Lausanne, Switzerland, April 22, 2025 (GLOBE NEWSWIRE) -- Distalmotion, the global MedTech company empowering access to the benefits of robotic surgery, progresses on the path to expand its US footprint with the completion of cholecystectomy and benign hysterectomy clinical trials - to support 510(k) pre-market submissions for additional indications - and product enhancements to further increase procedural fluidity and wristed instrument dexterity.
The DEXTER Robotic Surgery System - used to provide minimally invasive care in almost 2,000 procedures across thirty unique general, gynecological, colorectal, and urological procedures in Europe - received FDA De Novo market authorization in Q4 2024 for inguinal hernia repair. With robotic utilization expected to grow to ~5M soft tissue procedures by 20321 and general and gynecological procedures leading a migration of US procedures to outpatient sites of care, Distalmotion is focused on expanding DEXTER indications to high volume outpatient procedures in the US.
To support this US indication expansion, the company has completed two pivotal studies - the NEST study (NCT06473688) focused on cholecystectomy and the HYPER study (NCT06473675) pertaining to benign hysterectomy - and included endpoint data in its Q1 2025 and April pre-market 510(k) submissions respectively. Distalmotion has also initiated its sacrocolpopexy clinical study, with the first patient enrolled in Q1 2025.
“The US market for hysterectomy, cholecystectomy, and sacrocolpopexy collectively represents over 1.5 million procedures annually,” said Distalmotion CEO Greg Roche. “These are among the most commonly performed surgeries in outpatient settings and DEXTER is designed to uniquely meet the clinical and operational needs of this setting.”
In parallel, Distalmotion has initiated the introduction of DEXTER system enhancements in Europe - further reinforcing its commitment to broadening access to best-in-class minimally invasive care.
“Our team continuously innovates to bring surgeons the best technology,” added Michael Friedrich, COO at Distalmotion. “Our latest DEXTER upgrade is being rolled out in Europe and is planned for the US this summer pending regulatory authorization. These enhancements are designed to simplify operating room setup, streamline procedural workflows, and optimize instrument performance.”
With these clinical and technical advancements, Distalmotion continues to deliver innovative surgical solutions to meet the evolving needs of healthcare providers—empowering access to the benefits of surgical robotics across more sites of care.
1 Clarivate, “Market Insights Laparoscopic Surgical Robotic Devices Global.” 27 Dec 2023.
Note: The DEXTER Robotic Surgery System is currently authorized for use only in inguinal hernia repair in the United States.
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).
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 and seamless transitions between laparoscopic and robotic techniques, as desired.
Its open architecture enables compatibility with existing and future OR technologies, including visualization systems and advanced devices, for cost effective supply operations and use of new innovation.
The instinctive DEXTER design ensures an efficient, effective learning curve for setup and use.
DEXTER comes with a suite of fully wristed single use robotic instruments that enhance dexterity and precision.
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.
US: The DEXTER® Robotic Surgery System is intended for use in laparoscopic inguinal hernia repair. The system is indicated for adult use, defined as 22 years old and older.
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 and has a US office in Cleveland, Ohio.
For more information, visit www.distalmotion.com and connect with us on LinkedIn/Twitter: @Distalmotion.
For media inquiries: press@distalmotion.com
Attachments
- About DEXTER
- Distalmotion is focused on expanding DEXTER indications to high volume outpatient procedures in the US.
Greg Roche Distalmotion +1 216 440 3775 greg.roche@distalmotion.com
