SS Innovations International, Inc.: Form 10-K for the period ended Dec 31, 2025

Overview

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 Surgical Robotic System (the “SSi Mantra”) intended for use in urology, general, gynecology, colorectal, gastroenterology, head and neck, thoracic and cardiac surgeries. 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. Food and 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:

* Includes: 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 procedures. 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 and Nigeria. 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 the EU. 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. We offer our SSi Mantra through three selling models: (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. We 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 expenses.

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:
• 498,753 shares to Dr. Sudhir Srivastava, our Chairman and Chief Executive Officer at $4.01 per share amounting to $2,000,000;
• 501,253 shares to Dr. Frederic Moll, our Vice Chairman at $3.99 per share amounting to $2,000,000;
• 300,000 shares to Tim Adams, a director at $3.99 per share amounting to $1,197,000; and
• an aggregate 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 per share.

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

The Company was incorporated in the state of Florida on February 4, 2015, under the name “Avra Surgical Microsystems, Inc.,” and changed its name to “Avra Medical Robotics, Inc.” on November 5, 2015.

Our principal executive offices are located at 404-405, 3rd 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 only.

Products

The SSi Mantra

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 components:

Surgeon Console. The SSi Mantra 3 allows surgeons to operate while comfortably seated at an ergonomic open-faced console. Surgeons use a special pair of passive 3D glasses to view a 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. The robotic arm carts are modular in design with robotic arms mounted on individual carts, each with a maximum height of 7.2 feet. The modular design offers the flexibility of cart and robotic arm positioning to provide better placement in relation to the procedure and avoid collisions. Further, there is the option of using three, four or five robotic arm configurations based on the users’ preference and specific surgical procedures. Each robotic arm cart includes stability via parking locks, freedom of patient docking and advanced touch-screen controls. Each robotic arm cart has a built-in auto-leveling feature which allows each individual arm cart to be perfectly horizontally level with respect to uneven floor surfaces that may be present in an operating room.

Vision Cart. The vision cart provides an additional 32-inch 3D 4K resolution monitor, identical to the surgeon’s console, for the operating room staff. While wearing the 3D glasses, the entire operating team can view what the surgeon sees with the same depth perception. This ability also helps in reducing the entire team’s learning curve and translates into a safer and more efficient exchange of instruments and introduction of supplies required in surgery. The vision cart also houses the control system for the articulating endoscope and camera and pre-operative guidance software. 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 mentoring and proctoring, thereby resulting in efficient and cost-effective teaching and training capabilities.

Instruments and Accessories

We offer a comprehensive suite of stapling, energy and core instrumentation for our surgical systems, under the brand name of SSi Mudra.

Mudra Technology. The technology employed in our instruments is designed to transform the surgeon’s natural hand movements outside of the body into corresponding controlled movements inside the patient’s body, just as would be available to the surgeon in open surgery. With our technology, a surgeon can also use “motion scaling,” a feature that translates, for example, a three-centimeter hand movement outside the patient’s body into a one-centimeter instrument movement in the surgical field inside the patient’s body. Motion scaling is designed to allow precision and control for delicate tasks. In addition, the advanced software technology of the robotic system filters and eliminates any tremors that may be present in a surgeon’s hands.

Mudra Endo-surgical Instruments. Over 40 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. 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. We sell various accessory products, which are used in conjunction with the SSi Mantra as surgical procedures are performed. Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products—such as replacement 3D stereo endoscopes, cannulas for the instruments and camera and special seals to prevent leakage of carbon dioxide gas used during a procedure.

Tele proctoring and Telesurgery. We are the first surgical robotic company to have received a regulatory approval from CDSCO for both tele proctoring and telesurgery. Following 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 facility. Thereafter, we performed a simple robotic gall bladder removal (Cholecystectomy) to demonstrate safety and efficacy of our SSi Mantra 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 (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 (approximately 179 miles), marking the world’s first accomplishment in the field of robotic cardiac surgery. In 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

We also have a number of additional sophisticated instruments currently under development. These include:

NADI – Automated Coronary Anastomotic Connector. This instrument is a micro stapling device intended to join two arteries together in cardiac bypass procedures. We intend to offer the instrument in both robotic surgery and manual versions. The manual version is for use by cardiac surgeons who do not have a robotic system and can be utilized in an open or minimally invasive procedure.

SSi Multi-Fire Clip Applier. The SSi Multi-Fire Clip Applier is a cartridge-based clip applicator being developed to be utilized for the hemostasis of blood vessels. Use of such a device is a requirement during many surgical procedures. Currently, the clip applicators traditionally used in surgical procedures require withdrawal of the instrument after each clip is placed resulting in a time-consuming process. By providing a cartridge with multiple clips we believe the SSi Multi-Fire Clip Applier will allow for greater efficiency and time savings during surgical procedures.

SSi 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. 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. 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. 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 training. 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. 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. 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 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;
• 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; and
• Natural reconstruction of the 3D image by the human brain.

SSi MantraM. 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.

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. 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.

Services

General. We have a network of field service engineers in India and maintain relationships with various distributors around the globe. This infrastructure of service and support specialists offers a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system health monitoring.

Our comprehensive support and program assistance helps ensure customers and care teams maximize program performance and protect their investment.

Readiness and Maintenance Support. Readiness 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. 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 SSi Mantra.

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 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 population. 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 (http://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: India has a large and growing unmet need for advanced surgical care. 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: 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 procedures.

