EndoTheia Inc. Announces FDA Breakthrough Device Designation for Technology to Improve Endoscopic Surgery

NASHVILLE, Tenn.–(BUSINESS WIRE)–EndoTheia Inc., a Nashville-based medical device company, announced today that it has received priority status from the FDA, receiving the agency’s Breakthrough Device designation for its technology that radically advances minimally invasive flexible endoscopic surgery. It is only the seventh device in the ear, nose and throat (ENT) device category ever to receive this designation. This designation will streamline the regulatory process, allowing EndoTheia to rapidly introduce its innovative solution to physicians and patients.

EndoTheia’s Breakthrough Device uses basic technology originally invented at Vanderbilt and the University of Tennessee. Based on very thin-walled, laser-treated metal tubes, this technology allows for highly flexible, steerable devices that can pass through standard endoscopes while also carrying interventional instruments. The controllability these devices provide for endoscope-delivered instruments opens the door to new diagnostic and therapeutic applications for flexible endoscopy. EndoTheia’s disruptive platform technology can be used in many clinical specialties, including 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 efficiency through added flexibility and dexterity,” said Robert J. Webster, III, PhD, EndoTheia co-founder and president. “The EndoTheia technology is currently the only viable option to add dexterity to flexible endoscopy without redesigning the endoscope itself. This enables surgeons to provide much more accurate and precise therapeutic interventions across a wide range of clinical specialties. The National Institutes of Health have endorsed this view, awarding EndoTheia millions of dollars in funding to commercialize products in urology, gastroenterology and otolaryngology.

S. Duke Herrell, III, MD, FACS, EndoTheia’s co-founder and chief medical officer, added, “We are pleased that the FDA has recognized the tremendous potential of EndoTheia’s technology through Breakthrough Device designation. The FDA has confirmed our view that there is no other that could do what we’re doing for flexible endoscopy, and that our technology is a revolutionary treatment option for patients currently facing terminally debilitating diseases.

EndoTheia’s team of internationally recognized clinical and engineering experts includes Dr. Webster and Dr. Herrell, along with Joshua Gafford, PhD, Chief Technical Officer, and Caleb Rucker, PhD, Chief Scientific Officer and principal inventor of the company’s underlying technology. dr. Webster and Herrell, along with others, co-founded the Vanderbilt Institute for Surgery and Engineering (VISE), and Drs. Rucker directs the REACH Robotics Laboratory at the University of Tennessee, Knoxville. dr. Gafford has led EndoTheia’s internal development and commercialization efforts since the Company’s founding in 2018.

EndoTheia has demonstrated feasibility in animal, cadaver and tissue model studies in biliary surgery, ureteroscopy, endoscopic submucosal dissection (ESD), endoscopic neurosurgery, sinus surgery and middle ear surgery. EndoTheia’s technology can provide agility in any procedure where instruments are delivered using flexible endoscopes, including urology, neurology, interventional pulmonology, gastroenterology, colorectal, orthopedics, otolaryngology (ENT) and other subspecialties.

About EndoTheia, Inc.

EndoTheia has developed a revolutionary technology that radically improves minimally invasive endoscopic surgery. This technology harnesses the power of cleverly micromachined smart materials to create highly dexterous manipulators at millimeter and submillimeter scales to improve therapeutic outcomes in complex flexible endoscopic procedures. This proprietary technology was developed by EndoTheia’s founders at Vanderbilt University and the University of Tennessee at Knoxville with funding from the National Institutes of Health. For more information about EndoTheia and the FDA Breakthrough Device designation, visit www.endotheia.com.


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