CMR Surgical receives U.S. FDA Marketing Authorization for

Versius granted marketing authorization through FDA’s De Novo process which establishes initial indication for adults undergoing cholecystectomy
Globally, Versius is the second most utilized surgical robotic system, with over 26,000 surgical procedures completed across Europe, Latin America, Asia, Middle East and Africa
With its unique compact design and portability, Versius can increase surgical options for any care setting in the U.S.

Cambridge, UK – 15 October 2024, 12:00 (BST). CMR Surgical (CMR or ‘the Company’), a global surgical robotics business, today 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.

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Important Safety Information

The Versius Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

The Versius Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy. For important safety information, indications for use, risks and warnings, please refer to: https://us.cmrsurgical.com/safety-information

About the Versius Surgical Robotic System

Versius is a next-generation, portable surgical robot designed to help surgeons perform minimal access surgery (MAS). The Versius Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

In the U.S. the Versius Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy. Clinical indications vary by geography.

Versius resets expectations of robotic surgery. Versius fits into virtually any operating room set-up and integrates seamlessly into existing workflows, increasing the likelihood of robotic MAS. The compact, portable and modular design of Versius allows the surgeon to only use the number of arms needed for a given procedure.

Biomimicking the human arm, Versius gives surgeons the choice of optimized port placement alongside the dexterity and accuracy of small fully-wristed instruments. With 3D HD vision, easy-to-adopt instrument control and a choice of ergonomic working positions, the open surgeon console has the potential to reduce stress and fatigue while allowing for clear communication with the surgical team. By thinking endoscopically and operating robotically with Versius, patients, surgeons and healthcare professionals can all benefit from the value that robotic MAS brings.

But it’s more than just a robot. Versius captures meaningful data with its wider digital ecosystem to support a surgeon’s continuous learning. Through the Versius Connect app, Versius Trainer and CMR clinical registry, Versius unleashes a wealth of insights to ultimately improve surgical care. For more information on Versius, please visit: https://us.cmrsurgical.com/.

About CMR Surgical Limited

CMR Surgical (CMR) is a global medical devices company dedicated to transforming surgery with Versius, a next-generation surgical robot.

Headquartered in Cambridge, United Kingdom, CMR is committed to working with surgeons, surgical teams and hospital partners, to provide an optimal tool to make robotic minimal access surgery universally accessible and affordable. With Versius, we are on a mission to redefine the surgical robotics market with practical, innovative technology and data that can improve surgical care. Founded in 2014, CMR Surgical is a private limited company backed by an international shareholder base.

References
ⁱ Mattingly AS, Chen MM, Divi V, Holsinger FC, Saraswathula A. Minimally Invasive Surgery in the United States, 2022: Understanding Its Value Using New Datasets. J Surg Res. 2023;281:33-36. doi:10.1016/j.jss.2022.08.006

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