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Company successfully completed a human factors validation study at Johns Hopkins Hospital Anticipates submitting a 510(k) premarket notification to the FDA in the fourth quarter of 2025 FORT LAUDERDALE, Fla., Oct. 02, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company success ...

Core Viewpoint - SS Innovations International, Inc. has appointed Naveen Kumar Amar as the new Chief Financial Officer, effective September 24, 2025, succeeding Dr. Vishwa Srivastava, who will continue as CEO for Asia Pacific [1][2][3]. 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 product offerings include the proprietary "SSi Mantra" surgical robotic system and the "SSi Mudra" surgical instruments, which support various surgical procedures, including robotic cardiac surgery [5]. Leadership Appointment - Naveen Kumar Amar brings over 25 years of global finance leadership experience across various industries and geographies, with expertise in financial accounting, reporting, planning, analysis, and corporate finance [2][3]. - Amar has previously held significant positions, including Global CFO for Munch Ado India Private Ltd. and Head of Finance & Commercial for SpiceXpress [2][3]. Strategic Vision - The company aims to expand the global presence of its advanced, cost-efficient surgical robotic systems, particularly the SSi Mantra [3]. - Amar expressed his commitment to democratizing access to advanced surgical robotic care and driving growth to deliver sustainable long-term shareholder value [3]. Product Details - The SSi Mantra surgical robotic system features a modular design with 3 to 5 robotic arms, an ergonomic surgeon command center, and advanced imaging capabilities [6]. - It has been clinically validated in India for over 100 different types of surgical procedures, showcasing its versatility and effectiveness [6].

Core Viewpoint - Stereotaxis will release its financial results for the second quarter of 2025 on August 7, 2025, and will host a conference call to discuss these results and corporate developments [1][2]. Company Overview - Stereotaxis is a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, focusing on the discovery, development, and delivery of robotic systems and solutions for interventional laboratories [4]. - The company's technology has been utilized to treat over 150,000 patients globally, enhancing patient care with robotic precision and safety [4]. Conference Call Details - The conference call will take place on August 7, 2025, at 4:30 p.m. ET, with dial-in numbers provided for both U.S. and international participants [2]. - A replay of the call will be available for one month following the event [3].

Core Insights - Stereotaxis reported a 9% increase in revenue for Q1 2025, totaling $7.5 million compared to $6.9 million in Q1 2024, driven by a 29% growth in recurring revenue [3][8] - The company is focused on advancing its innovation strategy, with key commercial advances including the initial commercialization of MAGiC in Europe and successful demonstrations of the GenesisX robot [2][8] - Stereotaxis expects double-digit revenue growth for the full year 2025, with system revenue projected at $2-3 million per quarter and recurring revenue scaling to $7 million in Q4 2025 [8][9] Financial Performance - System revenue for Q1 2025 was $2.0 million, down from $2.6 million in Q1 2024, while recurring revenue reached $5.5 million, up from $4.3 million [3][13] - Gross margin for Q1 2025 was 54%, with recurring revenue gross margin at 68% and system gross margin at 15% [4][14] - Operating loss for Q1 2025 was ($5.9) million, compared to ($4.7) million in Q1 2024, with adjusted operating loss at ($2.7) million [6][14] Cash and Liquidity - As of March 31, 2025, Stereotaxis had cash and cash equivalents of $10.7 million and no debt [7][15] - The company anticipates reduced cash use in 2025 compared to 2024, supported by growing recurring revenue and stable operating expenses [9] Regulatory and Market Outlook - Stereotaxis is advancing multiple regulatory efforts with six active reviews and plans for additional submissions, aiming for significant adoption of GenesisX pending regulatory approval in the U.S. [2][8] - The company expects substantial growth in 2026, supported by anticipated regulatory milestones and initial commercial launches in 2025 [8]

