EndoTheia

EndoTheia, founded in 2018, specializes in developing advanced medical devices for flexible endoscopy. The company's core technology is based on extremely thin-walled, laser-machined metallic tubes that enable the creation of highly flexible, steerable devices capable of passing through standard endoscopes while carrying interventional tools. This innovation aims to enhance the flexibility and dexterity of endoscopic procedures, potentially improving therapeutic yields across various clinical specialties including urology, gastroenterology, neurology, and otolaryngology.

In July 2023, EndoTheia completed a successful first-in-human clinical study at Vanderbilt University for its novel endoscopic surgery technology. The study met all primary and secondary endpoints without adverse events. The company's device is designed to address the FDA's concerns regarding infection rates in reusable duodenoscopes by providing inexpensive, disposable components that allow standard endoscopes to perform the same functions. This approach aims to benefit the approximately 700,000 patients suffering from biliary disease annually in the US.

EndoTheia's technology has received recognition from regulatory bodies. In January 2023, the FDA granted Breakthrough Device designation to EndoTheia's technology for improving minimally invasive flexible endoscopic surgery in the Ear Nose and Throat (ENT) category. This designation is expected to streamline the regulatory process, facilitating faster market entry. The company plans to submit an FDA 510(k) application for its biliary product later in 2023, with intentions to expand its product line to other medical specialties.

In November 2023, Nissha Medical Technologies entered into a capital and business partnership with EndoTheia. This collaboration aims to leverage both companies' design and engineering capabilities, along with Nissha Medical Technologies' manufacturing expertise, to drive innovation in medical device OEM platforms and create new opportunities for steering technology in devices.