Haimed Announces 12-Month FIM Clinical Results of LineMatrix Naimaitong®, China's First Small-Diameter Biological Vascular Graft
2026 | CCBPC
May 22 · Hefei
The 20th Conference on Critical Care Nephrology and Blood Purification (CCBPC) of the Chinese Society of Nephrology, hosted by the Chinese Medical Association and its Branch of Nephrology, and organized by the Anhui Medical Association and its Branch of Nephrology, was held in Hefei, Anhui Province, from May 19 to 23, 2026. As the most influential academic conference in the field of critical care nephrology and blood purification in China, this year’s conference featured in-depth exchanges on new theories in the diagnosis and treatment of critical kidney diseases, recent advances in blood purification technologies, and frontier achievements in renal replacement therapy. At the opening ceremony, Academician Chen Xiangmei released data from the Chinese National Renal Data System (CNRDS) regarding patients registered for hemodialysis and peritoneal dialysis in 2025, reporting 1.137 million hemodialysis patients and 162,000 peritoneal dialysis patients.
Professor Li Hua from the Department of Nephrology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, shared insights on LineMatrix at the conference.®December Clinical Results of the First-in-Human (FIM) Study on China’s First Small-Diameter Biological Artificial Vascular Graft.
Professor Li Hua:
LineMatrix Naimaitong®The first-in-human (FIH) clinical trial of the bioengineered vascular graft enrolled its first patient on September 24, 2024. All patients completed the 6-month postoperative follow-up as per the study protocol and are being continuously followed up to 12 months postoperatively. At 12 months postoperatively, the primary patency rate was 70%, and the cumulative patency rate was 100% (see figure below), significantly superior to that of traditional ePTFE vascular grafts. All patients underwent hemodialysis using the vascular grafts, with good recovery at dialysis puncture sites. Hemostasis time after each puncture was approximately 5–10 minutes, with no occurrences of bleeding, poor puncture site healing, or aneurysm formation. In the FIH clinical trial, LineMatrix Naimaitong®demonstrating its unique advantages: high patency rate, excellent biocompatibility, and puncture resistance, which preliminarily confirm the product’s safety and efficacy. LineMatrix Naimaitong®A prospective, multicenter, randomized controlled, non-inferiority clinical trial of bioengineered vascular grafts was initiated in June 2025, with a total of 326 subjects enrolled in a 1:1 ratio between the experimental and control groups; the control group utilized the GORE INTERING device, which is widely used in clinical practice.®Artificial vascular grafts are expected to complete nationwide, multicenter patient enrollment next month. We look forward to more encouraging results from the product’s randomized controlled trial (RCT) clinical study and hope that this product will be commercialized soon, bringing greater benefits to a broad population of hemodialysis patients.
LineMatrix Naimaitong®12-Month Postoperative Patency Rate of Bioengineered Vascular Grafts
About LineMatrix®
● Clinical Indications:Establishment of Vascular Access for Hemodialysis in End-Stage Renal Disease;
● Key Advantages:
The lumen can be effectively endothelialized;
Anti-infection;
No immune response;
Excellent biocompatibility;
Early puncture can effectively reduce the duration of central venous catheter use;
The natural vascular extracellular matrix (ECM) structure of the tube wall facilitates puncture site repair;
Fewer re-interventions, effectively reducing healthcare costs.
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, and the first enterprise in China—and the second globally—with the capability for mass production of 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, has studied abroad at the University of California, Berkeley; the California Institute for Regenerative Medicine (CIRM); and the University of California, Los Angeles.
The company specializes in 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), treatment of lower extremity atherosclerosis, and coronary artery bypass grafting. Leveraging this technological platform, the company is developing and manufacturing other regenerative medicine products, with plans to expand 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. In September 2025, it was named a “Star of Sci-Tech Innovation Future” by the Great Wall Enterprise Strategy Institute. In October 2025, it was included in the Suzhou Key Core Technology Breakthrough Projects and won first place in the Passive Medical Device Category Finals of the 8th (2025) China Medical Device Innovation and Entrepreneurship Competition. Over the past three years, the company has completed five 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 compliant with Class C+A standards, with an annual production capacity exceeding 30,000 units. LineMatrix Naimaitong, the first domestically produced biological artificial blood vessel.®Completed FIM clinical trials with outstanding clinical outcomes; initiated product registration clinical trials at 12 hospitals across China in August 2025, and formally entered the NMPA’s Special Review Procedure for Innovative Medical Devices in December 2025.