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What changed in SS Innovations International, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of SS Innovations International, Inc.'s 2023 and 2024 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 2024 report.

+224 added−197 removedSource: 10-K (2025-04-15) vs 10-K (2024-03-22)

Top changes in SS Innovations International, Inc.'s 2024 10-K

224 paragraphs added · 197 removed · 141 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

102 edited+50 added−21 removed125 unchanged
Biggest changeAs of the date of this Annual Report, our intellectual property portfolio consists of 33 granted utility patents and 63 pending utility patent applications as follows: Granted Pending Country No. of Patents Earliest Expiration Latest Expiration No. of Patents Earliest Expiration Latest Expiration Product China 4 October 6, 2034 June 5, 2038 2 October 31, 2038 June 20, 2039 MANTRA China 2 November 21, 2034 December 25, 2039 MUDRA Europe 2 December 26, 2034 June 5, 2038 4 February 8, 2043 December 1, 2043 MANTRA Europe 1 June 9, 2043 June 9, 2043 MAYA Europe 1 October 9, 2043 October 9, 2043 MUDRA Hong Kong 3 January 12, 2038 October 31, 2038 MANTRA India 9 October 7, 2033 March 29, 2042 22 October 6, 2034 March 11, 2044 MANTRA India 1 November 10, 2043 November 10, 2043 MANTRA & MAYA India 1 June 10, 2042 June 10, 2042 1 July 27, 2043 July 27, 2043 MAYA India 5 November 22, 2033 June 10, 2042 4 May 30, 2039 October 10, 2042 MUDRA Japan 2 January 12, 2038 June 5, 2038 MANTRA Singapore 3 October 31, 2038 June 20, 2039 MANTRA South Korea 3 January 12, 2038 June 5, 2038 MANTRA Taiwan 1 October 31, 2038 October 31, 2038 MANTRA USA 3 October 6, 2034 June 20, 2039 5 February 8, 2043 December 1, 2043 MANTRA USA 1 June 9, 2043 June 9, 2043 MAYA USA 1 November 21, 2034 November 21, 2034 3 November 4, 2042 October 9, 2043 MUDRA WIPO 7 August 28, 2024 July 7, 2025 MANTRA WIPO 1 January 10, 2025 January 10, 2025 MAYA WIPO 4 May 5, 2024 May 10, 2025 MUDRA Total 33 63 96 12 Further, our intellectual property portfolio also consists of 44 granted design patents and one pending design patent application as follows: Granted Pending Country No. of Patents Earliest Expiration Latest Expiration No. of Patents Earliest Expiration Latest Expiration Product China 6 December 1, 2027 May 24, 2028 MANTRA EUIPO 1 April 17, 2028 April 17, 2028 MANTRA India 30 December 1, 2027 January 25, 2034 1 December 20, 2033 December 20, 2033 MANTRA India 5 August 29, 2033 October 12, 2033 MUDRA Japan 1 April 17, 2028 April 17, 2028 MANTRA South Korea 1 April 17, 2028 April 17, 2028 MANTRA Total 44 1 45 In addition, we have filed 53 applications for trademark registrations in India of which 29 have been granted.
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.
Robotic assisted surgical capabilities may enable a large number of these procedures to be performed through a minimally invasive technique, conferring the benefits of minimally invasive surgery to a broader range of partial nephrectomy patients. Radical Nephrectomy . A radical nephrectomy is a surgery to remove the entire kidney, typically done to treat kidney cancers and occasionally or other reasons.
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.
In some instances, the adrenal gland and lymph nodes may be removed as well. Cystectomy . Robotic-assisted cystectomy is a minimally invasive bladder surgery with the same cancer removal success as open surgery. During a robotic cystectomy, robotically trained urology surgeons remove the bladder and redirect the urinary tract using a surgical robot.
In some instances, the adrenal gland and lymph nodes may be removed as well. Cystectomy . Robotic-assisted cystectomy is a minimally invasive bladder surgery with the same cancer removal success as open surgery. During robotic cystectomy, robotically trained urology surgeons remove the bladder and redirect the urinary tract using a surgical robot.
A hernia occurs when an organ or other tissue squeezes through a weak spot in a surrounding muscle or connective tissue. During a hernia repair surgery, the weakened tissue is secured, and defects are repaired. Common types of hernias are ventral and inguinal. Ventral, or abdominal hernia, may occur through a scar after surgery in the abdomen.
A hernia occurs when an organ or other tissue squeezes through a weak spot in a surrounding muscle or connective tissue. During hernia repair surgery, the weakened tissue is secured, and defects are repaired. Common types of hernias are ventral and inguinal. Ventral, or abdominal hernia, may occur through a scar after surgery in the abdomen.
The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo classification or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination.
The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo classification or a PMA in the first instance, but the FDA can review any such decision and disagree with the manufacturer’s determination.
If the FDA 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; 16 ● 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 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.
During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them.
During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigation devices or on making safety or effectiveness claims for them.
We have included our website address as an inactive textual reference only. 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. 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.
In general, we may not promote or advertise our products for uses not within the scope of our intended use statement in our clearances or make unsupported safety and effectiveness claims. In the U.S., our manufacturing processes will be required to comply with the Quality System Regulation (“ QSR ”).
In general, we may not promote or advertise our products for uses not within the scope of our intended use statement in our clearances or make unsupported safety and effectiveness claims. 19 In the U.S., our manufacturing processes will be required to comply with the Quality System Regulation (“ QSR ”).
We believe that these efforts will not only result in both increased usage and additional sales of instruments and systems at hospitals that purchase the system, but also increased demand from competing hospitals, surgeons and other physicians. 5 Focus on Leading Surgeons to Drive Rapid and Broad Adoption .
We believe that these efforts will not only result in both increased usage and additional sales of instruments and systems at hospitals that purchase the system, but also increased demand from competing hospitals, surgeons and other physicians. Focus on Leading Surgeons to Drive Rapid and Broad Adoption .
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. 15 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 510(k) submission.
