#United States #Marlborough #Boston Scientific #Bolt Medical #IVL System

Boston Scientific Expands Cardiovascular Portfolio with Bolt Medical Acquisition

In a significant move within the healthcare sector, Boston Scientific Corporation (NYSE: BSX) announced its agreement to acquire Bolt Medical, Inc., a company at the forefront of developing advanced medical technologies for treating coronary and peripheral artery diseases. This acquisition is pivotal in expanding Boston Scientific's portfolio, particularly in the fast-evolving field of intravascular lithotripsy (IVL), a technology designed to tackle complex calcified arterial diseases through minimally invasive methods.

Enhancing Treatment Options for Patients

As cardiovascular diseases remain the leading cause of mortality worldwide, the need for innovative treatment solutions has never been more urgent. Narrowed arteries, typically caused by cholesterol build-up and calcium deposits, restrict blood flow and can lead to severe health complications. The incorporation of Bolt Medical’s IVL system into Boston Scientific’s offerings is expected to address a significant unmet need for thousands of patients.

The Bolt IVL™ system utilizes a novel application by generating acoustic pressure waves through a balloon catheter to fracture hardened calcium deposits, thereby restoring adequate blood flow. This innovative approach marks a substantial advancement in lithotripsy technology, which is critical for treating calcified lesions in arteries.

Lance Bates, Senior Vice President and President of the Interventional Cardiology Therapies at Boston Scientific, expressed his enthusiasm, noting, “The addition of this system to our offerings can help us better serve physicians and their patients and provides a platform for future innovation.”

Financial Details of the Deal

Boston Scientific’s agreement involves an initial payment of approximately $443 million for the 74 percent stake in Bolt Medical that it does not currently own. Additionally, the deal could see up to $221 million in payments, contingent upon achieving certain regulatory milestones. Boston Scientific’s history with Bolt Medical dates back to 2019 when it initially helped establish the company and held a minority equity stake of about 26 percent.

Clinical Trials and Regulatory Pathway

Recently, Bolt Medical completed pivotal clinical trials, known as RESTORE ATK and RESTORE BTK, which evaluated the effectiveness of its IVL systems in treating peripheral artery disease in patients facing moderate to severe calcified lesions. The results from these trials are set to support regulatory submissions to the U.S. Food and Drug Administration (FDA) and receive CE Mark approval for commercial usage in Europe.

Further strengthening its positioning, Bolt Medical has obtained FDA approval to initiate the global FRACTURE IDE clinical trial, exploring the effectiveness of its coronary system in treating significantly calcified coronary artery disease. This rigorous approach to clinical validation showcases Bolt Medical's commitment to bringing cutting-edge technologies to market.

Anticipating Future Developments

The transaction is expected to finalize in the first half of 2025, pending standard closing conditions. Financial analysts indicate that the acquisition will have a slightly dilutive effect on Boston Scientific’s adjusted earnings per share (EPS) for the year, yet the company aims to mitigate this through internal efficiencies. On a GAAP basis, it is projected to be even more dilutive due to amortization expenses linked to the acquisition, albeit short-term benefits may be recognized from Boston Scientific's previously held equity interest in Bolt Medical.

With this acquisition, Boston Scientific reinforces its role as a leader in medical technology, committed to innovating patient care and enhancing treatment modalities for cardiovascular conditions. The collaboration with Bolt Medical signals a promising future for the development of life-saving medical devices designed to alleviate some of the most challenging health issues facing cardiovascular patients today.

For more details on Boston Scientific's expanding portfolio and its transformative impact on healthcare, visit their official website at Boston Scientific.