JenaValve Announces First Patient Enrolled in ARTIST Randomized Controlled Trial (RCT) Evaluating the Trilogy™ System in Aortic Regurgitation (AR)

IRVINE, Calif., July 14, 2025

JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that patient enrollment has begun in the ARTIST study, an RCT evaluating the safety and effectiveness of the Trilogy System compared to surgical aortic valve replacement (SAVR) in patients with AR. The study is now enrolling patients in both transcatheter and surgical arms with the first case being performed in Los Angeles, California at Cedars- Sinai Medical Center.

ARTIST is designed to provide critical evidence for the treatment of moderate-to-severe and severe AR in patients that are not at high-risk for surgical aortic valve replacement and is the first ever randomized study comparing SAVR vs. transcatheter aortic valve replacement (TAVR) in AR patients. The company anticipates this study will help continue to elevate the versatility of the Trilogy System, following the outcomes achieved in AR patients that are at high surgical risk.

“It’s incredibly rewarding to have enrolled and treated the first randomized patient in the ARTIST trial,” said Dr. Raj Makkar, MD, Cedars-Sinai Medical Center. “In a single day, we performed multiple Trilogy cases, including as mentioned our first ARTIST case as well as implanting Trilogy in a patient with LVAD- related AR disease who was enrolled into the JENAVAD Registry. These experiences highlight just how much demand exists for less invasive solutions in this complex and undertreated population; it’s a glimpse into how the Trilogy valve could reshape care for patients with AR.”

“ARTIST is a landmark study designed to answer a critical question of how to best treat patients with severe AR,” said Dr. Torsten Vahl, principal investigator of the ARTIST trial and interventional cardiologist at Columbia University Irving Medical Center. “Building on ALIGN-AR, which established TAVR as a solution for high-risk AR patients, ARTIST has the potential to expand TAVR to a broader population of severe AR patients. It is also the first prospective head-to-head evaluation of TAVR versus surgery ever conducted in this patient population. The results will provide critical data to guide future treatment decisions in the structural heart community.”

“The launch and enrollment of ARTIST marks a defining moment for both JenaValve and the structural heart field,” said John Kilcoyne, Chief Executive Officer of JenaValve. “ARTIST reflects our commitment to generating the highest level of clinical evidence as we work to bring a less invasive solution to a larger group of patients suffering from this challenging 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 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.

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