Core Insights - The company has successfully performed over 150 cumulative telesurgeries using the SSi Mantra surgical robotic system, with recent approvals for telesurgeries in Indonesia and the Philippines [1][4] - The SSi Mantra system is designed to make robotic surgery more affordable and accessible globally, showcasing advanced capabilities in telesurgery [4][6] Company Developments - SS Innovations International, Inc. has achieved a significant milestone by surpassing 150 telesurgeries, primarily conducted in India [1][4] - The company is hosting the Global Multi-Specialty Robotic Surgery Conference 2026 in New Delhi, where over 20 live telesurgeries will be performed using the SSi Mantra [5] Technological Advancements - The SSi Mantra surgical robotic system features a modular design with 3 to 5 robotic arms, a 3D 4K monitor, and the ability to utilize over 40 different types of robotic endo-surgical instruments [7] - Recent telesurgeries included 18 procedures performed in an eight-hour period, demonstrating the system's efficiency and capability [2][3] Market Expansion - The approval for telesurgeries in Indonesia and the Philippines marks a significant step in the company's efforts to expand its market presence [1][4] - The company aims to drive equitable access to quality healthcare through its innovative surgical technologies [4][6]

Core Insights - SS Innovations International, Inc. reported strong growth in SSi Mantra installations, procedures, and revenues for the fourth quarter and full year of 2025, highlighting significant market share gains in India and expansion into new global markets [4][5][6]. Financial Performance - Fourth quarter revenue increased by 79.1% to $14.5 million from $8.1 million in Q4 2024, with gross profit rising 60.7% to $6.4 million [5][7]. - For the full year 2025, total revenue reached $42.5 million, a 105.7% increase from $20.6 million in 2024, with gross profit up 131.2% to $19.5 million [5][9]. - The company reported a net loss of $2.5 million in Q4 2025, compared to a net loss of $1.9 million in Q4 2024, and a full-year net loss of $12.1 million, an improvement from a net loss of $19.2 million in 2024 [5][9]. Operational Highlights - SSi Mantra installations totaled 40 in Q4 2025, an increase of 81.8% from 22 installations in Q4 2024, and 103 installations for the full year, up 119.1% from 47 in 2024 [5][9]. - Cumulative surgeries reached 7,885, including 120 telesurgeries, with significant growth in various surgical procedures [5][9]. Strategic Initiatives - The company completed a private placement of common stock, generating approximately $18.6 million in gross proceeds to support growth initiatives [4][10]. - SS Innovations is progressing towards FDA approval for the SSi Mantra surgical robotic system and aims to obtain CE marking certification in the EU within the year [4][10]. Market Positioning - The company has gained significant share in the surgical robotics market in India and is preparing for entry into the U.S. and EU markets, enhancing its global presence [4][10]. - The SSi Mantra system is designed to be user-friendly and cost-effective, with advanced technology features aimed at making robotic surgery more accessible [12][11].

