Oct. 22, 2025 — Nyra Medical, a leading innovator in structural heart therapies, has announced the initiation of its first-in-human clinical study evaluating its novel Cardiac Leaflet Enhancer (CARLEN) System in patients with functional (secondary) mitral regurgitation (FMR).
The study, focused on clinical safety and technical performance, has successfully enrolled more than 10 patients, many with at least 30-day follow-up to date. The early clinical experience marks a significant milestone in the company's mission to transform the treatment of mitral valve disease.
Nyra Medical's proprietary transcatheter technology is designed to repair FMR by augmenting the native mitral valve. The CARLEN System is a single-leaflet implant designed to restore coaptation while preserving the valve's natural motion and orifice area. With the ability to implant on either the anterior or posterior leaflets, the CARLEN System offers broad clinical applicability and minimal anatomical or clinical exclusions. This versatile design aims to address the anatomical and functional challenges that have limited the success of earlier therapies.
"Achieving first-in-human data is a major milestone event for any medtech company," said Lori Chmura, CEO of Nyra Medical. "Nyra's early clinical results underscore the potential of this platform to redefine how we treat structural heart disease."
With heart failure incidence rising globally, and limited treatment options for patients with FMR, Nyra Medical's solution intends to offer a differentiated, minimally invasive approach with broad potential applicability.
"We are entering a new era of transcatheter therapy where meaningful mitral repair is finally within reach. The data we've seen so far is compelling and gives us confidence to push forward thoughtfully but decisively," said Dr. Azeem Latib, Director of Interventional Cardiology and Structural Heart, Montefiore Medical Center. Dr. Susheel Kodali, Director of Structural Heart & Valve Center, New York Presbyterian Medical Center, added "This approach offers a promising path forward for patients. The early results suggest we may be on the cusp of an important clinical advancement."
The CARLEN implantation procedure leverages many parallels to the established workflow, utilizing familiar echocardiographic guidance and intraprocedural imaging to support precise positioning and real-time assessment of valve function. Dr. Edwin Ho, Director of the Structural Heart Imaging at Montefiore Medical Center, commented "For interventional echocardiographers, CARLEN introduces innovation without adding complexity. By maintaining the familiar imaging workflow, we can focus on optimizing outcomes with confidence as we visualize leaflet engagement and function with remarkable clarity."
This ongoing first-in-human study is being supported by leading US Physicians Edwin Ho, Azeem Latib, and Susheel Kodali. It is being conducted at leading international centers in the Republic of Georgia, Paraguay and Uzbekistan with the renowned Drs Ebner, Gogorishvili, Shaburishvili, Yuldoshev, and Djafarov. Enrollment is expected to broaden over the coming months as additional patients are screened and treated. Insights gained from this early clinical experience will play a critical role in refining procedural workflows and device performance ahead of expanded clinical investigation.
The data will directly inform the company's global regulatory strategy, including engagement with the U.S. Food and Drug Administration (FDA) and other regulatory bodies. These findings will shape the design of future clinical studies, including a potential early feasibility study and pivotal trial in the United States. Early analysis from the First-in-Human study will be presented at the upcoming TransCatheter Therapeutics (TCT) Conference in San Francisco on Oct. 28, 2025 by Dr. Susheel Kodali.
Visit nyramedical.com for more information.
October 31, 2025 
