cultivate(MD) Capital Funds Portfolio Company Virtual Incision Submits FDA De Novo Request for Market Authorization of MIRA

News provided by

May 22, 2023, 05:45 ET

GRAND RAPIDS, Mich., May 22, 2023 /PRNewswire/ -- cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage healthcare companies with innovative technologies, announced today that one of their portfolio companies, Lincoln, Nebraska-based Virtual Incision Corporation, has submitted a De Novo request to the U.S. Food and Drug Administration (FDA) to market its MIRA Surgical System for use in bowel resection procedures. The submission comes on the heels of Virtual Incision's completed Investigational Device Exemption (IDE) clinical study that evaluated the company's MIRA Surgical System for use in bowel resection.

Virtual Incision Corporation is a medical device company developing the world's first miniaturized robotic-assisted surgery (RAS) system, MIRA. Its small, sleek design offers the benefits of RAS during bowel resection procedures without the logistical inefficiencies of traditional mainframe robotics. If granted market authorization, MIRA will become the world's first miniaturized RAS device cleared through the De Novo pathway for use in bowel resection procedures, making it a trailblazer for a new category of soft tissue robotics. Beyond granting Virtual Incision the ability to sell MIRA in the U.S. for its intended use, an authorization may enable additional procedural indications, entry into international markets, the release of new instruments and accessories, and future miniaturized generations of the surgical system.

"Throughout the history of RAS, only a few companies have managed to reach this significant milestone," said John Murphy, President, and Chief Executive Officer of Virtual Incision. "If we are successful with our submission, the FDA De Novo pathway will establish MIRA in a brand-new medical device category of miniaturized RAS. Our design is disruptive and highly differentiated among the current landscape of available and emerging technologies. We are proud of the data we collected, as they demonstrate the capabilities of MIRA in one of the most complex multi-quadrant abdominal procedures. We also observed many operational efficiencies that make the miniaturized approach so unique and potentially scalable to the millions of patients who could be candidates for RAS each year."

R. Sean Churchill, MD, MBA, Executive Director of Genesis Innovation Group said, "cultivate(MD) Capital Funds is proud to have partnered with the Virtual Incision team over the past 4 years. John Murphy and his team have held true to their vision of developing the most versatile, minimally invasive, and cost-effective robot there is for abdominal surgical procedures. Completing the IDE study design is a monumental accomplishment and truly recognizes the safety and efficiency of their RAS system. We look forward to continuing our relationship with Virtual Incision to help bring this technology to surgeons and hospitals worldwide."

Due to the reproducibility of RAS as a minimally invasive approach, its demand continues to rise and so does the need for easy-to-use, differentiated RAS options that are accessible to all hospital architectures. MIRA's miniaturized design introduces a new category of RAS that pairs the strength and precision surgeons expect with the miniaturization required to feasibly bring broad adoption of RAS to ambulatory surgical centers (ASCs), rural hospitals, and large health systems alike. When granted market authorization, Virtual Incision will work to deploy a limited market release of MIRA in pursuit of expanding access to RAS, either as a complementary or standalone option.

About Virtual Incision
Virtual Incision is on a mission to simplify robotic-assisted surgery (RAS), so more patients and their surgeons can access its benefits every day. Headquartered in Lincoln, Nebraska, and holding over two hundred patents and patent applications, the company is developing MIRA, the first-of-its-kind miniature RAS platform. Virtual Incision's goal is to make every operating room RAS-ready. For more information, visit their website.

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies. cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness. For more information, visit: https://cultivate-md.com

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations, assumptions, and other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date on which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions.

SOURCE cultivate(MD)