Readiness support is operational support to ensure smooth onboarding and adoption of new systems and technology. Maintenance support helps to maximize operational efficiency and reduce unplanned equipment downtime. It includes services care plans, support teams, monitoring, software upgrades and updates, as well as a customer portal.
Readiness support is operational support to ensure smooth onboarding and the adoption of new systems and technology. Maintenance support helps to maximize operational efficiency and reduce unplanned equipment downtime. It includes services care plans, support teams, monitoring, software upgrades and updates, as well as a customer portal.
When using the SSi Mantra, the surgeon is able to sit in an ergonomic position and can see both the specific positioning of his or her hands and feet, thereby reducing the learning curve and maintaining comfortable ergonomics during the surgical procedure.
When using the SSi Mantra 3, the surgeon is able to sit in an ergonomic position and can see both the specific positioning of his or her hands and feet, thereby reducing the learning curve and maintaining comfortable ergonomics during the surgical procedure.
We believe that robotic-assisted surgery with the SSi Mantra provides patients the opportunity to receive a minimally invasive treatment as an alternative to an open hysterectomy. Sacro colpopexy. The abdominal (open) sacro colpopexy is one of the operations performed to treat vaginal vault prolapse.
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.
A robotic cystectomy is performed through a series of small keyhole-sized incisions across the abdomen, which is less painful, heals faster, and produces significantly less surface scarring than the larger incision associated with open surgery. 7 General Surgery Hernia Repair .
A robotic cystectomy is performed through a series of small keyhole-sized incisions across the abdomen, which is less painful, heals faster, and produces significantly less surface scarring than the larger incision associated with open surgery. General Surgery Hernia Repair .
This infrastructure of service and support specialists, along with advanced service tools and solutions, offers a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system health monitoring. 10 Research and Development We focus our research and development efforts on enhancing and improving our products and services with a view to fulfilling our vision that the benefits of advanced robotic surgery should be cost-effective and available to everyone.
This infrastructure of service and support specialists, along with advanced service tools and solutions, offers a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system health monitoring. 13 Research and Development We focus our research and development efforts on enhancing and improving our products and services with a view to fulfilling our vision that the benefits of advanced robotic surgery should be cost-effective and available to everyone.
Instruments and Accessories We offer a comprehensive suite of stapling, energy and core instrumentation for our surgical systems, under the brand name of SSi Mudra. Mudra Technology .
Instruments and Accessories We offer a comprehensive suite of stapling, energy and core instrumentation for our surgical systems, under the brand name of SSi Mudra. 4 Mudra Technology .
This versatility attracts hospitals and clinics aiming to offer comprehensive robotic surgical services which is expected to drive the market growth. High initial costs associated with acquiring and implementing robotic systems, including infrastructure and training, pose a financial challenge for many healthcare facilities which may impede market growth.
This versatility attracts hospitals and clinics to aim to offer comprehensive robotic surgical services which is expected to drive the market growth. High initial costs associated with acquiring and implementing robotic systems, including infrastructure and training, pose a financial challenge for many healthcare facilities which may impede market growth.
However, the systems segment is expected to register the highest CAGR during the forecast period, owing to a rise in technological advancements and an increase in demand for advanced robotic surgical systems. By Surgery Type The general surgery segment dominated the global surgical robotics market share in 2022 and is anticipated to continue this trend during the forecast period.
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.
Contemporaneously with the Closing on April 14, 2023, the Company changed its name to “ SS Innovations International, Inc., ” effected a one-for-ten reverse stock split and increased its authorized common stock to 250,000,000 shares. In connection with the consummation of the CardioVentures Merger, Dr.
Contemporaneously with the closing of the CardioVentures Merger on April 14, 2023, the Company changed its name to “ SS Innovations International, Inc., ” effected a one-for-10 reverse stock split and increased its authorized common stock to 250,000,000 shares. In connection with the consummation of the CardioVentures Merger, Dr.
Clinical Applications The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than fifty different types of surgical procedures in India without any device related adverse events.
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.
Our products have multiple joints that emulate the surgeon’s shoulders and elbows, allowing exact positioning of the instruments inside the patient’s chest. In addition, our Mudra instrument joints is designed to permit the surgeon to reach behind the tissues for easier dissection of the internal mammary artery.
Our products have multiple joints that emulate the surgeon’s shoulders and elbows, allowing exact positioning of the instruments inside the patient’s chest. In addition, our Mudra instrument joints are designed to permit the surgeon to reach behind the tissues for easier dissection of the internal mammary artery.
A company’s facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA. Failure to maintain compliance with applicable QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of marketed products.
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.
Ltd., an Indian private limited company, which developed and manufactures and markets the SSi Mantra, which is designed to provide an advanced, yet cost-effective surgical robotic system which make the benefits of robotic surgery available to a larger part of the global population.
Ltd., an Indian private limited company (“ SSI-India ”), which developed and manufactures and markets the SSi Mantra, which is designed to provide an advanced, yet cost-effective surgical robotic system which make the benefits of robotic surgery available to a larger part of the global population.
Our principal executive offices are located at 404-405, 3 rd Floor, iLabs Info Technology Centre, Udyog Vihar, Phase III, Gurugram, Haryana 122016, India. Our telephone number is +91 73375 53469. Our corporate website is https://ssinnovations.com. Information appearing on our corporate website is not part of this prospectus and is not incorporated by reference herein.
Our principal executive offices are located at 404-405, 3 rd Floor, iLabs Info Technology Centre, Udyog Vihar, Phase III, Gurugram, Haryana 122016, India. Our telephone number is +91 73375 53469. Our corporate website is https://ssinnovations.com. Information appearing on our corporate website is not part of this Annual Report and is not incorporated by reference herein.
Additionally, after a trial begins, we, the FDA, or the IRB could suspend or terminate a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.
Additionally, after a trial begins, we, the FDA, or the IRB could suspend or terminate a clinical trial at any time for various reasons, including a belief that the risks to studying subjects outweigh the anticipated benefits.
North America accounted for a major share of the surgical robotics industry in 2022 in terms of number of surgical robotic systems installed and is expected to maintain its dominance during the forecast period.
