SS Innovations International, Inc. is making strides toward U.S. FDA approval for its SSi Mantra Surgical Robotic System. The company aims to introduce a cost-effective alternative in the robotic surgery market, enhancing accessibility for a broader patient population. Following an interactive pre-submission meeting with the FDA, SS Innovations is refining its regulatory strategy and clinical trial plans to meet U.S. requirements.
FDA Engagement and Regulatory Pathway
Earlier this year, SS Innovations engaged with the FDA to discuss the SSi Mantra's regulatory pathway. The feedback received covered key areas such as biocompatibility assessment, reprocessing validation, and clinical data requirements. Based on this guidance, the company will pursue a de novo pathway for pre-market submission, targeting multiple indications simultaneously.
SS Innovations plans to hold further pre-submission meetings with the FDA in the coming months. The company anticipates submitting an Investigational Device Exemption (IDE) application in the first quarter of 2025 to initiate clinical trials in the United States.
Clinical Trial Strategy
The company is planning concurrent clinical trials for a range of surgical applications, including abdominal, pelvic, thoracic, and cardiac procedures. SS Innovations believes it can efficiently meet clinical trial requirements due to the SSi Mantra's established safety and efficacy in India, where it has been used in various surgical procedures. Data from these ongoing clinical uses in India can be included in the FDA clinical trials, and the company also intends to conduct trials within the United States, particularly for cardiac applications, where potential testing sites have already been identified.
Anticipated Approval Timeline
SS Innovations estimates that, assuming no unforeseen delays, it could secure pre-market approvals by the end of 2025. This timeline reflects the company's proactive engagement with the FDA and its strategy to leverage existing clinical data while initiating new trials in the U.S.
SSi Mantra: Features and Applications
The SSi Mantra Surgical Robotic System is designed to support a wide array of surgical specialties, including cardiothoracic, head and neck, gynecology, urology, and general surgery. Its features include a modular arm configuration, 3D 4K vision, an open-console design, and enhanced ergonomics, all intended to improve surgical precision and efficiency. The system has already received regulatory approval in India (CDSCO) and has been clinically validated in over 80 different types of surgical procedures.
