Dive Brief:
- Edwards Lifesciences will pay a $10 million penalty to the Federal Trade Commission to settle charges it purchased JC Medical from Genesis MedTech without complying with the notification and waiting period requirements of the Hart-Scott-Rodino Act, the FTC said Monday. Genesis will pay a $2 million penalty under the proposed final judgment.
- The settlement resolves allegations that Edwards and Genesis intentionally structured the deal to stay below the transaction size threshold that would have triggered an FTC review under the HSR Act.
- Edwards, in an email to MedTech Dive, said the agreement does not admit wrongdoing. “We maintain that Edwards complied with the requirements of the law,” spokesperson Amy Meshulam wrote.
Dive Insight:
Genesis said Edwards acquired JC Medical and the rights to its J-Valve system in an August 2024 statement. According to the FTC, Edwards agreed to pay Genesis $115 million plus milestone payments, a sum that fell just below the minimum threshold of $119.5 million that would have required HSR Act review.
Edwards, however, also agreed to make a $25 million equity investment in Genesis to support product and market development efforts. Taken together, the payments would have exceeded the HSR Act reporting threshold at the time, according to a complaint filed in the U.S. District Court for the District of Columbia.
When the JC Medical deal was announced in 2024, the company was in trials to bring to market transcatheter aortic valve replacement devices to treat aortic regurgitation. Edwards acquired JC Medical without filing under the HSR Act. Edwards then attempted to acquire JC Medical competitor JenaValve Technology for $945 million. Had that deal succeeded, Edwards would have owned the only two companies in the U.S. with TAVR devices for aortic regurgitation in clinical trials, the FTC said.
The commission sued to block Edwards’ acquisition of JenaValve, alleging it was anticompetitive, and in January, the court granted the FTC’s request for a preliminary injunction. Edwards then dropped its plans to buy JenaValve, but said it disagreed with the court’s ruling.
The FTC said the $12 million total penalty is the largest ever for failing to make an HSR Act filing.
“Companies that try to sneak deals through without lawful FTC review should take notice,” Chairman Andrew Ferguson said in a statement. “The FTC will be vigilant in enforcing the requirements of the Hart-Scott-Rodino Act and we will not hesitate to seek penalties for its violation.”
Edwards will also be required to operate a program that ensures compliance with the judgment and antitrust laws and to provide advance written notice to the FTC before acquiring an ownership interest in any company that sells, or runs clinical trials for, a TAVR device to treat aortic regurgitation.
“After careful consideration, we believe resolving this with the FTC is the best path forward as we proceed with a clear focus on our mission to innovate for structural heart patients, including those with aortic regurgitation,” Edwards’ Meshulam said.
Meshulam added that the company would continue to work to develop treatments for the underserved patient group by advancing its Sojourn transcatheter AR valve and enrolling patients in the JOURNEY pivotal trial.
Genesis did not respond to a request for comment from MedTech Dive by publication time.
