

is responsible for overseeing cybersecurity risk management and for implementing our cybersecurity program.

Management provides updates

to senior leadership on cybersecurity matters, including the status of implementation efforts and any identified cybersecurity risks

or incidents.

We monitor cybersecurity risks on an ongoing

basis and intend to establish regular internal reporting processes as our cybersecurity program matures.

Management may also engage external

cybersecurity consultants and service providers to support the implementation, monitoring, and improvement of cybersecurity controls.

As part of our ongoing implementation efforts,

we plan to obtain relevant cybersecurity and information security certifications and to enhance our capabilities to prevent, detect,

mitigate, and respond to cybersecurity incidents.

However, our cybersecurity program is still under development, and there can be no

assurance that these measures will be fully implemented in a timely manner or will be effective in preventing all cybersecurity incidents.

As of the date of this Annual Report, we had 483 employees, 204 of

whom were engaged in manufacturing, 122 in marketing, sales, clinical support and field service, 81 in research and development, 22 in

sourcing, 4 in quality control and 50 in administration.

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

Risk Factors.

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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