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CARLEN

Functional (Secondary) Mitral Regurgitation (FMR)

Feasibility / First-in-HumanActive

Key Facts

Indication
Functional (Secondary) Mitral Regurgitation (FMR)
Phase
Feasibility / First-in-Human
Status
Active
Company

About Nyra Medical

Nyra Medical is a clinical-stage medical device innovator targeting the significant unmet need in functional mitral regurgitation (FMR), a condition affecting millions of heart failure patients. Its core technology, CARLEN, is a transcatheter, single-leaflet augmentation device intended to correct regurgitation by enhancing the native leaflet, aiming to preserve natural valve function and treat a broader anatomical range than current edge-to-edge repair (TEER) systems. Led by industry veteran CEO Lori Chmura, the company has completed First-in-Human studies and is preparing for a U.S. Feasibility Study, backed by experienced medtech investors. Nyra aims to capture a portion of the multi-billion dollar transcatheter mitral valve repair market by addressing its current anatomical limitations.

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