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Provided by AGPIRVINE, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the appointment of Dave Haan as Vice President of Clinical Affairs. Dave will lead the company's clinical affairs strategy, overseeing the continued execution of JenaValve's clinical programs — including the ARTIST randomized controlled trial and the JENA-VAD Registry. His appointment strengthens the company’s clinical leadership during a pivotal period of organizational growth and commercial expansion following the recent FDA approval of the Trilogy THV System for symptomatic, severe aortic regurgitation (ssAR).
Dave brings more than 25 years of executive leadership experience in medical devices, with particular depth in interventional and catheter-based therapies, regulatory strategy, and global trial execution. He has a proven track record of building and scaling clinical organizations, securing regulatory approvals, and advancing evidence generation across complex, high-stakes programs.
Most recently, Dave served as Vice President of Global Clinical Affairs at Danaher's Beckman Coulter Diagnostics, where he led the integration of multiple operating companies into a unified Clinical Center of Excellence, delivering more than 50 regulatory approvals across the FDA, EU, and NMPA. Prior to that, Dave held clinical and product development leadership roles at Stryker Neurovascular, where he built and scaled a global clinical organization, secured FDA IDE and PMA approvals through large-scale clinical trials, and drove industry collaboration through active participation at MDIC. Dave holds a Master of Science in Materials Science Engineering and a Bachelor of Science from Rutgers University, an MBA from Santa Clara University's Leavey School of Business, and holds a PMP certification.
"Dave's appointment comes at a defining moment for JenaValve," said Duane Pinto, MD, MPH, Chief Medical Officer of JenaValve. "With commercial approval behind us, we look forward to the future of TAVR in AR. As such, Dave is a clinical affairs leader with a strategic vision and operational depth that matches the scale of our ambitions. His record of successfully delivering on complex global programs and regulatory approvals across multiple jurisdictions makes him exactly the right person to lead our program. I look forward to partnering closely with him as we generate the evidence that will bring TAVR with the Trilogy System to the broadest group of patients suffering from AR."
"I am thrilled to join JenaValve at such a pivotal moment in the company's evolution," said Dave Haan, Vice President of Clinical Affairs at JenaValve. "The clinical evidence supporting the Trilogy System is compelling, and the opportunity to lead the next phase of evidence generation, including the ARTIST trial, is an incredible privilege. I look forward to working alongside the talented JenaValve team to advance the science and ultimately expand access to life-changing treatment for patients with AR."
About the Trilogy™ THV System
The Trilogy THV System is the first and only transcatheter heart valve in the United States indicated for native, symptomatic, severe aortic regurgitation in patients who are judged by a Heart Team to be at high or greater risk for surgical aortic valve replacement. The Trilogy THV System received CE Mark in 2021, and has now been used in more than 1,200 commercial procedures in Europe.
The Trilogy System was purpose-built to address the unique anatomical challenges of aortic regurgitation. Unlike conventional TAVR valves that rely on annular calcification for anchoring — which is typically absent in AR patients — the Trilogy System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium. The locators also provide commissural alignment for precise valve positioning and ensure a reliable seal to minimize paravalvular regurgitation. The system's large, open-cell nitinol frame is designed to preserve future coronary access.
About JenaValve
JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company's Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR, and symptomatic, severe aortic stenosis (AS) who are at high surgical risk. The Trilogy THV System bears the CE Mark for the treatment of AR and AS and is FDA approved for the treatment of AR.
JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany.
JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.
Additional information is available at www.jenavalve.com.
JenaValve Contact:
Daniel Sun
dsun@jenavalve.com
Investor Contacts:
Marissa Bych or Webb Campbell
Gilmartin Group LLC
Webb@Gilmartinir.com
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