22 April 2025 | News
Image Courtesy: Public Domain
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.
