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. These approvals mark a significant expansion of the company's global footprint and its commitment to democratizing access to robotic surgery in underserved regions.
The Colombian approval was granted by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in November 2025. In Oman, the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) approved the system in November 2025. The National Medicines Regulatory Authority (NMRA) in Sri Lanka and the Pharmacy and Poisons Board (PPB) in Kenya both granted approval in January 2026. These approvals allow the company to market the SSi Mantra for multiple indications in these countries.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, emphasized the strategic importance of these approvals: '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. Over the past few months, our advanced, cost-efficient SSi Mantra surgical robotic system has received regulatory approval in Colombia, Oman, Sri Lanka, and Kenya.'
The SSi Mantra is designed to be user-friendly and cost-effective, featuring a modular multi-arm system with advanced technology including 3D 4K visualization, virtual real-time imaging, and telesurgery capability via the optional SSi MantrAsana Tele Surgeon Console. The system supports over 40 different robotic endo-surgical instruments and has been clinically validated in India in more than 100 types of surgical procedures.
With these additions, the SSi Mantra has now received regulatory approval 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 cumulative installed base totaled 168 systems across ten countries, and cumulative surgeries reached 7,885, including 390 cardiac procedures and 121 pediatric surgeries. Additionally, more than 150 telesurgeries have been performed with the system.
The company believes its cost advantages, combined with advanced features and ease of training, position it favorably to address underpenetrated markets. Looking ahead, SS Innovations anticipates that the U.S. Food and Drug Administration will complete its review of the 510(k) premarket notification for the SSi Mantra by mid-2026, and it continues to pursue European Union CE marking certification, which it believes can be obtained in 2026.
