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, broadening the company's global footprint and advancing its mission to make robotic surgery affordable and accessible. The approvals were granted by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia and the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) in Oman in November 2025, and by the National Medicines Regulatory Authority (NMRA) in Sri Lanka and the Pharmacy and Poisons Board (PPB) in Kenya in January 2026.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, emphasized the significance of these milestones: '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. We are committed to decentralizing excellence in surgical robotic care in these new jurisdictions, among others.'
The SSi Mantra is designed to address underpenetrated markets through its cost advantages, advanced technology, and ease of training. With these additions, the system has now been approved in eleven countries, including India, Ecuador, Guatemala, Indonesia, the Philippines, Ukraine, the United Arab Emirates, and others. As of December 31, 2025, the cumulative installed base of SSi Mantra systems totaled 168 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 using the system.
Looking ahead, SS Innovations anticipates that the U.S. Food and Drug Administration will complete its review of the company's 510(k) premarket notification for the SSi Mantra by mid-2026. Separately, the company continues along the pathway toward European Union CE marking certification, which it believes it can obtain in 2026.
SS Innovations, an American company headquartered in India, plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. For more information, visit the company's website at ssinnovations.com or their LinkedIn page. The latest news and updates relating to $SSII are available in the company's newsroom at https://tinyurl.com/ssiinewsroom.
