Edwards’ JenaValve acquisition nixed as FTC injunction approved by court

Edwards Lifesciences has announced that the US District Court for the District of Columbia has approved an injunction question issued by US Federal Trade Commission (FTC), putting the brakes connected the medtech giant’s plans to get JenaValve.

Edwards volition nary longer proceed with the acquisition of JenaValve, shaper of a transcatheter aortic valve replacement strategy for aortic regurgitation (TAVR-AR). Disagreeing with the court’s decision, Edwards emphasised that the acquisition would person been successful the champion interests of a “large, increasing and underserved” diligent population.

Due to this development, Edwards is revising its full-year 2026 net guidance to betwixt $2.90-$3.05 per stock from $2.80-$2.95 previously.

Edwards added that it volition proceed its absorption connected advancing the SOJOURN transcatheter AR valve and enrolling patients into JOURNEY, a pivotal proceedings (NCT06455787) evaluating the J-Valve TAVR AR system. Edwards inherited J-Valve from JC Medical aft acquiring the US institution from Singapore-based Genesis MedTech successful August 2024.

JenaValve’s pb merchandise for TAVR-AR is the Trilogy Heart Valve. The strategy is presently pending marketplace support from the FDA, having been successful objective trials nether an investigational instrumentality exemption (IDE) granted successful 2021. Edwards reached an statement to get JenaValve successful July 2024 alongside Endotronix successful a combined $1.2bn woody to fortify the company’s structural bosom portfolio.

No TAVR devices with an AR denotation are presently disposable connected the US market, with JC Medical and JenaValve the farthest on successful their devices’ objective development. For this reason, the FTC sued Edwards successful August 2025 to halt its acquisition of JenaValve. With JC Medical present a subsidiary of Edwards, the FTC claimed the company’s acquisition of JenaValve stood to destruct contention that has spurred innovation successful the TAVR-AR space.

At the time, Daniel Guarnera, manager of the FTC’s Bureau of Competition, said: “The FTC is taking enactment to halt this anticompetitive woody and guarantee that JenaValve and Edwards’ JC Medical subsidiary proceed competing to innovate, grow attraction eligibility, and support down costs.”

Edwards’ stock terms connected the New York Stock Exchange (NYSE) fell by 1.32% to $84.01 successful pre-market trading connected 12 January, down from an $85.13 adjacent connected 9 January. Edwards, which has a marketplace headdress of $50bn, released its connection aft markets closed connected 9 January.

According to GlobalData analysis, the wide TAVR marketplace is increasing astatine a compound yearly maturation complaint (CAGR) of 7.2% and forecast to treble its valuation to $12.8bn successful 2034. GlobalData analysts antecedently stated that the summation of AR arsenic a caller denotation successful the attraction modality could perchance accelerate the market’s CAGR into treble digits.