Virtual Incision Receives Investigational Device Exemption (IDE) to Initiate Study of First-of-its-Kind MIRA Platform

Company Prepares MIRA for Use in Minimally-Invasive Laparoscopic Colon Surgery

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Oct 28, 2020, 06:12 ET

HOLLAND, Mich., Oct. 28, 2020 /PRNewswire/ -- Genesis Innovation Group's cultivate(MD) Capital Fund II LP, a fund focused on investments into early stage healthcare companies with innovative technologies, announces that one of their portfolio companies, Virtual Incision Corporation (VIC), a medical device company pioneering a first-of-its-kind miniaturized surgical platform, has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the company's MIRA^® ("miniaturized in vivo robotic assistant") Platform.

The MIRA^®Surgical Platform features a small, self-contained surgical device that is inserted through a single midline umbilical incision in the patient's abdomen. Virtual Incision's technology is designed to enable complex multi-quadrant abdominal surgeries utilizing existing minimally invasive tools and techniques familiar to surgeons, and does not require a dedicated operating room or specialized infrastructure. Because of its small size, the device is expected to offer a cost effective and accessible option for laparoscopic surgery.

The IDE will allow the company to initiate a clinical study of MIRA at a limited number of U.S. hospitals in support of the system's regulatory pathway to approval.

David Blue, Director of Cultivate(MD) Fund II states,"We are so excited about the advanced progress being made by VIC. The VIC team has continued to remain very focused on being the leader of bringing cost effective portable mini robotic abdominal surgery to every healthcare facility in the country, and thus the much needed access for patients to receive this innovative minimally invasive option."

"Because of its clear benefits for patients, the demand for robotically-assisted surgery continues to increase, though challenges still inhibit broader adoption. MIRA is intended to overcome these limitations, with a simple and cost-effective solution that offers the potential to bring minimally invasive laparoscopic surgery to many more patients," said John Murphy, president and CEO of Virtual Incision. "The IDE approval for MIRA is an exciting and critical next step that will allow us to evaluate the safety and effectiveness of this novel device in patients. We look forward to working closely with the surgical teams and study sites to advance the MIRA surgical platform with the goal of making minimally invasive surgery more accessible."

Colorectal and lower gastrointestinal procedures are among the fastest growing surgeries in the U.S., with more than 400,000 colon resection procedures performed each year. Minimally invasive colectomies have been shown to reduce mortality, and can also reduce a patient's healing time, pain, complications, and hospital readmissions. Manual laparoscopic colectomies, though also minimally invasive, can be difficult to perform and can have less than ideal cosmetic outcomes.

"Many benign and malignant conditions require removal of a portion of the colon. Currently the most common approach is open surgery, which involves a very large incision, a long hospital stay and several weeks of recovery," said Dr. Dmitry Oleynikov, co-founder and Chief Medical Officer of Virtual Incision. "Open colectomies carry a high risk of surgical site infection and other complications that can negatively affect a patient's quality of life."

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.

This press release does not constitute an offer to sell or solicitation of an offer to buy any securities in any offering of securities. There will not be any sale of any securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

For more information, visit: https://genesisinnovationgroup.com/

About Virtual Incision

Virtual Incision is reimagining robotic support for minimally invasive (MIS) procedures with simple innovations offering mobility, flexibility, and accessibility to provide MIS options to more patients. The company is developing the MIRA ("miniaturized in vivo robotic assistant") Platform, a first-of-its-kind miniaturized surgical robotic support device, focusing first on colon resection, with follow-on specialty robots for additional potential applications. The company is headquartered in Lincoln, Nebraska. For more information, visit https://virtualincision.com/.

The MIRA Surgical Platform is an investigational device that is not available for sale in the United States.

SOURCE Genesis Innovation Group