Virtual Incision Announces Approval to Complete Clinical Study Enrollment for its MIRA® Platform

FDA decision supported by an interim clinical study report on patient safety

Lincoln, Neb. – April 19, 2022 – Virtual Incision Corporation, a medical device company pioneering the world’s first miniaturized robotic-assisted surgery (RAS) platform, today announced the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement to complete the final stage of its clinical study analyzing the MIRA® Platform in bowel resection procedures. The approval was supported by a favorable interim clinical study report on the safety profile of MIRA.

The IDE supplement approval puts Virtual Incision on track to obtain the clinical evidence needed to bring new innovation to the soft tissue surgical robotics industry, a market that has been historically dominated by a single player. Results of the completed study will support MIRA’s upcoming FDA De Novo application for market authorization.

The first cases of the study were completed at Bryan Medical Center in Lincoln, Neb. by Dr. Michael Jobst and Dr. Kelly Krier, and at Lankenau Medical Center in Wynnewood, Pa. by Dr. John Marks and Dr. Henry Schoonyoung.

“Our clinical experience has been extremely positive so far,” said Dr. Jobst, the first surgeon in the world to operate with the device. “I was able to perform 100% of the dissection with MIRA in all of my cases. We have also been pleased with its accessibility and efficiency. I operated on eight patients in five different operating rooms, and that’s something that’s just not possible with mainframe RAS platforms. MIRA has the potential to bring the benefits of minimally invasive surgery to more patients, and that’s truly exciting.”