Core Viewpoint - The PTCA balloon industry in China is experiencing steady growth due to the increasing prevalence of cardiovascular diseases, the expansion of coronary intervention treatments, and the rise of domestic medical device manufacturers. The market size is projected to grow from 1.059 billion yuan in 2021 to 1.366 billion yuan in 2024, with expectations to exceed 2.274 billion yuan by 2030 [1][11]. Industry Overview - PTCA balloons are medical devices used in cardiovascular interventions to dilate narrowed or blocked coronary arteries, improving blood flow and myocardial supply [1]. - The industry chain consists of upstream raw materials and equipment supply, midstream production, and downstream application in various medical institutions for treating cardiovascular diseases [2]. Industry Environment - The incidence of coronary artery disease (CAD) is rising in China, with the number of patients increasing from 25.272 million in 2020 to 27.953 million in 2024, and projected to exceed 30 million by 2030 [4]. - The mortality rate for CAD has also increased significantly, indicating a growing demand for treatment options [4]. Industry Status - Percutaneous coronary intervention (PCI) is a key treatment method for CAD, with a record of 1.63 million PCI procedures performed in 2023, marking a growth rate of 26.44% [7]. - Despite the increasing number of PCI procedures, the market penetration rate in China remains low at 690.9 procedures per million people, compared to 3022.1 in the U.S., suggesting significant growth potential [9]. Competitive Landscape - The global PTCA balloon market is dominated by international giants like Boston Scientific and Medtronic, which hold over 60% market share, particularly in high-end drug-eluting balloons [13]. - Domestic companies account for 60% of the number of firms but only 40% of the market share, indicating a competitive landscape where local firms are striving to catch up through innovation [13]. Future Trends - The industry is witnessing significant technological innovation and product upgrades, with new polymer materials enhancing balloon performance and the introduction of drug-coated balloons reducing the risk of restenosis [19]. - The trend towards domestic substitution is accelerating, with local companies like MicroPort and Lepu Medical increasing their market share due to improved product quality and performance [20]. - The demand for PTCA balloons is expected to grow as their application expands beyond traditional coronary disease treatment to include peripheral and intracranial vascular diseases [21].

Core Viewpoint - The European Union has voted to restrict Chinese medical device manufacturers from entering its procurement market, which could significantly impact companies like Bluestar Medical, although the company has developed strategies to mitigate risks associated with international trade policies [1][2]. Group 1: Impact of EU Decision - The EU's decision could ban Chinese companies from participating in tenders exceeding €5 million for five years, which may limit their access to a large market [1]. - Bluestar Medical's low-value consumables segment is expected to be minimally affected, as individual glove tender sizes are unlikely to reach the €5 million threshold [1]. - The company anticipates maintaining stable operational rhythms in its glove business despite the EU ban [1]. Group 2: Strategic Positioning - Bluestar Medical's cardiovascular business has effectively avoided the EU ban's impact through its overseas production bases in Singapore and Germany, ensuring that its international products are manufactured abroad [2]. - The company has established a "China innovation + global delivery" model, with localized R&D, production, and sales teams across China, Singapore, and Germany, creating a robust support system covering Asia-Pacific and Europe [2]. - This globalized production layout allows the company to respond effectively to potential future trade barriers [2]. Group 3: Product Development and Innovation - The cardiovascular division is experiencing a product harvest period in 2024, with several key products being launched, including the coronary artery balloon dilation catheter [3]. - The company has developed a comprehensive clinical solution with its products, marking a transition from simple to complex PCI lesion solutions [3]. - Bluestar Medical has built a full-chain international operation system and a marketing network that spans over 130 countries, positioning itself to withstand unpredictable global trade conditions [3].