IRVINE, Calif., June 03, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the appointment of Maria Jose Arana as Vice President of Quality and Compliance. Maria Jose will lead the company’s quality assurance and compliance strategy, overseeing the implementation of critical quality and compliance systems as JenaValve expands its commercial operations and advances its clinical programs. Her appointment continues the company’s commitment to quality and patient safety during a pivotal period of organizational growth and commercial expansion following the recent FDA approval of the Trilogy THV System for high risk, symptomatic, severe aortic regurgitation (ssAR). Maria Jose brings more than 25 years of executive leadership experience in quality and regulatory affairs across medical devices, diagnostics, and combination product environments. She has a proven track record of building and scaling compliant Quality Management Systems (QMS), advancing regulatory workflows, and leading global inspection readiness programs across organizations. Most recently, Maria Jose served as Senior Director of Quality & Compliance at Johnson & Johnson Electrophysiology, where she led global Quality Systems, Compliance, and Quality Engineering organizations of more than 300 employees across cardiovascular device portfolios spanning predevelopment through commercialization. Prior to J&J, she served as Head of Quality & Compliance at Accriva Diagnostics, leading global QMS and validation teams across multiple markets. She also held quality and regulatory leadership roles at Volcano Corporation, CryoCor, and Medtronic Vascular. Maria Jose holds advanced degrees from Instituto Tecnologico de Monterrey and is certified as a Six Sigma Black Belt and ISO 13485 Lead Auditor. “Maria Jose’s appointment comes at an important moment for JenaValve,” said John Kilcoyne, CEO of JenaValve. “With FDA approval and U.S. commercial launch behind us, we are expanding meaningfully, and the quality and compliance infrastructure we build now will be foundational to our long-term success. Maria Jose brings quality and compliance expertise, cross-functional partnership skills, and the depth of leadership that this stage of growth demands. I look forward to working closely with her as we continue to advance the Trilogy System and expand access to treatment for patients suffering from high risk ssAR.” “I am thrilled to join JenaValve at such a defining moment in the company’s evolution,” said Maria Jose Arana, Vice President of Quality and Compliance at JenaValve. “The clinical evidence supporting the Trilogy System is compelling, and the opportunity to build a world-class quality organization that supports both the commercial launch in the U.S. and the ongoing ARTIST trial is an incredible privilege. I look forward to partnering with the JenaValve team to ensure the highest standards of quality and compliance as we work to bring this life-changing therapy to the broadest group of patients suffering from AR.” About the Trilogy™ THV SystemThe 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 1,000 commercial procedures in Europe. The Trilogy System was purpose-built to address the unique anatomical challenges of aortic regurgitation (AR). 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 JenaValveJenaValve 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 has regulatory approvals in the United States and Europe for its intended use, and reflects JenaValve’s focus on addressing unmet clinical needs in aortic valve disease, including aortic regurgitation. 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 CampbellGilmartin Group LLCWebb@Gilmartinir.com
