Edwards Lifesciences Corp. faced a legal loss early this month that forced it to call off its $945 million acquisition of structural heart company JenaValve Technology Inc.
The U.S. District Court for the District of Columbia on Jan. 9 granted the U.S. Federal Trade Commission’s (FTC) motion for an injunction blocking the proposed deal. The FTC alleged that Edwards’ acquisition of JenaValve would result in reduced innovation, diminished product quality and potentially increased prices for consumers.
“Edwards disagrees with the decision and believes that the acquisition would have been in the best interest of a large, growing and underserved group of patients,” the company said in a statement.
Officials declined to give further comment.
Edwards in 2024 announced its intent to acquire JenaValve and another company called Endotronix for a total of $1.2 billion as part of the company’s efforts to expand into two new areas of care.
Chief Executive Bernard Zovighian previously told the Business Journal that Edwards sees emerging opportunities in heart failure and aortic regurgitation (AR), a condition where the heart’s aortic valve doesn’t close properly, causing blood to flow backward into the heart.
Anticompetition Concerns
Anticompetition sits at the center of the legal feud between Edwards and the FTC.
In August, the FTC moved to challenge the acquisition, alleging that if it went through, Edwards would be in control of the only two companies with ongoing clinical trials in the U.S. for a transcatheter aortic valve replacement (TAVR) device developed for aortic regurgitation.
JenaValve, based in Irvine, is poised to bring its TAVR device, the Trilogy system, for aortic regurgitation to market in the U.S. upon getting FDA approval. The company claims it has the only approved transcatheter valve indicated for aortic regurgitation in Europe.
If JenaValve received approval, it would provide a minimally invasive solution to a condition in which the current standard of care is traditional open heart surgery to replace the aortic valve.
One month after Edwards announced plans to buy JenaValve, it closed on an acquisition of JC Medical Inc. for an upfront amount of $116.3 million and an additional $200 million in future payments to be made over the next 12 years, according to a 10-K filing.
JC Medical, which was previously owned by Singapore-based medical device maker Genesis MedTech, is another company developing a TAVR called the J-Valve system to treat severe aortic regurgitation and stenosis.
“Edwards’ attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves,” Daniel Guarnera, director of the FTC’s Bureau of Competition, said in a statement.
Edwards said that it will continue to focus on advancing its Sojourn transcatheter AR valve and enrolling patients in its Journey trial, which will evaluate the safety and efficacy of the J-Valve system it acquired from JC Medical.
Sapien M3 Approval
The market didn’t seem too shaken by the news, as Edwards shares fell only 2.5% to $83.01 following the announcement.
At press time, Edwards sported a $49.6 billion market cap, making it the second most valuable publicly traded company in Orange County.
In the same announcement, Edwards revised its full-year EPS guidance to $2.09 and $3.05, up from its earlier guidance of $2.80 to $2.90.
Analyst firm TD Cowen recently upgraded Edwards to Buy and raised its price target to $97.
“The combination of commercial momentum experienced in 2025, regulatory tailwinds and pipeline progress provides us with increased conviction that Edwards can return to and sustain a double-digit organic revenue growth trajectory,” TD Cowen analysts Joshua Jennings and Colin Clark wrote in a Jan. 9 note to investors.
Among its growing pipeline, the firm cited Edwards receiving FDA approval in December for its Sapien M3 mitral valve replacement system.
Approval came earlier-than-expected, which gave analysts “confidence in Edwards’ ability to meet or exceed its 2026 TMTT growth target (35%-45%).”
Sapien M3 received CE Mark approval for use in Europe last April, making it the world’s first approved transcatheter valve replacement therapy using a transfemoral, or left side of the heart, approach to treat mitral regurgitation, according to the company.
