Boston Scientific (BSX) to Acquire Bolt Medical

Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Bolt Medical, Inc., the developer of an intravascular lithotripsy (IVL) advanced laser-based platform for the treatment of coronary and peripheral artery disease.

"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 vice president 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."

Cardiovascular diseases are the leading cause of death globallyⁱ and are commonly due to narrowing of coronary and peripheral arteries, which can restrict blood flow. These narrowed arteries are often created by cholesterol deposits and may also have buildup of calcium that can increase the complexity of potential treatments. Lithotripsy is a procedure in which a physician breaks up hardened masses such as calcium to help restore blood flow. The Bolt IVL™ system is designed with a novel application of lithotripsy to fracture calcium by creating acoustic pressure waves inside of a balloon catheter. The system also includes visible, directional emitters for consistent energy delivery in the treatment of the calcified lesions.

Boston Scientific initially developed the concept for the Bolt IVL system which helped establish Bolt Medical in 2019. As a strategic investor in Bolt Medical, Boston Scientific has an equity stake of approximately 26 percent. As a result, the transaction consists of an upfront payment of approximately $443 million for the 74 percent stake not yet owned and up to $221 million upon achievement of certain regulatory milestones.⁺

Bolt Medical recently announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the Bolt IVL™ Above the Knee (ATK) and Below the Knee (BTK) systems for the treatment of peripheral artery disease in patients with moderate to severely calcified lesions. The data from both studies will be used to support U.S. Food and Drug Administration (FDA) and CE Mark regulatory submissions for the devices. In December 2024, Bolt Medical received FDA approval to commence the global FRACTURE IDE clinical trial in the U.S., which is investigating the use of the Bolt IVL™ Coronary System for the treatment of coronary arterial disease with severely calcified lesions.

Boston Scientific anticipates the transaction to be completed in the first half of 2025, subject to customary closing conditions. On an adjusted basis, the company expects the transaction to be slightly dilutive to adjusted earnings per share (EPS) in 2025, and to offset via internal cost efficiencies and trade-offs. On a GAAP basis, the transaction is expected to be more dilutive due to amortization expense and acquisition-related charges, except for a one-time gain to be recognized at closing associated with the company's previously held equity interest in Bolt Medical.

⁺On a 100% basis before consideration of Boston Scientific's current equity ownership in Bolt Medical, debt and other closing adjustments, the transaction price consists of $600 million up front, and up to $300 million upon achievement of certain regulatory milestones.

Caution: The Bolt IVL™ system is an investigational device, which is not yet cleared for commercial distribution in any country.

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