Sutra TMVR delivery system development and VandV testing

PROJECT SUMMARYMitral regurgitation (MR) is the most prevalent valvular heart disease in the U.S. There are 4.1 million patients in the US with moderate to severe MR requiring treatment. However, only approximately 50,000 patients in the U.S. undergo surgery for MR each year due to concerns about procedural complexity and patient safety. There is great enthusiasm among the heart valve industry and clinicians to develop transcatheter mitral valve repair (TMVRep) and replacement (TMVR), offering less invasive treatment options for MR patients. After more than a decade of development, only one device, the MitraClip, has been approved by the FDA and is commercially available. While safe with proven clinical benefits, the MitraClip is not effective in eliminating MR in all patients, and even mild MR is associated with increased morbidity and mortality. TMVRep and TMVR devices in development are only safe and effective for carefully selected patients.In this proposal, Dura Biotech proposes to develop the novel Sutra Hemi-valve TMVR system which combines the best aspects of surgical MV replacement, TMVR, and TMVRep approaches to pose an elegant and effective solution for MR. The implanted Sutra Hemi-valve TMVR system replaces the native posterior mitral leaflet with a novel tri-leaflet prosthetic valve that mimics the native posterior mitral leaflet in design and function, to provide predictable and consistent MR reduction. Because the Sutra Hemi-valve TMVR system only covers the posterior portion of the MV, it eliminates left ventricular outflow tract obstruction seen commonly with other replacement devices, and enables a smaller device profile for safe, trans-septal access and delivery. The feasibility of the Sutra Hemi-valve TMVR system has been demonstrated through rigorous bench and preclinical animal testing.The goal of this CRP project is to finalize the late stage development and commercialization of the novel Sutra Hemi-valve TMVR system. To achieve this goal, in aim 1 of this project, the Sutra delivery system will be optimized through GLP in vivo animal studies. In aim 2, verification-and-validation tests will be performed on the final Sutra system design, and the data will be complied for submission of an Early Feasibility Study (EFS) application to the FDA. Successful completion of this CRP project will help Dura cross the “valley of death” between development and commercialization to help bring the Sutra Hemi-valve TMVR system to market and serve millions of patients suffering from MR with little-to-no treatment options.PROJECT NARRATIVEThe goal of this CRP project is to further the late stage development and commercialization efforts of the Sutra Hemi-valve transcatheter mitral valve replacement (TMVR) system, a novel minimally invasive medical device for treatment of patients with mitral regurgitation (MR). Currently the approximately 4.1 million patients in the U.S. with moderate to severe MR have limited treatment options. The Sutra system was designed to address this critical clinical need and business opportunity.