North America accounted for a major share of the surgical robotics industry in 2024 in terms of the number of surgical robotic systems installed and is expected to maintain its dominance during the forecast period.
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 seventy-nine countries require only minimal registration.
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.
It has uninterruptible power supply battery backup, universal safety features and incorporates an Omni 3DHD multimedia recording and streaming platform. Tele-Proctoring/Tele-Mentoring Capabilities . The SSi Mantra has a built-in live streaming platform, which provides for remote proctoring, thereby resulting in efficient and cost-effective teaching and training capabilities.
It has uninterruptible power supply battery backup; universal safety features and incorporates the SSi Mantra multimedia recording and streaming platform. Tele-Proctoring/Tele-Mentoring Capabilities . The SSi Mantra has a built-in live streaming platform, which provides for remote mentoring and proctoring, thereby resulting in efficient and cost-effective teaching and training capabilities.
Segmental Overview The surgical robotics industry is segmented into components, surgery type, and region. By component, the market is categorized into systems, accessories, and services. On the basis of surgery type, the market is segregated into gynecology surgery, urology surgery, neurosurgery, orthopedic surgery, general surgery, and other surgeries.
Segmental Overview The surgical robotics industry is segmented into components, surgery type, and region. By component, the market is categorized into systems, accessories, and services. Based on surgery type, the market is segregated into gynecology surgery, urology surgery, neurosurgery, orthopedic surgery, general surgery, and other surgeries.
We generally consider our relationship with our employees to be good.
We generally consider our relationship with our employees to be good. 22
Sudhir Srivastava, through his holding company, assigned all patents, trademarks and other intellectual property used in the development, commercialization, manufacturing and sale of its medical and surgical robotic systems and products to one or more wholly owned subsidiaries of SSi.
Sudhir Srivastava, through Sushruta, assigned all patents, trademarks and other intellectual property used in the development, commercialization, manufacturing and sale of its medical and surgical robotic systems and products to one or more wholly owned subsidiaries of SSi.
The device sponsor must proceed with and fulfill the requirements of the more rigorous requirements of the premarket approval (“ PMA ”) process or can request a risk-based classification determination for the device in accordance with the de novo classification pathway, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.
The device sponsor must proceed with and fulfill the requirements of the more rigorous requirements of the premarket approval (“ PMA ”) process or can request a risk-based classification determination for the device in accordance with the de novo classification pathway, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device. 18 The PMA process is more demanding than the 510(k) premarket notification process.
In addition, the advanced software technology of the robotic system filters and eliminates any tremors that may be present in a surgeon’s hands. 3 Mudra Instruments . Most of the more than 30 instruments that we manufacture incorporate Mudra technology with wristed joints for natural dexterity and tips customized for various surgical procedures.
In addition, the advanced software technology of the robotic system filters and eliminates any tremors that may be present in a surgeon’s hands. Mudra Instruments . Most of the more than 30 instruments that we manufacture incorporate Mudra technology with wristed joints for natural dexterity and tips customized for various surgical procedures. Mudra instruments are offered in an 8mm diameter.
As of the date of this Annual Report, surgeons have performed approximately 800 surgical procedures in India in a wide array of fields using the SSi Mantra, including many complex surgeries. The SSi Mantra offers the entire operating room staff three-dimensional, high definition (“ 3DHD ”) vision, and gives the surgeon a magnified view up to ten times magnification.
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.
Using electronic hardware, software, algorithms and mechanics, our technology translates the surgeon’s hand movements into precise and corresponding real-time movements of the SSi Mantra instruments positioned inside the patient.
Using electronic hardware, software, algorithms and mechanics, our technology translates the surgeon’s hand movements into precise and corresponding real-time movements of the SSi Mantra instruments positioned through surgical ports going inside of the patient.
Through ingenuity and intelligent technology, we believe that we can expand the potential of physicians to heal without constraints due to both cost and accessibility of these technologies. We employ engineering and research and development staff to focus on delivering future innovations and sustaining improvements that advance our mission.
Through ingenuity and intelligent technology, we believe that we can expand the potential of physicians to heal without constraints due to both cost and accessibility of these technologies. We employ engineering and research and development staff and currently have a research and development team of 65 employees to focus on delivering future innovations and sustaining improvements that advance our mission.
We have also been in discussions with an EU Notified body for the CE certification. There can be no assurance as to when we will secure such regulatory approvals, if at all.
We have also been in discussions with an EU Notified Body for the CE certification, which will allow us to market the SSi Mantra in the EU. There can be no assurance as to when we will secure such regulatory approvals, if at all.
Our direct sales organization is composed of a capital sales team of six individuals, which is responsible for selling systems, and a clinical support team of twenty individuals, which is responsible for supporting the systems used in procedures performed at our hospital accounts.
Our direct sales organization is composed of a capital sales team of ten individuals, who are responsible for selling systems, and a clinical support team of thirty individuals, which is responsible for supporting the systems used in procedures performed at our hospital accounts.
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.
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.
We have received regulatory approval to market and sell our products in the United Arab Emirates and Guatemala and have initiated the regulatory approval process, which if successful, will allow us to market our products in more than fifty (50) countries within approximately one year.
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.
Key elements of this strategy include: Focus on underserved markets . India, where our operations are based and where we have commercially launched the SSi Mantra, has a population of approximately 1.4 billion people and 70,000 hospitals. However, only about 0.1% of global robotic surgical procedures. As a comparison, there are only approximately 6,120 hospitals in the U.S.
India, where our operations are based and where we have commercially launched the SSi Mantra, has a population of approximately 1.4 billion people and 70,000 hospitals. As a comparison, there are only approximately 6,120 hospitals in the U.S. However, only about 0.1% of global robotic surgical procedures are done in India.
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.
Unlike directives, regulations are directly applicable in EU member states without the need for member states to implement them into national law.
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 .
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.
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.
(*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.
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. 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.
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.
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.
A variety of instruments may be selected and used interchangeably during surgery. All instruments are sterilizable at the hospital, and all are reusable for a defined number of procedures. A programmed memory chip inside each instrument performs several functions that help determine how the SSi Mantra and instruments work together.
