SS Innovations International Files Its Response To Request Additional Information Letter With FDA For Its Submission Of SSi Mantra Surgical Robotic System

SS Innovations International, Inc. (the "Company" or "SS Innovations") (NASDAQ:SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that, on October 5, 2026, the Company submitted its response to a request for additional information letter (the "AINN") received from the United States Food and Drug Administration (the "FDA") with regard to the Company’s 510(k) submission for its SSi Mantra surgical robotic system (the "SSi Mantra"). 

The Company’s response to the AINN includes final data from an expanded human clinical and human factors validation study (the "Study") for the SSi Mantra.  The completion of the Study was designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for safety, efficacy and feasibility, and is an important part of the Company’s 510(k) premarket notification.