Increasing health insurance penetration: 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 hospitals. 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 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: India’s 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 Strategy

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 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. and Europe. Key elements of this strategy include:

Focus on underserved markets. India, where our operations are based and where we have commercially launched the SSi Mantra, has a population of approximately 1.4 billion people, supported by an extensive network of roughly 70,000 hospitals providing diverse care across urban and rural regions. Compared 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 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 “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. We intend to continue developing and enhancing our technology and products and to communicate the benefits and advantages of the SSi Mantra (lower cost, ease of training and improved patient outcomes) in India and the other markets we plan to enter.

Evaluation, Familiarization and Training Agreements with Major Medical Facilities. We have and intend to continue entering into agreements with major medical facilities to install the SSi Mantra 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 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 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 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 system. 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 one hundred different types of surgical procedures in India without any device related adverse events. 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. In a coronary artery bypass graft procedure used in cardiac surgery, a blocked coronary artery is bypassed with a graft. When available, an artery from the chest called the internal mammary artery is dissected from its natural position and grafted into place to perform the bypass. 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 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 heart.

Mitral and Aortic Valve Repair/Replacement. Valve repair and replacement surgeries are challenging even when using open surgical techniques. Significant exposure of the surgical field is essential to the identification and precise manipulation of valves and other structures inside the heart and is key to successful surgical outcomes with minimal complications. Motion scaling allows a surgeon using the SSi Mantra to maneuver instruments inside the patient even more precisely than is possible in open surgery. The SSi Mantra has enabled heart valve repairs to be performed through small ports in a manner that could not have been accomplished with open surgery.

Thoracic Surgery

Conventional approaches to surgical procedures in the thorax include both open and video-assisted thoracoscopic approaches. Procedures performed via these methods include pulmonary wedge resection, pulmonary lobectomy, thymectomy, mediastinal mass excision and esophagectomy.

Head and Neck Surgery

Transoral Surgery. Head and neck cancers are typically treated by either surgical resection or chemo-radiation, or a combination of both. Surgical resection performed by an open approach may require a “jaw-splitting” mandibulotomy. This procedure, while effective in treating cancer, is potentially traumatic and disfiguring to the patient. Less invasive approaches via the mouth (transoral surgery) are challenged by line-of-sight limitations dictated by conventional endoscopic tools. Chemo-radiation as a primary therapy allows patients to avoid traumatic surgical incisions however, medical literature suggests that this modality diminishes patients’ ability to speak and swallow normally. Robotically 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

Hysterectomy. Removal of the uterus 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 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.

Sacro colpopexy. 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 technique; however, it is often difficult and cumbersome to perform. Robotic assisted surgical capabilities enable a larger number of these procedures to be performed through a minimally invasive technique, conferring the benefits of MIS to a broader range of Sacro colpopexy patients.

Urologic Surgery

Prostatectomy. Radical prostatectomy is the removal of the prostate gland and accompanying lymph nodes in patients diagnosed with clinically localized prostate cancer. The standard 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. Partial nephrectomy is the removal of a small portion of a kidney (typically, an area of the kidney containing a tumor). Partial nephrectomies are most commonly performed in patients diagnosed with clinically localized renal cancer. Excluding robotic-assisted surgery, there are three common surgical approaches to performing partial nephrectomies: open surgical technique, laparoscopy, and hand-assisted laparoscopy, which is a hybrid of open surgery and laparoscopic techniques. Robotic assisted surgical capabilities may enable a large number of these procedures to be performed through a minimally invasive technique, conferring the benefits of MIS to a broader range of partial nephrectomy patients.

Radical Nephrectomy. Radical nephrectomy is a surgery to remove the entire kidney, typically done to treat kidney cancers and occasionally or other reasons. In some instances, the adrenal gland and lymph nodes may be removed as well.

Cystectomy. Robotic-assisted cystectomy 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.

General Surgery

Hernia Repair. A hernia occurs when an organ or other tissue squeezes through a weak spot in a surrounding muscle or connective tissue. During hernia repair surgery, the weakened tissue is secured, and defects are repaired. Common types of hernias are ventral and inguinal. Ventral, or abdominal hernia, may occur through a scar after surgery in the abdomen. Inguinal hernia is a bulge in the groin and is more common in men.

Colorectal Surgery. These procedures typically involve benign or cancerous conditions of the lower digestive system, in particular the rectum or colon. Common procedures in this area include hemicolectomy, sigmoidoscopy, low anterior resection and abdominoperineal resection.

Cholecystectomy. Cholecystectomy, or the surgical removal of the gall bladder, is a commonly performed general surgery procedure. Cholecystectomy is the primary method for the treatment of gallstones and other gall bladder diseases. Most cholecystectomies are performed using multi-port MIS techniques, although some surgeons choose to perform cholecystectomies using manual single-port instrumentation.

The Global Robotic Surgery Market

General

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. Surgical robots offer significant advantages in MIS 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.

Market Dynamics

Increase in demand and acceptance of laparoscopic 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 invasive procedures, which involve smaller incisions, reduced trauma to surrounding tissues, and quicker recovery times. Patients are increasingly seeking procedures that result in less pain and shorter hospital stays, and surgical robots fulfill these demands and the rise in adoption of minimally invasive procedures has fueled market growth.

Many surgical robotic systems incorporate advanced visualization technologies, such as high-definition 3D imaging and augmented reality. These technologies grant surgeons a clearer view of the surgical site, enhancing their ability to visualize complex anatomical structures and perform intricate tasks. The growth of the surgical robotics market is expected to be driven by the availability of improved healthcare infrastructure, increase in unmet healthcare needs, rise in prevalence of chronic diseases, and surge in demand for advanced surgical robotics products.

