FDA decision supported by an interim clinical study report on patient safety
Grand Rapids, Mich., February 28, 2023— 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 completed its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study. Virtual Incision Corporation is a medical device company developing the world’s first miniaturized robotic-assisted surgery (RAS) system. The study was designed to evaluate the company’s MIRA Surgical System for use in bowel resection procedures and it is an important achievement towards bringing new technologies to hospitals and their surgical robotics programs regardless of the site of care.
The surgical cases were completed at three hospitals across the country. Patients who participated in the study were followed after their procedure to fulfill study requirements. The complete data will be correlated and submitted to the FDA as part of the company’s De Novo request for market authorization. Virtual Incision is the first RAS developer to complete a U.S. IDE study to support a De Novo request in bowel resection.
“The investigators are very encouraged by our experiences trialing the MIRA Surgical System,” said Michael A. Jobst, MD, colorectal surgeon. “Across the sites, we’ve seen MIRA efficiently integrate into existing RAS programs and witnessed how it is mobile enough for use in any operating room. Some sites have even completed multiple cases in a single day. We are eager to fulfill the clinical requirements of the study in hopes that MIRA can help expand RAS access to more patients in the future.”
R. Sean Churchill, MD, MBA, Executive Director of Genesis Innovation Group said, “cultivate(MD) Capital Funds is proud to have partnered with Virtual Incision Corporation over the past four years. The ability of the MIRA Surgical System to bring robotic surgery to every hospital, not just large research centers, sets Virtual Incision apart from other robotic manufacturers. cultivate(MD) immediately recognized the unmet need for more cost effective and versatile robotics in the operating room and is a firm supporter of bringing this technology into practice. The MIRA platform has numerous products to address all aspects of abdominal surgery and stands to be the leader in minimally invasive robotic surgery.”
There are 5 million Americans who undergo abdominal soft tissue procedures annually, however, more than 90 percent go without access to RAS. If authorized by the FDA, MIRA’s miniaturized, strong, and easy-to-use design could potentially increase the overall availability of RAS. It has the potential to integrate into any facility or operating room by serving as a complement to the existing mainframe RAS systems, or by expanding into new sites of care and geographies as a standalone. Virtual Incision aims to increase patient access through a clinically, operationally, and economically sound platform available to all providers.
“Completing MIRA’s IDE clinical study is a critical milestone in our journey to making RAS more accessible,” said John Murphy, president and chief executive officer of Virtual Incision. “Currently, less than 10 percent of the 90,000 operating rooms in the U.S. are equipped with mainframe RAS systems. Beyond the incredible progress of the industry pioneer, it’s still in the early days of the adoption of soft tissue surgical robotics. Our ultimate goal is to develop world-class miniature RAS devices with the required strength and dexterity to enable positive clinical outcomes for a broad range of procedure types.”
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 200 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.
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://genesisinnovationgroup.com/
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Contact:
Jill Wachter
Genesis Innovation Group
jill.wachter@genesisinnovationgroup.com