Early feasibility to global pivotal trial for mitral valve innovation

Valvular heart disease, a condition in which one or more of the heart’s four valves aredamaged, is one of the most common diseases in the US. Among this, mitral valvular disease i.e. conditions affecting the heart’s mitral valve, is one of the most diagnosed diseases in the recent era. The issue is large with an added unmet clinical need – there was no repositionable transcatheter mitral valve replacement (TMVR)system available for patients unsuitable for surgery. Recognizing this, our client developed Tendyne with a goal to improve both heart function and quality of life for patients.

Mobius was initially brought on to commence early-feasibility studies in Australia to gather early clinical data. As we demonstrated our high-level of excellence and expertise, the scope of the project expanded. A single protocol progressed to a global pivotal trialevaluating performance, safety and effectiveness.

The results were game-changing. The studies demonstrate promising survival, durable valve function, and marked improvements in heart failure symptoms and quality of life. Furthermore, a CE Mark was secured in 2020, and FDA approval achieved in 2025. Today the Tendyne TMVR solution is accessible to patients as an option over more invasive surgery while offering excellent outcomes.

At Mobius, we are expert sat taking innovations from blueprint to breakthrough, together. If you have an innovation that can advance care – reach out.

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