SS Innovations International, Inc. (SSII) announced that its SSi Mantra surgical robotic system has received regulatory approval in four new markets—Colombia, Oman, Sri Lanka and Kenya—through the respective national authorities: INVIMA in Colombia, DGPA&DC in Oman, NMRA in Sri Lanka and PPB in Kenya. The approvals were granted between November 2025 and January 2026, with Colombia and Oman receiving clearance in November and Sri Lanka and Kenya in January.
The new clearances bring SSII’s total addressable market to eleven countries, expanding its footprint beyond the existing ten‑country base. As of December 31 2025, the company had 168 SSi Mantra units installed across ten countries and had performed 7,885 cumulative surgeries. The addition of Colombia, Oman, Sri Lanka and Kenya is expected to accelerate the growth of both the installed base and surgical volume, reinforcing the company’s strategy of delivering low‑cost robotic solutions in emerging markets.
SSII’s 2025 financial results underscore the momentum behind the expansion. Revenue rose 105.7% to $42.5 million from $20.6 million in 2024, while the gross margin improved to 46.0% from 40.9%. The company’s net loss narrowed to $12.1 million, a significant improvement from the $19.2 million loss in 2024. The low‑cost positioning of the SSi Mantra—roughly 25% of the price of Intuitive Surgical’s da Vinci system in India—has driven strong demand and helped the company achieve a high utilization rate across its existing installations.
SSII is also advancing its U.S. and European regulatory agenda. A 510(k) pre‑market notification was submitted to the FDA in December 2025, with the agency expected to complete its review by mid‑2026. The company anticipates obtaining CE marking in 2026, positioning it to enter the major Western markets within the next 12–18 months.
Dr. Sudhir Srivastava, Chairman and CEO, said, “We anticipate that the U.S. Food and Drug Administration will complete its review of our 510(k) pre‑market notification for the SSi Mantra by mid‑2026.” He added that the company’s “cost‑efficient” platform is “highly compelling” for hospitals and surgeons in the United States, especially those serving underserved patient communities.
The regulatory approvals in Colombia, Oman, Sri Lanka and Kenya strengthen SSII’s competitive position against dominant players such as Intuitive Surgical. By expanding into price‑sensitive emerging markets, the company is poised to capture a larger share of the global surgical robotics market, while its improving financials and ongoing regulatory progress signal a clear path toward broader adoption and revenue growth.
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