Haimai Medical Successfully Holds Investigator Meeting for China's First Domestic Biological Vascular Graft LineMatrix Naimaitong®
On June 22, 2025, Dr. Li Hua from Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and Dr. Shi Yaxue from Longhua Hospital, Shanghai University of Traditional Chinese Medicine, served as the principal investigators for the LineMatrix NaimaiGeneral®The First Investigator Meeting and Kick-off Meeting for the Registration Clinical Trial of Bioengineered Vascular Grafts Was Successfully Held in Suzhou. This study is the first prospective, randomized controlled, non-inferiority, multicenter clinical trial for a domestically produced bioengineered vascular graft, initiated by Hymed Medical Technology (Suzhou) Co., Ltd., a unicorn incubation enterprise in Suzhou Industrial Park. The trial will be conducted simultaneously at more than ten hospitals across China.
Key members of the National Vascular Access Expert Group, their teams, and representatives from the CRO company attended this meeting. First, Professor Li Hua, the Principal Investigator (PI) of the project, reported to the attending experts on LineMatrix Naimaitong.®Results from the First-in-Human (FIH) Clinical Trial of the Bioengineered Vascular Graft: Compared with ePTFE vascular grafts, this product demonstrated superior patency rates, with no infections observed. It exhibited tolerance to repeated punctures, and no aneurysms or seromas occurred. All patients remain under continuous follow-up. Director Li Hua and Director Shi Yaxue provided a detailed report on the protocol, procedures, standards, and specifications for the national multicenter registration clinical trial of the bioengineered vascular graft. Director Li Wei from Fuwai Hospital, Chinese Academy of Medical Sciences, gave a thorough explanation of the statistical aspects of the clinical research. The attending experts engaged in comprehensive discussions on how to ensure high-quality execution of this clinical trial and reached a consensus.
Professor Qiu Xuefeng, Founder, Chairman, and General Manager of Hymai Medical Technology (Suzhou) Co., Ltd., extended a warm welcome and sincere gratitude to the experts and department directors for attending the conference in Suzhou on behalf of the sponsor, and introduced LineMatrix Naimaitong to the attendees.®Structure and Performance of Biological Vascular Grafts: Featuring a design concept with low immunogenicity and anti-calcification properties that surpasses similar foreign products, this graft offers advantages over traditional polymer materials, including endothelialization capability, high patency rates, resistance to infection, and puncture resistance. These features significantly reduce the frequency of postoperative interventions, thereby lowering both health insurance expenditures and out-of-pocket medical costs for patients.
Following the kickoff meeting, the sponsor invited the experts to tour its GMP production facility located in Zone B, Phase III of bioBAY. Professor Qiu Xuefeng, the company’s founder, explained to the experts the key technical points and precautions for anastomosis specific to biological vascular grafts, as opposed to traditional synthetic vascular grafts. Several experts performed vascular graft suturing on-site, and LineMatrix (Naimaitong) received high acclaim from all participants.®The suture performance of biological artificial blood vessels is basically similar to that of autologous blood vessels, and significantly superior to traditional polymer-based artificial blood vessels such as ePTFE.
The successful convening of this conference marks LineMatrix Naimaitong®Bioengineered Vascular Grafts Officially Launch Nationwide Multicenter Registry Clinical Trials in China. The market prospect for small-diameter vascular grafts is substantial. Currently, the three FDA-approved small-diameter vascular graft products used in the U.S. market are ePTFE vascular grafts, bioengineered vascular grafts, and tissue-engineered vascular grafts. Traditional ePTFE vascular grafts have been on the market for 50 years and commonly suffer from drawbacks such as high infection rates, low patency rates, predisposition to thrombosis, seroma formation, and poor puncture resistance, with a typical service life of no more than two years. Bioengineered vascular grafts have been widely promoted since 2014, with over 600,000 clinical cases reported to date, a number that continues to increase annually. Humacyte’s Symvess®The tissue-engineered blood vessel received FDA approval for market launch on December 19, 2024, becoming the first tissue-engineered product worldwide to gain FDA approval. The first commercial implantation was completed in March 2025. Haimai Medical Technology (Suzhou) Co., Ltd. is currently the only company in China that manufactures both biological artificial blood vessels and tissue-engineered blood vessels. Its disruptive technological advantages place it in a leading position domestically and at parity with international competitors.
About Haimai Medical
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 is developing and producing other regenerative medicine products, expanding into global clinical research and commercialization.The company has been selected for the Suzhou Industrial Park Leading Talent Program, Gusu Leading Talent Program, 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 (Biomedicine 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 GMP production workshop and quality inspection center with Class C+A standards, achieving an annual production capacity of over 30,000 units. Its flagship product, LineMatrix (Naimaitong), is the first domestically produced biological artificial blood vessel.®The product has entered the clinical trial stage for regulatory registration.