Boston Scientific today announced it has entered into an agreement to acquire Bolt Medical, the developer of an intravascular lithotripsy (IVL) advanced laser-based platform for the treatment of coronary and peripheral artery disease.
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 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.
The Bolt IVL system is an investigational device, which is not yet cleared for commercial distribution in any country.
