Haimai Medical Announces 100% Patency in FIM Clinical Trial of LineMatrix Naimaitong®, China's First Domestic Bioengineered Vascular Graft
On June 6, 2025, Hymed Medical Technology (Suzhou) Co., Ltd. announced LineMatrix Naimaitong, the company’s first domestically produced biological artificial vascular graft.®FIM Clinical Trial Successfully Completes Follow-Up at the Department of Nephrology and Blood Purification Center, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine.
This clinical trial was led by Dr. Li Hua, Director of the Department of Nephrology and Hemodialysis Center at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, as the principal investigator. The first implantation was performed on September 24, 2024, and clinical follow-up for all enrolled patients was completed on June 5, 2025. Dr. Li Hua stated, “LineMatrix Naimaitong®Biological vascular grafts demonstrated excellent clinical outcomes in the creation of arteriovenous fistulas for patients with end-stage renal disease. The primary patency rates were 90.9% and 100% cumulative patency at three months post-operation, and 80.8% primary patency with 100% cumulative patency at six months post-operation. The grafts did not elicit immune responses, and no complications such as infection or aneurysm formation occurred. Their performance was significantly superior to that of expanded polytetrafluoroethylene (ePTFE) grafts. All patients underwent hemodialysis using the investigational grafts, preliminarily confirming the efficacy of LineMatrix Naimaitong.®Safety and Efficacy of Biological Vascular Grafts in the Human Body: Ongoing Patient Follow-Up Will Be Conducted. LineMatrix Naimaitong®“Biological vascular grafts demonstrate high patency rates. In contrast, the primary patency rate of traditional ePTFE vascular grafts at six months postoperatively does not exceed 50–60%. The use of biological vascular grafts significantly reduces the frequency of postoperative interventions, saves medical insurance funds, and substantially alleviates the financial burden on patients. This provides a domestically produced alternative for vascular access establishment, with the potential to gradually replace traditional ePTFE grafts and benefit a broad patient population.”
<Swipe to view the next image>
Clinical Trial Patients Use LineMatrix Naimaitong®Long-term Hemodialysis with Bioengineered Vascular Grafts: Angiographic Patency
Professor Qiu Xuefeng, Founder of Hymed Medical Technology (Suzhou) Co., Ltd., stated: “I came to Suzhou on June 12, 2022, to embark on a full-time entrepreneurial journey. Within three years, I led the startup team in completing the clinical trial of the first domestically produced biological artificial blood vessel. I extend my gratitude to all company members for their hard work and dedication! I am thankful for the strong support from shareholders, the Suzhou Industrial Park, bioBAY, and other sectors! Special thanks go to the Principal Investigator (PI) team for their assistance and guidance during the clinical trials!” Professor Qiu also announced that, based on the excellent clinical results from the First-in-Human (FIM) study, the company is about to launch LineMatrix Naimaitong.®A nationwide, multicenter product registration clinical trial for bioengineered vascular grafts is rapidly advancing the market launch of China’s first domestically produced bioengineered vascular graft, enabling domestic substitution with next-generation grafts that offer superior performance. Meanwhile, the company is developing a global first-in-class artificial blood vessel with a 3.5 mm inner diameter. Breakthrough progress has been achieved in an ovine orthotopic coronary artery bypass grafting model, poised to bring about a disruptive transformation in surgical techniques and outcomes for coronary artery bypass grafting (CABG) over the past 50 years.
Haimai Medical Technology (Suzhou) Co., Ltd. was established on September 1, 2021. It is a clinical-stage platform technology company specializing in tissue engineering and regenerative medicine. The company is the only enterprise 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. Indications for this product include the establishment of vascular access for chronic renal dialysis, vascular replacement for lower extremity arterial trauma (including battlefield vascular injuries), lower extremity atherosclerosis, and coronary artery bypass grafting. Leveraging this technology platform, the company develops and produces other regenerative medicine products, expanding into global clinical research and commercialization.The company has been selected for the Suzhou Industrial Park Leading Talent Program, the Gusu Leading Talent Program, the Jiangsu Provincial Talent Program, and the Suzhou Unicorn Cultivation Enterprise List. In November 2024, it won first place in the National Finals of the 13th China Innovation and Entrepreneurship Competition in the Biopharmaceutical sector, organized by the Ministry of Industry and Information Technology. Over the past three years, the company has completed four rounds of financing. In May 2024, it completed construction and put into operation a 2,243-square-meter Class C+A GMP production workshop and quality inspection center, with an annual production capacity exceeding 30,000 units. Its flagship product is LineMatrix (Naimaitong), the first domestically produced bio-artificial blood vessel.®Has entered the clinical trial phase.