Boston Scientific has begun a transaction to acquire Bolt Medical, developer of an intravascular lithotripsy (IVL) laser-based platform to treat coronary and peripheral artery disease.

Bolt IVL was designed with a novel lithotripsy application. It fractures calcium by creating acoustic pressure waves inside of a balloon catheter. It also features visible, directional emitters to consistently deliver energy for calcified lesion treatment.

Boston Scientific initially developed the Bolt IVL concept, which helped to establish Bolt Medical in 2019. The company is a strategic investor in Bolt and has an equity stake of about 26%. Therefore, the deal consists of an about $443 million upfront payment for the 74% stake not already owned and up to $221 million should certain regulatory milestones be achieved.

Bolt Medical recently revealed results of its RESTORE ATK and RESTORE BTK pivotal trials. These trials investigated the company’s Bolt IVL above the knee (ATK) and below the knee (BTK) systems to treat peripheral artery disease in patients with moderate to severe calcified lesions. Data from the two studies will be leveraged to support U.S. Food and Drug Administration (FDA) and CE mark submissions for the devices.

Last month, the company earned FDA approval to begin the FRACTURE IDE clinical trial in the U.S. FRACTURE IDE is investigating the Bolt IVL coronary system to treat coronary arterial disease with severely calcified lesions.

Boston Scientific anticipates that the deal will close in H1 2025. The company expects the transaction will be slightly dilutive to adjusted earnings per share (EPS) in 2025, and to offset internal cost efficiencies and trade-offs.

“Representing one of the fastest growing medical device segments, intravascular lithotripsy therapy addresses a significant unmet need for patients with complex calcified arterial disease through a minimally invasive approach,” said Lance Bates, senior VP and president, Interventional Cardiology Therapies, Boston Scientific. “Bolt Medical is developing a next-generation technology that is highly complementary to our existing portfolio. The addition of this system to our offerings can help us better serve physicians and their patients and provides a platform for future innovation.”

In November 2024, the company revealed it was acquiring Intera Oncology, a privately held company that offers the Intera 3000 hepatic artery infusion pump and floxuridine, both of which are FDA approved.