Group 1 - The core point of the article is that HeartLink Medical-B (02160.HK) has received CE mark approval for its Alwide Plus cardiac balloon dilation catheter, indicating compliance with health, safety, and environmental standards in the European Economic Area [1] - As of August 18, 2025, HeartLink Medical-B's stock closed at HKD 1.62, reflecting a 9.46% increase with a trading volume of 26.61 million shares and a turnover of HKD 41.78 million [1] - The stock has low attention from investment banks, with no ratings given in the past 90 days [1] Group 2 - HeartLink Medical-B has a market capitalization of HKD 3.571 billion, ranking 12th in the medical device II industry [1] - Key financial metrics for HeartLink Medical-B compared to the medical device I industry average are as follows: - ROE: -2.16% vs. -8.48% (20th rank) - Market capitalization: HKD 3.571 billion vs. HKD 5.866 billion (12th rank) - Revenue: HKD 362 million vs. HKD 1.236 billion (19th rank) - Net profit margin: -14.73% vs. -18.01% (20th rank) - Gross profit margin: 69.48% vs. 55.19% (65th rank) - Debt ratio: 16.97% vs. 27.72% (10th rank) [1]

Core Viewpoint - The company has received CE mark approval for its Alwide Plus balloon dilation catheter, enhancing its product offerings in the transcatheter aortic valve implantation (TAVI) market in Europe [1][2]. Group 1: Product Features and Benefits - Alwide Plus is designed to expand calcified aortic valves prior to TAVI, reducing the challenges associated with valve shaping during the procedure [2]. - Key features include ultra-low compliance for precise balloon expansion, high burst pressure for effectively opening severely calcified areas, rapid filling and deflation to minimize blood flow interruption, and excellent puncture resistance for enhanced safety during the procedure [2]. Group 2: Market Impact and Strategic Importance - The CE mark approval will optimize treatment options for TAVI in Europe, contributing to increased overseas revenue for the company [2]. - Alwide Plus is the fourth self-developed product to receive CE mark approval, enriching the company's product matrix in the structural heart disease market in Europe [3]. - The approval demonstrates the company's leading technological reserves and R&D capabilities in the global structural heart disease medical device sector, enhancing its competitive edge in the international high-end medical device market [3].