SS Innovations International, Inc. (Nasdaq: SSII), a developer of surgical robotic technologies, announced today that it has received regulatory approval for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya. The approvals were granted by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia in November 2025, the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) in Oman in November 2025, the National Medicines Regulatory Authority (NMRA) in Sri Lanka in January 2026, and the Pharmacy and Poisons Board (PPB) in Kenya in January 2026.
These approvals mark a significant expansion of the company's global footprint, bringing the total number of countries where the SSi Mantra is approved to 11, including India, Ecuador, Guatemala, Indonesia, the Philippines, Ukraine, the United Arab Emirates, and the newly added nations. The SSi Mantra system is designed to address underserved markets by offering cost advantages, advanced technology, and ease of training. As of December 31, 2025, the SSi Mantra had a cumulative installed base of 168 systems across ten countries, with cumulative surgeries reaching 7,885, including 390 cardiac procedures and 121 pediatric surgeries.
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. He noted that the company is also pursuing regulatory approval in the United States and the European Union, with expectations that the U.S. Food and Drug Administration will complete its review of the 510(k) premarket notification by mid-2026, and that CE marking certification in the EU could be obtained in 2026.
The SSi Mantra system is distinguished by its modular design, with 3 to 5 robotic arms, an open-faced ergonomic surgeon command center, and a large 3D 4K monitor. It supports over 40 types of robotic endo-surgical instruments, including 5mm instruments for pediatric and ENT surgeries. The system has been clinically validated in India in more than 100 different types of surgical procedures. Additionally, more than 150 telesurgeries have been performed with the SSi Mantra to date, showcasing its tele-surgery capabilities through the optional SSi MantrAsana Tele Surgeon Console.
SS Innovations believes these regulatory approvals position the company favorably to address underpenetrated markets where robotic surgery has been historically limited due to high costs. The company's strategy focuses on decentralizing excellence in surgical robotic care by providing affordable and accessible technology to a broader global population. For more information, visit the company's website at ssinnovations.com or follow updates on LinkedIn.
