Summary of Heart Medical's Conference Call Company Overview - **Company**: Heart Medical - **Industry**: Medical Devices, specifically focusing on interventional cardiology and oncology Key Financials - **Revenue**: In the first half of 2025, Heart Medical reported revenue of 714 million RMB, with domestic revenue around 600 million RMB and overseas revenue approximately 123 million RMB, marking a year-on-year growth of over 95% in overseas sales [2][3][10] - **Net Profit**: The net profit attributable to shareholders was 315 million RMB, with a basic earnings per share of 2.55 RMB [3] - **Dividend**: The company plans to distribute a cash dividend of 13 RMB for every 10 shares, totaling 157 million RMB (including tax) [3] Product Development and Market Strategy Aortic Intervention - **New Products**: The Coretex branched aortic stent system has been approved for domestic use, while the AG42 abdominal aortic stent system has completed pre-market clinical follow-up [4] - **Market Trends**: The company anticipates that the revenue share from aortic stent systems will drop below 50% next year due to centralized procurement, potentially leading to a 40-50% decline in aortic revenue [4][27] - **R&D Investment**: The company expects R&D investment to stabilize at around 10% of revenue, with a focus on developing differentiated products to mitigate procurement risks [4][22] Peripheral Intervention - **Product Pipeline**: The company is advancing several products, including a detachable fiber embolization spring coil currently under domestic registration review and a drug-coated balloon catheter that has completed pre-market clinical follow-up [6][14] - **Market Share**: The current market share for peripheral products is approximately 20%, with expectations for growth through centralized procurement [16] Oncology Intervention - **New Approvals**: The transjugular intrahepatic portosystemic shunt (TIPS) stent system has been approved for domestic use, with additional products under review [7] Global Expansion Strategy - **Market Penetration**: Heart Medical has entered over 2,700 hospitals across 31 provinces in China and is actively pursuing market access in Europe, Latin America, and Asia-Pacific [2][9] - **International Revenue Growth**: The overseas revenue growth is attributed to the consolidation of Longba's data and rapid growth in international business, with plans to enter approximately 10 new countries annually [24][30] Regulatory Environment and Competitive Landscape - **Policy Impact**: The company is optimistic about the government's stance against excessive price cuts, which may favor innovative products while maintaining quality [15][29] - **Market Dynamics**: The company is focusing on developing new differentiated products to enhance market competitiveness and reduce risks associated with centralized procurement [29][30] Future Outlook - **Profitability Goals**: Management is confident in achieving a profit target of 600 million RMB for 2025, with ongoing efforts to meet annual goals [22] - **R&D Focus**: Future R&D investments will prioritize market promotion and international expansion, with a stable investment ratio expected [23][24] - **U.S. Market Entry**: Heart Medical plans to conduct its first implant surgery in the U.S. within the next two to three months, marking its official entry into the U.S. market [32] Conclusion Heart Medical is strategically positioned for growth in both domestic and international markets, with a strong focus on product innovation and regulatory compliance. The company's proactive approach to market expansion and adaptation to policy changes will be critical in navigating the competitive landscape of the medical device industry.

Group 1 - Jiangsu Changyida Medical Technology Co., Ltd. and Morningstar (Nantong) Medical Device Co., Ltd. have received approval from the National Medical Products Administration for their innovative Class III medical devices, namely the "Intracranial Aneurysm Assisting Embolization Stent" and the "Pulmonary Artery Thrombectomy Stent System" respectively [1][2] - In 2023, a total of 9 innovative Class III medical devices have been approved for market entry in Jiangsu Province [1] - The "Intracranial Aneurysm Assisting Embolization Stent" features a self-expanding elastic structure with adjustable length and flared ends, aimed at reducing vascular damage and enhancing vascular adhesion [1] Group 2 - The "Pulmonary Artery Thrombectomy Stent System" is designed for mechanical thrombectomy via the femoral vein, utilizing a large-caliber thrombus suction catheter to quickly restore blood flow [2] - This device offers a short preoperative preparation time, high efficiency in thrombus removal during the procedure, and rapid postoperative recovery [2] - The stent system includes various models with a gradient design for the mesh disk, which is intended to be more compatible with target blood vessels and reduce the risk of vascular damage [2] Group 3 - The Jiangsu Provincial Drug Administration is focusing on core technology breakthroughs and addressing "bottleneck" technologies to promote innovative medical device development [3] - The administration aims to enhance the transformation of clinical research results into practical applications, fostering collaboration between medical and industrial sectors [3] - Efforts are being made to reform the review and approval system, optimize the industrial ecosystem, and increase the international competitiveness of high-end medical devices in Jiangsu Province [3]