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Our one-of-a-kind valve offers durability and avoids common failure complications, such as calcification and valvular degeneration of the pericardial leaflets, unlike other valves currently available or being developed.

 

The efficacy of our valves has been demonstrated showing successful durability after 200,000+ cycles and performing well in acute and chronic tests.

Our customers can be defined in many ways. Customers of our product will ultimately be heart valve replacement patients seeking a better, long-term solution to valve replacement yet retaining an active lifestyle.

Customers can also be represented by the "strategic" companies that have created this patient option but lack the urgent need to introduce transformational improvements to the market segment that they created.

Customers can also be defined as payors - whereby we will be providing a more cost-friendly solution. 

Unlike our competitors, our valve addresses the durability problem, requires no anticoagulation therapy for patients, and is easily scalable for mass production, and a reduction in production complexity and overall cost.

The heart valve replacement rate is expected to grow in the coming decade. 

The global transcatheter heart valve replacement (THVR) market is expected to be $11.63 billion by 2027. Transcatheter aortic valve replacement (TAVR), which constitutes most of the THVR market, is expected to be $9.3 billion by 2027. This is largely caused by a growing aged population and THVR approval for younger and lower surgical risk patients.

The 2019 FDA approval for low-risk (younger patients) is contributing to this market expansion. Valves will need to last 15 years or more in younger patients treated with TAVR. Structural Valve Deterioration (SVD) is the driving factor behind the need for increased durability.