Novel Over-the-Scope Platform for Control of Variceal Bleeding

Endonavis, Llc, Louisville KY

Investigators

Abstract

Abstract Upper gastrointestinal (UGI) bleeding from variceal hemorrhage marks a major turning point in the life of a patient with cirrhosis. Up to 20% of these patients will die from the event. A major shortcoming in the treatment of UGI variceal hemorrhage stems from the lack of a safe and effective method for controlling refractory bleeding episodes and maintaining that control until a long-term, definitive therapy can be deployed. Definitive therapy is generally only available at specialized/tertiary centers. Even at these locations, assembly of the therapeutic team may take hours before the patient receives the required procedure to stop the bleeding. Massive resuscitation efforts may be required to maintain the patient’s life prior to definitive therapy. Stop gap measures do exist today, in the form of blindly placed hemostatic balloons. Many shortcomings have been attributed to the use of these devices, including esophageal perforation and death. Their ability to stop bleeding varies by location of the bleeding site, with control rates as low as 0-50% for gastric varices and 50-80% for esophageal varices. Few clinicians properly deploy these devices, which contributes to the low rates of utilization despite an urgent need. EndoNavis is a rising medical device company focusing on the focused application of single-use, disposable, low profile endoscopes for novel clinical applications in the GI space. Our pioneering Over-the-Scope technology provides new approaches to common clinical disorders. In the setting of variceal hemorrhage, our approach of endoscopic visualization during placement ensures proper alignment of the balloon with the bleeding site. Furthermore, direct visualization allows for active monitoring of bleeding cessation. The scope of this project will focus on mating existing single-use endoscope technology developed by EndoNavis with a novel balloon design. The project has been tailored to assess essential characteristics of this technology in benchtop anatomic and bleeding models to verify function and efficacy. Specific Aim 1 will focus on designing a therapeutic balloon/catheter capable of passage through the UGI anatomy with appropriate optical qualities to ensure excellent endoscopic visualization. Specific Aim 2 will establish the optimal balloon design to control bleeding from both esophageal and gastric variceal sources. Specific Aim 3 will assess feasibility of the bleeding control platform in conducting post-treatment monitoring. The overall deliverable from this project will consist of a functional bleeding control system ready for next stage verification and validation testing. EndoNavis will seek approval via the 510(k) pathway. EndoNavis has substantial experience navigating the regulatory hurdles required for single-use endoscopes. This Phase I grant will support the steps required to establish design freeze for this technology platform. Additional funds from either a Phase II grant or A round of investor funding will allow EndoNavis to take the final steps to commercialization. EndoNavis will likely utilize current OEM partners to fully take this platform to market. An effective, user-friendly and safe alternative to current technology will be a welcome addition, providing a sure path for entry into the $850B hemostasis segment of the GI market.