JenaValve Presents Late-Breaking JENA-VAD Data at TCT 2026, Demonstrating High Technical Success and 30 Day Safety of the Trilogy System in LVAD Patients Under IDE

• Data reflects outcomes from 50 patients with Left Ventricular Assist Devices (LVADs) and Clinically Significant Aortic Regurgitation (AR) treated with the Trilogy System
• Demonstrated 96% technical success with no deaths or strokes, at 30 days in a patient population with significant comorbidities and limited options
• Data simultaneously published in the Journal of the American College of Cardiology (JACC)
• Additionally, the Company successfully presented a live Trilogy case from Cedars-Sinai

IRVINE, Calif., November 9, 2026

JenaValve Technology, Inc., developer and manufacturer of the Trilogy^® Transcatheter Heart Valve (THV) System, today announced highlights from the 2026 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Diego, CA. JenaValve presented late-breaking data from the JENA-VAD Registry investigational study in the US, a prospective, multicenter registry evaluating the Trilogy System in patients with an LVAD and clinically significant AR. Early outcomes were shown from fifty patients, demonstrating high technical success with no adverse events or serious complications and early improvements in functional status and patient-reported quality of life.

Dr. Torsten Vahl, director of translational research and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center presented the results of the JENA-VAD Registry, which were simultaneously published in the Journal of the American College of Cardiology (JACC), linked here.

AR has historically been reported in up to 20% to 30% of patients within two to three years of continuous-flow LVAD support. In these patients, AR creates a recirculation loop between the pump and the left ventricle, which reduces systemic flow and leads to congestion and recurrent heart failure. Surgical options carry high risk in this population. Transcatheter valves designed for aortic stenosis often anchor poorly in the noncalcified anatomy typical of AR, which can lead to migration or the need for a second valve. The Trilogy System instead uses locators that clip the native aortic leaflets, so it does not depend on annular calcification to anchor.

“Many patients with LVADs develop aortic regurgitation, yet treatment options remain extremely limited, considering the very high risk of surgery. The continuous mechanical support provided by the LVAD, combined with the absence of leaflet calcification, creates a particularly high risk of valve embolization with TAVR devices developed for aortic stenosis,” said Dr. Vahl. “In the JENA-VAD Registry, the Trilogy valve was successfully implanted in 50 patients with LVADs, with no instances of valve migration, embolization or need for a second valve. We observed high rates of technical and device success without any deaths or strokes within 30 days, and no significant paravalvular leak. These results are exceptionally encouraging and demonstrate the feasibility of the Trilogy valve in this particularly challenging patient population. We are excited that this technology may finally offer a meaningful treatment option for patients with LVADs who develop aortic regurgitation.”

Fifty patients were treated in the JENA-VAD Registry at 14 U.S. centers. All patients were NYHA class III or IV at baseline, and all had undergone prior open-heart surgery. Technical success and 30-day device success were each 96.0%. Ninety percent of patients were free from the VARC-3 early safety composite at 30 days. There were no deaths or strokes within 30 days and no moderate or greater prosthetic regurgitation. No patient had valve migration or needed a second valve. Early findings also point to improvements in symptoms: at 30 days, 72.3% of patients assessed had mild or no heart failure symptoms (NYHA class I or II), compared with none before the procedure. JENA-VAD is being conducted under an investigational device exemption (IDE) and is nested within the ALIGN-AR trial.

“Historically, patients with an LVAD who develop AR have had very few good options, and the functional improvements we saw in JENA-VAD are highly encouraging,” said Ravi Ramana, DO, Heart Care Centers of Illinois and national principal investigator of the prospective JENA-VAD Registry. “It remains early, but we look forward to continuing to follow these patients. The thrombosis findings and open questions about anticoagulation in this population call for systematic imaging and longer follow-up, and the one-year results will be essential.”

“The JENA-VAD Registry reflects our commitment to evaluating the Trilogy System rigorously in patients with few alternatives and to reporting what we learn transparently,” said Gabriel Sayer, MD, Associate Director of Advanced Heart Failure, Cardiac Transplantation and Mechanical Circulatory support at New York-Presbyterian and national principal investigator of the JENA-VAD Registry. “These results provide promising data in a very high-risk population and we look forward to continued follow up and further research to better define what this device may mean for LVAD patients with AR in the future.”

An additional highlight of TCT 2026 was a live case broadcast from Cedars-Sinai Medical Center in Los Angeles, featuring the successful implantation of the Trilogy transcatheter heart valve in a patient with severe aortic regurgitation. The procedure was performed by Raj Makkar, MD, of Cedars-Sinai Medical Center, providing attendees with a real-time demonstration of the Trilogy system in clinical practice.

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
Gilmartin Group LLC
marissa@gilmartinir.com