Furthermore, the increase in need for automation in the healthcare industry and the shifting trend towards advanced robotic surgeries fuels market growth. Moreover, untapped economies such as Brazil, India, China and other developing economies create a lucrative surgical robotics market opportunity.

The demand for surgical robotics is not only limited to developed countries such as the U.S. but is also being witnessed in the developing countries, such as China, and India, which fuel the growth of the market. Factors such as the rise in the number of surgeries drive the adoption of robotic technologies across different specialties, contributing to the robust growth of the surgical robotics market.

Furthermore, as the global population ages, we expect that there will be a greater need for surgical interventions to address age-related health conditions which boosts market growth. Surgical robots assist surgeons in handling the complexities of these procedures, allowing for safer and more effective outcomes in elderly patients. Moreover, initially limited to specific procedures, robotic technologies are now being adapted for a broader spectrum of surgeries across various medical fields, including cardiac, neurology, urology, gynecology, and more. This versatility attracts hospitals and clinics 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 of robotic procedures, slow down the adoption process. In addition, the intricate nature of surgical robotics necessitates specialized training for surgeons, potentially leading to a shortage of skilled professionals. These factors collectively have hindered expansion of the surgical robotics market.

Segmental Overview

The surgical robotics industry is segmented into components, surgery type, and region. By component, the market is categorized into systems, accessories, and services. Based on 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 (“LAMEA”).

By Component

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. However, the systems segment is expected to register the highest CAGR during the forecast period, owing to a rise in technological advancements and an increase in demand for advanced robotic surgical systems.

By Surgery Type

The general surgery segment dominated the global surgical robotics market share in 2023 and is anticipated to continue this trend during the forecast period. This is attributed to versatility and effectiveness of surgical robotics in a wide range of general surgery procedures, increase in patient demand for minimally invasive surgeries, and ongoing advancements in technology.

By Region

The surgical robotics market size is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America accounted for a major share of the surgical robotics industry in 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 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 region.

India

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 expansion.

India’s healthcare sector has expanded rapidly over the past decade, growing from approximately $110 billion in 2016 to about $372 billion in 2023. Over the 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

Sales Model

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, interacting with surgeons and physicians, operating room staff and hospital administrators to develop and sustain successful robotic-assisted surgery. They assist the hospital in identifying surgeons or physicians who have an interest in robotic-assisted surgery and the potential benefits provided by the SSi Mantra. Our clinical sales team provides current clinical information on robotic-assisted surgery and new product applications to the hospital teams.

We offer our SSi Mantra through three selling models— outright purchase, purchase on a deferred or installment payment basis, and purchase on a pay-per-procedure basis.

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 supplies of instruments and accessories on a regular basis. New direct customers who purchase a system typically place an initial stocking order of instruments and accessories soon after they receive their system.

To date, substantially all of our sales have been in India, with one sale each in the United Arab Emirates, Ecuador, Iraq and Nepal, and two sales in Colombia, Indonesia and the Philippines.

Training and Customer Support

We also provide training for surgeons, physicians and staff on the operation and use of the SSi Mantra using a variety of training approaches. These include didactic modules training, hands on training, dry runs with the surgeons and their entire team, in-person proctored initial cases, on-site support for additional cases and remote proctoring support for complex cases. 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 support engineers in India and are establishing relationships with various distributors around the globe where we intend to market and sell the SSi Mantra. This infrastructure of service and support specialists, along with advanced service tools and solutions, offers a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system health monitoring.

Research and Development

We focus our research and development efforts on enhancing and improving our products and services with a view to fulfilling our vision that the benefits of advanced robotic surgery should be cost-effective and available to everyone. Through ingenuity and intelligent technology, we believe that we can expand the potential of physicians to heal without constraints due to both cost and accessibility of these technologies. We employ engineering and research and development staff 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 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 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 major assemblies through purchase orders rather than long-term supply agreements and generally do not maintain large volumes of finished goods relative to our anticipated demand.

Subject to receipt of necessary financing, we plan to expand our in-house manufacturing capacity in order to meet anticipated increases in demand and to reduce our reliance on third-party suppliers.

Competition

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 limited to: Intuitive Surgical, Inc.; Asensus Surgical, Inc.; avateramedical GmbH; CMR Surgical Ltd.; Johnson & Johnson; Medicaroid Corporation; Medrobotics Corporation; Medtronic plc; meerecompany Inc.; Olympus Corporation; Samsung Electronics Co., Ltd.; Shandong Weigao Group Medical Polymer Company Ltd.; Shanghai Microport Medbot (Group) Co., Ltd.; and Titan Medical Inc. Most, if not all of these companies have longer operating histories and greater financial resources than SSi. In addition, other companies with substantial experience in industrial robotics could potentially expand into the field of medical robotics and become competitors.

Our failure to compete effectively with these existing and potential competitors could adversely affect our results of operations, business and prospects.

Intellectual Property

We place considerable importance on obtaining and maintaining patent, copyright, and trademark protection for our technologies, products and processes.

We generally rely upon a combination of intellectual property laws, confidentiality procedures and contractual provisions to protect our proprietary technology. For example, we have patents and trademarks, both registered and unregistered, that provide distinctive identification of our products in the marketplace.

As of the date of this Annual Report, our intellectual property portfolio consists of 15 granted utility patents and 70 pending utility patent applications, and 8 PCT international WIPO applications as follows:

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Further, our intellectual property portfolio also consists of 8 PCT international WIPO applications as follows:

Further, our intellectual property portfolio also consists of 32 granted design patents and 4 pending design patent application as follows:

In addition, we have filed 98 applications for trademark registrations in India of which 56 have been registered. Further, we have filed 21 applications for trademark registrations through both Madrid and direct foreign filings of which 10 have been registered.

