Dive Brief:
- SS Innovations International expects to secure U.S. pre-market authorization for its surgical robotic system by the end of 2025, based on feedback from a pre-submission meeting with the Food and Drug Administration.
- The company intends to pursue numerous indications simultaneously for the SSi Mantra robot, using the FDA’s de novo pathway, SS Innovations said in a Wednesday statement.
- The progress update comes as the company works with a new accounting firm, BDO India, to restate certain financial statements after the U.S. Securities and Exchange Commission barred its former accounting firm, BF Borgers, from practicing.
Dive Insight:
SS Innovations has focused its strategy on expanding access to surgical robotic technologies in underserved regions of the world and positions SSi Mantra as an affordable system.
In a September securities filing, the company said it had sold more than 30 systems and installed five other systems on a pay-per-use or revenue share basis as of June 30. The company’s surgical robot has received regulatory approvals in India, Indonesia, Nepal, Guatemala and Ecuador.
Earlier this month, the company announced that Frederic Moll, a co-founder of Intuitive Surgical, would join its board as vice chairman.
As it sets its sights on the U.S. market, SS Innovations said it believes it can meet the FDA’s clinical trial requirements “relatively quickly” because the robotic system’s safety and efficacy have been demonstrated in ongoing clinical use in India. It also intends to conduct some clinical trials in the U.S., particularly for cardiac procedures.
The company plans simultaneous trials for indications that include abdominal, pelvic, thoracic and cardiac.
