Singapore's Genesis MedTech sells aortic valve disease solutions to Edwards Lifesciences in US

Singapore-basedGenesis MedTech has sold JC Medical, Inc. to Edwards Lifesciences in the US, including the intellectual property and commercial rights of its J-Valve System, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation. The transaction includes an upfront payment plus potential sales-based contingent milestones.

Genesis MedTech has maintained the exclusive right to develop, manufacture and commercialise the J-Valve Systemin in Greater China. In July 2023, Genesis MedTech successfully completed patient enrollment for clinical study of J-Valve transfemoral system for the treatment of aortic regurgitation (referred to as J-Valve TF) in China, and recently concluded the one-year patient follow-up.

In August 2023, JC Medical's J-Valve TF was granted the 'Breakthrough Device Designation' by the US 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. Approval from US FDA for JC Medical to initiate its pivotal clinical trial of J-Valve TF was received in the first half of 2024.

Additionally, Edwards has made an equity investment of $25 million in Genesis MedTech. This investment will support Genesis MedTech's product and market development efforts, showcasing the recognition of Genesis MedTech's product development capabilities and operational model by a global medtech leader.