We intend to apply for additional utility patents, designs and trademarks in various jurisdictions.

Notwithstanding the foregoing, we cannot be certain as to the scope of protection that the patents granted will afford our technology and products, nor can we be certain that any pending or future patent applications will be granted. Furthermore, if any protection we obtain is reduced or eliminated, others could use our intellectual property without compensating us, resulting in harm to our business. In addition, others may assert that our products infringe on their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also cause us to pay substantial damages and prohibit us from selling our products.

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

Government Regulation

General

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 management system for the design, development and manufacture of medical devices. It sets out the requirements for a quality management system specific to the medical device industry. This standard is designed to be used by manufacturers 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 EU quality management systems requirements.

We received ISO 13485 certifications in 2021. 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

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 safety. Our systems and related devices are primarily regulated under 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, these regulations mandate that devices be safe and perform their intended function.

Based on intended use of the device, the risks associated with the device and other parameters referred to in the IMDR, the Central Licensing Authority of India classifies Medical Devices into four risk classes: A (low risk); B (low moderate risk); C (moderate high risk); and D (high risk).

The CDSCO has further divided the device classifications into 24 panels, where our surgical robotic system is classified as a Class B device pertaining to operating room procedures. This license 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 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.

U.S. Regulation

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 U.S. FDA, requesting feedback on the SSi Mantra. 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 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 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 to general controls, and most require premarket demonstration of adherence to certain performance standards, as specified by the FDA, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents.

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 approval.

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. 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 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. 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 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. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance, approval of a PMA or issuance of a de novo classification. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.

In addition, the FDA may place significant limitations upon the intended use of our 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, installation and servicing of all medical devices intended for human use. The QSR also requires maintenance of extensive records, which demonstrate compliance with the FDA regulations, the manufacturer’s own procedures, specifications and testing, as well as distribution and post-market experience. Compliance with the QSR is necessary for a manufacturer to be able to continue to market cleared or approved product offerings in the U.S. A company’s facilities, records and manufacturing processes are subject to periodically scheduled or unscheduled inspections by the FDA. 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. 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 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 or modified systems or devices;
• withdrawing 510(k) clearances or PMA approvals that have already been granted;
• refusal to grant export approvals for our systems and related devices; or
• criminal prosecution.

In addition, the discovery of previously unknown 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. by 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. regulations and carefully document the eventual distribution or re-exportation of such products. Failure to comply with all applicable regulations could prevent us from having access to products or components critical to the manufacture of finished products and lead to shortages and delays.

European Union Regulation

In the EU, all medical devices placed on the EU market must meet the essential requirements (“Essential Requirements”), including the requirement that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients or the safety and health of users and others. In addition, the device must achieve the performance intended by the manufacturer and be designed, manufactured and packaged in a suitable manner.

All medical devices are currently regulated by Regulation (EU) No 2017/745 (the “EU Medical Devices Regulation” or the “MDR”), which became effective on May 26, 2021, and replaced the former regulatory framework set forth in Council Directive 93/42/EEC (the “MDD”).

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. This aims to increase harmonization across the EU member states.

The MDR requires that, before placing a device on the market, other than a custom-made device, manufacturers (as well as other economic operators, such as authorized representatives and importers) must register by submitting identification information to the EUDAMED electronic system, which is in the process of being implemented. The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons responsible for regulatory compliance. The MDR also requires that, before placing a device on the market, other than a custom-made device, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database.

All manufacturers placing medical devices on the market in the EU must comply with the EU medical device vigilance system. Under this system, serious incidents and Field Safety Corrective Actions (“FSCAs”) must be reported to the relevant authorities of EU member states. These reports are to be submitted through EUDAMED (once fully functional) and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states, other actors, such as the economic operators in the supply chain, will also be informed. Until EUDAMED is fully functional, the corresponding provisions of the MDD continue to apply. Manufacturers are required to take FSCAs, which are defined as any corrective action for technical or medical reasons to prevent or reduce 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 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.

Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts,” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the 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 to carry out announced and, if necessary, unannounced inspections of companies, as well as of suppliers and/or sub-contractors and, where necessary, the facilities of professional users. Failure to comply with the applicable regulatory requirements could require time and resources to respond to the regulatory authorities’ observations and to implement corrective and preventive actions, as appropriate. Regulatory authorities have broad compliance and enforcement powers and, if such issues cannot be resolved to their satisfaction, can take a variety of actions, including untitled or warning letters, fines, consent decrees, injunctions, or civil or criminal penalties.

The aforementioned EU rules are generally applicable in the EEA, which consists of the twenty-seven EU member states, as well as Iceland, Liechtenstein and Norway.

Other countries

Regulations in other countries, including the requirements for approvals, certification or clearance and the time required for regulatory review, vary from country to country. Certain countries, such as South Korea, Brazil, Australia and Canada, have their own regulatory agencies. These countries typically require regulatory approvals and compliance with extensive safety and quality system regulations included in the Medical Device Single Audit Program that we will be required to comply with on an ongoing basis. 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 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 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, and standards govern the collection, use, access to, confidentiality, and security of health-related and other personal information and could apply now or in the future to our operations or the operations of our partners. In the U.S., numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

We collect, process, share, disclose, transfer, and otherwise use data, some of which contains personal information about identifiable individuals including, but not limited to, our employees, clinical trial participants, partners, and vendors. Therefore, if we commence marketing our 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, sharing, disclosure, transfer and other use of data relating to an identifiable living individual or “personal data,” including a principle of accountability and the obligation to demonstrate compliance through policies, procedures, training, and audits.

