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New Evidence Further Defines Distinct Clinical Considerations for Transcatheter Aortic Valve Replacement (TAVR) in Aortic Regurgitation (AR) and Advances Understanding of the Trilogy^® System in Patients with Left Ventricular Assist Devices (LVADs)

IRVINE, Calif., July 01, 2026 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy Transcatheter Heart Valve (THV) System, today announced highlights from the New York Valves 2026 conference, where two late-breaking clinical presentations offered new insights into TAVR with the Trilogy™ System in patients with aortic regurgitation (AR). The conference also featured a live case broadcast of a Trilogy implant in a patient with pure native AR and several AR-focused sessions, including one that highlighted left ventricular remodeling trajectories, showing that recovery is variable and time‑sensitive in AR, underscoring the importance of earlier identification and treatment.

In the first late-breaking presentation, James McCabe, MD, Beth Israel Deaconess Medical Center, presented data on pacemaker implantation rates after a TAVR procedure in patients with AR. Key findings indicated that predictors of pacemaker implantation in TAVR for AR reflect the disease’s unique pathophysiology as it progresses, rather than factors such as oversizing that are typically implicated in aortic stenosis (AS).

“The ALIGN-AR data continue to reveal important distinctions in how AR patients present and respond to TAVR. Understanding the drivers of pacemaker implantation reinforces that AR imposes unique physiological demands, AR is a distinct entity separate from AS, and our clinical management must evolve to reflect this reality,” said Dr. McCabe.

In the second late-breaking presentation, Ravi Ramana, DO, Heart Care Centers of Illinois and national principal investigator of the prospective JENA-VAD Registry, delivered his retrospective data analysis of early Expanded Access Trilogy in LVAD patients. This retrospective investigator-initiated study examined outcomes in patients with continuous-flow left ventricular assist devices (cfLVADs) and significant AR treated with the Trilogy System under Expanded Access in the US (i.e., compassionate use and emergency use). Patients with LVADs who develop significant AR face poor clinical outcomes and very limited treatment options. In 28 LVAD patients treated under Expanded Access, Trilogy demonstrated high procedural success and low 30-day mortality with no major complications. One-year mortality was 7.3%, and these findings complement the ongoing prospective JENA-VAD Registry (IDE study sponsored by JenaValve Technology), which is designed to collect clinical evidence on Trilogy in LVAD patients.

“Patients with LVADs and clinically significant AR represent one of the most vulnerable and underserved populations in structural heart disease. This data is encouraging, demonstrating that treatment with a dedicated AR device is feasible in this setting and was achieved with low complication rates despite significant disease complexity. These findings begin to lay the foundation for a much-needed option for these patients," said Dr. Ramana.

"The data presented at New York Valves reflect the expanding depth of clinical evidence and growing real-world experience with the Trilogy System,” said Duane Pinto, MD, MPH, Chief Medical Officer of JenaValve. “The ALIGN‑AR findings reinforce that AR is a distinct disease that demands distinct thinking, while the LVAD results bring us closer to addressing one of the most urgent unmet needs in structural heart disease."

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
Marissa@gilmartinir.com
Webb@gilmartinir.com