Core Insights - SS Innovations International, Inc. plans to submit a De Novo Classification Request to the FDA for the SSi Mantra 3 surgical robotic system in July 2025, aiming to enhance market access in the U.S. [1][2] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies to make robotic surgery affordable and accessible globally [6]. - The company has already marketed its SSi Mantra surgical robotic system in six countries and is pursuing further global expansion [5]. Product Performance - Since the launch of the SSi Mantra system in August 2022, 80 systems have been installed in 75 hospitals, with over 3,800 surgeries performed, including more than 200 robotic cardiac surgeries [3]. - The SSi Mantra 3 version, launched in June 2024, has seen 37 installations and over 750 multispecialty robotic surgical procedures, including 70 cardiac cases, with no device-related mortality or complications reported [3][4]. Clinical Validation - Real-world clinical data, validated by a leading contract research organization, supports the safety and efficacy of the SSi Mantra 3 for a variety of surgical procedures [4]. - The planned FDA submission will include applications for multispecialty indications such as urology, gynecology, general surgery, and thoracic and cardiac surgery [4]. Technological Features - The SSi Mantra Surgical Robotic 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 [7]. - It utilizes over 40 different types of robotic endo-surgical instruments to support various specialties, including cardiac surgery [7].

Core Viewpoint - SS Innovations International, Inc. is focused on making robotic surgery affordable and accessible globally, and it has reiterated its guidance for the first quarter of 2025, indicating a positive growth trajectory following its uplisting to Nasdaq [1][2]. Company Updates - The company anticipates reporting its first quarter 2025 financial results around May 15, 2025 [2]. - As of March 31, 2025, a total of 78 SSi Mantra surgical robotic systems have been installed, with 14 systems installed during the first quarter of 2025 [6]. - Revenue for the first quarter of 2025 is expected to be approximately $6.4 million, with a gross margin of around 45% based on preliminary unaudited results [6]. - By April 30, 2025, 80 SSi Mantra robotic surgical systems were installed in 75 hospitals, and over 3,800 surgeries have utilized the SSi Mantra, including more than 200 robotic cardiac surgeries [6]. - In April 2025, the company received 9 orders for the SSi Mantra robotic surgical system, representing a 200% increase from 3 orders in April 2024 [6]. Product Information - The SSi Mantra Surgical Robotic System features a modular design with 3 to 5 robotic arms, an ergonomic surgeon command center, a large 3D 4K monitor, and a virtual real-time image display [4]. - The system supports various surgical specialties, including cardiac surgery, and has been clinically validated in over 100 different types of surgical procedures in India [4].

Core Viewpoint - SS Innovations International, Inc. has received approval for its common stock to be listed on The Nasdaq Capital Market, with trading expected to commence on April 25, 2025, under the ticker symbol "SSII" [1][2] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies aimed at making robotic surgery affordable and accessible globally [4] - The company is headquartered in India and plans to expand its global presence with advanced, user-friendly, and cost-effective surgical robotic solutions [4] Product Information - The SSi Mantra Surgical Robotic System is a modular, multi-arm system featuring advanced technology such as 3 to 5 robotic arms, a 3D 4K monitor, and over 40 types of robotic endo-surgical instruments [5] - The SSi Mantra has been clinically validated in over 100 different types of surgical procedures in India [5] Recent Achievements - The company has installed 80 SSi Mantra systems in 75 hospitals across India and other countries, performing over 3,500 surgeries, including 195 robotic cardiac surgeries with no reported device-related complications [7] - SS Innovations is the first company in India to receive regulatory approval for telesurgery and tele-proctoring procedures, having conducted 16 telesurgeries, including the world's first robotic cardiac telesurgeries over distances up to 1,200 miles [7] - For the year ended December 31, 2024, the company reported revenue of $20.6 million, a 251% increase from $5.9 million in 2023, with a gross margin of 40.9%, up from 12.3% in 2023 [7][8] Strategic Expansion - The uplisting to Nasdaq coincides with the company's global expansion plans into countries such as Nepal, Ecuador, Guatemala, the Philippines, Indonesia, Sri Lanka, and Ukraine, as well as strategic entry into Europe and the United States [3] - The company is pursuing EU CE Mark and U.S. FDA approval for the SSi Mantra surgical robotic system, anticipated in late 2025 and early 2026, respectively [3]