Atlanta, Georgia, USA, October 27, 2026
Nyra Medical, Inc., a clinical-stage medical technology company developing transcatheter treatments for heart valve disease, has strengthened its leadership team as it advances clinical evaluation of its investigational CARLEN™ System for functional mitral regurgitation (FMR). The company appointed Suzanne Wallace, CRNP, as Vice President of Clinical and Market Development and Scott Tyler as Senior Director of Clinical Engineering and Development. The appointments come as Nyra builds on its first-in-human clinical experience and advances enrollment and clinical execution in its U.S. Early Feasibility Study (EFS). CARLEN is designed to improve the function of the mitral valve through a minimally invasive, catheter-based approach that aims to restore proper valve leaflet closure while preserving natural valve movement and the opening through which blood flows. The new appointments are intended to strengthen clinical development, procedural refinement, physician engagement and future commercialization planning as the company gathers additional evidence for this investigational technology.
Leadership Appointments Support Clinical Development
Suzanne Wallace brings more than 15 years of medical technology experience spanning clinical marketing, medical affairs and commercialization. Her previous industry roles include positions at Vesper Medical, Shockwave Medical and HeartWare, where she contributed to clinical and commercial strategies at different stages of company development. At Nyra Medical, Wallace will lead clinical and market development, working with physicians to communicate the investigational approach behind CARLEN and translate emerging clinical evidence into information that can support future adoption decisions. Her responsibilities will also help connect clinical research with market development as the company evaluates how its technology may fit into structural heart treatment pathways. Scott Tyler brings more than 12 years of experience in structural heart technologies, including transcatheter mitral and tricuspid interventions. At Edwards Lifesciences, he held engineering and therapy leadership roles supporting development and commercialization of the PASCAL™ Transcatheter Valve Repair System and the EVOQUE™ Transcatheter Tricuspid Valve Replacement System. At Nyra, Tyler will oversee clinical engineering and procedural development, collaborating with physicians and the product development team to translate clinical observations into device refinements and procedural best practices. Together, the appointments are designed to strengthen the connection between clinical experience, engineering development and future market readiness.
CARLEN System Targets Functional Mitral Regurgitation
Functional mitral regurgitation occurs when the mitral valve does not close effectively, allowing blood to flow backward from the left ventricle into the left atrium. The condition can be associated with changes in the heart’s structure or function and may contribute to symptoms such as breathlessness, fatigue and reduced exercise tolerance. Treatment decisions depend on the underlying cause, disease severity, patient characteristics and suitability for available medical or procedural interventions. Nyra’s CARLEN System, also known as the Cardiac Leaflet Enhancer, is an investigational transcatheter technology designed to augment the native mitral valve and restore leaflet coaptation—the point at which the valve leaflets meet to limit backward blood flow. Its single-leaflet implant design aims to improve closure while preserving the valve’s natural motion and orifice area. This approach is intended to address limitations associated with existing mitral valve interventions and potentially provide another option for selected patients with FMR. However, the system remains under clinical evaluation, and its safety and effectiveness must be established through further studies before its potential role in treatment can be determined.
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U.S. Early Feasibility Study Moves Forward
Nyra is advancing its U.S. Early Feasibility Study to build clinical evidence and refine the CARLEN procedure. Early feasibility studies typically assess the initial safety and performance of a new medical device in a limited group of patients, while helping investigators identify technical considerations and opportunities for procedural improvement. The company’s first-in-human experience has provided information to guide continued device and procedure development. As the U.S. study progresses, Nyra plans to expand clinical experience, improve procedural consistency and strengthen its understanding of how the system performs in real clinical settings. Wallace’s clinical and market development background and Tyler’s structural heart engineering experience are expected to support these objectives by connecting physician feedback with product development and clinical execution. The company is also considering clinical evaluation across additional studies and geographies as its program develops. The CARLEN System is investigational and is not approved for commercial use. Further evidence will be needed to establish its safety, performance and potential benefits for patients with functional mitral regurgitation. Nyra’s latest leadership appointments mark an organizational milestone as it works toward those goals and builds the clinical foundation needed for subsequent development decisions.
Source: Nyra Medical press release
