Scope: Mark Fritz:State Matching: Kentucky Network for Innovation & Commercialization (#KYNETIC#) Yr 3

Most commercially available channeled endoscopes are single channel devices, which means the working channel used to pass instruments is the same one used for other purposes such as suction and bleeding control. With the expansion in interventional endoscopic procedures in gastroenterology, pulmonology, and otolaryngology, doctors are observing more procedure-related bleeding. During such procedures, suction becomes necessary to remove blood and fluid from a field to allow for better visualization which is key for procedure success and saves valuable time in the operating room. Due to the limited lumen size of the endoscopic channel, the actions of suction and bleeding control (coagulation) are typically performed sequentially in time because none of the commercial available coagulator devices are equipped with a suction function. Thus, there is an unmet need for a coagulation device in these fields with simultaneous suction capability that can work through an endoscope. We have developed a working prototype of a suction coagulator device that combines the suction and coagulation functions in a long and small-diameter flexible tubing allowing it to pass through an endoscope. Working with the University of Kentucky, we have also filed a PCT utility patent in March 2021 for this novel device. We now seek funding to further refine the prototype and test the device. We believe this work will provide crucial missing pieces to not only help advance the technology development but also raise interest for industrial collaboration and partnership in commercialization of the technology. With KYNETIC funding, we plan to develop several more working iterative prototypes and complete additional validity testing and in vitro safety data. We aim plan to further develop our prototype and, by June 2022, have a working setup by which to provide further in vitro testing in simulated models to further validate our device and concept. If our concept is not able to work in the in vitro setting by June 2022, that would be our nogo date. With the prototype and patent protection expected during 2022 or early 2023, we would then plan to submit an STTR grant for further funding. Our next milestone after that setup would then be to file for an Investigational device exemption with the FDA to test the safety of it in vivo and ultimately file for an FDA 510(k) clearance, aiming for late 2023. After FDA clearance, we would seek partnerships to help bring it to market either through distribution companies or acquisition. Our team has several strengths in that we all have backgrounds in pushing the technology within our field to the limit, developing new techniques and surgeries, experience in intellectual property and startups in the past and actively pursuing further resources.