SS Innovations International, Inc. (Nasdaq: SSII) announced today that it has obtained regulatory approval for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya, marking a significant expansion of the company's global footprint. The approvals from INVIMA in Colombia, DGPA&DC in Oman, NMRA in Sri Lanka, and the Pharmacy and Poisons Board in Kenya were granted in November 2025 and January 2026, respectively. These clearances position the company to address underpenetrated markets where the SSi Mantra's cost advantages, advanced technology, and user-friendly design are expected to drive adoption.
The SSi Mantra has now been approved in eleven countries, including India, Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the United Arab Emirates. As of December 31, 2025, the system had an installed base of 168 units across ten countries and had been used in 7,885 cumulative surgeries, including 390 cardiac procedures and 121 pediatric surgeries. Additionally, over 150 telesurgeries have been performed using the SSi Mantra, highlighting its telesurgery capabilities enabled by the optional SSi MantrAsana Tele Surgeon Console.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, emphasized the company's commitment to democratizing access to robotic surgery. "We continue to expand SS Innovations' global opportunity with an eye on democratizing access to cutting-edge robotic surgery for patients in underserved regions of the world," he said. "We are committed to decentralizing excellence in surgical robotic care in these new jurisdictions, among others, while pursuing the established United States and Europe Union markets." The company anticipates that the U.S. Food and Drug Administration will complete its review of the SSi Mantra's 510(k) premarket notification by mid-2026, and it expects to obtain a European Union CE marking certification in 2026.
The SSi Mantra is a modular, multi-arm robotic system featuring 3 to 5 arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and over 40 types of robotic endo-surgical instruments. It supports various specialties, including cardiac surgery, and offers 5mm instruments for pediatric and ENT procedures. The system has been clinically validated in India in more than 100 different types of surgical procedures. For more information, visit the company's website at ssinnovations.com or follow on LinkedIn.
This expansion into new markets underscores SS Innovations' strategy to make robotic surgery affordable and accessible globally. With regulatory approvals in hand and a growing installed base, the company is well-positioned to capture demand in regions where cost-effective surgical solutions are urgently needed. The implications are significant: patients in Colombia, Oman, Sri Lanka, and Kenya may soon have access to advanced robotic-assisted procedures that were previously unavailable or prohibitively expensive. As the company continues to pursue approvals in major markets like the US and EU, its impact on global surgical care could be transformative.
