Virtual Incision's Robotic Surgery Device FDA Approved

Photo:Representative Image

Virtual Incision, a company in the cultivate (MD) portfolio, has received marketing authorization from the US FDA for the MIRA Surgical System (MIRA). This is a significant milestone as MIRA becomes the first miniaturized robotic-assisted surgery device worldwide to be approved for adult colectomy procedures.

R. Sean Churchill, MD, MBA, Managing Director of Cultivation (MD), expressed his enthusiasm for the US FDA's approval. He said, "Cultivate (MD) Capital Funds is proud to have partnered with Virtual Incision Corporation on their developmental journey. We have long recognized the need for mainstream robotics in medicine that can simultaneously provide minimally invasive surgery with system portability, allowing use in large university-based hospital systems and smaller community hospitals, all cost-effectively and efficiently. Virtual Incision Corporation accomplished these goals and has redefined the future of robotic surgery."

Virtual Incision sees MIRA's innovative design as a potential game-changer in the surgical technology realm. With its compact size (weighing less than two pounds) and user-friendly tray-to-table setup, MIRA aims to enhance operating room efficiency. This approach intends to facilitate the integration of robotic surgery in a wider range of healthcare settings and potentially overcome the logistical challenges associated with the large surgical robots currently available.

"We have been in awe of watching this incredible innovative technology and team for years, creating and thinking outside of the box," said David Blue, Director of cultivate (MD) Capital Funds. "These miniature robots will be the future and continue to amaze the rest of the surgical robotics world. It will be fun seeing them lead us into this new world! We are so excited and honored to be on this journey with Virtual Incision!"

Virtual Incision aims to initiate MIRA's commercial rollout in select centers in the United States with the US FDA authorization in hand.

MIRA's broader commercialization and expansion of its roadmap for future indications includes gynecology, general surgery, urology, and other soft tissue and solid organ surgery.

Moreover, a new version of the technology tailored to general surgery is in the design phase and expected to be used in a first-in-human study outside the US later this year.