- SS Innovations International, Inc. (SSII) successfully completed a **human factors validation study** for its SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025.  **[1676163_0001213900-25-095851_ea026018501ex99-1_ssinnova.htm:0]** **[1676163_0001213900-25-095851_ea0260185-8k_ssinnova.htm:1]** 
- The company anticipates submitting a **510(k) premarket notification to the FDA in the fourth quarter of 2025** for the SSi Mantra.  **[1676163_0001213900-25-095851_ea026018501ex99-1_ssinnova.htm:0]** **[1676163_0001213900-25-095851_ea0260185-8k_ssinnova.htm:1]** 
- Potential FDA clearance for the SSi Mantra in the U.S. is expected in the **first half of 2026**, based on standard review timelines.  **[1676163_0001213900-25-095851_ea026018501ex99-1_ssinnova.htm:0]** 
- As of September 30, 2025, the SSi Mantra had a cumulative installed base of **125 systems** across six countries, with over **6,000 surgical procedures** performed.  **[1676163_0001213900-25-095851_ea026018501ex99-1_ssinnova.htm:0]**

SS Innovations International, Inc. Provides U.S. Regulatory Update for SSi Mantra Surgical Robotic System

- **SS Innovations International, Inc. (SSII)** announced the successful completion of the **world's first pediatric pyeloplasty telesurgery** utilizing its **SSi Mantra surgical robotic system** on **September 16, 2025**.  **[1676163_0001213900-25-087939_ea025749301ex99-1_ssinnov.htm:0]** **[1676163_0001213900-25-087939_ea0257493-8k_ssinnov.htm:1]** 
- The procedure was performed remotely by Dr. Chandra Mohan Vaddi from Gurugram, India, on a 16-month-old patient located nearly **1,000 miles away** in Hyderabad, India.  **[1676163_0001213900-25-087939_ea025749301ex99-1_ssinnov.htm:0]** 
- This milestone highlights the SSi Mantra's advanced capabilities in robotic telesurgery, with the system having been used for over **50 telesurgeries** across various specialties at distances up to **4,000 miles**.  **[1676163_0001213900-25-087939_ea025749301ex99-1_ssinnov.htm:0]** 
- The company plans to further expand the SSi Mantra's capabilities in pediatric robotic surgery through the development of smaller instrumentation, aiming to make robotic surgery affordable and accessible globally.  **[1676163_0001213900-25-087939_ea025749301ex99-1_ssinnov.htm:0]**

SS Innovations International (SSII)