The GDPR also regulates cross-border transfers of personal data out of the EEA. Recent legal developments in Europe have created complexity and uncertainty regarding such transfers, in particular in relation to transfers to the U.S.

Cybersecurity

In the normal course of business, we may collect and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets, intellectual property, patient information, sensitive third-party information and employee information. To protect this information, our existing cybersecurity policies require continuous monitoring and detection programs, network security precautions, encryption of critical data and in-depth security assessments of vendors. We maintain various protections designed to safeguard against cyberattacks, including firewalls and virus detection software. We have established and regularly test our disaster recovery plan, and we protect against business interruption by backing up our major systems. In addition, we periodically scan our environment for any vulnerabilities, perform penetration testing and engage third parties to assess the effectiveness of our data security practices.

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.

Employees

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.

As a “smaller reporting company,” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we are not required to provide the information required by this Item.

In the normal course of business, we may collect and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets, intellectual property, patient information, sensitive third-party information and employee information. To protect this information, our existing cybersecurity policies require continuous monitoring and detection programs, network security precautions, encryption of critical data and in-depth security assessments of vendors. We maintain various protections designed to safeguard against cyberattacks, including firewalls and virus detection software. We have established and regularly test our disaster recovery plan, and we protect against business interruption by backing up our major systems. In addition, we periodically scan our environment for any vulnerabilities, perform penetration testing and engage third parties to assess the effectiveness of our data security practices. Our information technology (“IT”) team is responsible for these ongoing monitoring and detection activities.

Our cybersecurity program is primarily overseen by our Head-Server and Network Administrator, who works closely with our information technology team and our senior management to develop and advance our cybersecurity strategy, as well as to respond to cybersecurity incidents. Our Head-Server and Network Administrator report to our Chief Operating Officer on cybersecurity matters and collaborates with stakeholders to assess risks and implement strategies.

The governance of our cybersecurity risks involves active and informed participation from our management team, our IT team and our board of directors. This oversight includes briefings by our IT team on the nature of the risks we face and the steps we are taking to mitigate these risks, as well as immediately reporting any significant cybersecurity incident that occurs to management and the board of directors.

We have engaged a specialized consulting firm from India to enhance and develop the cybersecurity framework for our products with the aim of protecting sensitive patient data and proprietary device information from cyber threats and ensuring compliance with the latest cybersecurity standards including, HIPPA, FDA regulations, IEC 62443, and NIST guidelines for medical devices.

We have not experienced a cybersecurity incident that has materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition. We continue to monitor potential cybersecurity threats and incorporate findings into our risk management strategies.

We lease approximately 75,000 square feet in Gurugram, Delhi NCR, India, which serves as our headquarters as well as our manufacturing facility. The facility, spread over three floors, is leased pursuant to a nine-year lease expiring in March 2030 for the third floor, another nine-year lease expiring in May 2032 for the ground floor, another six-year lease expiring in July 2030 for the first floor and a five-year lease expiring in March 2030 for Basement 3. All the leases are further renewable under similar mutually agreed terms.

1. In 2014, Avra Surgical Robotics, Inc., a Delaware corporation (“Avra Surgical”), of which Barry F. Cohen, our Chief Operating Officer – Americas and a director, was Chief Executive Officer, a director and a principal shareholder, had a dispute with Quinn Emmanuel Urquhart & Sullivan LLP (“Quinn Emmanuel”) over legal fees allegedly due to Quinn Emmanuel. Avra Surgical, which was seeking to develop a robotic surgery system using certain technology developed in Germany by then had ceased operations. These events occurred prior to our formation as Avra Medical Robotics, Inc. Other than the facts that both Avra Surgical and we shared the Avra name and that Mr. Cohen was an officer, director and principal shareholder of both companies, there was no relationship between the two companies.

On May 26, 2020, Quinn Emmanuel filed a petition in the Supreme Court of the State of New York, New York County against Avra Surgical, the Company (then known as Avra Medical Robotics, Inc.), Barry F. Cohen, Jared B. Stamell, an attorney affiliated with Avra Surgical, and various individuals who at that time were or had been affiliated with Avra Surgical and or us (collectively, “Respondents”). The petition sought to recover the legal fees from the Respondents on the basis that they were “alter egos” of Avra Surgical.

As we and Mr. Cohen never received notice of the filing of the petition or of subsequent proceedings (although Quinn Emmanuel filed affidavits with the court stating that they had been duly served), neither we nor Mr. Cohen entered an appearance in the matter.

In early 2024, we learned from a third party that in November 2020, the court had rendered a decision holding that we and Messrs. Cohen and Stamell were “alter egos” of Avra Surgical and therefore were liable for payment of the Quinn Emmanuel legal fees. In addition, we also learned that in December 2023, the court ordered the entry of a judgment against Avra Surgical, us and Messrs. Cohen and Stamell in the amount of $296,000 plus interest from November 2020.

In 2023, Mr. Stamell appealed the judgement against him on the basis that Quinn Emmanuel had not presented any evidence to support the finding that Mr. Stamell was an alter ego of Avra Surgical or that Avra Surgical had transferred any assets to us. The Appellate Division, First Department ruled in favor of Mr. Stamell and in December 2024 entered an order vacating the judgment against him.

