Vicarious Surgical (NYSE:RBOT) shared new details about clinical trial timelines for its surgical robot, leading to potential delays.
Waltham, Massachusetts-based Vicarious Surgical’s new CEO, Stephen From, said on the company’s second-quarter earnings call that the company plans to hold off on clinical trial initiation to further develop its surgical robot platform. The company previously expected to begin trials by the end of 2025.
The company designed its robot to increase the efficiency of surgical procedures. It hopes to improve patient outcomes and reduce healthcare costs. Through a novel approach, the Version 1.0 (V1.0) system uses proprietary, human-like surgical robots to transport surgeons inside the patient to perform minimally invasive surgery.
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This isn’t the first delay for Vicarious, which previously set its sights on first-in-human trials midway through this year.
However, the company pushed the robot’s timeline back in November 2023. In March 2024, the company maintained its timeline to have it’s “V1.0” system ready for an FDA submission by early- to mid-fiscal 2026.
Last fall, the company said it planned for a year-end cadaver lab for V1.0, followed by efforts toward verification, validation, and optimization of the system ahead of formal clinical testing. In May, Vicarious announced a new hospital collaboration, moving closer to bringing its surgical robot technology to patients.
However, with From only taking over officially last week, BTIG analysts Ryan Zimmmerman and Iseult McMahon say “it’s clear that the company is undergoing a pause until further notice,” while management doesn’t have a clear answer as to how this may impact longer-term timelines.
“We think the likely path is that insiders may help support the company in order to give it some breathing room to get towards the finish line,” the analysts wrote.
More about the latest developments at Vicarious
On the earnings call, From said testing determined that proceeding with the planned clinical trial now “would require using a non-production-equivalent system.” While that could still deliver some insights, he said, it would divert resources away from finalizing a production-equivalent robot.
Those resources remain limited, as the analysts say Vicarious’ capital position “remains its biggest challenge.” The company expects around $50 million in 2025 cash burn, “forcing [it] to make some tough decisions.” The analysts say the company has to either reduce cash burn substantially or find sources of financing, potentially requiring a complete recapitalization.
“We believe [Vicarious] will need to seek non-dilutive financing in order to maintain operations or meaningfully cut expenses to elongate cash,” Zimmerman and McMahon said.
From said the company aims to concentrate all efforts on completing system design and readiness for the full verification of a commercial-ready system. He expects the assessment of the system to take about 4-6 weeks, after which he anticipates greater clarity on development timelines.
“We’ll conduct a deep dive into every aspect of our build to secure verification for a production-ready system,” he said. “This effort is critical not only for ensuring technical readiness, but also for generating a clear picture of our progress and readiness over the next month.”
Despite the delays and From’s relative newness to the company, he remains optimistic about the company’s future.
“I’ve begun to engage with the teams across all areas of business, listening, learning and gathering candid feedback on our product development, our clinical strategy, operations and organizational structure,” From said. “These conversations have only strengthened my confidence in our platform, our people and the opportunity we have ahead of us.”
