Virtual Incision is setting the groundwork for a clinical trial designed to test the safety and efficacy of its MIRA Surgical Robotic Platform for performing minimally-invasive colon resection surgeries.

The company filed an Investigational Device Exemption with the FDA, and has already raised $20 million in Series B+ financing for the investigational robot, which enables surgeons to perform minimally-invasive abdominal procedures in any hospital or surgical setting, without a dedicated space or infrastructure typically required by other mainframe robotic systems. The name, MIRA, stands for miniaturized in vivo robotic assistant.

"In colectomy, approximately 8-10" of the colon is usually resected and removed as treatment for colon cancer, diverticulitis, Crohn's disease and the like," John Murphy, CEO and president of Virtual Incision, told HCB News. "The MIRA system is used in the mobilization of the colon and the resection of diseased tissue using laparoscopic electrosurgery techniques. MIRA enables multi-quadrant abdominal surgery with a minimal footprint, no draping and easy manipulation of the robot (with no re-docking like other mainframe systems)."

More than 400,000 colon resection procedures are performed annually, signifying the fast growth in colorectal surgeries, along with lower gastrointestinal procedures, in the U.S. Surgeons often resort to colectomy to treat these types of patients, performing invasive open surgeries that may involve large incisions, long hospital stays and several weeks of recovery time, and carry a high risk of surgical site infection and other complications that can reduce a person’s quality of life.

MIRA is designed to provide alternative minimally-invasive colectomies, which have been proven to benefit patients. Its use of miniaturized robotic surgery is expected to potentially open up broader access to these benefits, as well as maximize hospital efficiency in various settings by significantly lowering cost of exams compared to those performed with currently available robotic systems, according to Virtual Incision. It also weighs two pounds, can be moved from room to room and is equipped with full robotic capabilities.

Virtual Incision expects MIRA to be especially popular among Academic Medical Centers, community hospitals and ambulatory surgical centers, which make up 80 percent of the market where smaller and simpler solutions are required, according to Murphy.

"Colorectal and lower gastrointestinal procedures are the fastest-growing procedures in the United States," he said. "Despite significant technological advancements and improved patient outcomes that can reduce the total cost of care, adoption of minimally-invasive colon resection has been limited even though rates of these conditions are growing. There is a significant opportunity to increase the adoption of minimally-invasive procedures for these patients by advancing the next generation of robot-assisted surgeries — and thereby offering reduced recovery time, pain, blood loss, and overall complications."

The company has begun to develop a family of procedure-specific mini-robots for other operations including hernia repair and gallbladder removal.

MIRA consists of more than 200 patents and applications.

The Series B+ financing was led by returning investor Bluestem Capital, with participation from returning investor PrairieGold Venture Partners, as well as from Genesis Innovation Group and other affiliated investors. The funds raised will support regulatory and clinical programs that will help pave the way for commercialization of MIRA.

The study will take place at a number of U.S. investigational sites.