VEITH 2025 First Look: LineMatrix Naimaitong® — China’s First Small-Diameter Biological Vascular Graft Demonstrates 100% Cumulative Patency at 6-Month FIM Clinical Trial Follow-Up

Prof. Xuefeng Qiu: It is a great honor to accept the invitation from VEITHsymposium 2025 to present LineMatrix (Naimaitong) on the international stage.^®Clinical Trial Results of Bioengineered Vascular Grafts. After years of research and development, Humstrix has launched LineMatrix (Naimaitong), the first domestically produced small-diameter bioengineered vascular graft.^®Entering the clinical trial phase in September 2024, this First-in-Human (FIH) clinical trial successfully completed the 6-month postoperative follow-up in June 2025, preliminarily confirming its safety and efficacy. We now invite Professor Li Hua, Principal Investigator of this clinical trial and from the Department of Nephrology at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, to share insights on LineMatrix Naimaitong.^®clinical use experience.

Prof. Li Hua: LineMatrix^®The first-in-human (FIH) clinical trial of the bioengineered vascular graft was initiated in 2024 and has successfully completed the 6-month postoperative clinical follow-up, with a cumulative patency rate of 100%. Currently, all patients are undergoing hemodialysis treatment using this vascular graft. In the clinical trial, LineMatrix Naimaitong^®Demonstrating its unique advantages: high long-term patency rate, excellent biocompatibility, strong resistance to infection, and superior puncture resistance, it addresses the shortcomings of previous ePTFE vascular grafts. We look forward to LineMatrix Naimaitong.^®The multicenter product registration clinical trials have yielded more encouraging results, and we hope that this product will be commercialized soon to provide superior quality solutions for hemodialysis patients.

The number of patients with chronic kidney disease (CKD) in China is growing rapidly. Currently, there are approximately 120 million CKD patients nationwide, among whom over 3 million require renal replacement therapy. In 2024, the number of patients receiving dialysis treatment exceeded 1.183 million, including 1.027 million hemodialysis patients. The five-year survival rate was only 33.4%, and the average survival time for hemodialysis patients was just 4.4 years, far below the levels observed in developed countries in Europe and America.

The FDA has approved three categories of small-diameter synthetic vascular grafts: expanded polytetrafluoroethylene (ePTFE) grafts, biological grafts, and tissue-engineered vascular grafts. ePTFE grafts are associated with low patency rates, a high propensity for thrombosis, and elevated infection rates. Biological grafts offer advantages such as excellent biocompatibility, high patency rates, and low infection rates; within 3–6 months post-implantation, they achieve complete luminal endothelialization and adventitial recellularization. Tissue-engineered vascular grafts received FDA approval in 2024 and are currently indicated only for the replacement of damaged peripheral arteries, while clinical trials for hemodialysis applications are ongoing.

Currently, the only small-diameter synthetic vascular grafts available for hemodialysis patients in China are ePTFE-based products, such as LineMatrix (Naimaitong).^®It is the first domestically produced small-diameter bioengineered vascular graft: Its wall features a biomimetic extracellular matrix (ECM) structure and offers advantages such as self-repair and regeneration capabilities, antithrombotic and anti-infective properties, puncture resistance, low immunogenicity, reduced or eliminated need for reintervention, and high cost-effectiveness.

Studies show that LineMatrix Naimaitong^®The biological artificial vascular graft wall is free of residual cell nuclei, with quantitative detection of residual DNA in the vascular wall tissue below 10 ng/mg of tissue dry weight, significantly lower than the international industry standard (<50 ng/mg of tissue dry weight). The α-Gal antigen clearance rate exceeds 90%, further confirming LineMatrix Naimaitong.^®Extremely low immunogenicity; H&E staining and scanning electron microscopy of the vessel wall revealed that the structure of the bioengineered vascular graft was highly similar to that of native blood vessels, with the collagen fiber architecture of the vascular wall ECM fully preserved.

