Edwards Lifesciences announced two investments: one agreement to acquire JenaValve, and another to exercise the option to acquire Endotronix.

JenaValve is a pioneer in transcatheter treatment for aortic regurgitation (AR). The company released positive results from its U.S. pivotal trial for treatment of symptomatic, severe AR in high-risk patients late last year.

Edwards said it expects U.S. Food and Drug Administration (FDA) approval for JenaValve’s Trilogy heart valve system in late 2025. It will represent the first approved therapy for patients suffering from AR.

Building on an investment in 2016, Edwards exercised its option to acquire Endotronix, a developer of heart failure (HF) management solutions. The deal will expand Edwards’ portfolio into a new therapeutic area—many structural heart patients also suffer from HF with limited options.

Last month, Endotronix earned FDA approval for its Cordella implantable pulmonary artery pressure sensor. Cordella allows early, targeted intervention and a CMS national coverage determination is anticipate in early 2025.

The aggregate, upfront purchase price for these investments is about $1.2 billion. Edwards said it expects minimal revenue contribution from these transactions in 2025.

“These acquisitions expand our opportunities to address the unmet needs of aortic regurgitation and heart failure patients around the world,” said Bernard Zovighian, Edwards’ CEO. “We are pleased to enter these structural heart therapeutic areas with innovation, world-class science and clinical evidence to provide access to life-saving technologies for patients around the world.”