SS Innovations International, Inc. (Nasdaq: SSII) announced today that its SSi Mantra surgical robotic system has received regulatory approval in Colombia, Oman, Sri Lanka, and Kenya, marking a significant expansion of the company's global footprint. The approvals were granted by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia, the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) in Oman, the National Medicines Regulatory Authority (NMRA) in Sri Lanka, and the Pharmacy and Poisons Board (PPB) in Kenya, with Colombia and Oman approvals in November 2025 and Sri Lanka and Kenya in January 2026.
These new markets are characterized by underpenetrated access to robotic surgery, and SS Innovations believes the SSi Mantra's cost advantages, advanced technology, and ease of training position it favorably to address these needs. The SSi Mantra is a modular, multi-arm system with features including 3D 4K visualization, a virtual real-time image of robotic arms, and optional telesurgery capability via the SSi MantrAsana Tele Surgeon Console. As of December 31, 2025, the system had an installed base of 168 units across ten countries, with cumulative surgeries reaching 7,885, including 390 cardiac and 121 pediatric procedures. More than 150 telesurgeries have been performed to date.
Dr. Sudhir Srivastava, Chairman and CEO, stated, "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 also noted that the company anticipates U.S. FDA review of its 510(k) submission by mid-2026 and expects European Union CE marking in 2026. The SSi Mantra is now approved in eleven countries, including India, Ecuador, Guatemala, Indonesia, Philippines, Ukraine, and the United Arab Emirates.
The company's strategy focuses on making robotic surgery affordable and accessible globally. For more information, visit the company's website at ssinnovations.com or its LinkedIn page. The latest news and updates are available in the company's newsroom at https://tinyurl.com/ssiinewsroom.
