海迈医疗完成国产生物型人工血管首次人体试验

Core Insights - Haimai Medical Technology (Suzhou) Co., Ltd. has completed the follow-up of its first domestic biological artificial blood vessel, LineMatrix Naimaitong® FIM clinical trial, marking it as the first company in China to achieve this milestone [1][2] - The clinical trial demonstrated high patency rates for the biological artificial blood vessel, with a primary patency rate of 90.9% at three months and 80.8% at six months, significantly outperforming traditional ePTFE artificial blood vessels [2][3] - The company plans to initiate nationwide multi-center product registration clinical trials for the Naimaitong® biological artificial blood vessel to accelerate its market launch and is also developing a groundbreaking 3.5mm diameter artificial blood vessel [3] Summary by Sections Company Overview - Haimai Medical is recognized for its innovative approach in developing the first domestic biological artificial blood vessel, which addresses the limitations of existing treatment methods for vascular injuries [1][2] Clinical Trial Results - The FIM clinical trial results showed that the biological artificial blood vessel had a primary patency rate of 90.9% at three months and 80.8% at six months, with a cumulative patency rate of 100% [2] - No immune reactions, infections, or complications such as aneurysms were reported, indicating the safety and effectiveness of the product [2] Market Implications - The high patency rates and reduced need for postoperative interventions suggest that the biological artificial blood vessel could significantly lower healthcare costs and alleviate the financial burden on patients [2] - The company aims to replace traditional ePTFE artificial blood vessels with its innovative product, potentially benefiting a large patient population [2][3] Future Developments - Haimai Medical is set to launch nationwide multi-center clinical trials for product registration, aiming for the commercialization of its biological artificial blood vessel [3] - The company is also working on a pioneering 3.5mm diameter artificial blood vessel, which could revolutionize coronary artery bypass surgery techniques and outcomes [3]