Edwards Lifesciences agreed to pay a $10 million penalty to settle Federal Trade Commission charges that it sidestepped antitrust review when it bought JC Medical from Genesis MedTech.
FTC says deal was structured to avoid Hart‑Scott‑Rodino filing
The commission alleges the transaction was deliberately arranged so the total value stayed under the reporting threshold of $119.5 million that would have triggered a Hart‑Scott‑Rodino (HSR) filing. Edwards paid Genesis $115 million for JC Medical and its J‑Valve system, according to the FTC filing, a figure that fell just short of the threshold.
In addition, Edwards pledged a $25 million equity investment in Genesis to fund product development and market expansion. When combined, the payments would have exceeded the HSR reporting limit, the complaint said.
Genesis will also pay a $2 million penalty under the proposed final judgment. Edwards’ spokesperson Amy Meshulam stated, “We maintain that Edwards complied with the requirements of the law.”
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Background on the JC Medical acquisition and related antitrust concerns
When Edwards announced the purchase in 2024, JC Medical was conducting trials for transcatheter aortic valve replacement (TAVR) devices aimed at treating aortic regurgitation. The FTC noted that Edwards later attempted a separate $945 million acquisition of JenaValve Technology, which would have left Edwards as the sole owner of the two U.S. companies testing TAVR devices for that condition.
The commission sued to block the JenaValve deal, arguing it would reduce competition. A federal court granted a preliminary injunction in January, and Edwards subsequently abandoned the JenaValve purchase, disputing the ruling.
As part of the settlement, Edwards must establish a compliance program to ensure future adherence to antitrust laws. The company also agreed to give the FTC advance written notice before acquiring any ownership stake in firms that sell or run clinical trials for TAVR devices targeting aortic regurgitation.
The $12 million total penalty is the largest ever imposed for failing to file under the HSR Act, FTC Chairman Andrew Ferguson said, adding that companies “should take notice” and that the agency will remain vigilant.
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Edwards’ spokesperson emphasized that the settlement allows the firm to focus on its mission to innovate for structural heart patients, including those with aortic regurgitation. Meshulam said the firm will keep advancing its Sojourn transcatheter AR valve and enrolling patients in the JOURNEY key trial.
While the FTC’s action sends a clear signal to the industry, the broader impact on future M&A activity remains uncertain. Companies may reassess how they structure deals to stay under thresholds, but they also risk heightened scrutiny if regulators perceive intentional avoidance.
Genesis did not respond to a request for comment from MedTech Dive at the time of publication.
The case draws attention.