As a result of the foregoing, in April 2025, Quinn Emmanuel moved to sever Mr. Stamell from the case and for judgement to be reentered against Avra Surgical, Mr. Cohen and us. That motion was granted on July 22, 2025. In addition, in June 2025, Quinn Emmanuel moved on an ex parte basis to authorize service on Mr. Cohen and us by email to Mr. Cohen’s email or text to his cell phone. In connection therewith, Quinn Emmanuel alleged that Mr. Cohen and we had made efforts to evade service. That motion was granted on July 1, 2025. Quinn Emmanuel entered a revised judgment against Avra Surgical, Mr. Cohen and us on November 13, 2025. We are not aware of any efforts Quinn Emmanuel has undertaken to enforce the judgment since that time.

Notwithstanding the foregoing, Mr. Cohen and the Company have entered into an indemnification agreement, pursuant to which Mr. Cohen has agreed to fully indemnify us for any damages and costs (including legal fees) we incur in connection with the action.

2. In April 2024, an ex-shareholder of Otto Pvt Ltd., an indirect wholly owned Bahamian subsidiary of the Company (“Otto”) commenced litigation in the Bahamas, seeking legal confirmation that it holds 9,000 shares (approximately a 9% interest) in Otto. The litigation, in which Otto is one of the defendants, relates to a purported transaction in 2021, at which time Dr. Sudhir Srivastava, our Chairman, Chief Executive Officer and principal shareholder, was the sole shareholder of Otto. The plaintiff in the litigation alleges that at that time, it acquired the 9,000 Otto shares from Dr. Srivastava. However, as the plaintiff failed to pay the agreed upon consideration for the shares, in July 2022, the shareholding was cancelled. Dr. Srivastava along with Otto, has recently filed an action in the Bahamas to confirm the cancellation of the shares and reconfirm their ownership and both actions are pending in the Bahamian courts. The Bahamian court has issued an interim order to maintain the status quo as it stands today with respect to the 9,000 Otto shares at the center of the dispute, as well as Otto’s shareholdings in Sudhir Srivastava Innovations Pvt. Ltd., our Indian operating subsidiary (“SSI-India”) and SSI-India’s assets during the pendency of the litigation. Based on legal opinions obtained from counsel, we believe that there will be a favorable outcome in this case.

Notwithstanding the foregoing, we have entered into an Indemnification Agreement with Dr. Srivastava on October 12, 2024, pursuant to which Dr. Srivastava has agreed to fully indemnify us for any claims, damages and costs (including legal fees) which we incur in connection with this litigation or in relation to any of his ventures prior to consummation of our acquisition by merger of CardioVentures, Inc. in April 2023.

Other than the foregoing, there are no legal proceedings currently pending or threatened against us. However, from time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in any such matter may harm our business.

Introduction

The Company is engaged in the business of developing, manufacturing, and selling a surgical robotic system under our proprietary brand “SSi Mantra,” together with related accessories and a wide range of surgical instruments capable of supporting cardiac and a variety of other surgical procedures under our proprietary brand “SSi Mudra.” Having commenced commercial sales of our surgical robotic system in the second half of 2022, the year 2023 was our first full year of commercial sales and during the year 2024, we further consolidated our installed base of SSi Mantra in various parts of India and also expanded our presence in the global markets.

Our financial performance is largely driven by increasing awareness of the benefits of robotically assisted surgery, reduced learning curves for robotic surgeons and the affordability and accessibility of surgical robotic technology. Our financial performance is also dependent on our obtaining regulatory approvals in various regulated markets where we have plans to sell our products. Robotically assisted surgeries are increasingly being recognized as an approved treatment modality from an insurance coverage perspective.

Our manufacturing operations being based in India derive significant operating cost advantages in terms of availability of quality and cost-effective fabrication/3D printing solutions, electronic/electrical/mechanical components, outsourced services and skilled manpower. All these factors help us in having lower costs of production which eventually helps us make our surgical robotic system cost effective and relatively affordable.

Results of Operations

Introduction

The consolidated financial statements appearing elsewhere in this Annual Report have been prepared assuming that we will continue as a going concern. We are still in our initial years of revenue generation by way of the sale of our product and have not yet established consistent operational revenue cash flows to meet all our fixed operating costs and hence may continue to incur losses for some time. These conditions raise substantial doubt about our ability to continue as a going concern.

The following table provides selected financial data about our Company at December 31, 2025, and December 31, 2024:

Balance Sheet Data

** Represents Fixed Deposits held by the bank as security for bank facilities and certain performance guarantees.

To date, the Company has mainly relied on debt and equity raised in private offerings to finance its operations. During 2026, the Company plans to raise additional capital through further private or public offerings. However, if we are unable to do so and if we experience a shortfall in operating capital, we could be faced with having to limit our expansion plans, research and development and marketing activities.

Year ended December 31, 2025, as compared to year ended December 31, 2024

Revenues. During the year ended December 31, 2025, the Company had revenues of $42,484,747 (comprising $38,353,048 of system sales, $3,183,757 of instrument sales, $877,033 of warranty sales and $70,909 of lease income), compared to revenues of $20,649,528 (comprising $19,457,767 of system sales, $942,548 of instrument sales, $177,518 of warranty sales and $71,695 of lease income) during the year ended December 31, 2024. The increase in revenue is primarily due to sale of increased number of surgical robotic systems and instruments in the year ended December 31, 2025 as compared to the year ended December 31, 2024.

Research and Development Expenses. Research and Development expenses during the year ended December 31, 2025, were $3,685,840, as compared to $2,491,771 for the year ended December 31, 2024. The increase in the research and development expenses as compared to the previous year is in line with the Company’s continued focus on improving the design and technological capabilities of its existing SSi Mantra system and further expanding its product offerings.