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.
Mudra instruments are offered in an 8mm diameter. Various Mudra instrument tips include forceps, scissors, electrocautery tools, scalpels and other surgical tools that are familiar to the surgeon from open surgery and conventional minimally invasive surgery (“ MIS ”). We have also developed and made available a variety of cardiac surgery specific instruments.
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.
These include: NADI – Automated Coronary Anastomotic Connector . This instrument is a micro stapling device intended to join two arteries together in cardiac bypass procedures. We intend to offer the instrument in both robotic surgery and manual versions.
Instruments under Development We also have a number of additional sophisticated instruments currently under development. These include: NADI – Automated Coronary Anastomotic Connector . This instrument is a micro stapling device intended to join two arteries together in cardiac bypass procedures. We intend to offer the instrument in both robotic surgery and manual versions.
The PMA process is more demanding than the 510(k) premarket notification process. In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the PMA application must be supported by extensive data, including data from preclinical studies and human clinical trials.
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.
By Component With a consistently expanding installed base of surgical robotic systems globally and increasing utilization thereof, the accessories and services segment dominated the global surgical robotics market in 2022 and is expected to remain dominant throughout the forecast period, due to a further rise in the number of surgical robotics procedures performed with precision, accuracy, and improved patient outcomes, coupled with the increased adoption of surgical robotics technology.
Region wise, the market is analyzed across North America, Europe, Asia-Pacific, Latin America, the Middle East and Africa (“ LAMEA ”). 11 By Component With a consistently expanding installed base of surgical robotic systems globally and increasing utilization thereof, the accessories and services segment dominated the global surgical robotics market in 2022 and is expected to remain dominant throughout the forecast period, due to a further rise in the number of surgical robotics procedures performed with precision, accuracy, and improved patient outcomes, coupled with the increased adoption of surgical robotics technology.
As of the date of this Annual Report, we have installed 25 systems in India, which have been used to perform close to eight hundred surgical procedures, including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries.
As of the date of this Annual Report, we have installed 75 systems in India and overseas, which have been used to perform more than three thousand surgical procedures, including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries.
Moreover, untapped economies such as Brazil, India, China and other developing economies create a lucrative surgical robotics market opportunity. 8 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.
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.
After validating the SSi Mantra Surgical Robotic System in these markets, which we believe we are currently accomplishing, we intend to leverage its advanced technology, significantly lower cost (approximately one third of the cost of existing systems) and ease of training to move into other markets, such as the United States and Europe.
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 .
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.
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.
Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products—such as replacement 3D stereo endoscopes, cannulas for the instruments and camera and special seals to prevent leakage of carbon dioxide gas used during a procedure. Instruments under Development We also have a number of additional sophisticated instruments currently under development.
Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products—such as replacement 3D stereo endoscopes, cannulas for the instruments and camera and special seals to prevent leakage of carbon dioxide gas used during a procedure. Tele proctoring and Telesurgery .
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. 4 SSi Mixed Reality Headset - The SSi Mixed Reality headset is a medical-grade device that we hope will revolutionize intraoperative experiences by seamlessly interfacing with the SSi Mantra Surgical Robotic System.
It includes a state-of-the-art AI enabled application viewer which is seamlessly integrated with the SSi Mantra Surgical Robotic System to provide surgeons with comprehensive tools to enhance their surgical confidence and precision in the operating room. SSi Mixed Reality Headset .
The service plan portfolio offers flexible service plans to ensure reliability of the systems and instruments and help optimize the robotics program. The support team of expert field service, remote technical support and customer care agents resolve and prevent any technology issues that could inhibit optimal utilization. Software upgrades and updates enable the latest product innovations, enhancements and reliability improvements.
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.
This procedure, while effective in treating cancer, is potentially traumatic and disfiguring to the patient. Less invasive approaches via the mouth (transoral surgery) are challenged by line-of-sight limitations dictated by conventional endoscopic tools.
Surgical resection performed by an open approach may require a “jaw-splitting” mandibulotomy. This procedure, while effective in treating cancer, is potentially traumatic and disfiguring to the patient. Less invasive approaches via the mouth (transoral surgery) are challenged by line-of-sight limitations dictated by conventional endoscopic tools.
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.
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.
Most, if not all of these companies have longer operating histories and greater financial resources than SSi. In addition, other companies with substantial experience in industrial robotics could potentially expand into the field of medical robotics and become competitors.
Most, if not all of these companies have longer operating histories and greater financial resources than SSi. In addition, other companies with substantial experience in industrial robotics could potentially expand into the field of medical robotics and become competitors. Our failure to compete effectively with these existing and potential competitors could adversely affect our results of operations, business and prospects.
Manufacturers are required to take FSCAs, which are defined as any corrective action for technical or medical reasons to prevent or reduce a risk of a serious incident associated with the use of a medical device that is made available on the market. 17 The advertising and promotion of medical devices is subject to some general principles set forth in EU legislation.
Manufacturers are required to take FSCAs, which are defined as any corrective action for technical or medical reasons to prevent or reduce the risk of a serious incident associated with the use of a medical device that is made available on the market.
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 Services We have a network of field service engineers in India and maintain relationships with various distributors around the globe.
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.
The manufacturing of our products is a complex operation involving a number of separate processes and components. We purchase both custom and off-the-shelf components from a large number of suppliers and subject them to stringent quality specifications, inspections, and processes.
We purchase both custom and off-the-shelf components from a large number of suppliers from both within India and overseas and subject them to stringent quality specifications, inspections, and processes.
The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, recordkeeping, complaint and adverse event reporting, clearance, approval, certification, promotion, marketing, export, import, distribution and service of medical devices in the U.S. to ensure that medical devices distributed domestically are safe and effective for their intended uses. 14 We have filed a pre-submission application with the FDA requesting feedback on the SSi Mantra Surgical Robotic System and we received acknowledgment of the filing on January 17, 2024.
The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, recordkeeping, complaint and adverse event reporting, clearance, approval, certification, promotion, marketing, export, import, distribution and service of medical devices in the U.S. to ensure that medical devices distributed domestically are safe and effective for their intended uses.
