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What changed in SS Innovations International, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of SS Innovations International, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+310 added−256 removedSource: 10-K (2026-03-10) vs 10-K (2025-04-15)

Top changes in SS Innovations International, Inc.'s 2025 10-K

310 paragraphs added · 256 removed · 183 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

137 edited+94 added−54 removed86 unchanged
Biggest changeAs of the date of this Annual Report, our intellectual property portfolio consists of 5 granted utility patents and 65 pending utility patent applications, and 10 PCT international WIPO applications as follows: Granted Pending Country No. of Patents Earliest Expiration Latest Expiration No. of Patents Earliest Expiration Latest Expiration Product Europe 5 February 8, 2043 December 1, 2043 MANTRA Europe 1 June 9, 2043 June 9, 2043 MAYA India 4 January 28, 2042 June 28, 2042 15 March 3, 2042 October 11, 2044 MANTRA India 3 March 31, 2043 December 1, 2043 MANTRA & MAYA India 1 June 10, 2042 June 10, 2042 1 July 27, 2043 July 27, 2043 MAYA India 6 September 28, 2041 March 17, 2045 MUDRA USA 10 January 28, 2043 December 27, 2044 MANTRA USA 1 July 15, 2044 July 15, 2044 MANTRA & MAYA USA 1 June 9, 2043 June 9, 2043 MAYA USA 1 November 4, 2042 November 4, 2042 MUDRA Japan 2 September 19, 2044 December 27, 2044 MANTRA Japan 1 August 2, 2044 August 2, 2044 MANTRA & MAYA Korea 2 September 19, 2044 December 27, 2044 MANTRA Korea 1 August 2, 2044 August 2, 2044 MANTRA & MAYA Singapore 2 September 19, 2044 December 27, 2044 MANTRA Singapore 1 August 2, 2044 August 2, 2044 MANTRA & MAYA Australia 2 September 19, 2044 December 27, 2044 MANTRA Australia 1 August 2, 2044 August 2, 2044 MANTRA & MAYA Israel 2 September 19, 2044 December 27, 2044 MANTRA Israel 1 August 2, 2044 August 2, 2044 MANTRA & MAYA BRAZIL 3 February 08, 2043 December 27, 2044 MANTRA BRAZIL 1 July 15, 2044 July 15, 2044 MANTRA & MAYA INDONESIA 1 October 20, 2043 October 20, 2043 MANTRA INDONESIA 1 June 09, 2043 June 09, 2043 MAYA Total 5 65 70 15 Further, our intellectual property portfolio also consists of 10 PCT international WIPO applications as follows: Granted Pending Country No. of Patents Earliest Expiration Latest Expiration No. of Patents Earliest Expiration Latest Expiration Product WIPO 7 May 21, 2025 December 9, 2026 MANTRA WIPO 1 February 27, 2026 February 27, 2026 MAYA WIPO 2 October 31, 2025 June 10, 2026 MANTRA & MAYA Total 10 10 Further, our intellectual property portfolio also consists of 30 granted design patents and 4 pending design patent application as follows: Granted Pending Country No. of Patents Earliest Expiration Latest Expiration No. of Patents Earliest Expiration Latest Expiration Product India 23 January 31, 2038 September 27, 2039 1 December 20, 2038 December 20, 2038 MANTRA India 7 August 29, 2038 December 23, 2039 3 October 25, 2039 March 17, 2040 MUDRA Total 30 4 34 In addition, we have filed 93 applications for trademark registrations in India of which 40 have been registered.
Biggest changeFor example, we have patents and trademarks, both registered and unregistered, that provide distinctive identification of our products in the marketplace. 15 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: Granted Pending Country No. of Patents Earliest Expiration Latest Expiration No. of Patents Earliest Expiration Latest Expiration Product Europe 5 February 8, 2043 December 1, 2043 MANTRA Europe 1 June 9, 2043 June 9, 2043 MAYA India 12 January 28, 2042 May 09, 2044 12 March 3, 2042 February 17, 2042 MANTRA India 1 November 10, 2043 November 10, 2043 1 March 31, 2043 March 31, 2043 MANTRA & MAYA India 1 June 10, 2042 June 10, 2042 1 July 27, 2043 July 27, 2043 MAYA India 7 October 05, 2041 August 23, 2045 MUDRA USA 1 June 10, 2043 June 10, 2043 9 January 28, 2043 December 27, 2044 MANTRA USA 1 July 15, 2044 July 15, 2044 MANTRA & MAYA USA 2 June 9, 2043 June 27, 2044 MAYA USA 1 November 4, 2042 November 4, 2042 MUDRA Japan 4 November 09, 2043 December 27, 2044 MANTRA Japan 1 July 15, 2044 July 15, 2044 MANTRA & MAYA Korea 3 November 09, 2043 December 27, 2044 MANTRA Korea 1 July 15, 2044 July 15, 2044 MANTRA & MAYA Singapore 2 September 19, 2044 December 27, 2044 MANTRA Singapore 1 July 15, 2044 July 15, 2044 MANTRA & MAYA Australia 4 October 20, 2043 December 27, 2044 MANTRA Australia 1 July 15, 2044 July 15, 2044 MANTRA & MAYA Israel 2 September 19, 2044 December 27, 2044 MANTRA Israel 1 July 15, 2024 July 15, 2024 MANTRA & MAYA BRAZIL 6 February 08, 2043 December 27, 2044 MANTRA BRAZIL 1 July 15, 2044 July 15, 2044 MANTRA & MAYA INDONESIA 2 October 20, 2043 November 09, 2043 MANTRA INDONESIA 1 June 09, 2043 June 09, 2043 MAYA Total 15 70 85 16 Further, our intellectual property portfolio also consists of 8 PCT international WIPO applications as follows: Granted Pending Country No. of Patents Earliest Expiration Latest Expiration No. of Patents Earliest Expiration Latest Expiration Product WIPO 7 August 18, 2026 June 27, 2027 MANTRA WIPO 1 June 10, 2026 June 10, 2026 MANTRA & MAYA Total 8 8 Further, our intellectual property portfolio also consists of 32 granted design patents and 4 pending design patent application as follows: Granted Pending Country No. of Patents Earliest Expiration Latest Expiration No. of Patents Earliest Expiration Latest Expiration Product India 24 January 31, 2038 September 27, 2039 2 October 28, 2040 October 31, 2040 MANTRA India 8 August 29, 2038 January 20, 2040 2 October 25, 2039 March 17, 2040 MUDRA Total 32 4 36 In addition, we have filed 98 applications for trademark registrations in India of which 56 have been registered.
