SS Innovations International is progressing towards securing pre-market authorization in the U.S. for its surgical robotic system, the SSi Mantra, by the end of 2025. This optimistic projection follows a pre-submission meeting with the Food and Drug Administration (FDA), as stated by the company in a recent announcement. Planning to use the FDA’s de novo regulatory pathway, SS Innovations aims to receive approval for multiple indications at once for their robotic system.
The announcement also covered the company’s change in accounting firms, with BDO India stepping in to restate certain financial statements after the U.S. Securities and Exchange Commission prohibited its previous firm, BF Borgers, from practicing.
SS Innovations has strategically focused on making surgical robotic technology more accessible, particularly targeting underserved regions globally. The SSi Mantra is marketed as an affordable option in the field of surgical robotics. As of June 30, the company reported selling over 30 systems and has additionally installed five systems based on a pay-per-use or revenue-sharing model. This system has already been approved in multiple countries including India, Indonesia, Nepal, Guatemala, and Ecuador, which supports its proven track record and reliability.
Adding to its strategic advancements, SS Innovations recently welcomed Frederic Moll, a pioneer in robotic surgery and a co-founder of the major industry player Intuitive Surgical, as the vice chairman of its board. This move is expected to bolster SS Innovations’ expertise and credibility, particularly as it prepares to enter the competitive U.S. market.
Regarding its operations in the U.S., SS Innovations is optimistic about meeting the FDA’s clinical trial requirements swiftly, citing the ongoing clinical use and demonstrated safety and efficacy of the SSi Mantra robot in India as a significant advantage. The company also has plans to conduct trials within the U.S., with a keen focus on cardiac procedures among other indications covering abdominal, pelvic, and thoracic surgeries.
The push towards multinational approvals and the inclusion of high-profile industry experts indicates a robust strategy aiming for a significant presence in the global market, particularly with an eye on setting a strong foothold in the U.S. market by the targeted timeline of 2025.
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