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 CE (Conformité Européene) marked may be marketed and advertised in the EU in accordance with their intended purpose.
Procedures performed via these methods include pulmonary wedge resection, pulmonary lobectomy, thymectomy, mediastinal mass excision and esophagectomy. Head and Neck Surgery Transoral Surgery . Head and neck cancers are typically treated by either surgical resection or chemo-radiation, or a combination of both. Surgical resection performed by an open approach may require a “jaw-splitting” mandibulotomy.
Thoracic Surgery Conventional approaches to surgical procedures in the thorax include both open and video-assisted thoracoscopic approaches. Procedures performed via these methods include pulmonary wedge resection, pulmonary lobectomy, thymectomy, mediastinal mass excision and esophagectomy. Head and Neck Surgery Transoral Surgery . Head and neck cancers are typically treated by either surgical resection or chemo-radiation, or a combination of both.
There can be no assurance that the outcomes from such documentation and testing will be acceptable to any particular regulatory agency or will continue to be acceptable over time.
All such regulations are revised from time to time and, in general, are increasing in complexity and in the scope and degree of documentation and testing required. There can be no assurance that the outcomes from such documentation and testing will be acceptable to any particular regulatory agency or will continue to be acceptable over time.
Employees As of the date of this Annual Report, we had 239 employees, 102 of whom were engaged in manufacturing and service, 38 in marketing and sales, 50 in research and development, 4 in quality control and 45 in administration. Most of our employees are based at our facility in Gurgaon, Delhi NCR, India.
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.
From inception through April 13, 2023, we were engaged in developing a fully autonomous medical robotic system using proprietary software which integrated Artificial Intelligence and Deep Learning, or Machine Learning.
From inception through April 13, 2023, we were engaged in developing a fully autonomous medical robotic system using proprietary software which integrated Artificial Intelligence and Deep Learning, or Machine Learning. Our research and development efforts were based in Orlando, Florida, where we established a research partnership with the University of Central Florida.
However, there can be no assurance as to when we will secure any such regulatory approvals, if at all. 18 Data Privacy and Security Laws Numerous state, federal, and foreign laws, regulations, and standards govern the collection, use, access to, confidentiality, and security of health-related and other personal information and could apply now or in the future to our operations or the operations of our partners.
Data Privacy and Security Laws Numerous state, federal, and foreign laws, regulations, and standards govern the collection, use, access to, confidentiality, and security of health-related and other personal information and could apply now or in the future to our operations or the operations of our partners.
Sudhir Srivastava, who, through his holding company, owned a controlling interest in CardioVentures. CardioVentures, through a subsidiary, owned a controlling interest in Sudhir Srivastava Innovations Pvt.
Ltd. (“ Sushruta ”), owned a controlling interest in CardioVentures. CardioVentures, through a subsidiary, owned a controlling interest in Sudhir Srivastava Innovations Pvt.
Under the FFDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness. We believe that our current SSi Mantra Surgical Robotic System and other products will be classified as Class II medical devices.
Under the FDA’s regulatory scheme, medical devices are classified into one of three classes—Class I, Class II or Class III, depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness.
Our system uses specialized instrumentation, including a miniaturized surgical camera (endoscope) and wristed instruments (for example, scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction of anatomical structures within the body. 2 The SSi Mantra is comprised of the following components: Surgeon Console .
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.
Corporate Information The Company was incorporated in the state of Florida on February 4, 2015, under the name “ Avra Surgical Microsystems, Inc., ” and changed its name to “ Avra Medical Robotics, Inc. ” on November 5, 2015.
We believe that the SSi Mantra benefits patients, physicians and hospitals by providing access to an advanced and optimized robotic system. 2 Corporate Information The Company was incorporated in the state of Florida on February 4, 2015, under the name “ Avra Surgical Microsystems, Inc., ” and changed its name to “ Avra Medical Robotics, Inc. ” on November 5, 2015.
The surgeon also has a second large 23-inch 2D touch monitor for system controls and DICOM applications. The surgeon’s fingers grasp extremely precise ergonomic hand controls, with the surgeon’s hands naturally positioned relative to his or her eyes, thereby minimizing strain during the surgeon’s movements.
The surgeon’s fingers grasp extremely precise ergonomic hand controls, with the surgeon’s hands naturally positioned relative to his or her eyes, thereby minimizing strain during the surgeon’s movements.
Following approval by the Indian regulatory body (CDSCO), the systems commercially installed in India have been used to perform more than seven-hundred surgical procedures, including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries. The SSi Mantra Surgical Robotic System has additionally been granted regulatory approval in Guatemala.
Our commercially installed SSi Mantra Surgical Robotic systems in India have been used to perform more than 3,500 surgical procedures, including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries. The SSi Mantra 3 has also been granted regulatory approval in Guatemala, Nepal, Ecuador and Indonesia, although our marketing efforts in those countries have been limited to date.
These include didactic modules training, hands on training, dry runs with the surgeons and their entire team, in-person proctored initial cases, on-site support for additional cases and remote proctoring support for complex cases.
These include didactic modules training, hands on training, dry runs with the surgeons and their entire team, in-person proctored initial cases, on-site support for additional cases and remote proctoring support for complex cases. With respect to sale of surgical robotic systems, training is provided at the time of delivery to the end customer, however the effort involved is considered negligible.
We commenced development of the SSi Mantra in 2014, received regulatory approval for its sale and use in India and commercially launched sales in August 2022.
We commenced development of the SSi Mantra in 2014, received regulatory approval by the Central Drugs Standard Control Organization (“ CDSCO ”) India’s equivalent of the U.S. Food and Drug Administration (“ FDA ”), for its sale and use in India and commercially launched sales in August 2022.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeItem 1A. Risk Factors. As a “ smaller reporting company ,” as defined in Rule 12b-2 under the Securities Exchange Act of 1924, as amended (the “ Exchange Act ”), we are not required to provide the information required by this Item. Item 1B. Unresolved Staff Comments. Not applicable.