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.
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.
European Union Regulation In the European Union (the “ EU ”), all medical devices placed on the EU market must meet the essential requirements (“ Essential Requirements ”), including the requirement that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients or the safety and health of users and others.
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.
These requirements include establishment registration and device listing with the FDA; compliance with medical device reporting regulations, which require that manufacturers report to the FDA if their device caused or contributed, or may have caused or contributed, to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; compliance with corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FFDCA that may present a risk to health; the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
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.
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 .
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. 9 Mitral and Aortic Valve Repair/Replacement .
We first conducted two animal trials at a leading laparoscopy hospital in Delhi NCR region located five kilometers away from our telesurgery lab in our facility. Thereafter, we performed a simple robotic gall bladder removal (Cholecystectomy) to demonstrate safety and efficacy of our SSi Mantra Surgical Robotic System, when utilized in a remote setting.
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.
Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and contain general rules, such as, for example, requiring that advertisements are evidenced, balanced and not misleading. Specific requirements are defined at a national level.
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.
Robotic assisted surgical capabilities enable a larger number of these procedures to be performed through a minimally invasive technique, conferring the benefits of minimally invasive surgery to a broader range of Sacro colpopexy patients. Urologic Surgery Prostatectomy . Radical prostatectomy is the removal of the prostate gland and accompanying lymph nodes in patients diagnosed with clinically localized prostate cancer.
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.
We intend to continue developing and enhancing our technology and products and to communicate the benefits and advantages of the SSi Mantra System (lower cost, ease of training and improved patient outcomes) in India and the other markets we plan to enter. Evaluation, Familiarization and Training Agreements with Major Medical Facilities .
We 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 .
The advertising and promotion of medical devices is subject to some general principles set forth in EU legislation. According to the MDR, only devices that are CE (Conformité Européene) marked may be marketed and advertised in the EU in accordance with their intended purpose.
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.
Removal of the uterus is one of the most performed surgeries in gynecology and is performed for a variety of underlying benign and cancerous conditions. Hysterectomies can be performed using open surgery or minimally invasive techniques, which include vaginal, laparoscopic, and robotic-assisted approaches.
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.
Intellectual Property We place considerable importance on obtaining and maintaining patent, copyright, and trademark protection for our technologies, products and processes. 14 We generally rely upon a combination of intellectual property laws, confidentiality procedures and contractual provisions to protect our proprietary technology.
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.
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 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. 8 Continued Development and Marketing .
Some salient 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 ● Natural reconstruction of the 3D image by the human brain SSi MantraM.
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.
Various Mudra instrument tips include forceps, scissors, electrocautery tools, scalpels and other surgical tools that are familiar to the surgeon from open surgery and conventional minimally invasive surgery (“ MIS ”). We have also developed and made available a variety of cardiac surgery specific instruments. A variety of instruments may be selected and used interchangeably during surgery.
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.
We are the only 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 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.
Through ingenuity and intelligent technology, we believe that we can expand the potential of physicians to heal without constraints due to both cost and accessibility of these technologies. We employ engineering and research and development staff and currently have a research and development team of 65 employees to focus on delivering future innovations and sustaining improvements that advance our mission.
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.
Robotic assisted surgical capabilities may enable a large number of these procedures to be performed through a minimally invasive technique, conferring the benefits of minimally invasive surgery to a broader range of partial nephrectomy patients. Radical Nephrectomy . Radical nephrectomy is a surgery to remove the entire kidney, typically done to treat kidney cancers and occasionally or other reasons.
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. 10 Radical Nephrectomy . Radical nephrectomy is a surgery to remove the entire kidney, typically done to treat kidney cancers and occasionally or other reasons.
While surgical robotic systems have gained acceptance globally in the past two decades for providing greater efficiency, better clinical outcomes and reducing healthcare costs, access to such systems remains largely limited to developed countries such as the United States, the European Union (the “ EU ’) and Japan.
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.
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 2024 and is anticipated to continue this trend during the forecast period.
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.
