Nyra Medical Wins 2026 Jon DeHaan Foundation Award for Novel Mitral Valve Repair Technology
Key Insights
Nyra Medical (search) received the 2026 Jon DeHaan Foundation (search) Award for Cardiovascular Innovation at EuroPCR 2026 in Paris for its CARLEN™ System, a novel transcatheter mitral valve repair technology.
The CARLEN System (search) is designed to treat functional mitral regurgitation (search) (FMR) by augmenting leaflet coaptation while preserving native valve anatomy, addressing limitations of current transcatheter therapies.
Early first-in-human clinical results presented by Dr. Susheel Kodali showed encouraging safety and performance outcomes, with 12-month follow-up data expected at New York Valves on June 24, 2026.
Nyra Medical (search) has been selected as the recipient of the 2026 Jon DeHaan Foundation (search) Award for Cardiovascular Innovation, presented during EuroPCR 2026 in Paris, France — the world's leading course in interventional cardiovascular medicine. The Atlanta-based medical device company was honored for its development of the CARLEN™ System, a novel transcatheter mitral valve repair technology designed to preserve native valve function while expanding treatment options for patients with functional mitral regurgitation (search) (FMR).
The award follows Nyra's successful first-in-human clinical experience and reflects growing recognition of the company's differentiated approach to mitral valve repair.
"Receiving the Jon DeHaan Foundation (search) Award is an extraordinary honor and a meaningful validation of both our technology and our mission," said Lori Chmura, Chief Executive Officer of Nyra Medical (search). "CARLEN was developed to address critical limitations in current transcatheter mitral repair approaches and expand treatment options for patients living with functional mitral regurgitation (search)."
A Differentiated Approach to Mitral Valve Repair
The CARLEN System (search) is an investigational single-leaflet implant that restores coaptation while preserving the valve's natural motion and orifice area. Unlike existing transcatheter therapies, the system is designed to augment leaflet coaptation while maintaining native anatomy and supporting future treatment flexibility — a feature that may prove critical for patients who require additional interventions over time.
Functional mitral regurgitation (search) affects millions of patients worldwide and remains associated with significant morbidity, mortality, and healthcare utilization. Despite advances in transcatheter therapies, many patients remain untreated or are not optimal candidates for existing approaches. Nyra Medical (search)'s technology was specifically developed to address this unmet need.
"The Jon DeHaan Foundation (search) Award is intended to recognize innovations that address meaningful unmet clinical needs while demonstrating strong scientific, clinical, and commercial potential," said Tom DeHaan, Jon DeHaan Foundation Trustee. "Nyra Medical (search)'s CARLEN technology represents a thoughtful and differentiated approach to mitral valve repair."
Early Clinical Evidence and Upcoming Data
The clinical results were presented at EuroPCR 2026 by Dr. Susheel Kodali, Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Irving Medical Center and Avanessians Professor of Medicine at Columbia University. Dr. Kodali, a leader in the development and adoption of transcatheter structural heart therapies, highlighted the encouraging safety and performance outcomes observed to date.
"The early clinical results support continued evaluation of CARLEN as a promising new approach to mitral valve repair," said Dr. Kodali. "As physicians, we are continually seeking therapies that can expand treatment options for patients with mitral regurgitation while preserving future therapeutic pathways. These early findings provide an important foundation for continued clinical study."
Nyra Medical (search) has announced plans to share new data at New York Valves on Wednesday, June 24, 2026, including 12-month outcomes from the first patients treated in its first-in-human study. The presentation is expected to provide the longest-term clinical follow-up reported to date for the CARLEN System (search) and further demonstrate the potential of the technology to deliver durable mitral regurgitation reduction while preserving native valve function.
About the Jon DeHaan Foundation (search)
The Jon DeHaan Foundation (search) has become one of the most respected organizations supporting innovation in cardiovascular medicine. Through its annual award program presented at EuroPCR, the Foundation identifies emerging technologies with the potential to improve patient care and accelerate the translation of breakthrough concepts into clinical practice. Recipients are selected based on factors including clinical need, technological innovation, intellectual property, proof of concept, regulatory readiness, and commercial potential.
Chmura reinforced the company's commitment to advancing the technology: "This recognition reinforces our belief that preserving native valve function through a less complex and more adaptable approach has the potential to improve outcomes for a broader patient population. We are grateful to the Foundation, EuroPCR, our clinical investigators, the patients and our team for helping advance this important work."