The first domestic bio-inspired artificial blood vessel FIM clinical study results officially released

From June 27 to 29, 2025, the 10th China Blood Dialect Vascular Access Qianjiang Forum, hosted by the Nephrology Committee of the Zhejiang Provincial Society of Mathematical Medicine and the Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, was grandly held in Hangzhou. Over 100 renowned experts in the field of hemodialysis from across China and abroad, along with key members of national vascular access expert groups, delivered outstanding and innovative invited presentations.

Professor Li Hua, Chairman of the Qianjiang Forum on Vascular Access for Hemodialysis in China and Director of the Department of Nephrology and Hemodialysis Center at Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, spoke at the conference about LineMatrix Naimaitong.^®Special report on the FIM clinical study results of the biological artificial blood vessel: LineMatrix Naimaitong^®The primary patency rate of the biologic prosthetic vascular graft was 90.9% at 3 months postoperatively, and the cumulative patency rate was 100%. At 6 months postoperatively, the primary patency rate was 80.8%, and the cumulative patency rate remained 100%. The biologic prosthetic vascular graft did not trigger immune reactions in the human body, and no complications such as infection, aneurysm, or serum swelling occurred. All patients underwent dialysis using the graft. Preliminary results show that LineMatrix Naimaitong^®The patency rate of the biological artificial blood vessel is significantly superior to that of traditional ePTFE artificial blood vessels. Based on the FIM clinical study results, Professor Li Hua announced the launch of LineMatrix Naimaitong.^®Prospective, large-sample, randomized controlled, multicenter clinical trial of biologic artificial blood vessels for arteriovenous graft fistulas.

Since the first "China Hemodialysis Vascular Access Qianjiang Forum" was held in 2016, ten years have passed, and this forum has become an important academic exchange platform for experts and physicians in the field of vascular access both domestically and internationally. The 10th Qianjiang Forum, themed "Perfect Techniques Through a Decade, Innovating Through Refinement," shares cutting-edge information in the hemodialysis industry and explores new technologies, products, and methods in the field of hemodialysis access.

CNRDS data shows that the number of registered hemodialysis patients was 283,500 in 2013 and had increased to 916,600 by 2023. However, the one-year patency rate of commonly used ePTFE artificial grafts for hemodialysis is only 10–40%, with a high incidence of thrombosis, requiring repeated interventions to maintain patency, and prone to complications such as infection and seroma, severely affecting patients' quality of life and clinical outcomes. LineMatrix Naimaitong^®The biological artificial blood vessel has been verified by a domestic third-party authoritative testing institution to possess excellent biocompatibility. Compared with ePTFE artificial blood vessels, it offers advantages such as higher long-term patency rates, resistance to infection and calcification, absence of seroma, and durability against puncture. It significantly reduces the need for re-interventions, providing a new domestically produced solution for dialysis vascular access, and is expected to gradually replace traditional synthetic polymer artificial blood vessels after market launch.

Haimai Medical Technology (Suzhou) Co., Ltd. was established on September 1, 2021. It is a clinical-stage tissue engineering and regenerative medicine platform company, and the only company in China and the second globally capable of mass-producing small-diameter (inner diameter ≤6mm) tissue-engineered blood vessels. The company's founder, Professor Qiu Xuefeng from the Department of Cardiovascular Surgery at Union Hospital, affiliated with Huazhong University of Science and Technology, previously studied at the University of California, Berkeley, the California Institute for Regenerative Medicine (CIRM), and the University of California, Los Angeles. The company focuses on the standardized large-scale cultivation and production of small-diameter tissue-engineered blood vessels. This product is indicated for applications including creation of vascular access for chronic hemodialysis, vascular replacement for lower-limb arterial trauma (including battlefield vascular injuries), treatment of lower-limb arteriosclerosis, and coronary artery bypass grafting. Based on this technological platform, the company is also developing and manufacturing other regenerative medicine products, expanding into global clinical studies and commercialization. The company has been selected into the Suzhou Industrial Park Leading Talent Program, the Gusu Leading Talent Program, the Jiangsu Provincial Talent Program, and the Suzhou Unicorn培育 Program. In November 2024, it won first place in the national finals of the 13th China Innovation and Entrepreneurship Competition (Biopharmaceuticals), organized by the Ministry of Industry and Information Technology. Over the past three years, the company has completed four financing rounds. In May 2024, it completed construction and commenced operations at a 2,243-square-meter GMP production and quality inspection facility rated Class C+A, achieving an annual production capacity of over 30,000 units. Its first domestically developed biological artificial blood vessel is called LineMatrix Naimaitong.^®Has entered the clinical trial phase for product registration.