Boston Scientific to Acquire Bolt Medical for $664M to Enter IVL Market

Following Stryker's $36 billion acquisition of Inari Medical, the medical device market witnesses the second major acquisition at the start of the year.

On January 8, Boston Scientific Corporation (Stock Code: BSX) announced that it had reached a definitive acquisition agreement with Bolt Medical. Boston Scientific will acquire Bolt Medical for $6.64 billion (equivalent to RMB 4.8 billion). The $6.64 billion purchase price consists of a $4.43 billion upfront payment (for 74% equity, as Boston Scientific already owns 26% before the acquisition) and $2.21 billion in milestone-based earnouts. The transaction is expected to be completed in the first half of 2025.

Bolt Medical's core product, Bolt IVL, was initially developed as a concept product by Boston Scientific. In 2019, Bolt Medical was established based on the Bolt IVL concept product. As a strategic investor in Bolt Medical, Boston Scientific holds approximately 26% of the equity.

The core of Bolt IVL lies in its laser-based IVL technology. This technology ingeniously transmits laser energy through optical fibers to multiple positions within the balloon, thereby exciting plasma inside the balloon, which is converted into powerful shockwaves to achieve intravascular lithotripsy effects. In addition, Bolt IVL is equipped with enhanced treatment options, highly deliverable catheters, and visible directional emitters, ensuring precise treatment for various calcified lesions with consistent energy.

In May 2024, Bolt Medical announced the results of the clinical study (RESTORE ATK) on the treatment of above-the-knee calcified lesions with Bolt IVL. In this clinical study involving 60 patients, no serious adverse events were reported within 30 days post-operation, including severe dissections, perforations, or unplanned major amputations of the target limb, and there were also no instances of clinically-driven target lesion revascularization.

In terms of efficiency, Professor Marianne Brodmann from the Medical University of Graz also stated that the RESTORE ATK trial demonstrated excellent safety and effectiveness in 60 reported patients within 30 days. Among them, the enrolled patients had severe calcification, and 26% of the lesions were chronic total occlusions. The increased pulse and targeted treatment of Bolt IVL provides progress in addressing unmet needs in IVL treatment to independently treat these complex patients. Importantly, the required post-dilation rate was as low as 12%.

In 2024, Boston Scientific Corporation originally planned to acquire Shockwave Medical (SWAV.O) for up to 70 billion RMB, enhancing the depth and breadth of its cardiovascular product line.

Prior to this, in February 2023, Abbott, another giant in the cardiovascular industry, took the lead by acquiring Cardiovascular Systems, a direct competitor of Shockwave Medical in the peripheral interventional rotational atherectomy field, for $890 million, thereby entering the vascular calcification treatment sector.

After April 2024, the final destination of Shockwave Medical was settled, with Johnson & Johnson acquiring it for a high price of $13.1 billion, which triggered widespread attention in the industry on intravascular lithotripsy (IVL) technology.

Shockwave Medical's star product "Shockwave IVL" stands out with its unique treatment mechanism, becoming the only technology capable of effectively treating deep calcified lesions. This technology not only enhances the safety of surgeries but also achieves the restoration of vascular elasticity and the remodeling of blood flow while avoiding damage to the vascular intima, solving a major challenge in the management of vascular calcification.

In terms of commercialization, "Shockwave IVL" has also performed exceptionally well. The product quickly completed its layout in major cardiovascular disease markets such as the United States, Europe, China, and Japan. Its rapid commercialization speed, compared to other products that typically require a decade to achieve global commercialization, undoubtedly highlights the clinical community's high recognition of this technology. Within two years of its launch, the sales of the IVL system have approached $500 million, showing a high growth trend and is expected to become a blockbuster product in the coronary field.

After the acquisition, Johnson & Johnson launched the next-generation Shockwave e8 balloon in September, which, together with the existing Shockwave l6, Shockwave m5+, and Shockwave s4 IVL catheters, formed a complete IVL product portfolio. In addition, at the TCT2024 conference in October, Johnson & Johnson also unveiled its next-generation peripheral IVL catheter—Javelin, the world's first balloon-free IVL catheter specifically designed to treat totally occluded vessels.

After the failed acquisition of Shockwave Medical, Boston Scientific quickly adjusted its strategy and promoted an alternative solution, Bolt Medical, to ensure its leading position in the IVL field. Currently, the IVL market has become a new hotspot in the cardiovascular treatment sector, second only to the pulsed field ablation (PFA) market, with three out of the four giants in the cardiovascular industry already having a presence. Among all the latecomers in IVL technology, Boston Scientific is most likely to become Johnson & Johnson's strongest competitor in the IVL field, thanks to its robust R&D capabilities and market deployment.

In this race for the development and market launch of IVL products, Chinese manufacturers are not inferior.

In recent years, domestically produced IVL products have emerged like mushrooms after rain, among which notable players include Saihe Medical, Lepu Medical, and Puchuang Medical. In October 2023, Saihe Medical successfully launched the first domestically approved coronary shockwave treatment system in China. The system consists of the LiqMagic® C14 single-use coronary intravascular shockwave catheter and the ISL100 Pro intravascular shockwave treatment device, effectively improving the compliance of coronary arteries through innovative vascular calcified plaque cracking technology.

Following closely is LePu Medical. In January 2024, LePu Medical's VessCrack Shockwave Balloon Catheter was successfully approved for marketing. This catheter, used in conjunction with LePu Medical’s intravascular shockwave treatment device (Model: LP-AW-200A), provides an excellent solution for the pre-treatment and balloon dilation of primary coronary artery calcified lesions (coronary artery stenosis ≥50%) in adult patients.

In March 2024, Puchuang Medical successfully launched the coronary intravascular lithotripsy system, which consists of the SONICO-CX® single-use coronary intravascular lithotripsy catheter and intravascular lithotripsy equipment. With the highest number of pulses (120 times) among similar products, it has gained significant market attention.

In addition, Zhonghui Medical received approval for the listing of its intravascular shockwave treatment system in June 2024. Previously, its C-Wave® intravascular shockwave catheter and generator system were also approved for marketing in August 2023. Thus, Zhonghui Medical has become the only Chinese company to have IVL products approved in both coronary and peripheral vascular intervention fields in China.

In addition to the aforementioned products that have already been marketed, the research and development of multiple IVL products in China is proceeding vigorously. For instance, Xinkang Medical's peripheral shockwave balloon system initiated pre-market clinical research in June 2023 and successfully completed the enrollment of the first patient. MicroPort's coronary shockwave balloon also completed the enrollment of all patients in August 2023.

From the market performance, the Chinese-produced IVL products have achieved good results in less than a year after entering the market. Taking LePu Medical as an example, its Sonic Balloon has significantly contributed to the company's revenue growth starting from the second quarter since its launch in 2024. According to its semi-annual report, in the first half of 2024, LePu Medical’s coronary intervention business achieved a revenue of 850 million yuan, of which the Sonic Balloon contributed approximately 2%, or about 17 million yuan. LePu Medical expects that the Sonic Balloon will generate revenue between 150 million and 200 million yuan in 2024.

In addition, LePu Medical's Sonic Balloon product has signed agency contracts with more than 2,000 distributors, and has been trialed in over 600 hospitals. This achievement not only demonstrates the market potential of domestically produced IVL products but also indicates that the treatment level for vascular calcification in China is about to reach a new stage.

As the commercialization of domestically produced IVL products accelerates, the potential of IVL as a "blockbuster" has begun to emerge. In the future, domestically produced IVL products will also secure a position in the global market, offering higher quality and more efficient vascular calcification treatment solutions for patients worldwide.