Boston Scientific Announces Acquisition Agreement for Bolt Medical

January 8, 2025—Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Bolt Medical, Inc., the developer of an intravascular lithotripsy (IVL) laser-based platform for the treatment of coronary and peripheral artery disease (PAD). Boston Scientific anticipates the transaction to be completed in the first half of 2025, subject to customary closing conditions.

Boston Scientific stated that it initially developed the concept for the Bolt IVL system and helped establish Bolt Medical in 2019.

As a strategic investor in Bolt Medical, Boston Scientific has an equity stake of approximately 26%. Therefore, 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, advised Boston Scientific.

According to the press release, the Bolt IVL system uses 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.

The Bolt IVL system is an investigational device and is not yet cleared for commercial distribution in any country, noted Boston Scientific.

In November 2024, Bolt Medical 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 PAD in patients with moderately to severely calcified lesions.

The prospective, nonrandomized, multicenter studies were conducted in Europe. The data from both studies will be used to support FDA and CE Mark regulatory submissions for the devices, noted Boston Scientific.

The findings from the RESTORE ATK and RESTORE BTK trials were presented by Thomas Zeller, MD, at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

In December 2024, Bolt Medical received FDA approval to commence the global FRACTURE investigational device exemption clinical trial in the United States, which is investigating the use of the Bolt IVL coronary system for the treatment of coronary artery disease with severely calcified lesions, stated the press release.