Previous expectations earmarked mid-2024 for first-in-human trials and fiscal 2025 for de novo clearance submission. However, CEO Adam Sachs pushed V1.0’s timeline back in November 2023. The company outlined plans for a build and integration in fall 2024. Then, he earmarked early- to mid- 2026 for that de novo submission.
BTIG analyst Ryan Zimmerman issued a report noting that the company maintained its expectations for the robot’s regulatory submission. It still plans to have its Version 1.0 (V1.0) system ready for an FDA submission by early- to mid-fiscal 2026. Zimmerman said the company expects to begin cadaveric testing in the spring ahead of final software and hardware refinements. Integration remains on track for the fall.
He also outlined the company’s clinical trial plans, which include enrolling a 30-60 patient trial, including OUS patients. The primary efficacy and safety endpoints are a surgeon’s ability to complete the ventral hernia repair and the rate of adverse events through 30-day follow-up. The company plans to compare its outcomes against existing laparoscopic data.
“As [Vicarious] heads into FY24, the key is execution; on time and on budget, nothing more, nothing less,” Zimmerman wrote. “If [Vicarious] can stick to its timelines, we think the company has a shot to pick up incremental financing to support regulatory clearance and subsequent launch.”
The rest of the fourth-quarter results for Vicarious Surgical
Vicarious reported adjusted net loss per share of 7¢. That landed ahead of Wall Street’s expectations for losses of 12¢ per share. The company logged a net loss of $13.1 million in the quarter.
The company tightened its cash burn, setting its cash burn guidance for 2024 at $50 million. Vicarious enters the fiscal year with $98.2 million after burning $63.4 million in FY23.
Recent highlights include a nearly $50 million offering and the appointment of Randy Clark as president of the company.
“We made meaningful progress transitioning our Beta 2 surgical system into our highly anticipated Version 1.0 product in 2023. Through close collaboration with our surgeon and major hospital system partners, we refined our V1.0 system design and successfully constructed each subsystem,” said Sachs. “Although market headwinds and certain system integration hurdles drove us to prioritize capital efficiency and extend our timeline to build completion, we ended the year with a more resilient business structure, a defined regulatory strategy, and just under $100 million in cash and investments.
“We are well positioned to execute upon our 2024 milestones and look forward to our spring cadaveric testing, and completing the integration of our Version 1.0 system this fall.”
