Dive Brief:
- Edwards Lifesciences has purchased a transcatheter aortic valve replacement (TAVR) system from Genesis Medtech that is designed to treat severe aortic regurgitation.
- The sale of Genesis’ JC Medical business includes intellectual property and commercial rights for the J-Valve system. Edwards will pay an upfront sum and potential sales-based milestone payments. A sale price was not disclosed in Genesis’ Monday announcement.
- Edwards has also made an equity investment of $25 million in Singapore-based Genesis to support product and market development efforts.
Dive Insight:
Edwards has been on an acquisition spree. In July, the heart valve specialist said it would pay $1.2 billion to acquire JenaValve Technology, which is also developing an aortic regurgitation treatment, and Endotronix, maker of an implantable pulmonary artery pressure sensor for heart failure.
Also in July, Edwards exercised an option to buy Innovalve Bio Medical, developer of a transcatheter mitral valve replacement device, for about $300 million.
In another deal, Edwards agreed to pay 15 million euros for a stake in Affluent Medical, gaining an option to buy its mitral ring subsidiary and a global license for biomimetic mitral valve replacement technology.
The flurry of deals has come amid lower-than-expected TAVR volumes. Edwards executives said on a July earnings call that the slowdown was a surprise but stressed that the company’s competitive position in TAVR hasn’t meaningfully changed.
Genesis’ J-Valve transfemoral system received a breakthrough device designation from the Food and Drug Administration in August 2023. The designation followed completion of enrollment in July 2023 in a study of the system to treat aortic regurgitation in patients in China.
JC Medical completed enrollment in its early feasibility study for J-Valve in the U.S. this February. The company gained the FDA’s nod to begin a pivotal trial for the device in the first half of this year.
Genesis will maintain exclusive rights to develop, manufacture and commercialize the J-Valve system in China.
In June, BD agreed to buy Edwards’ critical care group for $4.2 billion in cash.