EndoTheia, Inc., a leader in innovative surgical technology co-founded by Caleb Rucker, an associate professor and B. Ray Thompson Professor in the Department of Mechanical, Aerospace, and Biomedical Engineering, has announced 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. Jake Childs (BS/ME, ’17; MS/ME, ’20; PhD/ME, ’22) played an instrumental role in the development of the FlexStone Basket as an engineer at EndoTheia.
“It’s very exciting to see concepts that originated in my lab at UT being integrated into products that will hopefully improve the lives of patients in the near future,” said Rucker, EndoTheia’s chief science officer. “Several of my students’ PhD dissertations helped invent and further our understanding of the technology that EndoTheia is building on. Our current work at UT looks further ahead toward robotic applications and helps inform EndoTheia’s product development through fundamental research insights.”
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 clinical trial for the FlexStone Basket was conducted at Vanderbilt University Medical Center by Nicholas Kavoussi and Ryan His, who served as the co-lead investigators.
To build off the successful clinical trial, EndoTheia has entered a strategic partnership with Nissha Medical Technologies to support the commercial scale-up of the FlexStone Basket and advance innovations in minimally invasive endoscopy. The collaboration will enable EndoTheia to accelerate its innovation pipeline and bring solutions to market more quickly.
EndoTheia will continue to collaborate with leading urologists to collect data on the FlexStone Basket’s performance and explore further applications for steerable devices in various medical specialties. 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.
The results from the FlexStone Basket clinical trial will be shared at the American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada, from April 26-30, 2025.
Contact
Rhiannon Potkey (865-974-0683, rpotkey@utk.edu)