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Item 1. Business

2025-04-15 compared with 2024-03-22 · 491 added, 331 removed, 752 unchanged (52% of the section changed)

Company Background

We design, develop, manufacture and market surgical

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

Our vision is to create

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

to benefit greater numbers of patients around the world.

Robotic surgical procedures have achieved acceptance

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

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

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

and steep learning curve for the existing systems.

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

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

We commenced development of the SSi Mantra

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

The SSi Mantra

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

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

As of December 31,

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

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

The SSi Mantra system installed in the Minimally

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

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

Following approval by the

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

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

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

However, as of the date of this

report, no systems have been installed in Guatemala.

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

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

We have filed a

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

We received an

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

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

We have also been in discussions with an EU Notified

body for the CE certification.

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

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

additional seventy-nine countries require only minimal registration.

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:

Type of Surgical Procedure

of Procedures

General Surgery

Gastroenterology

Head and Neck

Plastic/Reconstructive

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.

Corporate Information

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Sub ”), CardioVentures and Dr.

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

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, 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.

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,

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issued to it in connection with the CardioVentures Merger.

Contemporaneously with the Closing on April 14,

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

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

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

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

owned subsidiaries of SSi.

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

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Information appearing on our corporate website is not part of

this prospectus and is not incorporated by reference herein.

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

this Annual Report and is not incorporated by reference herein.

We have included our website address as an inactive textual reference

The SSi Mantra

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adverse events.

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

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

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

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 precise dissection and reconstruction of anatomical structures within the body.

The SSi Mantra is comprised of the following components:

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 3 is comprised of the following

Surgeon Console .

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

Mantra instruments positioned inside the patient.

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

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

during the surgical procedure.

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

stability for surgeons and operating room staff.

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.

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

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

It has uninterruptible power supply battery backup;

universal safety features and incorporates the SSi Mantra multimedia recording

and streaming platform.

Tele-Proctoring/Tele-Mentoring Capabilities .

The SSi Mantra

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

and training capabilities.

The SSi Mantra has a built-in live streaming platform, which provides for remote mentoring and proctoring, thereby resulting in efficient

and cost-effective teaching and training capabilities.

Instruments and Accessories

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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.

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

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

Mudra Instruments .

Most of the more than

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

various surgical procedures.

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

surgical procedures.

Mudra instruments are offered in an 8mm diameter.

Various Mudra instrument tips include forceps, scissors,

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

invasive surgery (“ MIS ”).

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.

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

All instruments are sterilizable at the hospital, and

all are reusable for a defined number of procedures.

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

determine how the SSi Mantra and instruments work together.

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

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

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.

Accessory Products .

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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 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.

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

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.

Instruments under Development

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

SSi Ultrasonic Surgical Device .

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

Ultrasonic energy is used in the harmonic

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

SSi Robotic Stapler .

We are in the process

of finalizing the design and manufacturing of our SSI Robotic Stapler that would have broad applications in General Surgery, Thoracic

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 .

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SSi Holographic Anatomy .

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

education, and offering guidance for surgical procedures.

This application will potentially present patients with three-dimensional DICOM

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

SSi Yog - Tele Proctor .

SSi Yog introduces a pioneering solution for tele-proctoring.

It is designed for remote surgical proctoring.

This software seamlessly

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

to real-time guidance over long distances.

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

surgeries making it versatile enough to address diverse surgical scenarios.

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 Chitrasa - Advanced DICOM Viewer .

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SSi Mixed Reality Headset .

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

with the SSi Mantra Surgical Robotic System.

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

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

The potentially seamless

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

advancements and pushing the boundaries of surgical excellence.

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:

resolution 3DHD vision

image projection which allows for one meter depth perception

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

reconstruction of the 3D image by the human brain

We have a network of field service engineers in

India and maintain relationships with various distributors around the globe.

This infrastructure of service and support specialists offers

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

health monitoring.

● Peripheral view

● 1080p resolution 3DHD vision

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

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.

We have a network of field service

engineers in India and maintain relationships with various distributors around the globe.

This infrastructure of service and support specialists

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

system health monitoring.

Our comprehensive support and program assistance

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Readiness and Maintenance Support .

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

Maintenance support helps to maximize

operational efficiency and reduce unplanned equipment downtime.

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

and updates, as well as a customer portal.

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

and instruments and help optimize the robotics program.