Biggest changeItem 1A. Risk Factors. As a “ smaller reporting company ,” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), we are not required to provide the information required by this Item. Item 1B. Unresolved Staff Comments. Not applicable.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur information technology (“ IT ”) team is responsible for these ongoing monitoring and detection activities. The governance of our cybersecurity risks involves active and informed participation from our management team, our IT team and our board of directors.
Biggest changeOur 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.
We have not experienced a cybersecurity incident that had a material impact on our business strategy, results of operations, or financial condition. We continue to monitor potential cybersecurity threats and incorporate findings into our risk management strategies. 19
We 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.
Added
Our information technology (“ IT ”) team is responsible for these ongoing monitoring and detection activities. Our cybersecurity program is primarily overseen by our Head-Server and Network Administrator, who works closely with our information technology team and our senior management to develop and advance our cybersecurity strategy, as well as to respond to cybersecurity incidents.
Added
We have engaged a specialized consulting firm from India to enhance and develop the cybersecurity framework for our products with the aim of protecting sensitive patient data and proprietary device information from cyber threats and ensuring compliance with the latest cybersecurity standards including, HIPPA, FDA regulations, IEC 62443, and NIST guidelines for medical devices.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties. We lease approximately 51,100 square feet in Gurgaon, Delhi NCR, India, which serves as our headquarters as well as our manufacturing facility. The facility, spread over two floors, is leased pursuant to a nine-year lease expiring in March 2030 for one floor and another four-year lease expiring in May 2032 for the other floor.
Biggest changeItem 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.
Removed
Both leases are further renewable under similar terms. Our principal executive offices and manufacturing facility are located at 404-405, 3 rd Floor, iLabs Info Technology Centre, Udyog Vihar, Phase III, Gurugram, Haryana 122016, India.
Added
The facility, spread over three floors, is leased pursuant to a nine-year lease expiring in March 2030 for the third floor, another nine-year lease expiring in May 2032 for the ground floor and another six-year lease expiring in July 2030 for the first floor. All the leases are further renewable under similar mutually agreed terms.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Removed
Item 3. Legal Proceedings. In 2014, Avra Surgical Robotics, Inc., a Delaware corporation (“ Avra Surgical ”), of which Barry F.
Added
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.
Removed
Cohen, our Chief Operating Officer – Americas and a director, was Chief Executive Officer, a director and a principal stockholder, got into a dispute with the law firm of Quinn Emmanuel Urquhart & Sullivan LLP (“ Quinn Emmanuel ”) over legal fees allegedly due Quinn Emmanuel.
Added
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.
Removed
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 the formation of the Company as Avra Medical Robotics, Inc. Other than the facts that both Avra Surgical and our Company shared the Avra name and that Mr.
Added
However, as the plaintiff failed to pay the agreed upon consideration for the shares, in July 2022, the shareholding was cancelled. Dr. Srivastava along with Otto, has recently filed an action in the Bahamas to confirm the cancellation of the shares and reconfirm their ownership and both actions are pending in the Bahamian courts.
Removed
Cohen was an officer, director and principal stockholder 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
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.
Removed
Stamell, an attorney affiliated with Avra Surgical and various individuals who at that time were or had been affiliated with Avra Surgical and or the Company (collectively, “ Respondents ”). The petition sought to recover the legal fees from the Respondents on the basis that they were “alter egos” of Avra Surgical.
Added
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.
Removed
Other than the commonality of the Avra name and Mr. Cohen having been an officer, director and principal stockholder of both companies, there was no relationship between the two companies. As the Company and Mr.
Added
Srivastava 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
Removed
Cohen never received notice of filing of the petition or of subsequent proceedings (although Quinn Emmanuel filed affidavits with the Court stating that they had been duly served), neither the Company nor Mr. Cohen entered an appearance in the matter.
Removed
The Company recently learned from a third party that in November 2020, the Court had rendered a decision holding that the Company and Messrs. Cohen and Stamell were “alter egos” of Avra Surgical and therefore were liable for payment of the Quinn Emmanuel legal fees.
Removed
In addition, the Company also recently learned that in December 2023, the Court ordered the entry of a judgment against Avra Surgical, the Company and Messrs. Cohen and Stamell in the amount of $296,000 plus interest from November 2020. The Company is currently evaluating its legal options with respect to the matter. Notwithstanding the foregoing, Mr.
Removed
Cohen and the Company have entered into an Indemnification Agreement, pursuant to which Mr. Cohen has agreed to fully indemnify the Company for any damages and costs (including legal fees) it incurs in connection with the action. Other than the foregoing, there are no legal proceedings currently pending or threatened against us.
Removed
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. Mine Safety Disclosures. Not applicable. 20 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeAs of the date of this Annual Report, an additional 4,891,213 shares of common stock are available for future issuances under the Incentive Stock Plan. 21 Recent Sales of Unregistered Securities In October 2023, the Company issued 90,514 shares of our common stock upon the exercise of warrants previously sold to two accredited investors at an exercise price of $4.00 per share generating $362,056 in total proceeds.
Biggest changeAs 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.
Item 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 OTCPink 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.
Item 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.
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 2,840,257 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 15,051,246 shares of common stock for these shareholders.
Moreover, until the review of the Form 15c2-11 which has been filed with FINRA on our behalf is completed and cleared (as to which no assurance can be given), our common stock is not eligible for proprietary broker-dealer quotations and may only be bought or sold in unsolicited customer orders. This further limits the trading market for our common stock.
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.
(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 12,181,226 shares (1) $ 3.692 4,891,213 shares (1) Equity compensation plans not approved by security holders 0 shares – 0 shares Total 12,181,226 (1) $ 0 4,891,213 (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 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 ”).
Holders of our Common Stock As of the date of this Annual Report, we had 170,724,381 shares of common stock issued and outstanding and 341 holders of record of our common stock.
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.
As of the date of this Annual Report, 12,181,226 shares of common stock (comprised of 7,880,059 stock options and 4,301,167 stock grants) were issued under the Incentive Stock 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.
Removed
In October 2023, the Company issued 3,000 shares of common stock to a consultant in exchange for advisory services to be rendered over a 12-month period effective June 2023. In October 2023, the Company issued 50,000 shares of common stock to an investor relations firm for investor relations and digital marketing services.
