Genesis MedTech has sold JC Medical to Edwards Lifesciences, in a deal that includes the intellectual property and commercial rights of its J-Valve transcatheter aortic valve implantation (TAVI) system for the treatment of severe aortic regurgitation (AR). 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 system in Greater China.
In July 2023, Genesis MedTech successfully completed patient enrolment for clinical study of J-Valve transfemoral system for the treatment of aortic regurgitation in China, and recently concluded the one-year patient follow-up.
J-Valve was granted the breakthrough device designation by the US Food and Drug Administration (FDA) in August 2023, and enrolment in an early feasibility study (EFS) of the transfemoral (TF) TAVI system in the USA was completed in February this year. 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 US$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, the company said in a press release.
“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.”
Through its acquisition of the J-Valve technology, Edwards Lifesciences has added a second TAVI platform capable of treating AR to its stable, following the agreement to acquire JenaValve Technology last month. These are among a spate of acquisitions by the company, spurred by Edwards’ sale of its Critical Care product group to BD in June. At the time the company said that this would fund strategic growth investments in technologies for aortic, mitral, tricuspid and pulmonic patients, as well as new therapeutic areas for interventional heart failure.
