As filed with the Securities and Exchange Commission on February 2, 2026 Registration No. 333- SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SS INNOVATIONS INTERNATIONAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Florida 3841 47-3478854 (I.R.S. Employer Identification No.) 405, 3 Floor, iLabs Info Technology Centre Udyog Vi ...

Market Growth and Projections - Revenue for 2025 is projected to increase by 158% compared to 2024, with a preliminary estimate of $251 million[5]. - The global surgical robotics market is expected to grow at a CAGR of 14.7%, reaching approximately $27.1 billion by 2030[8]. - The surgical robotics market was valued at $851 million in 2023 and is anticipated to reach nearly $4 billion by 2031[10]. - Estimated unaudited revenue for the twelve months ended December 31, 2025, is projected at $4.3 billion[24]. Company Performance and Financials - The company generated approximately $43.0 million in revenue for 2025, representing a preliminary estimated growth of 251% compared to previous years[22]. - Gross margin improved significantly, with a jump of 2,858 basis points from 12.35% in 2023 to 40.63% in 2025[22]. - Gross profit margin for the nine months ended September 30, 2025, is reported at 48.1%[24]. - Operating income loss for the twelve months ended December 31, 2025, is estimated at $(20.9 million)[24]. - Net income loss for the twelve months ended December 31, 2025, is projected at $(0.14) per diluted share[24]. - Total assets as of September 30, 2025, amount to $21.1 billion[24]. - Current assets reported at $148.4 million as of September 30, 2025[24]. - Total stockholders' equity is noted at $11.7 billion[24]. - Current liabilities include long-term debt, with restricted cash of $6.0 million[24]. - Revenue for the nine months ended September 30, 2025, is reported at $76.1 million[24]. Product Development and Innovation - The company has established a comprehensive suite of surgical instruments supporting various procedures, including robotic cardiac surgery[4]. - The company has developed five new 5-millimeter surgical robotic instruments for clinical use across multiple specialties, including pediatric and cardiac surgery[14]. - The SSi Mantra Tele Surgeon Console enables telesurgery from various locations, with the first successful telesurgery completed in October 2025[17]. - The company aims to enhance its robotics platform through continuous innovation and new product development, targeting underserved markets and established hospitals[23]. Operational Highlights - The SSi Mantra installed base currently spans 10 countries with 168 systems installed and over 7,800 multi-specialty surgeries performed[4]. - SS Innovations has performed over 400 robotic cardiac surgeries and 120 telesurgeries with zero significant safety events reported[4]. - The installed base of the SSi Mantra system increased by 158% year-over-year, with completed procedures rising by 186%[19]. - The company has established a world-class R&D and manufacturing facility in India, with a production capacity of 20 systems per month as of October 31, 2025[18]. Strategic Goals and Market Expansion - The company aims to expand its presence in Europe and the United States while maintaining a strong foundational market in India[4]. - The company plans to expand its global presence, with 91% of revenue currently generated from India, and anticipates significant growth from international markets[20]. - SS Innovations is focused on enhancing access to surgical robotics in underserved regions, addressing the shortage of trained healthcare workers[8]. - The company is pursuing FDA approval for multi-specialty indications, with a 510(k) submission expected in Q4 2025 and market clearance anticipated in H1 2026[21]. Leadership and Ownership - SS Innovations has a strong insider ownership of 76.5%, indicating confidence from its leadership[5]. - The company has a distinguished leadership team with extensive experience in surgical robotics technology[6].

Core Viewpoint - SS Innovations International, Inc. anticipates strong revenue growth driven by increased unit sales of its SSi Mantra surgical robotic system, with significant growth expected in both the fourth quarter and full year of 2025 [1][3]. Financial Performance - For the fourth quarter of 2025, the company expects revenue of approximately $15.0 million, representing an 85% increase from $8.1 million in the fourth quarter of 2024 [7]. - For the full year 2025, the company expects revenue of approximately $43.0 million, which is a 108% increase from $20.6 million in 2024 [7]. - The cumulative installed base of the SSi Mantra reached 168 units as of December 31, 2025, marking a 158% increase from 65 units as of December 31, 2024 [2]. Product Development and Market Expansion - The SSi Mantra surgical robotic system is designed to be cost-effective and user-friendly, with advanced features such as modular robotic arms and a 3D 4K monitor [6]. - The company is committed to expanding its market presence in India, the United States, and Europe, with expectations for FDA review and EU CE marking certification in the first half of 2026 [3].

