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US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.
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JenaValve’s Trilogy THV System Highlighted at CRT 2024

JenaValve’s Trilogy THV System Highlighted at CRT 2024

IRVINE, Calif., March 18, 2024 – JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024. JenaValve’s Trilogy THV system, a TAVR system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR), and symptomatic, severe aortic stenosis (ssAS), was featured in multiple scientific sessions highlighting the significant unmet need for devices to treat ssAR.

The clinical value of the Trilogy valve was illustrated by Dr. Luca Testa, Head of the Coronary Revascularization Unit and Clinical Research Unit at IRCCS San Donato Hospital, Milan, during a session titled Performance of Purpose-Built Versus Off-Label Transcatheter Devices for the Treatment of Aortic Regurgitation: The Purpose Study. This session reviewed an observational study examining outcomes of patients with ssAR treated with off-label THV’s versus a device designed to treat ssAR. Results showed significantly better technical and device success in the Trilogy arm, with significantly less valve embolization, need for a second valve, and post-procedural aortic regurgitation.

Dr. Testa stated, “The results of the PURPOSE study, the first comparison of off-label THVs versus a dedicated device, such as the JenaValve Trilogy THV, showed that the Trilogy represents a better option for inoperable patients with ssAR, in terms of both procedural and device success, according to the VARC-3 definitions.”

“We are encouraged by the sheer number of presentations and conversations surrounding ssAR. We know that there is a significant unmet need for patients with this disease and are pleased to see greater recognition of the importance of dedicated treatment options,” said John Kilcoyne, Chief Executive Officer of JenaValve. This substantial clinical focus is further validation of the work we are doing and the expansive market opportunity ahead of us.”

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.

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.

Investor Relations Contact:
Marissa Bych
marissa@gilmartinir.com

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The information in this Reimbursement Guide is provided for educational purposes only and is not intended to be coding or billing advice. This coding information is based upon publicly available information and is current as of April 1, 2026 and subject to change without notice. JenaValve Technology, Inc. cannot guarantee that any product or service billed with the codes listed will be covered or, if covered, the listed payment amount will be paid by any payer. It is the responsibility of the provider to select appropriate codes for each patient and to submit appropriate codes, charges, and modifiers for services rendered. Providers should contact insurers to verify correct coding procedures prior to submitting claims related to the use of JenaValve products. In all cases, providers must bill according to the rules, policies and procedures of individual payers. The medical record should document that the product or procedure was medically necessary and furnished or performed as reported. Clinical need, not reimbursement amount, should always drive clinical decision making. If you have any questions about appropriate billing for products or services, please consult your local payer. The information contained in this guide is provided to assist providers in understanding the reimbursement process. It is intended to assist providers in obtaining accurate and appropriate reimbursement for the healthcare services provided. It is not intended to increase or maximize reimbursement by any payer. It is strongly recommended that providers consult with their payer organizations with regard to local reimbursement policies. The information contained herein is provided for information purposes only and represents no statement, promise, or guarantee by JenaValve Technology, Inc. concerning levels of reimbursement, payment, or charge. Similarly, all CPT codes are supplied for information purposes only and represent no statement, promise, or guarantee by JenaValve Technology, Inc. that these codes will be appropriate or that reimbursement will be made. For additional information, please contact us at reimbursement.usa@jenavalve.com.