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JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial

JenaValve

IRVINE, Calif., August 16th, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk aortic regurgitation.

Aortic regurgitation (AR) is a condition that occurs when a patient’s aortic valve does not close properly, resulting in reverse blood flow from the aorta back into the left ventricle. The current treatment for high surgical risk patients who are not candidates for open-heart surgery consists predominantly of medical management and off-label TAVR.

“We are pleased the FDA granted this IDE approval allowing us to continue our pursuit of an aortic regurgitation indication for the Trilogy Heart Valve System,” said John Kilcoyne, JenaValve’s CEO. “We believe the Trilogy Heart Valve System’s unique design provides patients with a minimally invasive transfemoral procedure that has the potential to change the treatment paradigm for what I believe is a vastly underdiagnosed and undertreated AR patient population.”

The ALIGN-AR Pivotal Trial will enroll patients to assess safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in the treatment of high surgical risk patients with symptomatic, severe aortic regurgitation (AR). The study design also allows for patients outside of the US to be included in the trial’s enrollment.

For additional information on The ALIGN-AR Pivotal Trial, visit: clinicaltrials.gov

About JenaValve

JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K. and Munich, Germany, develops and manufactures transcatheter aortic valve implantation (TAVI) 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 (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.

Additional information is available at www.jenavalve.com.

Contact:
Investor Relations
Matt Bacso
matt.bacso@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.