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JenaValve Appoints Tonya Porter as Vice President of Regulatory Affairs
IRVINE, Calif., May 20, 2026 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the appointment of Tonya Porter as Vice President of Regulatory Affairs. Tonya will lead the company’s regulatory affairs function as JenaValve advances its programs through clinical development and ongoing commercialization efforts. She succeeds Jane Metcalf, who is retiring following a distinguished tenure at JenaValve.
Tonya brings more than 20 years of clinical, regulatory, and quality experience in medical devices, with deep expertise in regulatory strategy from early development through post-market. Her career spans original IDE submissions, first-in-human feasibility studies, PMA approvals, and quality systems management, providing JenaValve with a seasoned leader well-positioned to support the company’s next phase of growth.
Most recently, Tonya served as Principal Consultant at Regulatory Scientist, Inc., where she supported multiple medical device companies across regulatory affairs, clinical affairs, and quality. Prior to her consulting work, Tonya spent more than a decade at ReVision Optics, ultimately serving as Vice President of Global Regulatory Affairs and Quality Assurance. Earlier in her career, Tonya served as an Engineer Technician at the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). Tonya holds a Bachelor of Science in Engineering from Harvey Mudd College and a Master of Science in Biomedical Engineering from the University of California, Irvine.
“Tonya brings exceptional regulatory depth and a proven track record of successfully navigating complex FDA pathways — exactly the expertise JenaValve needs as we enter this next phase of growth,” said John Kilcoyne, Chief Executive Officer of JenaValve. “We are deeply grateful to Jane Metcalf for her tremendous contributions to JenaValve, and I am confident that Tonya is the right leader to advance our regulatory strategy, strengthen engagement with the FDA and our Notified Bodies, and help drive the Trilogy System toward broader patient access.”
“I am thrilled to join JenaValve at such a pivotal moment for the company and for patients suffering from aortic regurgitation,” said Tonya Porter, Vice President of Regulatory Affairs at JenaValve. “The clinical evidence supporting the Trilogy System is compelling, and I look forward to working with this talented team to support our regulatory strategy and help bring this important therapy to the patients who need it most.”
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 (AR) 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. 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 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 Campbell
Gilmartin Group LLC
Webb@Gilmartinir.com
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