Added
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.
Removed
In November 2023, the Company issued 116,348 shares of common stock to Dr. S.P. Somashekhar, a director, in exchange for advisory services to be rendered over a five-year period. In November 2023, the Company issued a total of 22,541 shares of common stock to five physician consultants, in exchange for advisory services to be rendered over a five-year period.
Added
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.
Removed
In November 2023, the Company issued 75,000 shares of common stock to a firm that conducted online investment seminars in which the Company participated. In December 2023, the Company issued 12,500 shares of common stock upon the exercise of warrants previously sold to three accredited investors at an exercise price of $4.00 per share, generating $50,000 in total proceeds.

Item 7. Management's Discussion & Analysis

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

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Biggest changeCash Flows from Financing Activities During the year ended December 31, 2023, we had net cash provided by financing activities of $16,734,963, comprised of a $4,947,233 increase in restricted cash (i.e., fixed deposits provided to secure bank facilities and for providing guarantees), partially offset by an increase of $2,895,880 in proceeds from our bank overdraft facility, $808,244 from private securities offerings, $12,360 from the exercise of previously issued warrants, $22,980,000 in proceeds from promissory notes converted to common stock, $100,000 in proceeds from the exercise of stock options, as well as the reduction by conversion of promissory notes of $7,000,000.
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.
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. 23 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 Expense.
To date, the Company has mainly relied on debt and equity raised in private offerings to finance its operations. During 2024, 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 2025, the company plans to raise additional capital through further private or public offerings.
Financial Statements and Supplementary Data. See the Index to the Financial Statements beginning on page F-1 below. 26 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.
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.
As such, at the end of December 2023, we had a total of twenty-three installed systems of which 20 were installed during the year ended December 31, 2023. 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.
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.
The Company has recently commenced its commercial operations 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.
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.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 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.
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”.
However, if we are unable to do so and if we experience a shortfall in operating capital, we could be faced with having to limit our expansion plans, research and development and marketing activities. Year ended December 31, 2023, as compared to year ended December 31, 2022 Revenues.
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.
The substantial increase in the stock compensation expense in 2023 is primarily the result of the award 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 2023 under our Incentive Stock Plan, in recognition of their efforts in developing and commercializing our SSi Mantra system.
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.
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 are no assurances that we will be able to secure additional funding.
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.
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. 22 During the years ended December 31, 2023, and December 31, 2022, we sold twelve and three surgical robotic systems, respectively.
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.
Research and Development Expenses. Research and Development expenses during the year ended December 31, 2023, were $576,168, as compared to $83,282 for the year ended December 31, 2022.
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.
General and Administrative Expenses. We incurred $5,164,713 in general and administrative expenses during the year ended December 31, 2023, as compared to $3,251,794 for the year ended December 31, 2022.
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.
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 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.
During the year ended December 31, 2023, the Company had revenues of $5,879,710 (comprising $5,692,721 of system and instrument sales and $186,989 of warranty sales), compared to revenues of $1,458,315 (comprising $1,438,969 of system and instrument sales and $19,346 of warranty sales) during the year ended December 31, 2022.The increase in revenue is primarily due to sale of increased number of surgical robotic systems and instruments in the year ended December 31, 2023 as compared to the year ended December 31, 2022.
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.
We had stock compensation expenses of $13,425,319 and $1,135,468 during the years ended December 31, 2023, and December 31, 2022 respectively.
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.
If we cannot obtain financing, then we may be forced to further curtail our operations or consider other strategic alternatives.
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.
Other Income (Expenses) . We have incurred $273,599 in interest expenses during the year ended December 31,2023 as compared to net interest income of $77,729 during the year ended December 31, 2022. The increase in interest expense from 2022 to 2023 resulted from an increase in bank borrowings for working capital from HDFC Bank in India. Net Loss.
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.
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 of our surgical robotic system and its allied instruments and accessories.
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.
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. 25 Critical Accounting Policies Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States 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 financial statements and the reported amounts of revenues and expenses during the reporting period.
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.
During the year ended December 31, 2022, we had net cash provided by financing activities of $9,294,395, comprised of $145,000 in repayment of promissory notes, $2,583,798 of proceeds from our bank overdraft facility, $1,500,431 in proceeds from private securities offerings, $7,000,000 in proceeds from the issuance of 7% convertible promissory notes, $26,000 in common stock issued and a decrease of $1,670,834 in related party loans.
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.
In addition, during the year ended December 31, 2023, we also installed four systems in four hospitals, belonging to well-known hospital groups in India, for their clinical evaluation in anticipation of orders from these hospital groups. In addition to this, we also installed three systems on a pay-per-use basis.
In addition, during the year ended December 31, 2024, we also installed 11 systems on a pay-per-use basis.
We incurred a net loss of $20,941,972 for the year ended December 31, 2023, as compared to a net loss of $5,601,504 for the year ended December 31, 2022. The increase in net loss from 2022 to 2023 is primarily the result of the increase in stock compensation expenses as set forth above.
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.
The following table provides selected financial data about our Company at December 31, 2023 and December 31, 2022: Balance Sheet Data As of As of December 31, December 31, 2023 2022* Cash $ 2,022,276 $ 1,504,049 Restricted Cash** $ 5,010,725 $ 63,492 Total Assets $ 25,479,086 $ 8,676,204 Total Liabilities $ 11,181,102 $ 11,136,752 Total Shareholders’ Equity $ 14,297,984 $ (2,460,547 ) * Amounts for the year ended December 31, 2022, represent consolidated financials for AVRA Medical Robotics, Inc. and CardioVentures Inc. to reflect the effect of the CardioVentures Merger. ** Represents Fixed Deposits held by bank as security for bank facilities and certain performance guarantees.
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 systems were installed in December 2023 and accordingly had not generated any revenues as of December 31, 2023. We also installed one system at the Johns Hopkins Hospital, in Baltimore, Maryland at no cost, for clinical training and ongoing research and development purposes.
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.