Core Insights - SS Innovations International, Inc. has appointed Milan Rao as the Global Chief Operating Officer and Chief Financial Officer to enhance global growth and operational scale in affordable robotic surgery [2][3][5] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies aimed at making robotic surgery affordable and accessible to a larger global population [2][9] - The company’s product offerings include the proprietary "SSi Mantra" surgical robotic system and the "SSi Mudra" surgical instruments, which support various robotic surgical procedures, including cardiac surgery [9][10] Leadership Appointment - Milan Rao brings over 30 years of executive leadership experience, particularly in technology-enabled transformation and operational efficiency across various industries, including healthcare [4][6] - Rao will succeed Naveen Kumar Amar as CFO, who resigned for personal reasons, and will work closely with the executive leadership team during the transition [3][5] Strategic Goals - The appointment of Milan Rao reflects the company's commitment to attracting top talent to expand the global footprint of its advanced, cost-effective surgical robotic systems [5][6] - Rao is expected to play a crucial role in defining the company's growth strategy and enhancing operational readiness for long-term value creation [6]

Core Viewpoint - SS Innovations International, Inc. has appointed Milan Rao as the Global Chief Operating Officer and Chief Financial Officer, a newly created position, succeeding Naveen Kumar Amar who resigned for personal reasons [1][2]. Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies aimed at making robotic surgery affordable and accessible globally [5]. - The company's flagship product is the "SSi Mantra" surgical robotic system, which is designed to support various robotic surgical procedures, including cardiac surgery [5][6]. Leadership Appointment - Milan Rao brings over 30 years of executive leadership experience, particularly in technology-enabled transformation and operational efficiency across various industries, including healthcare [2]. - Rao has held significant roles in global companies, including Chief Operating Officer and Chief Revenue Officer at Markets and Markets, and has experience in managing operations, financial statements, M&A activities, and capital allocation strategies [2][3]. Strategic Vision - The appointment of Milan Rao is seen as a commitment to attracting top talent to enhance the executive team and expand the global footprint of the SSi Mantra surgical robotic system [3]. - Rao expressed enthusiasm about contributing to the company's strategic direction and operational readiness, emphasizing the potential for long-term value creation [3]. Product Features - The SSi Mantra system features a modular design with 3 to 5 robotic arms, an ergonomic surgeon command center, and advanced imaging capabilities, including a large 3D 4K monitor [6]. - The system has been clinically validated in India for over 100 different types of surgical procedures, showcasing its versatility and effectiveness [6].

Core Insights - SS Innovations International, Inc. has developed five new 5-millimeter surgical instruments aimed at enhancing robotic surgery across various specialties, including pediatric, cardiac, and head and neck surgery [1][2][3] Company Developments - The new instruments include a spatula cautery, hook cautery, needle driver, bipolar forceps, and grasping forceps, designed for use in critical surgical procedures [2] - The cumulative installed base of the SSi Mantra surgical robotic system reached 168 systems as of December 31, 2025, with 12 systems deployed in nine countries outside of India [3] - Over 7,800 surgical procedures have been performed using the SSi Mantra, including more than 120 telesurgeries and over 400 cardiac procedures [3] Market Opportunity - Approximately 1.7 billion children and adolescents globally lack access to essential surgical care, with over 390 million children under five in lower- and middle-income countries not receiving timely surgical interventions [3] - The development of smaller surgical instruments aims to make robotic surgery more accessible to pediatric patients, addressing a significant gap in the current healthcare landscape [3] Product Features - The SSi Mantra surgical robotic system is characterized by its user-friendly, modular design, featuring 3 to 5 robotic arms, a 3D 4K monitor, and advanced imaging capabilities [6] - The system has been clinically validated in India for over 100 different types of surgical procedures, showcasing its versatility and effectiveness [6] Future Focus - The company plans to continue developing differentiated surgical robotic technologies to benefit a larger segment of patients globally, particularly in underserved populations [3]

Core Viewpoint - SS Innovations has submitted a 510(k) premarket notification to the FDA for its SSi Mantra surgical robotic system, targeting multiple surgical specialties and aiming for U.S. market entry [1][3][5] Company Overview - SS Innovations International, Inc. is focused on developing innovative surgical robotic technologies to make robotic surgery affordable and accessible globally [8] - The company is headquartered in India and plans to expand its global presence with cost-effective surgical robotic solutions [8] Product Details - The SSi Mantra surgical robotic system supports various surgical specialties, including general, urological, colorectal, gynecological, and cardiac procedures [2][3] - The system features a modular design with 3 to 5 robotic arms, an ergonomic surgeon command center, a large 3D 4K monitor, and over 40 types of robotic endo-surgical instruments [10] Regulatory Progress - The 510(k) submission is part of the company's strategic plan to introduce the SSi Mantra system to the U.S. market, with the expectation of a review completion within 90 days, although actual approval may take longer [6] - The company is also pursuing EU CE Mark approval, which it anticipates could be obtained in the first half of 2026 [6] Market Presence - As of November 30, 2025, the SSi Mantra has a cumulative installed base of 138 systems across eight countries, with 137 hospitals utilizing the system and over 7,300 surgical procedures performed [6]

