NASHVILLE, Tenn.--(BUSINESS WIRE)--EndoTheia, Inc. has announced the completion of a successful first-in-human clinical study performed at Vanderbilt University for their groundbreaking technology that radically improves minimally invasive endoscopic surgery. EndoTheia is pleased to report that all primary and secondary endpoints were successfully met with no 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 new device is designed to answer the FDA’s “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,” said Robert J. Webster, III, PhD, Co-Founder and President of EndoTheia. “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 completely 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,” stated Joshua Gafford, PhD, Co-Founder and Chief Technology Officer of EndoTheia.
“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,” said Gafford. He went on to thank Launch Tennessee for their support and for helping to fund the successful trial through a generous SBIR/STTR matching grant awarded to EndoTheia in August 2022.
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.”
The results of this clinical study 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.
About EndoTheia, Inc.
EndoTheia has developed a novel technology that radically 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. For additional information about EndoTheia and the FDA Breakthrough Device designation, visit www.endotheia.com.