Virtual Incision clears another hurdle toward FDA approval of miniaturized surgical robot
posted - DEC 07, 2020Virtual Incision, a Nebraska Innovation Campus-based medical device company founded by University of Nebraska faculty, has reached another milestone on the road to transforming abdominal surgeries by way of a miniaturized, first-of-its kind surgical robot platform.
The Food and Drug Administration granted the company an investigational device exemption, which green lights a clinical study of the platform, called MIRA, to be carried out at a limited number of U.S. hospitals. This is a crucial step toward FDA approval of MIRA, which stands for “miniaturized in vivo robotic assistant.”
Nebraska engineer Shane Farritor, the company’s chief technology officer, said advancing the miniaturized device is critical to helping the more than 400,000 Americans each year who need colon resection procedures to treat lower gastrointestinal diseases like diverticulitis, colon polyps, pre-cancerous and cancerous colon lesions and inflammatory bowel disease, among others.
Right now, the most common approach to colorectal procedures is open surgery, which requires a large incision, a lengthy hospital stay and several weeks of recovery, as well as a high risk of infection and other complications. MIRA, which weighs in at just 2 pounds, would enable minimally invasive, laparoscopic procedures with a recovery time of days rather than months.
“Demand for robotically-assisted surgery is increasing because it leads to improved patient outcomes and lower costs,” said Farritor, Lederer Professor of engineering. “But there are still barriers to widespread adoption. With this IDE, we can investigate in-depth the safety and effectiveness of MIRA in patients, bringing the platform one step closer to helping patients facing an abdominal surgery.”
The news from the FDA caps another exciting year for Virtual Incision. In February, the company announced it raised $20 million in Series B+ investment funding, which will support regulatory and clinical programs leading to commercialization of MIRA. In 2019, the team expanded its headquarters at NIC, moving into a facility that integrates research and development, quality control, assembly and test procedures – a first of its kind in Nebraska.
Farritor and University of Nebraska Medical Center surgeon Dmitry Oleynikov founded Virtual Incision in 2006. John Murphy of Pleasanton, California, joined as CEO in 2010.