The acquisition will expand Boston Scientific’s cardiovascular portfolio with a complementary and differentiated calcium modification platform, furthering the company’s strategy to address coronary and peripheral disease.
Summary:
Boston Scientific has announced plans to acquire Bolt Medical Inc, a company developing an investigational intravascular lithotripsy (IVL) platform for the treatment of calcified coronary and peripheral artery lesions. The acquisition includes the Bolt IVL system, which uses acoustic pressure waves to fracture calcium in arteries, aiming to restore blood flow in patients with complex calcified lesions. Boston Scientific, already a strategic investor in Bolt Medical, will pay $443 million for the remaining 74% stake and up to $221 million based on regulatory milestones. Clinical trial data from Bolt’s pivotal studies will support FDA and CE Mark submissions, with the transaction expected to close in the first half of 2025.
Key Takeaways:
- Strategic Acquisition: Boston Scientific will acquire the remaining stake in Bolt Medical, adding an investigational IVL platform to its cardiovascular portfolio.
- Ongoing Clinical Trials: Data from pivotal studies, including RESTORE ATK, RESTORE BTK, and the FRACTURE IDE trial, will support regulatory submissions for the Bolt IVL system.
- Future Approvals Pending: The investigational Bolt IVL system is not yet cleared for commercial use, with approvals dependent on the outcomes of ongoing clinical trials and regulatory reviews.
Boston Scientific Corp 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,” says Lance Bates, senior vice president and president, interventional cardiology therapies, Boston Scientific, in a release. “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.”
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Cardiovascular diseases are the leading cause of death globally 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.
Background and Clinical Trials
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%. As a result, the transaction consists of an upfront payment of approximately $443 million for the 74% 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 and Below the Knee 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 US 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 US, 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.
The Bolt IVL system is an investigational device, which is not yet cleared for commercial distribution in any country.
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