Sep 22, 2023

EndoTheia’s system eliminates the need for the duodenoscopes that concern the FDA. Michael Barbella, Managing Editor09.22.23 EndoTheia Inc.  has completed a first-in-human clinical study for technology that improves minimally invasive endoscopic surgery. The trial at Vanderbilt University achieved all primary and secondary endpoints without any adverse events. This news follows the company’s  recent announcement  that the FDA recently named EndoTheia’s ENT endoscopic surgery technology a Breakthrough Device. EndoTheia’s ENT Breakthrough Device is designed to answer the U.S. Food and Drug Administration’s (FDA) “call to action” highlighting alarming infection rates in difficult-to-sterilize reusable duodenoscopes, and calling on medical device companies to create new, cost effective, disposable devices to treat biliary disease. “EndoTheia is proud to have been able to respond to this call-to-action from the FDA in a unique and outside-the-box way,” EndoTheia President/Co-Founder Robert J. Webster, III, Ph.D., said. “We took a look at what others were doing within the space and saw mostly incremental advancements and/or costly fully disposable endoscope solutions.” EndoTheia’s system eliminates the need for the duodenoscopes that concern the FDA, replacing them with inexpensive, disposable components that allow standard endoscopes to perform their same functions. “EndoTheia is pleased to report the success of this first-in-human clinical study. It is a major milestone for EndoTheia and for the 700,000 patients suffering from biliary disease per year domestically,” EndoTheia Co-Founder/Chief Technology Officer Joshua Gafford, Ph.D., stated. “We are deeply appreciative of the patients and clinical investigators who participated in this study, and look forward to the broad clinical impact of this technology following FDA clearance." Dr. Keith Obstein, professor of Medicine, Division of Gastroenterology at Vanderbilt University Medical Center, noted, “This device enabled us to clearly visualize the duodenal papilla en face with a standard forward-viewing endoscope, which normally would not be possible, and has the potential to eliminate the risk of infection from reusable duodenoscopes. This would be a huge win for patients, hospitals, and healthcare systems.” Study results will support EndoTheia’s FDA 510(k) application for its biliary product, scheduled for submission later this year. EndoTheia plans to follow this initial product with several other product lines using its proprietary technology in urology, neurosurgery, interventional pulmonology, gastroenterology, orthopedics, and otolaryngology. EndoTheia has developed a technology that improves dexterity in minimally invasive endoscopic surgery. This technology harnesses the power of micro-machined advanced materials to create highly dexterous manipulators at millimeter and sub-millimeter scales to improve therapeutic outcomes in complex flexible endoscopic procedures. This patented technology was invented and developed by EndoTheia’s founders at Vanderbilt University and the University of Tennessee, Knoxville, with funding from the National Institutes of Health. Trending