Blue Sail Medical Achieves Domestic Breakthrough with IVL System as Boston Scientific and Abbott Show Strong Interest

At the beginning of 2023, a report from Bloomberg revealed that medical device giant Boston Scientific (BSX.N) intended to acquire cardiovascular medical device company Shockwave Medical (SWAV.O) for 70 billion RMB to expand its cardiovascular product portfolio. Prior to Boston Scientific, another cardiovascular giant, Abbott, also made a move in February 2023 to enter the vascular calcification market by acquiring Cardiovascular Systems, Inc. (CSI), the leading company in peripheral interventional rotational atherectomy and a direct competitor of Shockwave Medical, for $890 million. By April 2024, the fate of Shockwave Medical was finally sealed as Johnson & Johnson acquired the cardiac device company Shockwave Medical for $13.1 billion. This marks Johnson & Johnson's second major transaction in the cardiovascular field within two years, following its $16.6 billion acquisition of Abiomed in 2022.

Several major players have suddenly pushed the vascular calcification track into the spotlight, sparking industry-wide attention onIVL (Intravascular Lithotripsy, Intravascular Shock Wave Lithotripsy)The attention. After all, Shockwave Medical's star product "Shockwave IVL" is not only the only technology that has a therapeutic effect on deep calcified lesions, but also solves a major problem in vascular calcification treatment. Its unique mechanism of action can improve surgical safety, restore vascular elasticity and blood flow remodeling of diseased vessels, while avoiding damage to the vascular intima.

"Shockwave IVL" has also demonstrated outstanding performance in commercialization. On one hand, the product quickly achieved market entry in the major cardiovascular disease markets of the U.S., Europe, China, and Japan. Compared to other products that may require up to a decade to achieve global commercialization, the speed of IVL system's commercialization reflects clinical recognition of this technology. On the other hand, with nearly $500 million in sales within two years of its market launch, the IVL system is poised to become a blockbuster product in the coronary field under its high growth momentum.

Currently, Shockwave Medical's IVL system is the most commercially mature worldwide, but Chinese medical companies have rapidly advanced the development of this system and have successively received regulatory approval for domestic market entry in China, gradually achieving breakthroughs in domestically produced alternatives.

In February 2023, the General Hospital of the People's Liberation Army Northern Theater Command successfully used an IVL product independently developed by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. (hereinafter referred to as "Bluesail Boyuan"), a subsidiary of Bluesail Medical's Cardiovascular Division, to perform thorough pre-treatment on a patient with severe coronary artery calcification and successfully completed the interventional surgery. This marked the completion of the first case in China for the pre-market registration clinical study of the coronary intravascular lithotripsy system. The successful implementation of this interventional surgery further verified the safety and effectiveness of the domestically produced IVL system independently developed by Bluesail Boyuan.The product has also been approved recently.

Coronary artery calcification refers to the deposition of calcium salts on the walls of the coronary arteries, often occurring in areas of atherosclerotic plaque hardening. The occurrence of this condition can also increase the difficulty of stent placement and expansion, making it hard for coronary stents to be properly positioned and adhere to the vessel wall, thereby reducing the success rate of PCI surgery and leading to a poorer prognosis.

According to data from the CIC Report, the number of PCI procedures in the United States has increased from 592,700 cases in 2015 to 1 million cases in 2021. Among the 1 million patients undergoing PCI procedures annually in the U.S., up to 30% have vascular calcified lesions. Among over 1 million coronary artery patients undergoing PCI procedures in China, approximately 200,000 to 300,000 suffer from moderate to severe calcified lesions. Globally, at least 1 million patients require calcification management each year.

However, due to the high difficulty of surgical operation and the inability to guarantee the safety of traditional surgical methods, severe calcified lesions have always been a major challenge for interventional physicians.

Currently, the most common interventional treatment methods in clinical practice includeCutting Balloon Angioplasty (CBA), Coronary Rotational Atherectomy (RA), Excimer Laser Coronary Atherectomy (ELCA), etc.CBA is mainly used to treat patients with mild to moderate calcified lesions, and its effect on severe calcified lesions is limited. RA is primarily used for highly calcified lesions. This procedure requires a certain level of expertise from the operator, and improper handling can easily lead to complications such as coronary artery spasm, dissection, guidewire fracture, and perforation. ELCA is mainly suitable for mild to moderate calcified lesions, but its efficacy in treating severe calcified lesions is relatively low.

Intravascular Lithotripsy (IVL) solves the most challenging problems in the simplest way and significantly enhances the safety of treating related diseases.

IVL innovatively integrates calcification fracture technology with low-pressure angioplasty in a single catheter equipped with a pulsed click balloon. It then uses a charged high-voltage capacitor to deliver the required discharge energy to the discharge electrode, which immediately triggers explosive evaporation of the surrounding water medium through hydroelectric effects, forming a rapidly expanding plasma bubble.

After the bubbles form, they rapidly expand and collapse, ultimately generating short-duration, microsecond-level acoustic pressure waves in the surrounding liquid to crack calcified areas. When the shockwave encounters tissues with impedance differences or acoustic mismatch (e.g., the transition from soft tissue to calcium), a localized spallation phenomenon occurs, shattering the solid material at the conduction interface. The wave continues to propagate through liquid or liquid-like soft tissue media while gradually attenuating, causing no harm to the soft tissue, thereby significantly enhancing clinical treatment.

