Boston Scientific (NYSE: BSX) announced today that it agreed to acquire intravascular lithotripsy (IVL) platform developer Bolt Medical.
On a 100% basis — before considering an existing equity stake and other adjustments — the deal is valued at $600 million upfront with up to an additional $300 million upon achievement of certain regulatory milestones.
The acquisition marks a major entry into the hot IVL space, following Johnson & Johnson’s 2024 $13.3 billion acquisition of Shockwave Medical. Other companies, such as FastWave Medical, Vantis Vascular and Amplitude Vascular are making waves in IVL, too.
Bolt Medical designed its IVL advanced laser-based platform for the treatment of coronary and peripheral artery disease. Its novel application of lithotripsy fractures calcium by creating acoustic pressure waves inside a balloon catheter. The system also includes visible, directional emitters for consistent energy delivery in the treatment of calcified lesions.
The Bolt IVL system recently produced positive results in both the RESTORE ATK and RESTORE BTK pivotal clinical trials. Both studies will be used to support FDA and CE mark submissions for the investigational devices for above-the-knee (ATK) and below-the-knee (BTK) therapy.
Bolt Medical received FDA approval last month to conduct the global FRACTURE IDE study in the U.S. That study investigates the use of its IVL coronary system for treating coronary arterial disease with severely calcified lesions.
More details on the acquisition of Bolt Medical by Boston Scientific
Boston Scientific initially developed the concept for the Bolt IVL system, helping establish Bolt Medical in 2019. As a strategic investor, the Marlborough, Massachusetts-based company has an equity stake of approximately 26%.
As a result, the transaction includes an upfront payment of $443 million for the 74% stake not yet owned. The company also agreed to pay up to $221 million upon the achievement of certain regulatory milestones.
Boston Scientific expects to complete the transaction in the first half of 2025. On an adjusted basis, it expects a slightly dilutive impact to earnings per share in 2025. It anticipates offsetting that through internal cost efficiencies and trade-offs. On a GAAP basis, it anticipates a more dilutive impact, due to amortization expense and acquisition-related charges. That excludes a one-time gain at closing associated with the previously held equity interest in Bolt.
“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, SVP 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.”