Core Viewpoint - SS Innovations International, Inc. has submitted a 510(k) premarket notification to the FDA for its SSi Mantra surgical robotic system, aiming to enhance accessibility and affordability of robotic surgery in the U.S. market [1][2] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies to make robotic surgery accessible to a broader global population [5] - The company is headquartered in India and aims to expand its global presence with cost-effective surgical robotic solutions [5] Product Details - The SSi Mantra surgical robotic system features a modular design with 3 to 5 robotic arms, an ergonomic command center, and advanced imaging capabilities [6] - It has been clinically validated in India for over 100 different types of surgical procedures [6] Regulatory Progress - The FDA aims to complete reviews of 510(k) submissions within 90 days, although actual approval times may vary [3] - The company is also pursuing CE marking certification in the European Union, expected in the first half of 2026 [3] Market Presence - As of November 30, 2025, the SSi Mantra has a cumulative installed base of 138 systems across eight countries, with 137 hospitals utilizing the system [4] - Over 7,300 surgical procedures have been performed using the SSi Mantra, including 88 telesurgeries and 390 cardiac procedures [4]

Core Insights - The recent market correction has created buying opportunities for investors in high-growth companies that are addressing real-world problems, with many stocks trading at 30-day lows despite strong operational progress [1][2]. Group 1: Symbotic (SYM) - Symbotic develops AI-enabled robotic systems for automating high-volume warehouses, reporting Q3 2025 revenue of $592 million, a 26% year-over-year increase, and adjusted EBITDA rising to $45 million from $3 million [3][5]. - The company has a significant backlog of approximately $22.4 billion, primarily from long-term contracts with Walmart and GreenBox, providing multiyear revenue visibility [5][6]. - Despite a 14% decline in shares over the past 30 days, the company is positioned for growth with a substantial contracted workload ahead [6]. Group 2: AST SpaceMobile (ASTS) - AST SpaceMobile aims to create the first space-based cellular broadband network compatible with standard smartphones, achieving Q3 2025 revenue of $14.7 million, up from $1.1 million a year ago, driven by government contracts [7][9]. - The company has over $1 billion in contracted revenue commitments and has signed agreements with more than 50 mobile network operators, serving nearly 3 billion subscribers [9][10]. - Execution and launch timelines are critical factors, with recent revenue misses contributing to stock volatility, but the current weakness offers a favorable entry point for investors [10]. Group 3: SS Innovations International (SSII) - SS Innovations has installed over 100 SSi Mantra surgical robotic systems and completed over 5,000 procedures, indicating a transition from concept to scale [11][13]. - The company plans to file a 510(k) premarket notification in Q4 2025 for multiple surgical indications, which could expedite FDA clearance [13][14]. - This small-cap stock has shown less volatility compared to others, with only a 5% decline over the past 30 days as investors await regulatory updates [15].

Core Insights - SS Innovations has successfully completed the first telesurgery using its SSi Mantra Tele Surgeon Console (TSC), marking a historic milestone in robotic telesurgery [1][4][5] Group 1: Product Overview - The SSi Mantra Tele Surgeon Console is a compact, self-contained, chair-based system designed for telesurgery, allowing operations from various locations, including physician offices [2][4] - The TSC features 3D visualization, magnetic sensor controls, and a smaller footprint compared to traditional operating room setups, enhancing flexibility for surgical experts [7][9] Group 2: Surgical Achievement - Dr. Sudhir Srivastava performed a robotic-assisted coronary artery bypass surgery remotely from New Delhi on a patient located 185 miles away in Jaipur, demonstrating the TSC's capability to extend surgical expertise globally [3][5] Group 3: Company Vision and Future Plans - SS Innovations aims to make robotic surgery affordable and accessible to a broader global population, with plans to expand its presence and technological offerings [8] - The company has refined the TSC since its initial showcase at the Society of Robotic Surgery Meeting in June 2024, indicating ongoing innovation and development [5]