Vicarious Surgical is on track to bring the submission of its surgical robotic system to FDA by the end of next year. The Waltham, MA-based company updated its progress on the timeline for a submission during an earnings call, on Monday.
Vicarious is developing a robotic system that will be used to treat ventral hernias. The company’s surgical approach uses human-like surgical robots to transport surgeons inside the patient to perform minimally invasive surgery.
“The conversations [with FDA] have been really good, but the details of exactly when the sort of interim submissions happen are highly dependent on a variety of things, including the specific system buildouts as well as the balance of what's being tested through verification and specifically actually through validation in testing like summited testing vs. what's being tested in a clinical trial,” said Adam Sachs CEO at Vicarious according to a Seeking Alpha transcript of the call. “That being said, we are still tracking to an FDA submission for authorization of the use of our device around year-end of next year, year-end of 2024.”
Sachs noted that the device could eventually go beyond treating ventral hernia.
“As a reminder, we are not just iterating on our system for ventral hernia,” Sachs said, according to the Seeking Alpha transcript. “By garnering feedback from a number of specialties, we better understand the potential of our system across a broad spectrum of indications. “In addition to ventral hernia, we have used our Beta 2 system in cadaveric models for hysterectomy, inguinal hernia, cholecystectomy, and GI procedures such as bowel resection.”
The company has finalized the V1.0 system of the technology.
Ryan Zimmerman, an analyst with BTIG said, “Specifically, [Vicarious] has reduced the systems arms, which will allow for greater dexterity, refined system motor and joint controls, and updated video processing technology and software.”
Zimmerman added, “With V1.0 design finalized, management. is focused on streamlining the manufacturing process ahead of any regulatory approval or clinical trials. Vicarious will only need a handful of systems for clinical trials and does not anticipate any supply chain dynamics to impact timelines.”
A ‘Vicarious’ Position
A few months ago, Vicarious cut 14% of its staff. The firm’s reasoning behind the layoffs was to extend its cash runway ahead of FDA submission.
Vicarious exited 1Q23 with cash of ~$97.6M, representing a cash burn of $18.7 million. The company reaffirmed FY23 cash burn guidance of $55 million to $65 million and to exit FY23 with more than ~$55 million of cash. Management noted that most of the spending reductions were focused on SG&A and the R&D budgets remain unchanged.
The firm said it believes that $97.6M will provide two years of cash runway through the end of 2024.
Vicarious was formed in 2014 and became public via a $1 billion Special Purpose Acquisition Corporation merger with D8 Holdings in 2001.