Stock Compensation Expenses. We had stock compensation expenses of $8,128,103 for the year ended December 31, 2025, compared to $14,342,784 for the year ended December 31, 2024. The substantial decrease in stock-based compensation expense for the year ended December 31, 2025 was primarily due to award of stock options in February 2024 under the Company’s 2016 Incentive Plan to certain executive officers. These were vested immediately upon grant and were fully expensed in the year ended December 31, 2024, resulting in the recognition of approximately $4,656,807 of stock-based compensation expense in the previous year. These options were awarded in recognition of the executives’ efforts in advancing the development and commercialization of the Company’s SSi Mantra system and the residual impact is primarily due to resignation of employees in the current year.

Depreciation and amortization expenses. We had depreciation and amortization expense of $1,075,907 for the year ended December 31,2025, as compared to $436,005 in the year ended December 31, 2024. The depreciation and amortization expenses primarily consist of depreciation on fixed assets only.

Selling, General and Administrative expenses. We incurred $14,848,439 in selling, general and administrative expenses during the year ended December 31, 2025, as compared to $10,157,768 for the year ended December 31, 2024.

Our Selling, General and Administrative expenses (“SG&A”) comprise of expenses relating to salaries and benefits, retirement benefits as well as costs related to recruitment, other compensation expenses of sales and marketing and client management personnel, sales commission, travel and brand building, client events and conferences, training and retention of senior management and other support personnel in enabling functions, telecommunications, utilities, travel and other miscellaneous administrative costs. SG&A expenses also include legal and professional fees (which represent the costs of third party legal, tax, accounting, immigration and other advisors), investment in product development, digital technology, advanced automation and robotics, related to grant of our equity awards to members of our board of directors. We expect our SG&A costs to increase as we continue to strengthen our support and enabling functions and invest in leadership development, performance management and training programs. The increase in selling, general and administrative expenses resulted from the increased manpower strength and an increased scale of commercial operations during 2025 as compared to the year ended December 31, 2024.

Other Income (Expenses). We have recognized $33,087 in interest income (net) during the year ended December 31, 2025, as compared to an interest expense (net) of $175,235 during the year ended December 31, 2024. The increase in interest income by $343,724 relating to fixed deposits which is offset by increase in interest expense by $135,402 related to interest on our bank overdraft facility and convertible notes.

Net Loss. We incurred a net loss of $12,127,387 for the year ended December 31, 2025, compared to a net loss of $19,151,197 for the year ended December 31, 2024. The decrease in net loss of $7,023,810 was primarily attributable to an increase in gross profit of $11,091,889 and a decrease in stock-based compensation expense of $6,214,681. These favorable variances were partially offset by increases in research and development expenses of $1,194,069, depreciation expense of $639,902, selling, general and administrative expenses of $4,690,671, and income tax expense of $3,966,440.

Liquidity and Capital Resources

The Company expects to require substantial funds for scaling up its operations, incurring capital expenditures to have its own manufacturing facility for in-house machining and tooling capacity and to continue to finance its research and development work in the field of surgical robotics.

As of December 31, 2025, the Company had shareholders’ equity of $38,218,251 and a working capital surplus of $22,558,961 as compared to shareholders’ equity of $13,457,103 and a working capital surplus of $6,086,069 as of December 31, 2024.

29

Cash Flows Used in Operating Activities

Net cash used in operating activities was $18,542,987 for the year ended December 31, 2025, compared to $ 9,503,030 for the year ended December 31, 2024, representing an increase of $9,039,957 year over year, reflecting the increase in net cash used in operating activities was primarily driven by higher working capital requirements associated with the Company’s expanded scale of operations, which more than offset improvements in operating results. The major drivers contributing to the increase of $9,039,957 in net cash used in operating activities year-over-year included the following:

• Accounts receivable amounted to $13,037,284 in fiscal year 2025, compared to $4,890,032 in fiscal year 2024, reflecting higher billings and the timing of customer collections.
• Inventory amounted to $8,070,786 in fiscal year 2025, compared to $7,691,518 in fiscal year 2024, reflecting production levels and inventory management in support of anticipated demand.
• Prepaid expenses and other assets amounted to $5,101,794 in fiscal year 2025, compared to $1,411,621 primarily related to advance payments made in connection with operating activities.

These uses of cash were partially offset by deferred revenue of $3,953,938 in fiscal year 2025 and accounts payable of $2,877,810 in fiscal year 2025, reflecting customer advance payments and vendor activity.

In addition, net loss was $12,127,387 in fiscal year 2025, compared to $19,151,197 in fiscal year 2024, and stock-based compensation expense was $8,128,103 in fiscal year 2025, compared to $14,342,784 in fiscal year 2024. These items impacted operating cash flows during the respective periods and were considered together with the working capital changes discussed above.

Cash Flows from Investing Activities

During the year ended December 31, 2025, we had net cash used in investing activities of $3,659,058 resulting from purchases of property, plant and equipment.

During the year ended December 31, 2024, we had net cash used in investing activities of $661,479 resulting from purchase of property, plant and equipment.

Cash Flows from Financing Activities

During the year ended December 31, 2025, we had net cash provided by financing activities of $26,166,556, which comprised of $3,448,042 in proceeds from our bank overdraft facility, $28,000,000 in proceeds from the issuance of convertible notes to our principal shareholder, partially offset by repayments of $4,212,637 related to convertible notes to our principal shareholder, including interest, and repayments of $1,068,849 related to convertible notes to other investors, including interest.

During the year ended December 31, 2024, we had net cash, provided by financing activities of $9,425,980, which comprised of $1,975,980 in proceeds from our bank overdraft facility, $3,000,000 each in proceeds from issuance of convertible notes and promissory notes to our principal shareholder and $1,450,000 in proceeds from issuance of convertible notes to other investors.