If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: ● warning letters, untitled letters, fines, injunctions, consent decrees, administrative penalties, and civil or criminal penalties; ● recalls, withdrawals, or administrative detention or seizure of our products; ● operating restrictions or partial suspension or total shutdown of production; ● refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products; ● withdrawing 510(k) clearances or PMA approvals that have already been granted; ● refusal to grant export approvals for our products; or ● criminal prosecution.
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.
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 our SSi Mantra Surgical Robotic System and its efficacy and cost-effectiveness relative to other techniques.
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.
The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than fifty different types of surgical procedures in India without any device related adverse events.
The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than 100 different types of surgical procedures in India without any device related adverse events.
We place significant emphasis on marketing the SSi Mantra to leading surgeons who are considered to be the “thought leaders” in their institutions and fields. In this regard, we have established both an Indian Medical Advisory Board and an International Advisory Board consisting of leading surgeons in their respective fields.
We 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.
Robotically assisted transoral surgery allows them to operate on tumors occurring in the oropharynx (i.e., tonsil and base of tongue) and larynx via the mouth and to overcome some of the line-of-sight limitations of conventional transoral surgery. Gynecologic Surgery Hysterectom y .
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 Hysterectom y .
Thus, we believe that the internal mammary artery can be dissected with greater ease and precision using the SSi Mantra Surgical Robotic System. Totally Endoscopic Coronary Artery Bypass Surgery (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.
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.
Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts,” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on medical device manufacturers.
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.
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.
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).
The service care plan portfolio offers flexible service plans to ensure reliability of the systems and instruments and help optimize the robotics program. The support team of expert field service, remote technical support and customer care agents resolve and prevent any technology issues that could inhibit optimal utilization of our SSi Mantra system.
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.
We have included our website address as an inactive textual reference only. 3 Products The SSi Mantra The SSi Mantra Surgical Robotic System is designed to enable surgeons to perform a wide range of surgical procedures including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries.
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.
Clinical Applications The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than ninety different types of surgical procedures in India without any device related adverse events.
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.
In addition, the presence of well-established healthcare infrastructure, high purchasing power, and rise in adoption rate of advanced surgical robotics products are expected to drive the market growth. Furthermore, product launch, collaborations, and acquisitions adopted by the key players in this region boost the growth of the market.
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.
A company’s facilities, records and manufacturing processes are subject to periodically scheduled or unscheduled inspections by the FDA. Failure to maintain compliance with applicable QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of marketed products.
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.
We collect, process, share, disclose, transfer, and otherwise use data, some of which contains personal information about identifiable individuals including, but not limited to, our employees, clinical trial participants, partners, and vendors. Therefore, if we commence marketing our products in the U.S., the EU and other countries, we will be subject to U.S.
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.
Regulatory complexities and concerns regarding patient safety, as well as the need for rigorous clinical validation of robotic procedures, slow down the adoption process. In addition, the intricate nature of surgical robotics necessitates specialized training for surgeons, potentially leading to a shortage of skilled professionals. These factors collectively hinder the rapid expansion of the surgical robotics market.
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.
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, Nepal and Indonesia.
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.
In addition, the discovery of previously unknown problems with any marketed products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.
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.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or depending on the modification, PMA approval or de novo classification.
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.
Our ISO 13485 (quality management system) approval, CDSCO approval for the manufacture, sale and distribution of our products and our Indian export license allows us to market our products in fifty (50) non-FDA and non-CE (EU) countries without further regulatory approvals and in an additional seventy-nine (79) countries require only minimal registration.
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.
The aforementioned EU rules are generally applicable in the European Economic Area (“ EEA ”), which consists of the twenty-seven EU member states, as well as Iceland, Liechtenstein 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.
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. 21 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.
We received ISO 13485 certifications in 2021. During the course of 2024, we conducted recertification audit from EU Notified Body for EN ISO 13485 and ISO 13485 and we received the certification in Q4 of 2024.
During the course of 2024, we conducted a recertification audit from EU Notified Body for EN ISO 13485 and ISO 13485 and we received the certification in Q4 of 2024.
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. 9 Sacro colpopexy. The abdominal (open) Sacro colpopexy is one of the operations performed to treat vaginal vault prolapse.
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.
In addition, the FDA and the Federal Trade Commission also regulate the advertising and promotion of our products to ensure that the claims we make are consistent with our regulatory clearances, that there is scientific data to substantiate the claims and that our advertising is neither false nor misleading.
In 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.
The GDPR also regulates cross-border transfers of personal data out of the EEA. Recent legal developments in Europe have created complexity and uncertainty regarding such transfers, in particular in relation to transfers to the United States.
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.
As of the date of this Annual Report, surgeons have performed over 3,500 surgical procedures in India in a wide array of fields using the SSi Mantra, including many complex surgeries. The SSi Mantra offers the entire operating room staff three-dimensional, high definition (“ 3D4K ”) vision, and gives the surgeon a magnified view up to ten times magnification.
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.
However, there can be no assurance as to when we will secure any such regulatory approvals, if at all.
However, there can be no assurance as to when or if we will secure any such regulatory approvals.
We have and intend to continue entering into agreements with major medical facilities to install the SSi Mantra Surgical Robotic System for evaluation, familiarization and training purposes. As of the date of this Annual Report, we had entered into such agreements with approximately four hospital networks in India and with Johns Hopkins University in Baltimore, Maryland.
