Results of First Commercial Trilogy Heart Valve System Implants in EU

IRVINE, Calif., June 28, 2022 (GLOBE NEWSWIRE) —JenaValve Technology, Inc. (“JenaValve” or the “Company”), developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, announced positive results from the first Trilogy Heart Valve System commercial implants for high-surgical risk patients with severe, symptomatic aortic stenosis (AS) or aortic regurgitation (AR) in Europe, initially presented at EuroPCR 2022 on May 18.

“We are very pleased with the robust clinical outcomes experienced by our commercial European patients being treated for both AR and AS,” said John Kilcoyne, JenaValve’s CEO. “The early results demonstrate that our Trilogy Heart Valve System can be safe and effective for patients suffering from AR and AS outside a clinical trial. These results mark another milestone in JenaValve’s journey to becoming the standard of care for the treatment of AR, as these were the first implants of their kind in the real world.”

EuroPCR 2022 Highlights

Matti Adam, MD (University Hospital Cologne, Germany), reported the first 28 commercial implants of the Trilogy Heart Valve System for AS across six high-volume German centers. In Dr. Adam’s series, all patients presented with severe AS. At baseline, 61% of the patients presented with NYHA class III or IV heart failure (NYHA III/IV), and 29% had a left ventricular ejection fraction (LVEF) of less than or equal to 50%. The outcomes were positive, achieving 100% technical success, zero conversions to open surgery, zero new permanent pacemakers, and one patient death, which was non-device related. Post-operatively, 86% of the patients had none or trace paravalvular regurgitation (PVL) and no incidence of moderate or greater PVL.

“The JenaValve Trilogy is specifically and uniquely designed with locators that align the valve with the native cusps providing excellent commissural alignment with easy access to the coronary arteries, and form a secure seal for minimal PVL,” said Matti Adam, MD. “Given the unique design, we are seeing very positive results in AS patients, as well as in the AR cohort.”

Alexander R. Tamm, MD (Johannes Gutenberg-Universität, Mainz, Germany), presented data on 45 AR patients from the same six German heart centers. In this series, all patients presented with moderate-severe or severe AR. At baseline, 71% of the patients presented with NYHA III/IV, and 58% had an LVEF less than or equal to 50%. The outcomes of the AR series were also positive, with technical success achieved in all patients. There were no conversions to open surgery, stroke, or death. Post-operatively, 92% of the patients had none or trace PVL and nine patients required a new pacemaker. Of the patients requiring a pacemaker, at least 33% of the patients had pre-existing conduction system abnormalities.

“Before Trilogy’s CE Mark approval, TAVR for AR was performed off-label using devices designed for aortic stenosis – which posed procedural challenges with poorer outcomes,” said Alexander R. Tamm, MD. “The Trilogy valve is a game-changer, which delivers solid anchoring and commissural alignment due to the locator technology while also limiting protrusion into the left ventricle. Additionally, the hemodynamics are the best in class.”

About JenaValve

JenaValve Technology, Inc., with headquarters in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany, develops and manufactures transcatheter aortic valve replacement (TAVR) systems to treat patients suffering from aortic valve disease. JenaValve is backed by Bain Capital Life Sciences and Cormorant Asset Management, as well as European and Asian investors, including Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences, VI Partners, and Peijia Medical Limited.

Additional information is available at www.jenavalve.com.

US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

Contact:
Investor Relations
Matt Bacso, CFA
matt.bacso@gilmartinir.com