CMR surgical receives U.S. FDA marketing authorization for next-generation versius surgical system

CMR Surgical, a global surgical robotics business, announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Versius Surgical System (Versius), paving the way for a next-generation versatile, adaptable, and digitally driven surgical robot to be introduced in the United States. The FDA marketing authorization of Versius is a significant milestone for CMR as Versius is the first multi-port, soft tissue general surgical Robotic Assisted Surgical Device (RASD) to successfully be authorized through FDA’s De Novo application process. Versius is a RASD intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments and is indicated in the U.S. for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.

Versius is compact and modular, making it a versatile and portable surgical robot that can seamlessly integrate into virtually any operating room to perform cholecystectomy procedures. It can be easily moved between departments, making it suitable for any care setting. Versius is designed to biomimic the human arm, empowering surgeons through optimized port placement together with the dexterity and accuracy of small, fully wristed instruments. Versius offers 3D HD vision, easy-to-adopt instrument control, and a choice of ergonomic working positions, with an open surgeon console that has the potential to reduce stress and fatigue while allowing for clear communication with the surgical team.

Mark Slack, Chief Medical Officer and Co-founder at CMR Surgical, commented: “Securing FDA marketing authorization for Versius for use in cholecystectomy in adult patients is a significant milestone for CMR and, most importantly, for hospitals and patients who will now have greater access to robotic-assisted surgery in cholecystectomy procedures. With FDA authorization, we can now bring our compact and portable surgical robot to the world’s largest healthcare market, expanding the benefits of robotic-assisted surgery with Versius across various care settings in the U.S.”

As a digitally driven system, Versius is rooted in continuous innovation driven through software to ensure customers benefit from the latest technology updates. With a suite of digital apps to support surgeons, surgical teams and hospitals, Versius provides real time insights to improve proficiency and optimize surgical robotic programs. As CMR brings Versius to customers across the U.S., the Company will also roll out its state-of-the art global metrics-based training program. The training pathway draws on cutting-edge technology including Versius Trainer and the Versius eLearning platform, as well as peer to peer education through preceptoring and ongoing guidance and support, ensuring smooth transition from training to the operating room. CMR’s training pathway also includes Versius Virtual Reality and Versius Trainer in VR improving training pathway accessibility.

Massimiliano Colella, Interim Chief Executive Officer at CMR Surgical, commented: “The U.S. is an important strategic market so gaining FDA authorization for Versius for use in cholecystectomy procedures in adult patients is a significant step forward in CMR achieving its mission of bringing minimal access surgery to more patients around the world. The value of Versius as a compact and modular system has been demonstrated by leading hospitals around the world, and we look forward to working closely with hospitals in the U.S. to introduce Versius.”

Erik Wilson, M.D., Division Director and Vice Chair of Surgery at University of Texas McGovern Medical School at Houston, commented: “I have enjoyed being part of the development of Versius since 2017 and it is very exciting that hospitals across the U.S. can benefit from this next-generation technology. The U.S. is a mature market for surgical robots, so it is hard to believe that until today there was little choice when deciding to start a soft tissue robotics program. Versius securing FDA clearance is an important step forward for helping hospitals of any size to be able to offer robotic-assisted surgery.”

The U.S. is an important market with a strong demand for a flexible surgical robotic system that can be used across any care setting. Of nearly 10 million annual major operating room procedures in the U.S., only approximately 2.5% were robotic assisted.ⁱ Versius could enable patients to undergo minimal access surgery for cholecystectomy procedures closer to home thanks to this compact, modular, portable system. The FDA authorization of Versius is the first part of a multi-stage strategic plan that will involve initially partnering with a select number of U.S. hospitals, putting CMR and Versius in a strong position to enter the U.S. market and expand its partnership with hospitals across the country.

Steven D. Schwaitzberg, M.D., Chairman of the Department of Surgery at University at Buffalo School of Medicine and Biomedical Sciences, commented: “For more than a decade there has been a rapid expansion of procedures performed with robotic assistance. There has not been enough choice in the surgical arena for robotic systems in the U.S. I am delighted that Versius is entering into the marketplace with FDA marketing authorization. There is a real need for more compact, modular systems that can be adopted for care in a variety of settings. I look forward to exploring these new developments in robotic assisted surgery as Versius comes to the U.S.”

CMR secured CE Mark for Versius in 2019. Globally, Versius is the second most utilized surgical robotic system with over 26,000 surgical procedures completed in seven specialties as approved in those markets.