SS Innovations Targets Europe's CE Mark In Fourth Quarter, FDA Clearance In Early 2027
The surgical robot maker's October deck says its answer to FDA questions is due this month; 87% of 2025 revenue came from India.
SS Innovations International, the surgical robotics company, expects a European CE mark for its SSi Mantra system in the fourth quarter of 2026 and FDA clearance in the first quarter of 2027, according to an investor presentation attached to an 8-K accepted Monday at 8:00 a.m. ET. The US date depends on how the FDA review goes.
What the presentation says
The 8-K was filed under Regulation FD, the rule on sharing information with investors, and the company says the deck is "furnished" rather than "filed." SS Innovations said it intends to use the presentation in communications with shareholders and the investment community.
The company said the FDA sent an additional-information request on April 8, 2026, giving it 180 days to respond. Its response is scheduled for October 2026.
On the numbers, first-half 2026 revenue was $25.0 million, up 66% from $15.1 million a year earlier. Installed SSi Mantra systems reached 224 at June 30, 2026, from 105 a year before, and stood at 244 as of September 28, 2026.
As of September 28, the company counted 14,503 procedures on the system, including 755 robotic cardiac surgeries. It reported no significant safety events. The installed base spans 12 countries.
The catch: one market carries the business
About 87% of 2025 revenue came from India, and the company says it expects the rest-of-world share to expand significantly. For 2025 it reported a net loss of $8.2 million on $42.5 million of revenue, with a gross margin of 46.0%.
The deck describes the company as preparing for a potential strategic entry into Europe and the United States. Current production capacity is 20 systems per month at a facility of roughly 91,000 square feet in Gurugram, India, which the company plans to expand to match growth.
Ownership is concentrated. Chairman and CEO Sudhir Srivastava owns about 108.6 million shares, or roughly 54% of those outstanding, and Vice-Chairman Frederic Moll about 20.8 million, or roughly 10%. The deck puts the market value at about $0.6 billion, with a $2.75 price on October 1.
What to watch
Two items: the FDA response due in October, and whether the CE mark arrives in the fourth quarter as anticipated. The stock closed at $2.67 on Friday, down about 3%, before the filing was accepted (market data).
The company's own forward-looking caveat applies to both dates: actual results may differ materially from its expectations.
