ATLANTA, May 27, 2025 /PRNewswire/ -- Nyra Medical, a leading innovator in structural heart therapies, today announced two key executive appointments that further solidify the company's momentum as it advances its revolutionary Cardiac Leaflet Enhancer (CARLEN) System toward clinical and commercial milestones. Jennifer Mischke was appointed as Vice President of Regulatory and Clinical Affairs, bringing a distinguished background in global clinical trial execution and regulatory strategy. She joins Adam Martinez, Ph.D., Vice President of Product Development, whose deep technical expertise has been critical in guiding the CARLEN System from early prototyping through clinical-stage development.
Jennifer brings over two decades of leadership in regulatory affairs and clinical research, with a successful track record guiding cardiovascular and structural heart therapies through complex regulatory pathways. Her background in biostatistics and experience with global health authorities position her as a key leader in Nyra's strategy to bring meaningful innovation to patients with functional mitral regurgitation. Her insights are instrumental as Nyra transitions to a clinical-stage company and prepares for broader engagement with strategic partners and regulatory bodies.
Dr. Martinez, a seasoned innovator in the structural heart field, previously held leadership roles at Artivion where he played a vital role in developing and translating next-generation cardiac and vascular technologies. With more than 15 years of experience, he has led global multidisciplinary teams across product development, engineering, and operations. In the past 5 years, these teams have obtained IDE, PMA and MDD approvals on multiple products. At Nyra, he has been central to the evolution of the CARLEN System, helping to bring the platform from early design, prototyping and testing to preclinical validation to clinical cases.
"These strategic appointments come at a critical juncture for Nyra," said Lori Chmura, CEO of Nyra Medical. "Jennifer's expertise in regulatory and clinical affairs brings a level of sophistication and credibility essential for our current phase of growth. Her leadership will be invaluable as we execute the next phase of clinical validation and regulatory engagement. Adam's technical depth and product development leadership have laid the foundation for where we are today. Together, they represent the caliber of talent that will drive Nyra forward."
The CARLEN System offers a novel, minimally invasive approach to treating functional mitral regurgitation. By restoring proper leaflet coaptation, the technology is designed to improve outcomes for patients suffering from this complex condition.
About Nyra Medical
Nyra Medical is a privately held medical device company redefining transcatheter repair for functional mitral regurgitation with the Cardiac Leaflet Enhancer (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.
Contact
Nyra Medical
Lori Chmura
Email: info@nyra-medical.com
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SOURCE Nyra Medical, Inc
