The Federal Trade Commission (FTC) is taking a closer look at Boston Scientific’s $3.7 billion proposal to acquire neuromodulation developer Axonics, a move that could push back the closing of the deal.
In a filing this week with the Securities and Exchange Commission, Boston Scientific said that both it and Axonics received calls for additional information from the FTC. Officially known as a “second request” in the government watchdog’s acquisition review process, the move can extend certain waiting periods required under antitrust law.
Boston Scientific and Axonics said they plan to respond promptly to the FTC’s requests. While the deal had initially been slated for closure during the first half of this year—back when it was announced in January, during the J.P. Morgan Healthcare Conference—now the two companies are aiming to make the transaction official after the end of June.
The acquisition of the former Fierce Medtech Fierce 15 winner would place Boston Scientific in closer competition with Medtronic in the field of neurostimulation therapy for urinary and fecal incontinence. Both Axonics and Medtronic offer rechargeable and recharge-free sacral implants, with battery lives rated from at least 10 to over 20 years.
Boston Scientific has described sacral nerve neuromodulation as an “underpenetrated opportunity” in the U.S.—while Axonics has called it “historically a ‘secret’ therapy due to incumbent’s monopoly and lack of investment in patient awareness.” The companies estimate that its market size, pegged at $800 million in 2022, is expected to double to $1.6 billion by 2028.
The deal would also include Axonics’ Bulkamid, an FDA-approved, hydrogel-based urethral bulking injection for female stress urinary incontinence, which affects 28 million people. Axonics picked up that product through a $200 million acquisition of its own in early 2021.
Meanwhile, Boston Scientific could also inherit a long-running patent spat. In February, Medtronic petitioned the U.S. International Trade Commission to wade in and block sales, saying that Axonics’ neuromodulation implants infringe upon its designs for MRI compatibility. The medtech giant has also filed a parallel action in Delaware federal court.