Lausanne, Switzerland, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Distalmotion today announced continued momentum in its clinical trial plans to support indication expansion of its DEXTER^® Robotic Surgery System in the U.S. This announcement—focused on ventral hernia repair, sacrocolpopexy, and myomectomy clinical trials—follows recent news of the company’s completion of its hysterectomy trial and FDA clearance for use of the DEXTER system in cholecystectomy (gallbladder removal), its second U.S. indication.

As part of its regulatory pathway to broaden DEXTER use in high-volume outpatient procedures, the company is actively enrolling patients in two clinical trials:

• Ventral Hernia Trial (RAVEN): Initiated in June 2025, this general surgery study surpassed the 25% patient enrollment mark in July.
• Sacrocolpopexy Trial (SPARO): Enrollment is almost halfway complete in this gynecology study, with 42% of the target cohort enrolled.

Finally, Distalmotion announced that it has received FDA approval to initiate its pivotal trial, Dexter-Assisted Robotic Evaluation in Myomectomy (REAL-M). The study will evaluate the use of DEXTER in myomectomy procedures, with enrollment planned to begin in Q4 2025.

“The U.S. market continues to be a strategic priority for Distalmotion,” said Greg Roche, CEO of Distalmotion. “We’re pleased with the pace and execution of our ongoing trials, which are laying the groundwork for more outpatient sites to offer more patients the benefits of robotic surgery.”

Together with inguinal hernia repair and cholecystectomy, hysterectomy and ventral hernia procedures contribute the most volume to the three million total annual procedures performed in U.S. outpatient settings[1].

These developments mark continued momentum for Distalmotion’s clinical strategy and reinforce its commitment to building robust clinical evidence for the safe and effective use of DEXTER in outpatient sites of care, including ASCs.

Note: The DEXTER^® Robotic Surgery System is currently authorized for use only in inguinal hernia and cholecystectomy in the United States, while in Europe, it is authorized for use in all general surgery, gynecological, and urological procedures.

ABOUT DEXTER

The DEXTER® Robotic Surgery System is a soft tissue surgical robot that uniquely simplifies operations to make the benefits of wristed robotics accessible in any operating room (OR). DEXTER comes with a suite of fully wristed single use robotic instruments that enhance dexterity and precision. A small, mobile footprint allows DEXTER to integrate into any size OR, without modifications, and to be easily maneuvered between rooms to optimize efficiency. The sterile console supports flexible surgical workflows by positioning the surgeon close to the patient for quick bedside access, seamless transitions between laparoscopic and robotic techniques as desired, and enhanced communication with OR teams. DEXTER open architecture enables compatibility with existing and future OR technologies, including visualization systems and advanced devices, for cost effective supply chain operations. Its instinctive design ensures an efficient, effective learning curve for setup and use. 

Indications for use:

Europe: The DEXTER® Robotic Surgery System is intended to assist in the accurate control of robotic instruments during urologic laparoscopic surgical procedures, general laparoscopic surgical procedures and gynecologic laparoscopic surgical procedures. The system is indicated for adult use.

U.S.: The DEXTER® Robotic Surgery System is intended to assist in the accurate control of endoscopes as well as endoscopic instruments for endoscopic manipulation of tissue, including grasping, suturing, dissecting, coagulating and cutting, with or without high frequency functionality. The Distalmotion DEXTER System is intended for use in laparoscopic inguinal hernia repair and cholecystectomy. The system is indicated for adult use, defined as 22 years old and older. It is intended for use by trained laparoscopic or robotic surgeons in an operating room environment in accordance with the representative and specific procedures set forth in the Instructions for Use

ABOUT DISTALMOTION

Distalmotion is a global MedTech company with a mission to empower access to the benefits of robotic surgery by simplifying operations with its DEXTER robot. The company aims to broaden access to robotic surgery for more surgeons and sites of care globally, including hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs), to increase the number of patients who benefit from best-in-class minimally invasive care. Well-suited to any size OR, DEXTER is easily moved, quickly set up, and seamlessly integrated into existing procedures.  DEXTER is commercially available in the United States and Europe.

The company is headquartered in Lausanne, Switzerland with a U.S. office in Cleveland, Ohio.

For more information, visit www.distalmotion.com and connect with us on LinkedIn/Twitter: @Distalmotion.

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For media inquiries: press@distalmotion.com

[1] Overview of Major Ambulatory Surgeries Performed in Hospital-Owned Facilities, 2019 #287. hcup-us.ahrq.gov. https://hcup-us.ahrq.gov/reports/statbriefs/sb287-Ambulatory-Surgery-Overview-2019.jsp, adjusted by data on file and published secondary literature

Attachments

• About The DEXTER® Robotic Surgery System
• Distalmotion Marks Patient Enrollment Milestones in General Surgery and Gynecology Clinical Trials

Greg Roche
Distalmotion
+1 216 440 3775
greg.roche@distalmotion.com