Vicarious Surgical has delayed the clinical timeline for its surgical robot, having previously stated it would initiate first-in-human clinical trials by the end of 2025.
During a Q2 earnings call on 12 August, newly appointed CEO Steven Fromm told investors that Vicarious is focused on “executing with discipline” and that “design lock” will remain its primary focus, with the initiation of clinical trials of its system no longer anticipated for this year.
The US-based company’s V1.0 robot is designed for minimally invasive procedures using a single 1.5cm incision to access the surgical site and features a virtual reality (VR) interface, two robot arms and a 360° camera. The implementation of these features is designed to provide greater visualisation and manoeuvrability for surgeons in the operating room (OR).
Fromm explained: “Through testing conducted during our ongoing build and preparation for our first clinical use (FCU) trial, it became clear that proceeding now would require using a non-production equivalent system.
“While such a trial could provide some insights, it would divert our limited resources away from the higher priority goal of finalising a production equivalent system.”
Vicarious previously said it planned to submit a de novo filing with the US Food and Drug Administration (FDA) in 2026. Fromm stated that the company’s filing and other clinical milestones will now depend on V1.0’s FCU, which it remains non-committal about at this time.
However, Fromm said the company intends to conduct a “deep dive” to ensure its robot is “production-ready”, which is expected to take between four and six weeks.
Fromm concluded: “At that point, I expect to have greater clarity on our development status, timing to complete system integration and readiness to initiate full system verification.”
Q2 2025 financial highlights
Still a pre-commercial company, Vicarious reported no Q2 2025 revenue. Its financial highlights for Q2 2025 included shrinking operational expenses in the quarter to $13.5m, reflecting a 24% decrease from $17.7m in Q2 2024, and GAAP net losses of $13.2m, corresponding to $2.23 per share, improving upon net losses of $15.2m, or $2.59 per share, in Q2 2024.
Vicarious’ chief financial officer Sarah Romano commented: “We ended the second quarter of this year with approximately $24m of cash, cash equivalents and short-term investments on our balance sheet.
“This represents a second-quarter cash burn rate of approximately $13.4m. We continue to expect full year 2025 cash burn to be approximately $50m, and we remain committed to disciplined capital allocation.”
According to GlobalData analysis, the surgical robotics market is set to grow at a CAGR of 8% to reach $15.8bn by 2030.
Intuitive Surgical’s da Vinci line of robots is the dominant market leader in the US, but other companies, including Medtronic with its HUGO system, CMR Surgical, and Moon Surgical, are looking to gain a foothold in the US market.
