Robotic Surgery Advances: Monogram Secures FDA Clearance, Vicarious Faces Delays

Robotic surgery continues to evolve rapidly, with recent developments showcasing both progress and challenges in the field. Two companies at the forefront of this technology, Monogram Technologies and Vicarious Surgical, have reported significant updates that could shape the future of minimally invasive procedures.

Monogram's Robotic Knee System Receives FDA 510(k) Clearance

Monogram Technologies, an Austin, Texas-based company, has achieved a major milestone with the Food and Drug Administration (FDA) granting 510(k) clearance for its mBôS TKA System. This robotic platform is designed for total knee replacements and utilizes a personalized alignment approach to enhance surgical precision.

The company plans to strategically place the robot with key opinion leaders in select geographic areas to build clinical experience and demonstrate the platform's capabilities in real-world settings. Monogram is also working on integrating recent upgrades to the robot's cutting system and other enhancements into the cleared device over the coming months.

CEO Benjamin Sexson emphasized the system's ability to allow surgeons to make precise adjustments during procedures, potentially leading to greater patient satisfaction with knee replacement outcomes. The platform's design aims to facilitate better-fitting knee implants and is built with the flexibility to support future orthopedic applications beyond knee replacement.

Monogram, which went public in May 2023, is pursuing regulatory clearance for additional clinical applications and is working towards obtaining approval to begin trials in India. The company believes there is significant room for innovation and growth in the robotic-assisted joint reconstruction market, which they consider underpenetrated.

Vicarious Surgical Encounters Supply Chain Hurdles

In contrast to Monogram's progress, Vicarious Surgical, developer of a single-port robotic system for abdominal procedures, has announced delays in its regulatory timeline due to supply chain challenges. The company, based in Waltham, Massachusetts, now expects to treat its first clinical patients closer to the end of the year, pushing its de novo submission to the FDA to late 2026.

CEO Adam Sachs explained that material procurement issues at key suppliers have delayed the delivery of components necessary for completing production of their Version 1.0 robots. This setback has impacted the company's plans to begin clinical trials and subsequently file a de novo classification application with the FDA for the robot's use in ventral hernia procedures, which is intended to be its first indication.

The extended development timeline has raised concerns about Vicarious Surgical's financial position. BTIG analyst Ryan Zimmerman noted that the company will need to reduce its cash burn or secure additional financing sources, a challenging task in the current economic environment.

Despite these obstacles, Vicarious Surgical is making organizational changes to navigate the delay. The company recently appointed Sarah Romano as its new CFO, effective April 1, coinciding with the planned retirement of Chief Operating Officer John Mazzola.

As the robotic surgery landscape continues to evolve, these developments at Monogram Technologies and Vicarious Surgical highlight the industry's potential for innovation as well as the hurdles companies face in bringing new technologies to market. The coming months will be crucial for both firms as they work towards their respective goals in advancing minimally invasive surgical techniques.