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.
Our first Global SMRSC (SSI Mantra Robotic Surgery Conference) that was hosted in January 2024, was attended by over 700 national and international faculty who participated over the course of the two day event and our second Global SMRSC that was hosted in March 2025, was attended by over 1,200 participants and displayed the increased capabilities of the SSi Mantra 3, including the performance of telesurgery and the introduction of our mobile robotic surgical system.
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.
Chemo-radiation as a primary therapy does allow patients to avoid traumatic surgical incisions; however, the literature suggests that this modality diminishes patients’ ability to speak and swallow normally.
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.
In such cases, the manufacturer might be required to follow certain patient groups for a number of years and make periodic reports to the FDA on the clinical status of those patients. Clinical trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission.
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.
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 next generation SSi Mantra 3, which was introduced in June 2024.
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.
This aims to increase harmonization across the EU member states. 20 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 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.
We have received regulatory approval to market and sell our products in the United Arab Emirates, Nepal, Indonesia, Guatemala Philippines, Ukraine and Sri Lanka and have initiated the regulatory approval process, in many other countries, which if successful, will allow us to market our products in more than fifty (50) countries within approximately one year.
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.
It includes a state-of-the-art AI enabled application viewer which is seamlessly integrated with the SSi Mantra Surgical Robotic System to provide surgeons with comprehensive tools to enhance their surgical confidence and precision in the operating room. SSi Mixed Reality Headset .
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 .
Unlike directives, regulations are directly applicable in EU member states without the need for member states to implement them into national law.
Unlike directives, regulations are directly applicable in EU member states without the need for member states to implement them into national law. This aims to increase harmonization across the EU member states.
We 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.
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 .
Our ISO 13485 (quality management system) approval, CDSCO approval for the manufacture, sale and distribution of our products and our Indian export license allow us to market our products in fifty non-FDA and non-EU countries without further regulatory approvals. An additional 79 countries require only minimal registration.
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.
Further, we have filed 31 applications for trademark registrations through both Madrid and direct foreign filings of which 13 have been registered. We have also filed two copyright applications, both of which have been granted. We intend to apply for additional utility patents, designs and trademarks in various jurisdictions.
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.
Representative surgical applications are described below. 8 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.
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.
The standard approach to the removal of the prostate was via an open surgical procedure. The conventional laparoscopic approach is an option, but it is difficult and poses challenges to even the most skilled urologist. The SSi Mantra will enable a larger number of surgeons to convert from using an open surgical technique to a minimally invasive robotic surgical technique.
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 .
In approving a PMA application or clearing a 510(k) submission, the FDA may also require some additional manufacturing controls, design control activities and approvals, as well as specific post-market surveillance requirements when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
In 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.
We believe that our current SSi Mantra Surgical Robotic System and other products will be classified as Class II medical devices.
We believe that our current SSi Mantra system and related devices will be classified as Class II medical devices.
The 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.
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.
All instruments are sterilizable at the hospital, and all are reusable for a defined number of procedures. A programmed memory chip inside each instrument performs several functions that help determine how the SSi Mantra and our instruments work together.
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 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 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.
None of our patents and patent applications are licensed to or from third parties. 16 Government Regulation General Our products and operations are subject to regulation in India by the Central Drugs Standard Control Organization (the “ CDSCO ”), by the Food and Drug Administration (the “ FDA ”) in the U.S. and by similar agencies in other countries and regions in which we market or plan to market our 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.
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.
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.
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.
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. 11 Furthermore, the increase in need for automation in the healthcare industry and the shifting trend towards advanced robotic surgeries fuels market growth.
A new PLI 2.0 scheme is also being prepared for promotion of the in-vitro diagnostics market. 7 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 of and steep learning curve for existing systems.
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.
We also received ISO 13485 (quality management system) approval for the SSi Mantra 3. The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than 80 different types of surgical procedures in India without any device related adverse events.
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.
Surgeons use a special pair of passive 3D glasses to view a 3DHD image of the surgical field on a 32-inch 3D 4K resolution monitor with up to ten (10) times magnification, resulting in significantly enhanced vision for the surgeon. The surgeon also has a second large 23-inch 2D touch monitor for system controls and DICOM applications.
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.
Employees As of the date of this Annual Report, we had 378 employees, 175 of whom were engaged in manufacturing, 76 in marketing, sales, clinical support and field service, 61 in research and development, 26 in sourcing, 5 in quality control and 35 in administration. Most of our employees are based at our facility in Gurgaon, Delhi NCR, India.
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. 23
After validating the SSi Mantra Surgical Robotic System in these markets, which we believe we are currently accomplishing, we intend to leverage its advanced technology, significantly lower cost and ease of training to move into other markets, such as the United States and Europe. Key elements of this strategy include: Focus on underserved markets .
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 .
(*Source: https://www.marketsandmarkets.com/Market-Reports/surgical-robots-market-256618532.html) 10 Market Dynamics Increase in demand and acceptance of laparoscopic or minimally invasive surgery (“ MIS ”) due to the benefits to patients and surgeons, such as better screening, greater precision, shorter hospitalization, reduced pain and discomfort has fueled the growth in the global surgical robotics market.
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 FDA may place significant limitations upon the intended use of our products as a condition of granting marketing authorization. Moreover, after a device is placed on the market, numerous FDA and other regulatory requirements continue to apply.
Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties. 19 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.
Following the initial placement at a given hospital, we intend to expand the number of physicians who use the SSi Mantra Surgical Robotic System and work with the hospitals and their surgeons to promote patient education as to the benefits and cost effectiveness of our system.
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.
Software upgrades and updates enable the latest product innovations, enhancements and reliability improvements. 6 Macro Healthcare Trends Increasing demand for healthcare : The increasing demand for healthcare in emerging markets such as India is driven by population growth and a growing middle class, rising per capita incomes, growing health insurance penetration and changing lifestyles.
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.
(federal, state and local) and international laws and regulations, including those in the EEA regarding data privacy and security and our use of such data. If we market our products in the EU, we will be subject to the European Union General Data Protection Regulation 2016/679 and applicable national supplementing laws (collectively, the “ GDPR ”).
(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. 22 If we market our products in the EU, we will be subject to the GDPR.
Manufacturing Our systems and instruments are manufactured by our employees at our approximately 70,000 square-feet facility in Gurugram, Delhi NCR, India. The manufacturing of our products is a complex operation involving a number of separate processes and components.
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.
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.
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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe have not experienced a cybersecurity incident that have 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.
Biggest changeWe 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.
Our Head-Server and Network Administrator reports 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.
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.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe 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 and another six-year lease expiring in July 2030 for the first floor. All the leases are further renewable under similar mutually agreed terms.
Biggest changeThe 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.
Item 2. Properties. We lease approximately 70,000 square feet in Gurugram, Delhi NCR, India, which serves as our headquarters as well as our manufacturing facility.
Item 2. Properties. We lease approximately 75,000 square feet in Gurugram, Delhi NCR, India, which serves as our headquarters as well as our manufacturing facility.
Added
All the leases are further renewable under similar mutually agreed terms. 24

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeSrivastava has agreed to fully indemnify the Company for any claims, damages and costs (including legal fees) which it incurs in connection with this litigation or in relation to any of his ventures prior to consummation of the Company’s acquisition by merger of CardioVentures, Inc. in April 2023. Item 4. Mine Safety Disclosures. Not applicable. 23 PART II
Biggest changeSrivastava 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.
The litigation, in which Otto is one of the defendants, relates to a purported transaction in 2021, at which time Dr. Sudhir Srivastava, the Company’s 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.
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.
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. (“SSI-India”), our Indian operating subsidiary and SSI-India’s assets during the pendency of the litigation.
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, the Company believes that there will be a favorable outcome in this case. Notwithstanding the foregoing, Dr. Srivastava and the Company have entered into an Indemnification Agreement on October 12, 2024, pursuant to which Dr.
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.
Item 3. Legal Proceedings. In April 2024, an ex-shareholder of Otto Pvt Ltd., an indirect wholly owned Bahamian subsidiary of SSi(“Otto”) commenced litigation in the Bahamas, seeking legal confirmation that it holds 9,000 shares (approximately a 9% interest) in Otto.
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.
Added
Item 3. Legal Proceedings. 1. In 2014, Avra Surgical Robotics, Inc., a Delaware corporation (“ Avra Surgical ”), of which Barry F.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
Cohen has agreed to fully indemnify us for any damages and costs (including legal fees) we incur in connection with the action. 2.
Added
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. Item 4.
Added
Mine Safety Disclosures. Not applicable. 25 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently quoted on the OTC Pink tier of the over-the-counter market maintained by OTC Markets Group, Inc. under the symbol “ SSII. ” However, the trading market for our common stock is sporadic and extremely limited.
Biggest changeMarket Information Our common stock is listed on The Nasdaq Stock Market LLC and commenced trading on April 24, 2025, under the symbol “SSII.” Prior to this listing, our common stock was quoted on the OTC Pink tier of the over-the-counter market maintained by OTC Markets Group, Inc., where trading was sporadic and extremely limited.
One of these holders is CEDE and Company, which is the mechanism used for brokerage firms to hold securities in book entry form on behalf of their clients and as of the date of this Annual Report, they held approximately 15,051,246 shares of common stock for these shareholders.
One of these holders is CEDE and Company, which is the mechanism used for brokerage firms to hold securities in book entry form on behalf of their clients and as of the date of this Annual Report, they held approximately 42,977,899 shares of common stock for these shareholders.
Securities Authorized for Issuance under Equity Compensation Plans Plan category Number of securities to be issued upon exercise of outstanding options, grants warrants and rights Weighted- average exercise price of outstanding options, grants warrants and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) Equity compensation plans approved by security holders 12,142,838 shares (1) $ 3.863 7,213,096 shares (1) Equity compensation plans not approved by security holders 0 shares – 0 shares Total 12,142,838 (1) $ 0 7,213,096 (1) (1) Represents shares of common stock under our 2016 Incentive Stock Plan (the “ Incentive Plan ”).
Securities Authorized for Issuance under Equity Compensation Plans Plan category Number of securities to be issued upon exercise of outstanding options, grants warrants and rights Weighted- average exercise price of outstanding options, grants warrants and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) Equity compensation plans approved by security holders 11,647,844 Shares $ 4.343 7,787,826 Shares Equity compensation plans not approved by security holders 0 Shares - 0 Shares Total 11,647,844 $ 4.343 7,787,826 (1) Represents shares of common stock under our 2016 Incentive Stock Plan (the “ 2016 Incentive Plan ”).
