Vicarious Surgical On Track for First Surgical Robot Trials in Mid-to-Late 2025
Key Insights
Vicarious Surgical (search) remains on track to begin first-in-human trials of its Version 1.0 surgical robot in mid-to-late 2025, focusing on ventral hernia (search) procedures.
The trials will involve 30-60 patients, primarily at sites outside the U.S., with the aim of demonstrating the clinical value of their single-port robotic system.
Vicarious Surgical (search) anticipates an FDA de novo 510(k) submission in early-to-mid 2026 and is planning to expand indications to include inguinal hernia (search) repair, gynecology, gallbladder (search), and colorectal (search) procedures.
Vicarious Surgical (search) is moving forward with its plans to initiate first-in-human trials for its Version 1.0 (V1.0) surgical robot in mid-to-late 2025. The company, based in Waltham, Massachusetts, aims to enhance surgical procedure efficiency, improve patient outcomes, and reduce healthcare costs through its innovative robotic system.
The V1.0 robot utilizes proprietary, human-like surgical robots designed to transport surgeons inside the patient, facilitating minimally invasive surgery. Following the completion of a year-end cadaver lab for V1.0 in the coming weeks, the company will concentrate on verification, validation, and system optimization in preparation for formal clinical testing.
The initial clinical trial will focus on ventral hernia (search) procedures and is expected to include 30-60 patients. These procedures will primarily be conducted at sites located outside the United States. Vicarious Surgical (search) anticipates submitting a de novo 510(k) application to the FDA in early-to-mid 2026. The company plans to expand the system's indications to include inguinal hernia repair, gynecological procedures, gallbladder (search) surgeries, and colorectal (search) procedures.
BTIG analysts Ryan Zimmerman and Iseult McMahon maintain a "Neutral" rating on Vicarious Surgical (search), noting that while the company's progress towards its milestones could increase investor interest, the stock may remain range-bound due to its capital position. They also pointed out that financing remains an overhang, with cash on hand to get to 2026, but no commercialization until 2027.
Third-Quarter Financial Results
Vicarious Surgical (search) reported an adjusted net loss of $17 million for the third quarter, equating to a loss of $2.87 per share, which fell 22 cents behind Wall Street's expectations. However, this represents an improvement compared to the same quarter last year, which saw an adjusted net loss of $20.4 million.
As of September 30, 2024, the company reported $60.9 million in cash and investments, with a cash burn rate of $12.4 million for the quarter. Vicarious Surgical (search) has reiterated its expected full-year cash burn of approximately $50 million.
Management Commentary
Adam Sachs, co-founder and CEO of Vicarious Surgical (search), stated, "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. 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."