A company co-founded by Robert J. Webster III, Richard A. Schroeder Professor of Mechanical Engineering and associate professor of medicine and urology at Vanderbilt University, has received a breakthrough device designation from the U.S. Food and Drug Administration that could open the door for new diagnostic and therapeutic applications of flexible endoscopy.
The designation given to EndoTheia, Inc., a Nashville, Tenn.-based medical device company, will streamline the regulatory process, enabling the company to rapidly bring its solution to doctors and patients. Such designations are granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
EndoTheia’s device leverages foundational technology that was originally invented at Vanderbilt and the University of Tennessee-Knoxville. This technology, based on extremely thin-walled, laser-machined metallic tubes, enables the creation of highly flexible, steerable devices that can pass through standard endoscopes, while also carrying within themselves interventional tools.
The company’s platform technology can be used across a vast array of clinical specialties, including urology, gastroenterology, neurology, and otology to radically improve minimally invasive flexible endoscopic surgery. The device will particularly benefit ear, nose, and throat (ENT) specialists. It is only the seventh device in the ENT category to receive the FDA designation, according to Webster.
“EndoTheia was founded in 2018 to develop the next generation of medical devices for flexible endoscopy, with the goal of increasing therapeutic efficacy through added flexibility and dexterity,” said Webster, who is also president of EndoTheia. “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.”
S. Duke Herrell, III, MD, FACS, co-founder, and chief medical officer, added, “The FDA has affirmed … that our technology represents a breakthrough treatment option for patients who currently face irreversibly debilitating diseases.” Herrell is also a professor in the Department of Urology at Vanderbilt University Medical Center.
EndoTheia’s team of internationally recognized clinical and engineering experts includes Webster and Herrell, along with Joshua Gafford, Ph.D., chief technical officer and Caleb Rucker, Ph.D., chief scientific officer, and primary inventor of the company’s underlying technology. Webster and Herrell, along with others, co-founded the Vanderbilt Institute for Surgery and Engineering (VISE), and Rucker leads the REACH robotics lab at the University of Tennessee-Knoxville. Gafford has led the internal development and commercialization efforts at EndoTheia since the company’s incorporation.
EndoTheia has received millions of dollars in grant funding from the National Institutes of Health to commercialize products in urology, gastroenterology, and otolaryngology.