As a new technology targeting vascular calcification, large-scale clinical data has been published internationally, and numerous clinical trials have proven that postoperative complications such as vascular injury are very rare. IVL has now been..."Chinese Expert Consensus on the Diagnosis and Treatment of Coronary Artery Calcification" recommends it as a safer, more effective, and simpler technology compared to other techniques. It is also the only treatment technology currently effective for both superficial and deep calcified lesions.

Although Shockwave Medical was the first company in the world to commercialize the IVL system, Chinese manufacturers represented by Bluesail Medical have quickly caught up and made breakthroughs. Not only have they further optimized product performance based on domestically developed technology, but they also hold multiple patents, establishing a technological barrier.

Bluesail Medical's Subsidiary—Bluesail Boyuan Successfully Develops High-PerformanceCoronary Calcium Intravascular Lithotripsy System (IVL), and innovatively designed the product to achieve rapid and effective fragmentation of dense calcified plaques, optimizing balloon passage and other features, enabling the IVL system to more effectively address clinical pain points. It is reported that the product has full independent intellectual property rights.

To ensure good balloon passability, as well as the stability of sound pressure intensity and sound pressure distribution, addressing the difficulties in the clinical treatment of vascular calcified lesions,Bluesail Boyuan innovatively designed high-performance electrodes and strictly controlled the product assembly process.Ensure that the middle part between the two electrodes has a sufficiently high acoustic pressure energy distribution. This product is suitable for the treatment of long lesions. Meanwhile, by generating more efficient and comprehensive shockwave energy, it rapidly and effectively fragments dense calcified plaques. Utilizing pulse technology, it addresses the clinically challenging issue of vascular calcification.

In addition,Bluesail Boyuan's Innovative Double-Layer Structured Balloon MaterialThis provides higher post-expansion capability after sound pressure treatment, allowing for more thorough vascular pre-treatment. For IVL catheters, Bluesail Medical also offers a wide range of IVL catheter model specifications to more precisely meet the needs of complex lesion pre-treatment, assisting clinicians in managing longer segments of calcified lesions.

In order to further lower the product's usage threshold and learning curve, the therapy device adopts a high-definition large screen and desktop structure design, with two triggering methods: handle and foot pedal. The operation interface and process are simple, facilitating surgical operations. Its rechargeable therapy device main unit, along with easy-to-operate wire interfaces and trigger devices, makes equipment installation and overall operation more user-friendly.

In summary,Bluesail Boyuan has comprehensively improved the adaptability, effectiveness, and convenience of the high-performance coronary calcification shock wave system (IVL) through a series of technological breakthroughs.

It is worth mentioning that the design advantages and features of this IVL system have also been genuinely validated through clinical trials. The IVL system completed nearly 200 clinical trials across China in just 49 days and has recently been approved. It can better address the challenge of severe calcification lesion pre-treatment, bringing clinical benefits.

As the research and development of China-produced IVL systems continue to advance and they gradually enter the market, the technological gap between China-produced IVL systems and top international products will progressively narrow. At the same time, diverse solutions can provide better assistance to clinicians and bring more clinical benefits to patients.

Since the acquisition of Biosensors International and Germany's NVT in 2018, Bluesail Medical has embarked on a transformation journey from low-to-mid-value consumables to high-value medical devices. Currently, the company has formed an overall solution in the cardiovascular sector, covering four product lines: coronary intervention, structural heart disease, peripheral vascular intervention, and neurovascular intervention. It has established a fully globalized system encompassing R&D, clinical trials, registration, production, and sales.

Based on a deep understanding and insight into the global market, as well as the synergistic development of organic growth and external expansion, Bluesail Medical is able to quickly seize market opportunities and simultaneously achieve the rapid integration of domestic and international technical research and development capabilities, further promoting product innovation and creation. The innovation and breakthrough of Bluesail Boyuan's IVL product is a manifestation of the company’s capabilities empowered by its globalized system in research and development, clinical trials, registration, production, and sales.

The IVL system has obvious advantages, but the global IVL market is still monopolized by Shockwave Medical, with high treatment costs, preventing widespread adoption of the product. However, as domestically produced breakthroughs in this product gradually occur, it can truly reduce patient treatment costs, improve treatment safety, lower the operational threshold for the product, enable large-scale application, and genuinely benefit patients. The breakthrough of domestically produced IVL products holds significant social value.

Next, Bluesail Boyuan will continue to optimize and iterate on product performance with the IVL system at its core, while accelerating the process of product implementation. With the empowerment of Bluesail Medical's global R&D, clinical, registration, production, and sales systems, the future is promising.

References:

1. "Boston Scientific Exposes $10 Billion Major Acquisition: Why is this Track Heating Up?"

2. "Listed for Less Than 3 Years, Market Value Increased Over 10 Times: How Did This Company Solve the Problem of Vascular Calcification?"

3. "Shockwave Medical: The Unique Intravascular Lithotripsy (IVL)"