Vicarious Surgical (NYSE:RBOT) announced third-quarter results that included an update on planned clinical trials for its surgical robot.
Waltham, Massachusetts–based Vicarious develops its Version 1.0 (V1.0) robot aimed at increasing the efficiency of surgical procedures. The company hopes to improve patient outcomes and reduce healthcare costs. With a novel approach, V1.0 uses proprietary, human-like surgical robots to transport surgeons inside the patient to perform minimally invasive surgery.
The company previously eyed first-in-human trials midway through this year, but it pushed V1.0’s timeline back in November 2023. In March, the company maintained its timeline to have V1.0 ready for an FDA submission by early- to mid-fiscal 2026.
BTIG analysts Ryan Zimmerman and Iseult McMahon said in their report on Vicarious’ third-quarter earnings that the company plans to complete a year-end cadaver lab for V1.0 in the coming weeks. After this, it plans to focus efforts on verification, validation, and optimization of the system ahead of formal clinical testing.
As a result, the analysts say Vicarious still expects to complete the first patient ventral hernia procedure in mid-to-late 2025. It expects the trial to include 30-60 patients, with procedures conducted primarily at sites outside the U.S. The company maintains its expectations for an early-to-mid 2026 FDA de novo 510(k) submission. It plans to later pursue additional indications for the system, including inguinal hernia repair and procedures related to gynecology, gallbladder and colorectal.
Zimmerman and McMahon maintain a “Neutral” rating as they await the unfolding of these significant developments. They note that financing remains an overhang, with cash on hand to get to 2026, but no commercialization until 2027.
“We think if RBOT can show continued progress towards its milestones and subsequently hit them, investor interest may begin to increase,” they wrote. “That said, shares will likely remain range-bound given the company’s capital position.”
A quick look at the third-quarter results for Vicarious Surgical
Vicarious Surgical reported adjusted net loss for the quarter of $17 million. That equals a loss of $2.87 per share, falling 22¢ behind Wall Street’s expectations. It did mark an improvement from the same quarter last year, which featured an adjusted net loss of $20.4 million.
The company reports $60.9 million in cash and investments as of Sept. 30, 2024. Its cash burn rate for the quarter totaled $12.4 million.
Vicarious reiterated its expected full-year cash burn of approximately $50 million.
“Our team’s strong execution throughout the year, continuing in the third quarter, has us on track to achieve our Version 1.0 System integration milestone within the next few weeks,” said Adam Sachs, co-founder and CEO. “This sets the stage for us to complete our first clinical patient in less than a year, a critical step that we believe will demonstrate the immense clinical value of our single-port robotic system for both patients and surgeons.”
Shares of RBOT were down 16.2% to $9.34 apiece in midday trading on Wednesday, Nov. 13, following the company’s release of its earnings report after the market closed on Tuesday, Nov. 12.
