First Patient Enrolled in ENHANCE EFS of Nyra’s Carlen TMVR System for FMR

July 10, 2026—Nyra Medical, Inc. announced enrollment of the first patient in the ENHANCE early feasibility study (EFS) of the company’s investigational Carlen system.

The company stated that the ENHANCE EFS is designed to evaluate the safety, feasibility, and procedural performance of the Carlen system in patients with symptomatic functional mitral regurgitation (FMR). The multicenter study will include leading structural heart programs in the United States and Brazil. The company noted that commencement of the ENHANCE EFS comes after encouraging first-in-human clinical experience in which Carlen restored native mitral valve coaptation while preserving physiologic valve function in treated patients.

According to Nyra Medical, the Carlen system is designed to augment the native mitral leaflet without sutures, tethers, or permanent alteration of valve anatomy. The device is intended to restore leaflet coaptation while maintaining physiologic leaflet motion and preserving future treatment options.

InCor—University of São Paulo Hospital in São Paulo, Brazil, is the first enrolling clinical site in Brazil. The Principal Investigator at InCor is Director of Interventional Cardiology, Professor Alexandre Abizaid, MD.

“The first enrollment in the ENHANCE study marks an important step forward in evaluating a fundamentally different approach to treating functional mitral regurgitation,” commented Prof. Abizaid in the Nyra press release. “The ability to enhance native leaflet function while maintaining the natural mechanics of the mitral valve represents an exciting area of innovation, and we are pleased to contribute to the clinical evaluation of this technology.”

Gagan Singh, MD, Principal Investigator and Director of the Structural Heart Program at UC Davis Health in Sacramento, California, added, “FMR remains one of the most challenging conditions we treat because many patients have complex anatomy or underlying ventricular disease that can limit existing transcatheter repair options.” UC Davis Health is the first United States enrolling center in the ENHANCE EFS, noted Dr. Singh in the press release.