Dive Brief:
- Vicarious Surgical CEO Stephen From, who started his job last week, said Tuesday the company no longer expects to begin a clinical trial for its surgical robot by the end of this year and will instead focus on completing the design for the commercial version of the system. The company’s shares slid more than 24% to end at $7.83 on Wednesday, according to Yahoo Finance.
- The clinical trial’s timing will determine when the robot developer submits its de novo filing to the Food and Drug Administration, From said on Vicarious’ second-quarter earnings call. Vicarious had planned to make its FDA submission in late 2026, after delaying the start of the trial.
- The company plans to conduct an assessment over about four to six weeks to gauge readiness for verification of the system, From said, adding he would work with Vicarious’ board and investor base to evaluate the capital strategy for supporting its goals.
Dive Insight:
Vicarious, which counts large for-profit hospital operator HCA Healthcare and Bill Gates among its investors, is developing a single-port robotic system for abdominal procedures that will vie for market share with robot industry leader Intuitive Surgical. Vicarious is initially targeting hernia, gallbladder, gastrointestinal and gynecology procedures.
From, who joined Vicarious as co-founder Adam Sachs moved into the role of president, said the single-port robotic market is still in its early stages, and he believes the company’s differentiated platform and strong technical foundation will advance minimally invasive surgery.
“I see an industry here, which is dominated by one player, and I see a lot of others that are trying to copy what they're doing, and I saw this team wasn't,” said From. “This is a project and this is a system and a company that is worth investing in for the long term, because this is a system that isn't just a copycat. This is a system that deserves market share.”
Vicarious ended the second quarter with about $24 million in cash and expects its cash burn to be about $50 million for fiscal 2025. The company will likely need to seek non-dilutive financing to maintain operations or meaningfully cut expenses, BTIG analyst Ryan Zimmerman said in a note to clients Tuesday.
“It's clear that the company is undergoing a pause until further notice and [management] does not have a clear answer as to how this may impact longer-term timelines,” Zimmerman wrote. “We think the potential likely path is that insiders may help support the company in order to give it some breathing room to get towards the finish line.”