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

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

Software upgrades and updates enable the

latest product innovations, enhancements and reliability improvements.

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.

Macro Healthcare Trends

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.

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.

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.

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.

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.

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.

Our initial strategy is to focus on underserved

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

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

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

Key elements of this

strategy include:

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:

Focus on underserved markets .

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and 70,000 hospitals.

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

As a comparison, there are only approximately 6,120

hospitals in the U.S.

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

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

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.

Focus on key institutions .

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entered into such agreements with approximately four 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.

Clinical Applications

The SSi Mantra has been clinically

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

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

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

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

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

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

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

We maintain productive collaborations with leading surgeons to explore

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

We primarily focus our development efforts

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

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 Surgery

Cardiovascular

Internal Mammary Artery Dissection .

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instruments inside the patient’s chest.

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

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.

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

Gynecologic Surgery

Hysterectom y .

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

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

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.

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colpopexy patients.

Urologic Surgery

Prostatectomy .

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Radical Nephrectomy .

A radical nephrectomy

Radical nephrectomy

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

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

During a robotic cystectomy, robotically

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

A robotic cystectomy is performed through

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

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

During a hernia repair surgery, the weakened

During hernia repair surgery, the weakened

tissue is secured, and defects are repaired.

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The Global Robotic Surgery Market

The global surgical robotics market was

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

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

Surgical robots offer significant advantages in minimally invasive surgery

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

capabilities.

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

across numerous medical disciplines.

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

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

patient outcomes .

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

surgeries in 2020 to 6.2 million surgeries by 2030.

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

spaces, surpassing human capabilities.

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

in practice across numerous medical disciplines.

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

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

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

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This versatility attracts hospitals and clinics

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

High initial costs associated with acquiring

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

may impede market growth.

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.

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

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of the surgical robotics market.

Segmental Overview

The surgical robotics industry is segmented into

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

On the basis of

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

other surgeries.

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

Based on surgery

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

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

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

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

robotics products are expected to drive the market growth.

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

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

2024 in terms of the number of surgical robotic systems installed and is expected to maintain its dominance during the forecast period.

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

surgical robotics products are expected to drive the market growth.

Furthermore, product launch, collaborations, and acquisitions adopted

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

Asia-Pacific is expected to grow at the highest

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Historically, the lack of investment in healthcare

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

physicians per 1,000 population.

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

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

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

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.

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organization in India and, outside of India, through an expanding distributor network that, as of December 31, 2024, included distributors

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

We are further expanding our domestic Indian and

foreign distribution capabilities through the establishment of strategic partnerships.

In December 2023, we entered into a memorandum

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

System for the entire African continent.

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

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

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

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

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.

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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.

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.

Our customers place orders to replenish their

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To date, substantially all of our sales have been

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

prior to the commencement of clinical procedures.

Our strategic collaboration agreement with Medikabazaar,

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

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

centers across India.

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

Training and Customer

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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.

We have a network of field service and technical

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We employ engineering and research

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

In certain instances,

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

with Johns Hopkins University.

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.

Manufacturing

Our systems and instruments are manufactured by

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

The manufacturing of our products is a complex operation

involving a number of separate processes and components.

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.

We purchase both custom and off-the-shelf components

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

Some of the components

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

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

We believe, however, that alternative

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

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

from a large number of suppliers from both within India and overseas and subject them to stringent quality specifications, inspections,

and processes.

Some of the components necessary for the assembly of our products are currently provided to us by sole-sourced suppliers

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

We believe, however, that alternative suppliers are available if it should become necessary, although no assurance can be given that we

could secure such alternative sources of supply, if required, on commercially reasonable terms or without undue operational disruption.

We purchase the majority of our components and

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As of the date of this Annual Report, our intellectual

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

Earliest Expiration

Latest Expiration

Earliest Expiration

Latest Expiration

October 6, 2034

October 31, 2038

June 20, 2039

November 21, 2034

December 25, 2039

December 26, 2034

property portfolio consists of 5 granted utility patents and 65 pending utility patent applications, and 10 PCT international WIPO applications

