Wednesday, July 19, 2023
EndoTheia, Inc. is excited to announce the completion of a successful first-in-human clinical study conducted at Vanderbilt University for their groundbreaking technology that significantly enhances minimally invasive endoscopic surgery. The company is pleased to report that all primary and secondary endpoints were achieved without any adverse events. This recent development follows the FDA's recognition of EndoTheia's ENT endoscopic surgery technology as a Breakthrough Device.
EndoTheia's novel device addresses the FDA's call for new, cost-effective, disposable devices to treat biliary disease and combat the concerning infection rates associated with difficult-to-sterilize reusable duodenoscopes. "EndoTheia takes pride in responding to the FDA's call-to-action in a unique and unconventional manner," said Robert J. Webster, III, PhD, Co-Founder and President of EndoTheia. Rather than incremental advancements or costly fully disposable endoscope solutions, the company took a fresh approach.
The system developed by EndoTheia eliminates the need for the FDA-concerned duodenoscopes and replaces them with affordable, disposable components that enable standard endoscopes to perform their intended functions. Joshua Gafford, PhD, Co-Founder and Chief Technology Officer of EndoTheia, expressed enthusiasm about the successful clinical study and its significance for the 700,000 patients suffering from biliary disease annually. He emphasized the major milestone achieved and extended gratitude to the patients, clinical investigators, and Launch Tennessee for their support and funding.
Dr. Keith Obstein, Professor of Medicine in the Division of Gastroenterology at Vanderbilt University Medical Center, acknowledged the device's ability to visualize the duodenal papilla en face using a standard forward-viewing endoscope. This breakthrough has the potential to eliminate the risk of infection associated with reusable duodenoscopes, benefitting patients, hospitals, and healthcare systems.
The positive outcomes of the clinical study will support EndoTheia's FDA 510(k) application for its biliary product, scheduled for submission later this year. Additionally, EndoTheia plans to leverage its proprietary technology in various medical fields, including urology, neurosurgery, interventional pulmonology, gastroenterology, orthopedics, and otolaryngology, thereby expanding their product lines and making a significant impact on healthcare.