CMR Surgical is launching a multicenter pediatric clinical trial with its surgical robot, Versius. The first surgery was performed on a 7-year-old boy with ureteral obstruction at the University Hospital Southampton NHS Foundation Trust.
CMR Surgical’s trial will take place at three clinical sites in the UK: Southampton Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust, and Manchester University NHS Foundation Trust. It will focus on children under 18 with urological problems, performing procedures such as pyeloplasty, ureteroureterostomy, nephrectomy, and Mitrofanoff formation, reported CMR Surgical.
The clinical trial, approved by the West of Scotland Research Ethics Committee, the Medicines and Health Care Products Regulatory Agency (MHRA), and the Health Research Authorities (HRA), will include 150 patients. Patient recovery and clinical outcomes will be followed for up to one year following surgery.
“The small, modular design of Versius and small instrument diameter provides an opportunity to perform robotic-assisted surgery to treat pediatric patients. We are committed to the responsible introduction of Versius across new specialties, and we look forward to working with our partners as we undertake this clinical trial to ensure the safety and efficacy of Versius in pediatrics,” said Mark Slack, CMR Surgical co-founder, and chief medical officer.
Versius is “uniquely small, modular, and portable,” said CMR Surgical. It has four surgical arms, and the control unit sits on wheels. Surgeons can choose from various configurations, which can be helpful for procedures with limited or irregular access angles. (Also see "Ortho And Soft Tissue Robotics – Two Sides Of The Same Coin" - Medtech Insight, 6 October, 2023.)
The Versius robot is part of a wider digital ecosystem, including Vision for Versius. Vision for Versius allows 3D visualization of the minimally invasive surgery taking place. This is critical to keep an eye on the position of the robotics arms, consultant general and colorectal surgeon James Ansell told Medtech Insight. (Also see "Ortho And Soft Tissue Robotics – Two Sides Of The Same Coin" - Medtech Insight, 6 October, 2023.)
“Versius has now been used in over 23,000 surgical cases, with over 130 surgical procedures undertaken across seven surgical specialties including urology, general surgery, gynecology, colorectal surgery, and thoracic surgery,” said CMR Surgical.
CMR Surgical is running several clinical trials in tandem, investigating the use of the Versius device in transoral, abdominal hernia repair, colorectal cancer, and hysterectomy surgeries. The company is also running studies to compare postoperative outcomes for patients treated with Versius against those from other surgical robots, namely Intuitive Surgical’s DaVinci and the Medtronic Hugo, in the procedures prostatectomy, partial nephrectomy, and gastrectomy.
The first reported case of robotic surgery in pediatrics was in 2001 using the Da Vinci robot. However, the acceptance of robotic-assisted surgery in pediatrics has been “too slow,” according to scientific literature.
The company raised $165m in an oversubscribed funding round in September last year. The round was led by all of the company’s major pre-existing investors: Ally Bridge Group, Cambridge Innovation Capital, Escala Capital, LGT, Lightrock, RPMI Railpen, SoftBank Vision Fund 2, Tencent and Watrium. (Also see "Minute Insight: 15,000 Surgeries And More Funding For CMR Surgical" - Medtech Insight, 21 September, 2023.)
According to Citeline’s Meddevicetracker report on the “Robotically Assisted Surgical Devices Market,” the global robotically assisted surgery (RAS) is expected to grow at a compound annual growth rate of 10.8% from 2022, reaching nearly $13bn in 2027. Intuitive Surgical continues to dominate the RAS market worldwide with an estimated 80% market share. (Also see "Minute Insight: Virtuoso Surgical Unveiled Robotic System For Endoscopic Surgery" - Medtech Insight, 10 May, 2023.)
