Summary of Conference Call Notes Company and Industry - The company is focused on developing a biodegradable iron-zinc polylactic acid stent for the treatment of coronary heart disease [1] Core Points and Arguments - Product Advantages: - Simple operation process with lower operational costs [1] - Strong practicality, avoiding the drawbacks of permanent metal stents [1] - Excellent quality with good degradation speed and stability, with continuous improvements in clinical products [1] - Current Clinical Status: - Phase II clinical trials show a higher sample lesion rate but still yield good results [1] - Phase III clinical testing is complete, with follow-up required for 1-2 months [1] - Overall effectiveness is good, significantly better than competitors [1] - European Clinical Collaboration: - Ongoing discussions for collaboration with a European expert for clinical trials, which may enhance effectiveness and recognition [1] - Clinical testing process remains unpredictable [1] - Product Deficiencies: - Rapid corrosion rate of metal iron, with plans for future improvements [1] - Slow metabolic rate of iron and polylactic acid in the human body, though not a major concern [1] Additional Important Content - Market Entry Timeline: - CE application for the coronary stent submitted in May, with changes in European standards (MDD to MDR) causing delays [2] - Anticipation to obtain CE certification by the end of next year in China, requiring all clinical reports and data prior to submission [2] - Currently holds 50 technical patents in China and 24-25 in Europe [2] - Replacement Rate of Biodegradable Stents: - Achieving comparable effectiveness to permanent stents is considered a significant victory [3] - Permanent stents are prone to fatigue and fracture, leading to higher failure rates of target vessels [3] - Biodegradable stents perform better in secondary treatments, which is a concern for permanent stents [3] - Commercialization in Overseas Markets: - Seeking business development partnerships to aid international expansion, particularly in Japan [4] - Confident in the European market with ongoing clinical trials, which will facilitate CE certification [4] - No immediate plans for the U.S. market due to funding constraints for clinical testing [4] - Current Objectives: - Successfully complete European clinical tests and follow-ups to obtain CE certification [5] - Aim for commercialization and industrialization of the product [5] - Plan to apply for CE standards in South American and BRICS countries, which are easier to obtain [5]
先健科技会议纪要