As of the date of this Annual Report, 12,142,838 shares of common stock (comprised of 7,767,431 stock options and 4,375,407 stock grants) were issued under the Incentive Stock Plan.
As of the date of this Annual Report, 11,647,844 shares of common stock (comprised of 7,739,432 stock options and 3,908,412 stock grants) were issued under the Incentive Stock Plan.
Holders of our Common Stock As of the date of this Annual Report, we had 193,559,340 shares of common stock issued and outstanding and 343 holders of record of our common stock.
Holders of our Common Stock As of the date of this Annual Report, we had 194,356,696 shares of common stock issued and outstanding (not including 5,774,839 shares issuable in connection with the private placement completed on March 6, 2026 – See “ Item1. Business – Recent Development ”) and 303 holders of record of our common stock.
Removed
Moreover, until the review of the Form 15c2-11 which has been filed with FINRA on our behalf is cleared by FINRA (as to which no assurance can be given), our common stock is not eligible for proprietary broker-dealer quotations on the over-the-counter market and may only be bought or sold in unsolicited customer orders.
Added
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Removed
This further limits the trading market for our common stock. The Company has also applied to list its common stock on the Nasdaq Stock Market, LLC, although there is no assurance that such application will be approved or that in either case, a liquid trading market for the common stock will develop and be sustained.
Added
The listing of our common stock on Nasdaq represents a transition to a national securities exchange, which we believe enhances the visibility of our securities and provides greater access to institutional and retail investors.
Removed
As of the date of this Annual Report, an additional 7,213,096 shares of common stock are available for future issuances under the Incentive Stock Plan. 24 Recent Sales of Unregistered Securities In March 2024, the Company issued 15,000 shares of common stock to an investor relations firm for investor relations and digital marketing services.
Added
Notwithstanding our Nasdaq listing, there can be no assurance that an active, orderly, or liquid trading market for our common stock will be sustained, or that the market price of our common stock will not experience significant volatility.
Removed
In August 2024, the Company issued 125,000 shares to certain doctors/proctors for providing their proctoring/mentoring services. In December 2024, the Company issued 9,034 shares of common stock to a marketing advisory services firm for providing dedicated support, production, graphics, post-production and distribution services.
Added
Any future dividends will be subject to the discretion of our board of directors and will depend upon, among other things, our earnings (if any), operating results, financial condition and capital requirements, general business conditions and other pertinent facts.
Added
Under its bank overdraft facility with HDFC Bank, SSI–India is prohibited from declaring and paying dividends, which effectively makes us, as a parent holding company, unable to declare and pay dividends as well.
Added
The 2016 Incentive Plan (but not awards under the 2016 Incentive Plan) expired on February 1, 2026, in accordance with its terms. 26 Recent Sales of Unregistered Securities On October 22, 2025, the Company issued 16,000 shares of common stock to an advisor in exchange for advisory services to be rendered over a 5-year period.
Added
The total value of such services is $174,240. The value of services is calculated at the fair market value of shares as of the date of the advisory services contract. On December 12, 2025, the Company issued 667 shares of common stock to one individual upon the exercise of warrants previously issued by the Company.
Added
The warrants were exercised at $2.50 per share in accordance with their terms resulting in net proceeds of $2,500 in the Company.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

32 edited+9 added−15 removed6 unchanged
Biggest changeDuring the year ended December 31, 2023, we had net cash, provided by financing activities of $22,796,286, which comprised of $2,480,735 in proceeds from our bank overdraft facility, $412,056 in proceeds from issuance of common stock against warrant and options, $16,980,000 in proceeds from issuance of convertible notes to our principal shareholder, $3,000,000 in proceeds from issuance of convertible notes to other investors and $50,000 in proceeds from the exercise of stock options.
Biggest changeDuring 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. 30 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.
SG&A expenses also include acquisition-related costs, 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.
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.
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 Expense.
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 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 2024 as compared to the year ended December 31, 2023.
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.
Stock-based compensation expense associated with AVRA 2016 Stock 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.
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.
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 is material to investors. Item 7A. Quantitative and Qualitative Disclosures About Market Risk Not applicable. Item 8.
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. 31 Item 7A. Quantitative and Qualitative Disclosures About Market Risk Not applicable.
To date, the Company has mainly relied on debt and equity raised in private offerings to finance its operations. During 2025, the company plans to raise additional capital through further private or public offerings.
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.
As of December 31, 2024, 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 the Company’s stock at a specified price, within a defined period, as per the terms of the stock option agreement.
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.
Financial Statements and Supplementary Data. See the Index to the Financial Statements beginning on page F-1 below. 29 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.
Item 8. Financial Statements and Supplementary Data. See the Index to the Consolidated Financial Statements beginning on page F-1 below. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.
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. For the year ended S. No.
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.
Depreciation and amortization expenses. We had depreciation and amortization expense of $436,005 for the year ended December 31,2024, as compared to $152,738 in the year ended December 31, 2023. The depreciation and amortization expenses primarily consist of depreciation on fixed assets only. Selling, General and Administrative 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.
Cash Flows from Investing Activities During the year ended December 31, 2024, we had net cash used in investing activities of $661,479 resulting from purchases of property, plant and equipment. During the year ended December 31, 2023, we had net cash used in investing activities of $453,327 resulting from purchase of property, plant and equipment.
