JenaValve Presents ALIGN-AR 2-Year Follow-Up Data at TCT 2024 and Announces Commencement of ARTIST Randomized Controlled Trial (RCT)

IRVINE, Calif., November 7, 2024

JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, showcased 2-year follow up data from the ALIGN-AR Trial at TCT 2024. Concurrently, the company also announced the approval and initiation of the ARTIST randomized controlled trial (RCT).

The ALIGN-AR 2-year Follow-Up data confirmed the continued safety and efficacy of the Trilogy heart valve system for patients with severe, symptomatic aortic regurgitation (AR) at high risk for surgery. After two years, the all-cause mortality rate remained below the study’s predefined performance goal of 25% at one year. The 2-year data also reported excellent hemodynamic outcomes, very low rates of paravalvular leak, and sustained improvements in quality of life.

Looking ahead, JenaValve is expected to begin enrolling participants in the ARTIST RCT early next year. This prospective, randomized trial will compare outcomes between non-high-risk patients with moderate-to-severe and severe aortic regurgitation treated with the Trilogy device and those undergoing surgical aortic valve replacement (SAVR). The ARTIST study aims to provide critical information to clinicians on TAVR with the Trilogy valve as an option for patients with aortic regurgitation in comparison to surgery.

“We are incredibly pleased that the ALIGN-AR two-year follow up results reinforce the safety and efficacy endpoints of the THV system, highlighting its exceptional performance and ability to reverse cardiac damage caused by aortic regurgitation,” said Dr. Torsten Vahl, Columbia University Irving Medical Center, an ALIGN-AR principal investigator and presenter at TCT 2024.

“Our ARTIST RCT reflects our unwavering commitment to advancing research that enhances patient outcomes and offers effective treatment alternatives,” said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve. “With the commitment of our dedicated investigators, we anticipate a swift enrollment process that brings us closer to transforming existing treatment.”

“Aortic regurgitation is a deadly disease that is overlooked and undertreated” said Dr. Vinod H. Thourani, Chairman of Cardiovascular Surgery at Piedmont Heart Institute and an ARTIST principal investigator. “The rigorous trial design comparing to surgery, sets the stage for impactful future treatment decisions. Thank you to the clinical staff and everyone involved in initiating this important trial.”

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 who are at high surgical risk. The Trilogy THV System received CE Mark approval, providing European physicians with the first TAVR device with true dual-disease treatment capabilities. In the US, the Trilogy THV System is limited to investigation use only.

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. JenaValve recently reached an agreement to be acquired by Edwards Lifesciences.

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

Additional information is available at www.jenavalve.com

JenaValve Contact:

Daniel Sun
dsun@jenavalve.com