EndoTheia, Inc., a leader in innovative surgical technology, is pleased to announce the successful completion of the first-in-human clinical trial for the FlexStone™ Basket, the first-ever independently steerable kidney stone basket. This groundbreaking device enables unmatched precision and control in kidney stone removal, providing a significant advancement in urological care. The clinical trial was conducted at Vanderbilt University Medical Center by Nicholas Kavoussi, M.D., and Ryan Hsi, M.D., who served as co-lead investigators.
The FlexStone Basket empowers surgeons to directly steer the device, enabling more effective maneuvering around anatomical structures to reach stones in difficult-to-access locations within the kidney. 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,” said Dr. Nicholas Kavoussi, co-lead investigator. “It’s a game-changer that brings a new level of precision to kidney stone removal procedures.”
Dr. Ryan Hsi, co-lead investigator in the clinical trial, 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,” said Dr. Webster. “We are thrilled to be working with leading experts at Vanderbilt University on this groundbreaking achievement and look forward to bringing this technology to healthcare providers worldwide.”
Looking ahead, EndoTheia has entered into a strategic partnership with Nissha Medical Technologies to support the commercial scale-up of the FlexStone Basket and to advance innovations in minimally invasive endoscopy. This collaboration will enable EndoTheia to accelerate its innovation pipeline, bringing transformative solutions to market more quickly and enhancing surgical capabilities for physicians and patients globally.
EndoTheia will continue to collaborate with leading 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.
The results from the FlexStone Basket clinical trial will be shared at the American Urological Association (AUA) Annual Meeting, taking place in Las Vegas, Nevada, from April 26-30, 2025.
For more information on the FlexStone Basket, EndoTheia, and its partnership with Nissha Medical Technologies, please visit www.endotheia.com or contact Scott Webster, Ph.D., EndoTheia Chief Operating Officer, at scott.webster@endotheia.com.
About EndoTheia, Inc.
EndoTheia, Inc. is at the forefront of transforming minimally invasive endoscopic surgery with its groundbreaking 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. EndoTheia is committed to advancing surgical precision and improving patient care. For more information, visit www.endotheia.com.
About Nissha Medical Technologies
Nissha Medical Technologies is a Contract Development and Manufacturing Organization (CDMO) dedicated to accelerating the development and commercialization of innovative medical devices. By fostering strategic partnerships with academia and startups, Nissha Medical Technologies bridges the gap between groundbreaking research and real-world patient care. Their 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. For more information, visit www.nisshamedical.com.
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