Last month (July 2024) Edwards Lifesciences announced it is to acquire JenaValve Technology, a pioneer in the transcatheter treatment of aortic regurgitation (AR). At the same time the company announced it has also exercised its option to acquire Endotronix, a leader in heart failure (HF) management solutions. Now, less than a month later, comes the news that Edwards is also to acquire JC Medical, Inc. This includes the intellectual property and commercial rights of JC’s J-Valve® System, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation
Background
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. The company clearly anticipates these investments will strengthen its leadership in structural heart innovation and represent long-term growth opportunities.
JenaValve
Valve innovator, Edwards believes it is uniquely positioned to lead the next frontier of aortic valve disease treatment. JenaValve is no doubt a part of that picture. In fact late last year the company presented positive results of its U.S. pivotal trial for the treatment of symptomatic, severe AR in high-risk patients. Edwards anticipates FDA approval of the JenaValve Trilogy Heart Valve System(pictured) in late 2025. This will represent the first approved therapy for patients suffering from AR.
Endotronix
In 2016 Edwards made an investment in Endotronix in 2016. It has now exercised its option to acquire the company. Many structural heart patients Edwards serves today also suffer from HF with limited options. The company says this acquisition expands it into a new therapeutic area to address the large unmet needs of patients suffering from HF. Last month, Endotronix received FDA approval for Cordella, an implantable pulmonary artery pressure sensor. This device allows for early, targeted therapeutic intervention. Endotronix expects a CMS national coverage determination in early 2025.
JC Medical
In July 2023, Genesis MedTech, owner of JC Medical, successfully completed patient enrollment for clinical study of J-Valve transfemoral system for the treatment of aortic regurgitation. Moreover the system is referred to as J-Valve® TF in China. It recently concluded the one-year patient follow-up.
Genesis MedTech, maintains the exclusive right to develop, manufacture and commercialize the J-Valve® System in Greater China.
In August 2023, JC Medical’s J-Valve® TF was granted the “Breakthrough Device Designation” by the U.S. Food and Drug Administration (FDA). JC Medical completed enrollment in its early feasibility study (EFS) of J-Valve® TF in the United States in February 2024. FDA approved JC Medical to initiate the pivotal clinical trial of J-Valve® TF in the first half of 2024.
Edwards has made an additional equity investment of $25 million in Genesis MedTech. This investment will support Genesis MedTech’s product and market development efforts.
Edwards Lifesciences comments
Bernard Zovighian, Edwards’ CEO comments about Jenavalve and Endotronix.
“These acquisitions expand our opportunities to address the unmet needs of aortic regurgitation and heart failure patients around the world. 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.”
Genesis Medtech comments
Warren Wang, Chairman and CEO of Genesis MedTech Group speaks about J-VALVE®.
“J-VALVE® has unique advantages in treating aortic valve regurgitation. We hope that J-Valve® can expand its global impact, enabling more patients to benefit from this innovative product. We will continue strengthening our focus on developing innovative products and explore better medical solutions to benefit more patients worldwide.”
Sources: BusinessWire, PR Newswire
published: August 20, 2024 in: Cardio, Company News, Mergers and Acquisitions, Technology