Recently, JenaValve announced the successful completion of the first patient procedure in the registration of its Trilogy Transcatheter Heart Valve (THV) System. This milestone surgery marks an important step for JenaValve in advancing Transcatheter Aortic Valve Replacement (TAVR) technology for the treatment of severe Aortic Regurgitation (AR).

This surgery is part of the JENA-VAD clinical registry, a prospective, multicenter, single-arm study designed to evaluate the safety and efficacy of the Trilogy system in treating severe symptomatic AR in patients using continuous-flow left ventricular assist devices (cfLVAD).The first case was successfully performed by Dr. Raj Makkar from Cedars-Sinai Medical Center in Los Angeles, who is also an investigator for the registry.

Dr. Makkar stated that they will provide valuable data support for exploring treatment methods for a large number of LVAD patients with AR. He pointed out that the results of the ALIGN-AR study have already provided a strong rationale for continuing to use dedicated TAVR devices to treat patients with severe AR, and JENA-VAD will further validate the feasibility and effectiveness of this treatment strategy.

JenaValve CEO John Kilcoyne emphasized: "Our mission is to address the critical treatment needs of patients using left ventricular assist devices (LVADs) who develop severe aortic regurgitation (AR). These patients face a significant risk of heart failure, and current treatment options are extremely limited. With the Trilogy system, we hope to open up a new therapeutic pathway for these patients."

In fact, the clinical data of JenaValve has been highly anticipated within the industry. On March 28, the one-year clinical data from the pivotal clinical trial ALIGN-AR of the JenaValve Trilogy™ Heart Valve System, which features the world's first Locator design for treating aortic regurgitation, was published in the prestigious medical journal *The Lancet*. The trial results were inspiring. The publication of the ALIGN-AR trial data marks an important milestone in the use of transcatheter aortic valve replacement for treating aortic regurgitation, ushering in a new era of minimally invasive interventional treatment for high-risk surgical patients with symptomatic moderate-to-severe or severe aortic regurgitation.

In addition, JenaValve is about to be acquired by Edwards Lifesciences as part of a dual acquisition deal involving Endotronix, with a total value of up to $1.2 billion. On July 24 this year, JenaValve reached an agreement with Edwards Lifesciences, under which Edwards Lifesciences will fully acquire JenaValve. Currently, the Trilogy system has received the CE mark and is commercially available in Europe for the treatment of symptomatic AR. The company expects that the U.S. Food and Drug Administration (FDA) will approve the system for marketing in the United States by the end of 2025.

Chinese Company Peijia Medical Holds Exclusive Rights to the JenaValve Trilogy THV System in Greater China. At the end of 2021, Peijia Medical and JenaValve signed an exclusive license agreement for the Trilogy™ Heart Valve System in Greater China, with Peijia Medical also becoming a minority shareholder of JenaValve. Subsequently, Peijia Medical rebranded the technology as the TaurusTrio™ Transcatheter Aortic Valve System, initiating registration clinical trials in China. In January 2024, the company successfully completed full patient enrollment and entered the one-year follow-up phase.

The success of this surgery not only demonstrates the clinical potential of the Trilogy system but also brings new treatment hope for more AR patients in the future. With the continuous accumulation of clinical data, it is believed that the Trilogy system will gain wider application worldwide, offering better treatment options for patients with structural heart disease.

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