240228MIRA™ surgical robot approved by FDA

On February 24, 2024, Virtual Incision Corporation, a U.S. surgical robotics company, announced that its MIRA™ surgical robot had received marketing authorization from the U.S. Food and Drug Administration (FDA).

MIRA™ surgical robot approved by FDA

MIRA™ is the world's first small robot-assisted surgery (miniRAS) device for colectomy surgery, having previously submitted a De Novo application. The FDA authorization is based in part on the results of the company's investigational Medical Device Exemption (IDE) clinical study.

Minimally invasive surgery (MIS), with its smaller surgical incisions, has transformed the surgical care environment and patient outcomes by reducing pain, reducing complications, and shortening recovery time. The introduction of robot-assisted surgery further expands the use of MIS in complex surgeries, providing surgeons with greater precision and control than traditional techniques. Despite its advantages, approximately 90 percent of U.S. operating rooms (OR) are still unable to use the technology, most commonly due to complex logistics such as dedicated operating room space, specially trained staff, additional steps in the setup and turnaround process, and high equipment costs.

MIRA's innovative pallet-to-operating table design can provide healthcare facilities with the benefits of robotic surgery without the need to build a dedicated operating room for surgical robotic equipment, a common challenge for existing large surgical robots. MIRA's compact frame (less than one kilogram) is portable and designed to minimize setup time, which can make any operating room ready to use the robot in minutes.

Executive Evaluation & Future Outlook

John Murphy, president and chief executive officer of Virtual Incision, said, "This FDA approval marks a turning point for surgical robotics as the company reached an important milestone in small robotic surgery. For more than a decade, the company's team has been committed to the core mission of giving every operating room the opportunity to be equipped with surgical robots. I couldn't be prouder to see our efforts bear fruit. Thanks to the FDA's endorsement of MIRA technology, whether as a complement to existing large robots or as a standalone platform, the miniaturized design has the potential to accelerate the adoption of robot-assisted surgery.

Dr. Piet Hinoul, Chief Medical Officer at Virtual Incision, said, "Colectomy is one of the most complex multi-quadrant abdominal surgeries, with nearly 50% of surgeries still performed in the form of open surgery. Data from our IDE clinical study suggest that MIRA can successfully perform colon surgery in a minimally invasive manner. This surgical robot addresses a highly unmet need for colectomy, laying the groundwork for subsequent expansion into other indications. I would like to thank the researchers and patients who participated in the IDE clinical study and helped bring this product to market.

Virtual Incision will begin advancing the commercialization of MIRA surgical robots at selected centers across the United States through its "First Access Program." Over time, the company will ramp up MIRA production and expand to more plants.

In the future, MIRA robots will be commercialized more widely, gradually expanding indications to include gynecology, general surgery, urology, and other soft tissue and solid organs such as liver, kidney, spleen, pancreas, and thyroid. The study of MIRA in gynecological surgery is scheduled for 2024. In addition, new iterations of the technology for general surgery are being designed and are expected to be applied in the first human studies outside the United States later this year.

# About MIRA Surgical Robot platform

Virtual Incision's vision and mission is to simplify robot-assisted surgery by making robots accessible in every operating room and even every surgery. The company holds more than 200 patents and patent applications. MIRA is the first miniature and highly flexible RAS (Robot-Assisted Surgery) platform of its kind. The MIRA surgical system is designed to maximize the benefits of robot-assisted surgery during intestinal resection.

The MIRA system as a whole consists of a miniature arm, a companion trolley, and a doctor's console: 1. The Miniature Arm weighs about 2 pounds (900 grams) and is small, making it attractive to surgeons and hospital staff, as well as ideal for use in tight Spaces and long space missions. Once in space, MIRA will operate in a laboratory cabinet the size of a microwave oven and perform simulated surgeries, such as cutting simulated tissue and performing delicate manipulations. MIRA features a disposable end effector, bipolar gripper and unipolar scissors, as well as the world's first flexible tip robotic camera range visualization system.

The MIRA is equipped with a full HD (1080p / 60 Hz) camera that plugs into the MIRA via a mount link and extends down into the surgical environment. The camera has an automatic tracking function to keep the workspace in view. The camera is optimized for multi-quadrant surgery and features an articulated flexible tip that maintains a stable field of view and access to the surgical area. According to the official website, the MIRA micro arm has been iterated over five generations:

MIRA is initially focused on colectomy, and the specialized robots developed later will be available for other potential applications. Other potential applications include repair of hernias, gallbladder removal, anti-reflux surgery, splenectomy, adrenalectomy, gastric sleeve, gastric bypass, hysterectomy, and hepatopancreatic biliary surgery. Millions of operations are possible each year.

Founded in 2006 as a division of the University of Nebraska at Lincoln and headquartered in Pleasanton, California, Virtual Incision is a medical device company that developed the world's first micro-robot-assisted surgery (RAS) platform. It was founded by Shane Farritor, an engineering professor at the University of Nebraska who has studied at Kennedy Space Center, Goddard Space Flight Center and Jet Propulsion Laboratory, and Dmitry Oleynikov, a surgeon at the University's medical center.