MOMENTIS SURGICAL EXPANDS TO GENERAL SURGERY MARKET WITH FDA 510(k) CLEARANCE FOR ITS ANOVO ROBOTIC SYSTEM

Anovo robotic surgical platform is the world's first single port robotics platform approved for ventral hernia repairs in the US

TEL AVIV, Israel and FORT LAUDERDALE, Fla., Oct. 15, 2024 /PRNewswire/ -- Momentis Surgical Ltd., a medical device company dedicated to transforming robot-assisted surgery with its proprietary technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) Clearance to its Anovo™ robotic surgical platform for use in single site, abdominal access ventral hernia repair. The FDA clearance announced today complements the system's existing approvals in natural orifice laparoscopic-assisted transvaginal benign gynecology surgical procedures.

Dvir Cohen, CEO and Co-Founder of Momentis Surgical, said, "Leveraging the clinical achievements of our Anovo platform in gynecology and the connections we established with leading medical centers worldwide, we have seized the opportunity to expand to general surgery for our groundbreaking technology. Due to its size and mobility, our system can be used both in hospitals and outpatient settings, where most hernia surgeries can be performed, but are not currently, because of the limitations of existing robotic platforms. Anovo's unique features allow surgeons and patients access to robotic procedures outside the hospital by offering robotic technology to ambulatory surgical centers."

Anovo is the world's first single port robotics platform approved by the FDA to perform ventral hernia procedures. Performing procedures through a single port with multiple flexible instruments has the potential to result in less invasive and less traumatic outcomes for the tissue at the point of entry, enabled by the small portable robotic system. The Anovo system is the first and only FDA-authorized surgical robotic platform that features miniature humanoid-shaped robotic arms that provide human level dexterity, multi-planar flexibility and 360 degrees of articulation. The biomimetic instruments are designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow and wrist joints. Multiple instruments can be introduced to the body through a single portal and the 360-degree articulation offers obstacle avoidance as well as optimal access and working angles.

"This FDA authorization represents a significant advancement in the world of robotic surgery by making Anovo a versatile robotics platform for multi-specialty use," said Professor Tim Tollens, MD, Head of Surgery at Imelda Hospital in Bonheiden, Belgium, who performed a series of ventral hernia procedures using the Anovo system. "I have experience with other robotic systems and the Anovo platform is not only potentially better for my patients by reducing the number of incisions, but also incredibly easy for me and my OR staff to use. The average docking time for the robot was under 2 minutes, which is an order of magnitude faster than other robotic systems."

Frederic H. Moll, M.D., Momentis board member and founder of Intuitive Surgical and Auris Health, added, "I have spent my career developing groundbreaking surgical robotic technology and I believe the future of soft tissue robotics is flexible instruments. I am very impressed with what the Momentis team has achieved to date. As the company has now created a true robotics platform, this technology is clearly differentiating and will have an immediate impact on the way general surgery is performed as it has in gynecology."

"We are thrilled with adding a very high-volume surgical procedure to the approved indications for Anovo," said Maurice R Ferré, MD, Chairman of Momentis Surgical, Chairman and CEO of Insightec and Co-Founder and former CEO of MAKO Surgical. "This is only the beginning of the impact this single port, flexible robotics platform will have on robotic surgery."

About Momentis Surgical™
Momentis Surgical is dedicated to transforming the field of robotic surgery by developing innovative small footprint, cost-effective, robotic-assisted technologies and techniques for a growing number of clinical applications. Our goal is to empower surgeons to perform minimally invasive, complex procedures, enabling better patient outcomes, lowering cost of care, and opening access to surgical robotics to more surgeons, patients, hospitals, and surgery centers across the globe. For more information, visit: https://www.momentissurgical.com/.

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SOURCE Momentis Surgical