February 8, 2043

December 1, 2043

October 9, 2043

January 28, 2042

October 31, 2038

October 7, 2033

June 28, 2042

March 3, 2042

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March 31, 2043

November 10, 2043

December 1, 2043

MANTRA & MAYA

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July 27, 2043

November 22, 2033

June 10, 2042

October 10, 2042

January 12, 2038

October 31, 2038

June 20, 2039

September 28, 2041

March 17, 2045

January 28, 2043

October 31, 2038

October 6, 2034

June 20, 2039

February 8, 2043

December 27, 2044

November 21, 2034

July 15, 2044

MANTRA & MAYA

November 4, 2042

October 9, 2043

September 19, 2044

December 27, 2044

August 2, 2044

January 10, 2025

Further, our intellectual property portfolio

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

Earliest Expiration

Latest Expiration

Earliest Expiration

Latest Expiration

August 2, 2044

MANTRA & MAYA

September 19, 2044

December 27, 2044

April 17, 2028

August 2, 2044

MANTRA & MAYA

September 19, 2044

December 27, 2044

August 2, 2044

MANTRA & MAYA

September 19, 2044

December 27, 2044

August 2, 2044

MANTRA & MAYA

September 19, 2044

December 27, 2044

August 2, 2044

MANTRA & MAYA

February 08, 2043

December 27, 2044

July 15, 2044

MANTRA & MAYA

October 20, 2043

June 09, 2043

Further, our intellectual property portfolio also

consists of 10 PCT international WIPO applications as follows:

December 9, 2026

February 27, 2026

October 31, 2025

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:

January 31, 2038

September 27, 2039

December 20, 2038

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August 29, 2038

December 23, 2039

October 25, 2039

April 17, 2028

March 17, 2040

In addition, we have filed 93 applications for

trademark registrations in India of which 29 have been granted.

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

We intend to apply for additional patents in various

jurisdictions.

trademark registrations in India of which 40 have been registered.

Further, we have filed 31 applications for trademark registrations

through both Madrid and direct foreign filings of which 13 have been registered.

We have also filed two copyright applications,

both of which have been granted.

We intend to apply for additional utility patents,

designs and trademarks in various jurisdictions.

Notwithstanding the foregoing, we cannot be certain

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

ISO 13485 Quality Management

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 and end-users throughout the life

cycle of a medical device.

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

annual reassessment and audit procedures.

Our Company has developed an ISO 13485 QMS system

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

and European Union (“ EU ”) quality management systems

requirements.

We received ISO 13485 certifications in 2021 and

have successfully completed two surveillance audits.

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.

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.

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.

India Regulation

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

has been updated to Class C to be in line with the international classification System.

We currently have CDSCO approval for the manufacture,

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

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

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are safe and effective for their intended uses.

We have filed a pre-submission application with

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

Under the FFDCA, medical devices are classified

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

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

We believe that our current SSi Mantra Surgical Robotic System and

other products will be classified as Class II medical devices.

We have filed a pre-submission

application with the U.S.

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.

Under the FDA’s regulatory scheme, medical

devices are classified into one of three classes—Class I, Class II or Class III, depending on the degree of risk associated with

each medical device and the extent of control needed to ensure safety and effectiveness.

We believe that our current SSi Mantra Surgical

Robotic System and other products will be classified as Class II medical devices.

Class II medical devices are those that are subject

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

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

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

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

with all reporting and recordkeeping requirements.

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

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

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

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

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

If the FDA disagrees with a

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

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.

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product offerings in the U.S.

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

inspections by the FDA.

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

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

If the FDA determines that a manufacturer has failed to comply

with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following

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

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

operating restrictions or partial suspension or total shutdown of production;

A company’s facilities, records and manufacturing processes are subject to periodically scheduled

or unscheduled inspections by the FDA.

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

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

If the FDA determines that a manufacturer

has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result

in any of the following sanctions:

● warning letters, untitled letters,

fines, injunctions, consent decrees, administrative penalties, and civil or criminal penalties;

● recalls, withdrawals, or administrative

detention or seizure of our products;

● operating restrictions or partial

suspension or total shutdown of production;

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

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

refusal to grant export approvals for our products;

● withdrawing 510(k) clearances

or PMA approvals that have already been granted;

● refusal to grant export approvals

for our products;

criminal prosecution.

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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

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

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

made available on the market.

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

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

impact our ability to generate revenue and harm our business.

impact on our ability to generate revenue and harm our business.

In addition, local regulations may apply, which

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

Our ISO 13485

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

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

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

We have received regulatory approval to market

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

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

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.

Data Privacy and Security

and Security Laws

Numerous state, federal, and foreign laws, regulations,

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

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

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

in administration.

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

We generally consider our relationship

with our employees to be good.

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.

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