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.
Other Income (Expenses) . We have incurred $175,235 in interest expenses (net) during the year ended December 31, 2024, as compared to an interest expense (net) of $604,308 during the year ended December 31, 2023.
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.
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 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.
Research and Development Expenses. Research and Development expenses during the year ended December 31, 2024, were $2,491,771, as compared to $1,058,660 for the year ended December 31, 2023.
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.
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.
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. 28 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.
As of December 31, 2024, the Company had shareholders’ equity of $13,457,103 and a working capital surplus of $6,086,069 as compared to shareholders’ equity of $19,718,078 and a working capital surplus of $12,954,939 as of December 31, 2023. For the year ended S. No.
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. For the year ended S. No.
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.
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.
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.
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.
The Company is still in its initial years of revenue generation by way of the sale of its product and has not yet established consistent operational revenue cash flows to meet all its fixed operating costs and hence may continue to incur losses for some time. These conditions raise doubt about the Company’s ability to 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.
A summary of our significant accounting policies is included in Note 2 - Summary of Significant Accounting Policies to our consolidated financial statements under Part II, Item 15, “Exhibits and Financial Statements Schedules.” 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.
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.
Particulars December 31, 2024 December 31, 2023 1 Total Revenue 20,649,528 5,875,314 2 Cost of revenue (12,197,162 ) (5,149,786 ) 3 Gross profit 8,452,366 725,528 4 Research & development expense 2,491,771 1,058,660 5 Stock compensation expense 14,342,784 9,723,492 6 Depreciation and amortization expense 436,005 152,738 7 Selling, general and administrative expense 10,157,768 10,064,622 8 Loss from operations (18,975,962 ) (20,273,984 ) 9 Other income (expenses) (175,235 ) (604,308 ) 10 Income tax expense - - 11 Net loss (19,151,197 ) (20,878,292 ) 26 Year ended December 31, 2024, as compared to year ended December 31, 2023 Revenues.
For the year ended December 31, 2025 December 31, 2024 1 Total Revenue 42,484,747 20,649,528 2 Cost of revenue (22,940,492 ) (12,197,162 ) 3 Gross profit 19,544,255 8,452,366 4 Research & development expense 3,685,840 2,491,771 5 Stock compensation expense 8,128,103 14,342,784 6 Depreciation and amortization expense 1,075,907 436,005 7 Selling, general and administrative expense 14,848,439 10,157,768 8 Loss from operations (8,194,034 ) (18,975,962 ) 9 Other income (expenses) 33,087 (175,235 ) 10 Income tax expense 3,966,440 - 11 Net loss (12,127,387) (19,151,197 ) Year ended December 31, 2025, as compared to year ended December 31, 2024 Revenues.
Cash Flows from Financing Activities 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.
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.
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.
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.
The decrease in net loss from 2023 to 2024 is primarily due to increase in gross profit of $7,726,838, offset by increase in stock compensation expense and of $4,619,292 and decrease in interest expense (net) of $ 175,235 from $ 604,308 respectively. 27 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.
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.
The following table provides selected financial data about our Company at December 31, 2024, and December 31, 2023: Balance Sheet Data As of As of December 31, December 31, 2024 2023 Cash 466,500 2,022,276 Restricted Cash** 6,157,035 5,065,569 Total Assets 42,385,213 31,515,994 Total Liabilities 28,928,110 11,797,916 Total Shareholders’ Equity 13,457,103 19,718,078 ** Represents Fixed Deposits held by the bank as security for bank facilities and certain performance guarantees.
These conditions raise substantial doubt about our ability to continue as a going concern. 27 The following table provides selected financial data about our Company at December 31, 2025, and December 31, 2024: Balance Sheet Data As of As of December 31, 2025 December 31, 2024 Cash 3,206,406 466,500 Restricted cash** 6,396,614 6,157,035 Total Assets 74,226,217 42,385,213 Total Liabilities 36,007,966 28,928,110 Total stockholders’ equity 38,218,251 13,457,103 ** Represents Fixed Deposits held by the bank as security for bank facilities and certain performance guarantees.
Particulars December 31, 2024 December 31, 2023 Net cash provided by operating activities: 1 Net loss (19,151,197 ) (20,878,292 ) 2 Non-cash adjustments 16,435,264 15,699,110 3 Change in operating assets and liabilities (6,787,097 ) (10,182,463 ) 4 Net cash used in operating activities (9,503,030 ) (15,361,645 ) 5 Net cash used in investing activities (661,479 ) (453,327 ) 6 Net cash provided by financing activities 9,425,980 22,796,286 7 Net change in cash (738,529 ) 6,981,314 8 Effect of exchange rate on cash 274,219 (168,094 ) 9 Cash at beginning of year 7,087,845 274,625 10 Cash at end of year 6,623,535 7,087,845 Cash Flows Used in Operating Activities Net cash used in operating activities was $9,503,030 for the year ending 31 December 2024, compared to $15,361,645 for the year ending 31 December 2023, reflecting lower cash losses and decrease in working capital needs due to increased scale of operations.
