Nyra Medical Launches First-in-Human Study of CARLEN Leaflet Enhancer for Functional Mitral Regurgitation

Oct 22, 2025 22:11 CST Updated 22:11

Nyra Medical

Medical Device Developer

Nyra MedicalAnnounces the official launch of its Mitral Valve Enhancer---CARLENFirst-in-Human Clinical Study (FIM) for Patients with Functional (Secondary) Mitral Regurgitation (FMR)Currently, FIM has completed clinical enrollment for more than 10 patients, with the majority having at least 30 days of follow-up data available.

Expert Evaluation

"We are entering a new era of transcatheter therapies, and truly effective mitral valve repair has finally become a reality. The existing data is encouraging, driving us to move forward with both caution and determination."

---Azeem Latib Montefiore Medical Center

"This technology opens up a promising treatment pathway for patients, and early results suggest we may be at the threshold of a significant clinical breakthrough."

---Susheel Kodali New York Presbyterian Medical Center

"For interventional ultrasound physicians, CARLEN achieves technological innovation while maintaining traditional imaging workflows. With an unprecedented clear view of leaflet coaptation and functional status, we can confidently focus on optimizing treatment outcomes."

---Edwin Ho Montefiore Medical Center

Executive Evaluation

"Obtaining the first set of human data is a key milestone for all medical device companies. Our early clinical results confirm the potential of this technology platform to reshape the treatment landscape for structural heart disease. As the global incidence of heart failure continues to rise and treatment options for FMR patients remain limited, Nyra Medical's solution is expected to offer a differentiated minimally invasive treatment pathway with broad potential applicability."

---Lori Chmura CEO of Nyra Medical

CARLEN

CARLENIt is a novel type of natural leaflet augmentation implant, using a femoral artery/femoral vein delivery system to secure the leaflet augmentation implant.Mitral or tricuspidLeafletUp.

The enlarged native leaflets increase the valve's coaptation surface and eliminate regurgitation. After a few weeks,CARLENThe implant is engulfed by a layer of endothelialized tissue, providing localized augmentation of native leaflets tailored to the patient's valve geometry, addressing issues for a large number of patients.

CARLEN InstrumentFully Repaired FMR

CARLENCapable of fully repairing FMR without the risk of mitral stenosis. Using a single leaflet attachment mechanism, multiple adjacent implants can be deployed from one commissure of the valve to another without the concern of inducing mitral stenosis—a significant challenge faced by existing TEER devices.

Pre-implantation

After implantation

CARLEN Safety

Within 30 days after implantation,CARLENIt has already endothelialized and formed a thin layer of natural tissue on its surface. This makesCARLENIt has excellent blood compatibility and does not require the use of blood thinners. The leaflets remain highly flexible, preserving the mobility of the implant.

CARLENDemonstration

Nyra Medical

Nyra MedicalA new physiological adaptive, transcatheter mitral and tricuspid valve repair system is under development. The core technology focuses on enhancing the native heart valve leaflets through an implant that integrates into the native valve.LeafletIn China, and correct valve regurgitation without causing other side effects.