EndoTheia’s Tech to Boost Endoscopic Surgery Earns Breakthrough Status

Nashville-based EndoTheia has earned breakthrough status from the U.S. Food and Drug Administration (FDA) for its technology to radically improve minimally invasive endoscopic surgery. It’s the seventh device in the ear, nose, and throat (ENT) category to ever receive this designation.
 
EndoTheia’s device uses technology based on extremely thin-walled, laser-machined metallic tubes to enable creation of highly flexible, steerable devices that can pass through standard endoscopes, while also carrying interventional tools within themselves.
 
The steerability opens the door for new diagnostic and therapeutic flexible endoscopy applications. The company’s platform technology can be used across urology, gastroenterology, neurology, and otology.
 
“EndoTheia was founded in 2018 to develop the next generation of medical devices for flexible endoscopy with the goal of increasing effectiveness through added flexibility and dexterity,” Robert J. Webster, III, Ph.D., co-founder and president of EndoTheia, told the press. “EndoTheia’s technology is currently the only viable option to add dexterity to flexible endoscopy, without re-engineering the endoscope itself. This empowers surgeons to provide much more accurate and precise therapeutic interventions in a wide range of clinical specialties.”
 
The National Institutes of Health corroborated this sentiment by providing millions of dollars of grant funding to EndoTheia to commercialize products in urology, gastroenterology, and otolaryngology.
 
S. Duke Herrell, III, MD, FACS, co-founder and chief medical officer of EndoTheia, added, “We are excited that the FDA has recognized the huge potential of EndoTheia’s technology through Breakthrough Device designation. The FDA has affirmed our view that there is nothing else out there capable of doing what we do for flexible endoscopy, and that our technology represents a breakthrough treatment option for patients who currently face irreversibly debilitating disease.”
 
EndoTheia has demonstrated feasibility in animal, cadaver, and tissue model studies in surgeries for biliary disease, ureteroscopy kidney stone removal, endoscopic submucosal dissection (ESD), endoscopic neurosurgery, sinus surgery, and middle ear surgery.