Vicarious Surgical (NYSE:RBOT) announced in its quarterly earnings report that it set its FDA regulatory process in motion with a pre-submission.
CEO Adam Sachs said in a news release that the robotic surgery technology developer, which just completed its first quarter as a publicly-traded company, filed a “detailed regulatory plan” in the form of a pre-submission to the FDA as it looks to move toward 510(k) approval for its robotic surgical platform.
“This quarter marks our entry into the public markets, and I am incredibly proud of our teams and employees for their contributions to our company’s growth to date,” Sachs said in the release. “We are well-positioned to continue development of our next generation robotics system and are also pleased to announce that we have just filed a detailed regulatory plan in the form of a pre-submission to the FDA. We remain committed to transforming outcomes for surgeons and patients alike, and today, we are one step closer.”
BTIG analyst Ryan Zimmerman wrote in a report that, while it will take some time before Vicarious’ robotic system hits the market (expected in fiscal year 2023), analysts believe its system will be attractive to users because of more degrees of freedom, smaller ports, 360 degrees of view and an overall smaller footprint.
Along with the news of FDA pre-submission, Vicarious Surgical saw its shares rising today on the back of its third-quarter results. The Waltham, Massachusetts-based company posted losses of $65.5 million for a massive bottom-line slide from losses of $3.3 million this time last year.
Adjusted to exclude one-time items, losses per share were 9¢, registering 3¢ behind Wall Street projections.
Vicarious Surgical did not offer financial guidance for 2021.
RBOT shares were up 1.4% at $12.85 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down 0.4%.
Original Article: (https://www.massdevice.com/vicarious-surgical-details-its-regulatory-plans-with-fda/)
