SINGAPORE, Aug. 19, 2024 /PRNewswire/ — Genesis MedTech has sold JC Medical, Inc. to Edwards Lifesciences, 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 commercialize 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 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. Approval from 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.
“J-VALVE® has unique advantages in treating aortic valve regurgitation.” said Warren Wang, Chairman and CEO of Genesis MedTech Group. “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.”
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