A total of 18 ovine arteriovenous fistula models were established in preclinical studies, including LineMatrix Naimaitong^®Group 1: 12 cases; ePTFE group: 6 cases. LineMatrix (Naimaitong): 10 cases^®The 6-month postoperative patency rate was 100%. In the ePTFE group, the 6-month postoperative patency rate was 83% (6 cases). Two cases involved LineMatrix.^®At the 1-year follow-up, both vascular ultrasound and DSA confirmed that the prosthetic grafts remained patent.

Histopathological and scanning electron microscopy analyses at 6 months postoperatively showed: LineMatrix^®Immunofluorescence staining for von Willebrand factor (vWF) in biological vascular graft specimens revealed uniform endothelialization of the lumen, whereas no endothelial cells were observed in the lumen of the ePTFE group.

Quantitative Tissue Calcium Results at 6 Months Post-Operation: LineMatrix Humstrix^®There was no significant difference between the bioengineered vascular grafts and autologous arteries, whereas both were significantly lower than the ePTFE group.

This trial included a total of 12 patients, aiming to evaluate LineMatrix Naimaitong^®Preliminary Safety and Efficacy of Biological Vascular Grafts for Arteriovenous Fistulas in Patients with Chronic Renal Failure: A Final Follow-up of 10 Cases, with 2 Patients Withdrawing from the Study

● Safety: No stenosis, no infection, no seroma, no aneurysm or pseudoaneurysm, and no mortality; thrombosis occurred in 2 patients: in one case, it was due to improper hemostatic compression after the first hemodialysis puncture at one month postoperatively, and in the other case, it resulted from venous compression caused by the patient’s lateral decubitus position during hemodialysis at three months postoperatively.

● Efficacy: The primary patency rate was 90% at 3 months postoperatively and 80% at 6 months postoperatively, with a cumulative patency rate of 100%. As of November 15, 2025, all patients remained patent during continuous follow-up and underwent hemodialysis using arteriovenous grafts; the structure and function of the grafts remained normal across 159 dialysis sessions.

At 3 months post-operation in the FIM clinical trial, the primary patency rate was 90%, and the cumulative patency rate reached 100%; at 6 months post-operation, the primary patency rate was 80%, with a cumulative patency rate of 100%. No infections, aneurysms, seromas, or immune reactions were observed, preliminarily confirming the safety and efficacy of LineMatrix.^®Safety and Efficacy of Biological Vascular Grafts. Moreover, LineMatrix^®Biological vascular grafts enable early cannulation, allowing for dialysis access as soon as two weeks postoperatively. This effectively reduces the reliance on central venous catheters, while offering simplified surgical procedures and suturing, along with fewer postoperative reinterventions.

Humstrix 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 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 specializes in the standardized, large-scale culture 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 technology platform, the company is developing and producing other regenerative medicine products, with plans to expand into global clinical research and commercialization.The company has been recognized as a Leading Talent Enterprise in Suzhou Industrial Park, a Gusu Leading Talent Enterprise, and an Jiangsu Provincial Talent Program Enterprise, and has been included in Suzhou’s Unicorn Cultivation Plan. In November 2024, it won first place in the National Finals of the 13th China Innovation and Entrepreneurship Competition (Biopharmaceutical 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 selected for Suzhou’s Key Core Technology Breakthrough Projects and won first place in the Passive Medical Devices Category of the National Finals of the 8th (2025) China Medical Device Innovation and Entrepreneurship Competition.Over the past three years, the company has completed four rounds of financing. In May 2024, it completed construction and commenced operations of a 2,243-square-meter GMP production workshop and quality control center classified as Grade C+A, with an annual production capacity exceeding 30,000 units. Its flagship product, LineMatrix (Naimaitong), is the first domestically produced biological artificial blood vessel.^®The FIM study has been completed, yielding excellent clinical outcomes. Product registration clinical trials have now been initiated at 12 hospitals across China.