Global clinical program expands to the United States and Brazil following successful First-in-Human experience, marking a major milestone in development of the CARLEN™ System

ATLANTA, July 7, 2026 /PRNewswire/ -- Nyra Medical, Inc., a clinical-stage medical technology company developing a novel transcatheter solution for functional mitral regurgitation (FMR), today announced enrollment of the first patient in the ENHANCE Early Feasibility Study (EFS) evaluating the investigational CARLEN™ System.

The enrollment represents a significant milestone in Nyra Medical's clinical development strategy and follows encouraging First-in-Human clinical experience where CARLEN restored native mitral valve coaptation while preserving physiologic valve function in treated patients. The ENHANCE EFS is designed to evaluate the safety, feasibility, and procedural performance of the CARLEN System in patients suffering from symptomatic functional mitral regurgitation.

The multicenter study includes leading structural heart programs in both the United States and Brazil and represents the next phase of Nyra's global clinical evidence generation strategy.

"The initiation of our ENHANCE Early Feasibility Study reflects years of engineering innovation, disciplined clinical preparation, and close collaboration with world-renowned physicians," said Jennifer Mischke, Senior Vice President of Clinical, Regulatory & Quality at Nyra Medical. "This milestone validates both the strength of our clinical development program and our commitment to bringing physicians an innovative treatment option designed to expand access to transcatheter mitral valve repair. We are excited to begin generating the clinical evidence that will support future regulatory and commercial milestones."

Unlike conventional transcatheter edge-to-edge repair approaches, the investigational 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.

"The first enrollment in the ENHANCE study marks an important step forward in evaluating a fundamentally different approach to treating functional mitral regurgitation," said Prof. Alexandre Abizaid, Director of Interventional Cardiology and Principal Investigator at InCor - University of São Paulo Hospital, the first enrolling clinical site in Brazil. "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. I would like to extend my congratulations to Dr. Fabio Sandoli de Brito for performing the first procedure and thank the multidisciplinary team whose collaboration and commitment made this achievement possible. Milestones like this are only possible through exceptional teamwork and a shared dedication to advancing patient care."

"Functional mitral regurgitation 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," said Dr. Gagan Singh, Principal Investigator and Director of the Structural Heart Program at UC Davis Health. "The CARLEN System introduces a differentiated repair strategy that is intended to alleviate the limitations of current transcatheter approaches, addressing an important unmet clinical need and expanding the options available to physicians treating these patients. We are excited to be the first U.S. center participating in the ENHANCE Early Feasibility Study and look forward to supporting the clinical evidence needed to evaluate this novel therapy."

The ENHANCE Early Feasibility Study is evaluating the safety and performance of the CARLEN System in patients with symptomatic moderate-to-severe or severe functional mitral regurgitation. The study is being conducted at leading structural heart centers in the United States and internationally. It is a prospective, multi-center, single-arm study with safety, performance and clinical endpoints following patients through 5-years.

"This enrollment represents more than the beginning of another clinical study," said Lori Chmura, Chief Executive Officer of Nyra Medical. "It reflects the steady execution of our long-term strategy to redefine transcatheter mitral valve repair. We have assembled an exceptional team, partnered with leading structural heart physicians, and developed a differentiated technology designed to address a substantial unmet clinical need. We believe ENHANCE EFS positions Nyra for an exciting next phase of growth as we continue building the clinical evidence supporting the CARLEN platform."

The ENHANCE Early Feasibility Study represents the culmination of years of disciplined technology development and close collaboration with internationally recognized leaders in structural heart disease. Nyra Medical recognizes the important contributions of Dr. Edwin Ho, Dr. Azeem Latib, and Dr. Susheel Kodali, whose support during the first cases, as well as clinical expertise and strategic guidance have helped shape the evolution of the CARLEN™ System and the clinical program that has led to this milestone.

The company expects to continue enrolling patients at additional leading structural heart centers as part of its global clinical program.

About Nyra Medical

Nyra Medical is a privately held medical device company redefining transcatheter repair for functional mitral regurgitation with the CARLEN™ System. The CARLEN System is an investigational device designed as a single-leaflet implant that restores coaptation while preserving the valve's natural motion and orifice area. Visit nyramedical.com for more information.

Forward Looking Statements

This press release contains "forward-looking statements" concerning the development of Nyra Medical's products, their potential benefits and attributes, and the company's expectations regarding its prospects. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Nyra Medical undertakes no obligation to update these statements as circumstances change.

CARLEN™ and Nyra Medial™ are trademarks of Nyra Medical

Contact
Nyra Medical
Suzanne Wallace
Email: info@nyra-medical.com

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SOURCE Nyra Medical, Inc