Study Completed for EndoTheia’s FlexStone Basket

EndoTheia Inc. has completed the first-in-human clinical trial for the FlexStone Basket, the first-ever independently steerable kidney stone basket that gives physicians better precision and control in kidney stone removal. The clinical trial was conducted at Vanderbilt University Medical Center by co-lead investigators Nicholas Kavoussi, M.D., and Ryan Hsi, M.D.

The FlexStone Basket allows surgeons to directly steer the device, enabling more effective maneuvering around anatomical structures to reach stones in difficult-to-access locations within the kidney, according to EndoTheia. This capability addresses longstanding limitations of conventional kidney stone retrieval devices, potentially improving patient outcomes and reducing procedural complexity.

“The FlexStone Basket offers unprecedented flexibility and control, enabling us to access and retrieve stones in challenging locations that would otherwise be difficult to reach,” Dr. Kavoussi said. “It’s a game-changer that brings a new level of precision to kidney stone removal procedures.”

Dr. Hsi emphasized the device’s impact on patient care, stating, “This device enables us to minimize invasiveness while maximizing our efficiency and effectiveness in removing stones. FlexStone has the potential to transform how we approach complex kidney stone cases, and we’re thrilled to be part of this milestone in urological innovation.”

EndoTheia President Robert Webster III, Ph.D., highlighted the significance of FlexStone for the company and the field. “The successful first-in-human trial of the FlexStone Basket is a testament to EndoTheia’s commitment to pioneering transformative medical devices that empower physicians and improve patient care,” he stated. “We are thrilled to be working with experts at Vanderbilt University on this achievement and look forward to bringing this technology to healthcare providers worldwide.”

EndoTheia has entered into a strategic partnership with Nissha Medical Technologies to support the FlexStone Basket’s commercial scale-up and to advance innovations in minimally invasive endoscopy. The collaboration will enable EndoTheia to accelerate its innovation pipeline, bringing solutions to market more quickly and enhancing surgical capabilities for physicians and patients globally.

EndoTheia will continue to collaborate with urologists to gather data on the FlexStone Basket’s performance and explore further applications for steerable devices in various medical specialties. Building on the success of FlexStone, the company’s next innovation will be an independently steerable laser fiber, designed to speed up stone removal by enhancing access and precision during lithotripsy procedures. This clinical milestone represents a significant step forward for EndoTheia’s mission to provide cutting-edge tools that enhance the precision, safety, and effectiveness of minimally invasive surgeries.

Results from the FlexStone Basket clinical trial will be shared at the upcoming American Urological Association (AUA) Annual Meeting (April 26-30) in Las Vegas.

EndoTheia Inc. is attempting to transform minimally invasive endoscopic surgery with its technology. The company’s innovations leverage intelligently micro-machined smart materials to create highly dexterous, millimeter and sub-millimeter scale manipulators, enabling more precise and effective therapeutic outcomes in complex endoscopic procedures. Developed by EndoTheia’s founders at Vanderbilt University and the University of Tennessee, Knoxville, with funding from the National Institutes of Health and Launch Tennessee, this patented technology is designed to enhance the capabilities of flexible endoscopes and robotic platforms.

Nissha Medical Technologies is a contract development and manufacturing organization (CDMO) dedicated to accelerating medical device development and commercialization. By fostering strategic partnerships with academia and startups, Nissha Medical Technologies bridges the gap between research and real-world patient care. Its collaborative approach empowers early-stage innovators to bring cutting-edge technologies to market more rapidly, ultimately improving patient outcomes and advancing the field of minimally invasive surgery.