Surgical Robotics System - The SSi Mantra Surgical Robotic System has been installed in 168 systems globally, with 154 in India and 14 overseas, including 21 on a pay-per-use basis[24]. - More than 7,800 surgical procedures have been performed using the SSi Mantra, with general surgery accounting for 43.2% (3,409 procedures) and urology for 25.4% (2,004 procedures)[25]. - The SSi Mantra has received regulatory approval in multiple countries, including India, Colombia, Ecuador, and the UAE, and is expected to receive EU and U.S. regulatory approvals in 2026[28][30]. - The SSi Mantra has been clinically validated for safety and efficacy across more than 100 different surgical procedures without device-related adverse events[25]. - The company is the first surgical robotic firm to receive regulatory approval for both tele proctoring and telesurgery, successfully performing over 120 telesurgeries at distances up to 9,600 kilometers (6,000 miles) using the SSi Mantra system[50]. - In March 2025, the company achieved a milestone by performing robotic cardiac telesurgery over a distance of 2,000 kilometers (1,250 miles) and later completed the world's first inter-continental robotic cardiac telesurgery from Strasbourg, France to Indore, India, covering over 4,000 miles (2,500 kilometers)[50]. - The SSi Mantra system is expected to be classified as a Class II medical device by the FDA, with a 510(k) premarket notification submitted on December 5, 2025[158]. - The company has received regulatory approval to market its systems in 10 countries, including Colombia and the UAE, and aims to expand to over 50 countries within approximately one year[183]. Product Development and Innovation - The SSi Mantra 3 includes telesurgery and tele-proctoring capabilities, with over 120 telesurgeries performed as of December 31, 2025[27]. - The company has developed five new 5-millimeter surgical instruments for clinical use across multiple specialties, enhancing its product offerings[48]. - The company is developing several advanced surgical instruments, including the NADI automated coronary anastomotic connector and the SSi Multi-Fire Clip Applier, aimed at improving efficiency and reducing time during surgical procedures[51][52]. - The SSi Robotic Stapler is nearing completion, which will make the company the second globally to offer a robotic stapler compatible with its surgical platform[53]. - The SSi Maya digital platform enhances surgical capabilities with Mixed Reality (XR) and AI technologies, including tools for patient education and surgical guidance[54]. Market Growth and Trends - India's healthcare industry is projected to grow from $638 billion in 2025 to $1.5 trillion by 2030, driven by demographic shifts and increasing demand for advanced healthcare solutions[73]. - Over 30 million surgeries are performed annually in India, with robotic surgery adoption rapidly increasing, currently estimated at over 10,000 robotic-assisted procedures in 2024[74][75]. - The Indian medical tourism market is projected to grow from approximately $12.32 billion in 2026 to $22.1 billion by 2031, at a CAGR of 12.42%[79]. - The global surgical robotics market is expected to reach $27.14 billion by 2030, growing from $11.98 billion in 2024, at a CAGR of 14.7%[103]. - The surgical robotics market is fueled by the rise in chronic diseases and the increasing number of surgeries performed globally[108]. - The demand for minimally invasive procedures is driving the growth of the surgical robotics market, with patients seeking less pain and shorter recovery times[105]. - The accessories and services segment dominated the surgical robotics market in 2022 and is projected to maintain its dominance throughout the forecast period, driven by a rise in surgical procedures[112]. - The general surgery segment held the largest market share in 2023, attributed to the effectiveness of robotic systems in various procedures and the demand for minimally invasive surgeries[113]. - North America accounted for a major share of the surgical robotics market in 2024, supported by established healthcare infrastructure and high adoption rates of advanced technologies[114]. - Asia-Pacific is anticipated to experience the highest growth rate in the surgical robotics market, driven by increasing chronic disease prevalence and acceptance of minimally invasive procedures[115]. Regulatory Compliance and Quality Management - The company has developed a Harmonized ISO 13485 QMS system for compliance with U.S. and EU quality management requirements, receiving certification in 2021[147]. - The company must comply with extensive safety and quality system regulations in various countries, including those in the Medical Device Single Audit Program[180]. - The company is subject to numerous data privacy and security laws, including the GDPR if marketing in the EU, which imposes comprehensive compliance obligations[187]. - The company has established cybersecurity policies that include continuous monitoring, encryption of critical data, and regular testing of disaster recovery plans[189]. - Compliance with the Quality System Regulation (QSR) is necessary for the company to continue marketing cleared or approved products in the U.S.[165]. Financial Overview and Corporate Governance - The company completed a private placement generating gross proceeds of $18,621,498 for working capital and growth initiatives[33]. - The company commenced commercial sales of its surgical robotic system "SSi Mantra" in the second half of 2022, marking 2023 as its first full year of commercial sales[221]. - The company has not paid any dividends since inception and does not intend to pay cash dividends in the foreseeable future[215]. - The company has entered into an indemnification agreement with its Chief Executive Officer to cover any damages related to ongoing legal proceedings[208]. - The company is currently involved in litigation regarding share ownership in its Bahamian subsidiary, with a favorable outcome anticipated based on legal opinions[208]. - As of the date of the report, the company had 194,356,696 shares of common stock issued and outstanding, with 303 holders of record[214].

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]