Second dose of good news for EndoTheia Inc.
The start-up announced the completion of a successful first in-human clinical study performed at Vanderbilt University for its groundbreaking technology that radically improves minimally invasive endoscopic surgery.
Nashville’s EndoTheia Inc. has received another dose of good news.
The start-up announced the completion of a successful first in-human clinical study performed at Vanderbilt University for its groundbreaking technology that radically improves minimally invasive endoscopic surgery. This news follows the company’s announcement in January that the Food and Drug Administration (FDA) 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, Co-Founder and President of the company. “We took a look at what others were doing within the space and saw mostly incremental advancements and/or costly fully disposable endoscope solutions.”
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.
According to the news release announcing the latest milestone, 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.