Q&A with Dr. Thubrikar of Thubrikar Aortic Valve, Inc.

Our valve is significantly more durable. TAVR is the biggest revolution in valve replacement procedures because it eliminates the need for open-heart surgery. It is similar to the revolution of coronary artery stents, which eliminated the need for bypass surgeries. TAVR has become the standard of care for Surgery-Ineligible and High-Risk patients and the $5 Billion market for TAVs is expected to exceed $10 Billion.

However, the majority of patients are Medium- and Low-Risk patients, and are younger, so TAVR companies must prove that their valve has significantly more durability. Obviously, since most major TAVR companies also sell surgical valves, they could show that the durability of their TAVR valve is similar to that of their surgical valves. However, none of the companies have done so, and they are stuck. Ours is the only company claiming to have a valve with durability similar to - or better than - a surgical valve, which poses the biggest threat to incumbent TAVR companies.

When surgical heart valves were introduced in the 1960’s, they would start to fail at 5-6 years, mostly due to valvular calcification. When improvements were implemented, no one could wait for 10 years of clinical data to know if the valve durability was improved. Valve performance in young sheep at 5 months became a standard model, because the valve calcifies much faster in young sheep and the result can be extrapolated to young patients. As anti-calcification treatments for bioprosthetic valves began to evolve, the sheep model was used routinely and valves showing less calcification in sheep would be accepted as more durable for patients. In other words, the degree of calcification in sheep is used as the gold standard for comparing valve durability - rather than long-term clinical data. Our Optimum TAVI valve shows similar - and possibly less - calcification than a popular surgical valve in sheep, and thus we claim increased durability.

Not easily and not without infringing on our patent, we believe. If they could, they would already have done so. Edwards Lifesciences, the leader in heart valves, discontinued their self-expanding valve just last year, and in the majority of cases TAVR companies have not developed original products. Developing a new valve is an incredibly involved endeavor requiring many years of research and several million dollars because it is a highly specialized and regulated product. Hence, the large medical device corporations have acquired other companies rather than develop their own valve.