Vicarious Surgical plans for in

July 28, 2023 By Sean Whooley

Shares of RBOT fell 2.9% to $1.69 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even.

The company failed to beat Wall Street expectations but shared good news on the regulatory process for its surgical robot platform. Vicarious Surgical’s approach uses proprietary human-like surgical robots. It transports surgeons inside the patient to perform minimally invasive surgery.

In April, Vicarious completed a design freeze for its Version 1.0 (V1.0) system. Integration and the build of system units remain on track for fall 2023.

Having received some input from the FDA, Vicarious Surgical expects to begin first-in-human trials in mid-2024. The company expects to file for de novo clearance in fiscal 2025.

“Following our latest pre-submission meeting with the FDA, we are thrilled to have clarity on our regulatory pathway, giving us reassurance in our plans for a first in human procedure mid-next year,” said Adam Sachs, Vicarious Surgical CEO. “With a clear path ahead, our team is now hard at work assembling and integrating initial units ahead of V1.0 integration in the fall. We believe that our innovative approach will allow us to transform the standard of care in surgical robotics.”

BTIG analysts Ryan Zimmerman, Sam Durno and Iseult McMahon maintained a “Buy” rating for Vicarious Surgical. Should the timeline continue as planned, they expect Vicarious Surgical to become commercial in late 2025.

“This is a slight bump-out from our prior expectations, which called for more commercial revenue in FY25,” they wrote. “With shares having declined ~48.5% since the last earnings call, we think many investors were assuming that a trial would be necessary, but we actually believe the update on the trial was positive as it provides a clear pathway to commercialization. The wildcard will be cash burn as RBOT moves into FY24.”

The Waltham, Massachusetts-based company posted losses of $15.3 million for the quarter. In the same three-month period in 2022, the company recorded losses of $1.5 million. Vicarious Surgical’s adjusted net loss totaled $20.4 million.

Adjusted earnings per share came in at 16¢, falling 2¢ behind Wall Street projections.

Vicarious Surgical reported $21.5 million in operating expenses, compared to $19.1 million in Q2 2022.

The company reports $82.8 million in cash, cash equivalents and short-term investments as of June 30. That represents a quarterly cash burn of $14.9 million. Vicarious expects a full-year cash burn of between $55 million and $65 million.

Filed Under: Business/Financial News, Featured, Health Technology, MassDevice Earnings Roundup, News Well, Regulatory/Compliance, Robotics, Surgical, Wall Street Beat Tagged With: surgical robot, surgical robotics, Vicarious Surgical