83,000 life-saving prosthetic valve operations were performed in the US in 2014
with an average cost of $164k/procedure and $192k/procedure for re-replacement.
The global valve market is expected to surpass $ 4.9 B in 2017. There are two
types of prosthetic heart valves for replacement: mechanical and bioprosthetic.
Mechanical valves are very durable, but patients require daily anticoagulant
therapy because of an increased risk of thrombosis. Bioprosthetic valves do not
require anticoagulant therapy, but have other drawbacks, particularly leaflet
calcification, which limits durability and necessitates re-replacement. Both
options elevate the risk of endocarditis, a life-threatening infection of the
inner heart lining. OneValve aims to address the limitations of current prosthetics.
OneValve is a polyurethane heart valve (depicted: mitral valve prototype) that is non-thrombogenic, and capable of
mimicking native valve mechanics, micro-structure, anatomy and function in all
positions. Most importantly, the polyurethane core is replaced over time by
functional host tissue without calcifying. Animal studies have yielded
exciting results showing that the polyurethane valve will work well, reduce
complications, reduce healthcare costs, and save thousands of lives. Once it achieves clearance and commercialization, OneValve
will define a new generation of valvular heart disease technology, expanding
the cardiac surgeon’s ability to save lives efficiently while minimizing