Critical Accounting Estimates

Use of Estimates

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

We consider the policies discussed below to be critical to an understanding of our consolidated financial statements, as their application places the most significant demands on management’s judgment regarding matters that are inherently uncertain at the time an estimate is made.

These policies include fair value of stock options and standalone selling price in case of bundled revenue contracts.

These accounting policies, estimates and the associated risks are set out below. Future events may not develop exactly as forecasted and estimates routinely require adjustment.

Stock Compensation Expense

Under the fair value recognition provisions of ASC Topic 718, Compensation-Stock Compensation, cost is measured at the grant date based on the fair value of the award and is amortized on a straight-line basis over the requisite service periods of the awards, which is generally the vesting period.

Determining the fair value of stock-based awards at the grant date requires significant judgment, including estimating the expected term over which the stock awards will be outstanding before they are exercised and the expected volatility of our stock.

As of December 31, 2025, the Company has issued two types of equity incentives:

Stock Options: These provide employees with the right, but not the obligation, to purchase shares of our stock at a specified price, within a defined period, as per the terms of the stock option agreement. Stock-based compensation expense associated with our 2016 Incentive Plan is measured at fair value using a Black-Scholes option-pricing model at commencement of each offering period and recognized over that offering period.

Stock Units (Restricted Stock Units, or RSUs): These do not require the employee to exercise any options. Each stock unit automatically converts into a specified number of shares upon vesting. We use last three months’ average share price of common stock on OTC (prior to April 24, 2025) or on Nasdaq (subsequent to April 24, 2025) as grant date fair value for RSUs.

Standalone Selling Price

Our system sale arrangements contain multiple products and services, including system, accessories, instruments and services. Other than services, we generally deliver all of the products upfront. Each of these products and services is a distinct performance obligation. System, instruments, accessories and services are also sold on a standalone basis. For multiple-element arrangements, revenue is allocated to each performance obligation based on its relative standalone selling price. Standalone selling prices are based on observable prices at which we separately sell the products or services. If a standalone selling price is not directly observable, then we estimate the standalone selling prices considering market conditions and entity-specific factors including, but not limited to, historical pricing data, features and functionality of the products and services and industry benchmark. We regularly review standalone selling prices and maintain internal controls over establishing and updating these estimates. Revenue that is allocated to the service obligation is deferred and recognized ratably over the service period upon expiration of first year of service which is free and included in the system sale arrangements.

Off-Balance Sheet Arrangements

There are no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

Disclosure Controls and Procedures

Our Chief Executive Officer and Chief Financial Officer evaluated the effectiveness of the design and operation of our disclosure controls and procedures and internal control over financial reporting, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of December 31, 2025.

To ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC, including to ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Based on the evaluation performed as of December 31, 2025, as a result of the material weaknesses in internal control over financial reporting that are described below in Management’s Report on Internal Control Over Financial Reporting, our Chief Executive Officer and Chief Financial Officer determined that our disclosure controls and procedures were not effective as of such date.

Internal Controls over Financial Reporting

(a) Management’s Report on Internal Controls Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). A company’s internal control over financial reporting is a process designed by, or under the supervision of, its Chief Executive Officer and Chief Financial Officer, and effected by such company’s board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

• pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
• provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
• provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the consolidated financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements will not be prevented or detected on a timely basis.

Management, with the participation of our Chief Executive Officer and Chief Financial Officer, has conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2025, based on the framework set forth in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment, management has concluded that the Company did not maintain effective internal control over financial reporting as of December 31, 2025 due to the material weaknesses described below.

• We do not have written documentation of our internal control policies and procedures. Written documentation of key internal controls over financial reporting is a requirement of Section 404 of the Sarbanes-Oxley Act.
• We do not have sufficient segregation of duties within accounting functions, which is a basic internal control. Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate individuals.

(b) Remediation Plan

The Company has been addressing and remediating these material weaknesses with the support and assistance of the accounting and financial staff employed by SSI-India, our Indian operating subsidiary. We have enhanced the review process for significant transactions to ensure proper accounting treatment under applicable guidelines and have engaged the external experts to provide guidance to the Company staff in the areas of financial reporting, internal controls, and enterprise risk management and assist it in the application of accounting principles to complex transactions. This external expert group is also helping the Company in strengthening its existing internal controls, policies and Standard Operating Procedures (“SOPs”) in all the major functional areas.

In addition, we have also engaged services of external experts in the field of designing, development and implementation of a comprehensive cloud-based ERP system. The ERP implementation process involves a detailed process study of each of the business functions and engagement with their respective process owners, identifying their linkages with other business functions and designing report formats, data sourcing and customizing the ERP system and training of the respective teams to meet the business data flow and reporting requirements of each business function. Post completion of roll out of all the functional modules under this new cloud-based ERP system which is designed to integrate all business functions within the accounting and financial department would help us in further addressing the abovementioned weaknesses.

Our Chief Executive Officer and Chief Financial Officer do not expect that our disclosure controls or internal controls will prevent all errors and all fraud. Although our disclosure controls and procedures were designed to provide reasonable assurance of achieving their objectives, a control system, no matter how well conceived and operated, can provide only reasonable, not absolute assurance that the objectives of the system are met. Further, the design of any control system is subject to resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the fact that judgments in decision-making can be faulty, and that breakdowns can occur because of simple errors or mistakes. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

(c) Changes in Internal Controls Over Financial Reporting

Except for the remediation efforts described above, there were no changes in our internal controls over financial reporting that occurred during the last fiscal quarter covered by this Annual Report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.