During the year ended December 31, 2022, we had net cash used in investing activities of $2,735,814, resulting mainly from investment of $220,324 in purchases of fixed assets, reduction in Notes Receivable – Acquisition of $3,000,000 and realization of $484,510 from sale of fixed assets.
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.
Salaries and Payroll Expense . We had salary and payroll expense of $2,215,620 for the year ended December 31,2023, as compared to $1,698,283 in the year ended December 31, 2022.
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.
General and administrative expenses include sales, marketing and travel-related expenses, rent for the manufacturing facility offices, legal and other professional expenses related to the Company’s filings as a public company with the SEC. The increase in general and administrative expenses resulted from the increased scale of commercial operations during 2023. as compared to the year ended December 31, 2022.
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.
Removed
Accordingly, the operating results detailed below largely reflect the impact of the consummation of the CardioVentures Merger in April 2023, when compared with operating results for the corresponding period in 2022.
Added
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Removed
This increase in salary and payroll expense is a reflection of the increase in Company’s employee count from 102 at December 31, 2022 to 221 at December 31, 2023, commensurate with the expansion in the Company’s manufacturing and commercial sales operations during 2023 Salaries and payroll expense includes salaries and payroll expense related to executive officers of the Company.
Added
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.
Removed
The net loss for the year ended December 31, 2023, was also higher due to $1,668,146 of system sales revenue that stands to be transferred to unrealized deferred revenue pursuant to the application of ASC606.
Added
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.
Removed
On April 15, 2023, the Company executed a Convertible Promissory Note (the “ Line of Credit Note ”) with Sushruta Pvt Ltd. (“ Sushruta ”), the Bahamian holding company owned by Dr. Sudhir Srivastava, our Chairman, Chief Executive Officer and principal shareholder.
Added
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.
Removed
Pursuant to the Line of Credit Note, Sushruta, in its discretion could make multiple advances to the Company through December 31, 2023 (the “ Maturity Date ”), in an aggregate amount of up to $20 million for working capital purposes.
Added
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.
Removed
The advances under the Line of Credit Note did not bear interest and were due and payable on or before the Maturity Date.
Added
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.
Removed
During the year ended December 31, 2023, Sushruta made advances aggregating to $16,980,000 under the Line of Credit Note and exercised its option to convert the full amount of advances made into shares of our common stock at a conversion price of $0.74 per share.
Added
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.
Removed
Accordingly, 22,945,946 shares of our common stock were issued to Sushruta during the year ended December 31, 2023.
Added
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.
Removed
As of December 31, 2023, the Company had shareholders’ equity of $14.3 million and a working capital surplus of $9.1 million as compared to shareholders’ deficit of $2.46 million and a working capital deficit of $4.42 million as of December 31, 2022. 24 Cash Flows Used in Operating Activities During the year ended December 31, 2023, net cash used in operating activities was $13,572,758 resulting from our net loss of $20,941,972, partially offset by non-cash charges of $ 14,193,327 comprised mainly of depreciation, stock compensation expense and expenses for which common stock issued.
Added
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.
Removed
During the year ended December 31, 2023, we had net cash invested in our operating assets and liabilities of $6,962,654 primarily as a result of increases in prepaid expenses and other current assets to the extent of $9,200,688, including fixed deposits provided to HDFC bank to secure working capital facilities and an increase in accounts payable and accrued expenses of $2,238,034.
Added
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
During the year ended December 31, 2022, net cash used in operating activities was $5,555,345, resulting from our net loss of $5,601,504, partially offset by non-cash charges of $994,369 comprised mainly of depreciation and stock compensation expense.
Added
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
During 2022 we had net cash invested in our operating assets and liabilities of $948,209. primarily as a result of increased prepaid expenses and other current assets.
Added
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”).
Removed
Cash Flows from Investing Activities During the year ended December 31, 2023, we had net cash used in investing activities of $2,299,356, resulting mainly from investment of $563,967 in purchases of equipment, $2,199,418 towards the value of a Right of Use asset, as well as long term loans and advances and long-term receivables of $2,535,971 and receipt of funds through Note receivables – acquisition of $3,000,000.
Added
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.
Removed
We also had an increase in right of use liability (non-current portion) of $1,910,432.
Added
These policies include fair value of stock options and standalone selling price in case of bundled revenue contracts. These accounting policies, estimates and the associated risks are set out below. Future events may not develop exactly as forecasted and estimates routinely require adjustment.
Removed
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern; however, if the efforts noted above are not successful, it would raise substantial doubt about the Company’s ability to continue as a going concern.
Added
Stock Compensation Expense Under the fair value recognition provisions of ASC Topic 718, Compensation-Stock Compensation, cost is measured at the grant date based on the fair value of the award and is amortized on a straight-line basis over the requisite service periods of the awards, which is generally the vesting period.
Removed
Actual results could differ from those estimates. Significant estimates included deferred revenue, costs incurred related to deferred revenue, the useful lives of property and equipment and the useful lives of intangible assets. Income Taxes The Company accounts for income taxes in accordance with ASC 740, Accounting for Income Taxes, as clarified by ASC 740-10, Accounting for Uncertainty in Income Taxes.
Added
Determining the fair value of stock-based awards at the grant date requires significant judgment, including estimating the expected term over which the stock awards will be outstanding before they are exercised and the expected volatility of our stock.
Removed
Under this method, deferred income taxes are determined based on the estimated future tax effects of differences between the financial statement and tax basis of assets and liabilities given the provisions of enacted tax laws. Deferred income tax provisions and benefits are based on changes to the assets or liabilities from year to year.
Added
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.
Removed
In providing for deferred taxes, the Company considers tax regulations of the jurisdictions in which the Company operates, estimates of future taxable income, and available tax planning strategies. If tax regulations, operating results or the ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities may be required.
Added
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.
Removed
Valuation allowances are recorded related to deferred tax assets based on the “more likely than not” criteria of ASC 740. ASC 740-10 requires that the Company recognize the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit.
Added
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.
Removed
For tax positions meeting the “more-likely-than-not” threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority.
Added
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.
Added
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.
Added
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.

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