Particulars December 31, 2025 December 31, 2024 Net cash provided by operating activities: 1 Net loss (12,127,387 ) (19,151,197 ) 2 Non-cash adjustments 9,378,429 16,435,264 3 Change in operating assets and liabilities (15,794,029 ) (6,787,097 ) 4 Net cash used in operating activities (18,542,987 ) (9,503,030 ) 5 Net cash used in investing activities (3,659,058 ) (661,479 ) 6 Net cash provided by financing activities 26,166,556 9,425,980 7 Net change in cash 3,964,511 (738,529 ) 8 Effect of exchange rate on cash (985,026 ) 274,219 9 Cash at beginning of year 6,623,535 7,087,845 10 Cash at end of year 9,603,020 6,623,535 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.
Each stock unit automatically converts into a specified number of shares upon vesting. The Company uses last three months’ average share price of common stock on OTC exchange 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.
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.
During the year ended December 31, 2024, the Company had revenues of $20,649,528 (comprising $19,457,767 of system sales, $942,548 of instrument sales and $177,518 of warranty sales and $71,695 of Lease income), compared to revenues of $5,875,314 (comprising $5,225,777 of system sales, $647,766 of instrument sales and $1,771 of warranty sales) during the year ended December 31, 2023.The increase in revenue is primarily due to sale of increased number of surgical robotic systems and instruments in the year ended December 31, 2024 as compared to the year ended December 31, 2023.
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.
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. 25 During the year ended December 31, 2024, we sold 36 surgical robotic systems out of which 7 systems were sold on deferred payment basis.
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.
The decrease in interest expense (net) from 2023 to 2024 is due to increase in interest income on fixed deposits with HDFC bank in India and interest income recognized during the year related to deferred payment sales. Net Loss.
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 $19,151,197 for the year ended December 31, 2024, as compared to a net loss of $20,878,292 for the year ended December 31, 2023.
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.
Removed
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 allied 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”.
Added
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.
Removed
In addition, during the year ended December 31, 2024, we also installed 11 systems on a pay-per-use basis.
Added
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.
Removed
The system installed at the Johns Hopkins Hospital in Baltimore Maryland for research and clinical training, having completed one year period post its import into USA, was returned back to India in compliance with the Indian government regulations for medical devices exported overseas for exhibition/clinical training/research purposes.
Added
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.
Removed
During the year ended December 31, 2024, we also received back 3 systems which, as of December 31, 2023, were installed in 3 hospitals for evaluation purposes and as such we had no systems under evaluation at any of the hospitals as on December 31, 2024.
Added
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.
Removed
At the end of December 2024, we had a total of 62 installed systems of which 47 were installed during the year ended December 31, 2024. Results of Operations Introduction The financial statements appearing elsewhere in this report have been prepared assuming that the Company will continue as a going concern.
Added
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.
Removed
We had stock compensation expenses of $14,342,784 and $9,723,492 during the years ended December 31, 2024, and December 31, 2023 respectively.
Added
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.
Removed
The substantial increase in the stock compensation expense in 2024 is primarily the result of the award of second tranche of stock grants to employees of the Company and its subsidiaries and the issuance of stock awards and stock options to executive officers of the Company and its subsidiaries in November 2024 under our Incentive Stock Plan, in recognition of their efforts in Company’s operational growth.
Added
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.
Removed
We incurred $10,157,768 in selling, general and administrative expenses during the year ended December 31, 2024, as compared to $10,064,622 for the year ended December 31, 2023.
Added
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.
Removed
The major drivers contributing to the decrease of $5,858,615 in net cash used in operating activities year-over-year included the following: ● Decrease in net cash loss to the extent of $2,463,249 (net of non-cash adjustments) in fiscal year 2024 compared to fiscal year 2023.
Added
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.
Removed
Non-cash adjustments included stock compensation expense, credit loss reserve, operating lease expense, interest expense and depreciation. ● Decrease of $3,395,366 in operating assets and liabilities comprising mainly of an increase of $4,305,512 in deferred revenue and of $713,744 in accrued expenses and other liabilities in fiscal year 2024 as compared to 2023 and a net decrease of $1,623,890 in other operating assets and liabilities other than deferred revenue, accrued expenses and other liabilities. ● Changes in accounts receivable contributed to lower cash flow of $1,818,392 for fiscal year 2024 as compared to fiscal year 2023.
Removed
Although the Company’s revenue increased from system sales by $14,231,990, from instruments sales by $294,782, from warranty sales by $175,747 and from lease income by $71,695 in fiscal year 2024 compared to fiscal year 2023. ● Increased investment in inventory contributed to higher cash outflow of $7,691,518 for fiscal year 2024 compared to fiscal year 2023 due to revenue growth and expansion of business activities.
Removed
There was a decrease of $126,505 on account of repayment of term loans 28 While we have been successful in raising funds to finance our operations since inception and we believe that we will be successful in obtaining the necessary financing to fund our operations going forward, we do not have any committed sources of funding and there is no assurance that we will be able to secure additional funding.
Removed
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern; however, if we cannot obtain financing, then we may be forced to further curtail our operations or consider other strategic alternatives.
Removed
Even if we are successful in raising the additional financing, there is no assurance regarding the terms of any additional investment and any such investment or other strategic alternative would likely substantially dilute our current shareholders.
Removed
Critical Accounting Estimates Use of Estimates The discussion and analysis of our financial condition and results of operations are based upon the consolidated financial statements included in this Annual Report on Form 10-K, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).

Other SSII 10-K year-over-year comparisons