EndoTheia Announces Successful Clinical Study Results for a Novel Medical Device for Endoscopic Surgery

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.

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

EndoTheia Inc., a Nashville-based medical device company, announced today that it has gained priority status from the FDA by receiving a Breakthrough Device designation from the agency for its technology that radically improves minimally invasive flexible endoscopic surgery. It is only the seventh device in the category of Ear Nose and Throat (ENT) devices to ever receive this designation. The designation will streamline the regulatory process, enabling EndoTheia to rapidly bring its innovative solution to doctors and patients.

EndoTheia’s Breakthrough Device leverages foundational technology that was originally invented at Vanderbilt and the University of Tennessee. 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 steerability that these devices provide to endoscope-delivered tools opens the door for new diagnostic and therapeutic applications of flexible endoscopy. EndoTheia’s disruptive platform technology can be used across a vast array of 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 effectiveness through added flexibility and dexterity,” stated Robert J. Webster, III, PhD, Co-Founder and 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.” The National Institutes of Health has corroborated this sentiment by providing millions of dollars of grant funding to EndoTheia to commercialize products in urology, gastroenterology, and otolaryngology.

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’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 primary inventor of the Company’s underlying technology. Drs. Webster and Herrell, along with others, co-founded the Vanderbilt Institute for Surgery and Engineering (VISE), and Dr. Rucker leads the REACH Robotics Lab at the University of Tennessee, Knoxville. Dr. Gafford has been the leading the internal development and commercialization efforts at EndoTheia since the Company’s incorporation in 2018.

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. EndoTheia’s technology can provide dexterity in any procedures where tools are delivered through flexible endoscopes, including urology, neurology, interventional pulmonology, gastroenterology, colorectal, orthopedics, otolaryngology (ENT), and other sub-specialties.

About EndoTheia, Inc.

EndoTheia has developed a groundbreaking technology that radically improves minimally invasive endoscopic surgery. This technology harnesses the power of intelligently micro-machined smart 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 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.