Haimai Medical's LineMatrix Bioengineered Vascular Graft Enters NMPA Innovative Medical Device Fast-Track Program

On December 12, 2025, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration completed the public announcement of the review results for the latest batch of special examination applications for innovative medical devices (No. 12 of 2025). The domestically developed first bio-based artificial blood vessel (trade name: LineMatrix), independently researched and developed by Humstrix Medical Technology (Suzhou) Co., Ltd. (hereinafter referred to as “Humstrix Medical”),^®) The special review procedure for innovative medical devices is officially initiated upon a single submission.

This product is the first domestically produced small-diameter (≤6mm) biological artificial vascular graft to enter the special review process, marking a key technological breakthrough and significant milestone for high-end domestic medical devices in addressing the critical clinical need for vascular access in hemodialysis for patients with chronic renal failure.

The National Medical Products Administration’s Special Review Procedure for Innovative Medical Devices is widely regarded by the industry as a “green channel” that facilitates the translation of cutting-edge technologies. At its core, this procedure provides professional guidance characterized by “early intervention, dedicated personnel, and scientific review” from the National Medical Products Administration for innovative products with significant clinical value.

Entry into this program signifies authoritative recognition by regulatory authorities of the product’s fundamental innovation and urgent clinical need. More importantly, it enables the establishment of a closer and more efficient communication mechanism with the review department during subsequent registration submissions, thereby optimizing the review process and accelerating market approval while ensuring safety and efficacy, so that innovative achievements can benefit patients more rapidly.

LineMatrix Naimaitong, which has entered the special review process this time^®Bioengineered vascular grafts directly address the core challenges in the current hemodialysis field. China has the world’s largest population of hemodialysis patients. At the 19th Conference on Critical Kidney Diseases and Blood Purification, held by the Nephrology Branch of the Chinese Medical Association in 2025, Academician Chen Xiangmei from the PLA General Hospital (301 Hospital) presented data from the CNRDS (Chinese National Renal Data System), revealing that there were 1.027 million registered hemodialysis patients in China in 2024. Currently, establishing and maintaining long-term, reliable dialysis vascular access—the “lifeline” for hemodialysis patients—faces significant challenges. The clinically widely used ePTFE-material artificial blood vessels commonly suffer from drawbacks such as failure of postoperative luminal endothelialization, low patency rates, predisposition to thrombosis, high infection rates, seroma formation, and short service life.

Led by Professor Qiu Xuefeng, founder of Humstrix, the R&D team leveraged over two decades of research accumulation to develop China’s first bio-based artificial vascular graft using innovative technologies and patented processes. This product preserves and optimizes the intact three-dimensional structure of the natural extracellular matrix. Upon implantation, this biomimetic vascular graft effectively achieves complete endothelialization of the lumen, transforming the artificial graft into a “living vessel.” Furthermore, it enables human cells to self-repair the vessel wall at puncture sites, thereby significantly extending its service life.

LineMatrixNaimaitong^®Biological Artificial Blood Vessels

On November 19, 2025, Humstrix unveiled LineMatrix Naimai at the 52nd VEITHsymposium, the largest and most influential annual conference in the global field of vascular surgery.VCBeat^®Results of the First-in-Human (FIH) Clinical Trial for a Bioengineered Vascular Graft: This Innovative Product Demonstrates Significant Clinical Advantages Over ePTFE Vascular Grafts

Humstrix’s Biological Artificial Vessel Officially Enters the NMPA’s Special Review Procedure for Innovative Medical Devices, Marking a Significant Milestone.

First, domestically produced artificial heart valves and artificial hearts in the cardiovascular field have already been launched on the market; however, high-performance biological artificial blood vessels have yet to achieve domestic production. LineMatrix Naimaitong^®Bioengineered vascular grafts will break China’s long-standing reliance on imported artificial blood vessels, provide clinicians with more effective new options, and benefit the country’s millions of hemodialysis patients.

Secondly, this product originates from Humstrix’s globally leading tissue engineering and regenerative medicine technology platform. Its approval through the Special Review Procedure for Innovative Medical Devices has laid a solid foundation for extending the platform’s technologies to broader surgical indications, including lower extremity arterial injury repair, lower extremity atherosclerotic bypass surgery, and coronary artery bypass grafting.

Third, Humstrix’s successful regulatory approval sets a positive example for other domestic innovative medical device companies committed to source innovation. The collaborative interaction between the company and regulatory authorities to accelerate product market entry further demonstrates that China’s medical device review and approval system is increasingly supporting genuine original innovation, enabling the industry to transition from “following” and “keeping pace” to “leading” in certain frontier fields.

In August 2025, Humstrix initiated product registration clinical trials at 12 hospitals across China. As the product officially entered the National Medical Products Administration’s Special Examination Procedure for Innovative Medical Devices, LineMatrix Naimaitong^®Biological artificial blood vessels will accelerate their market launch, truly becoming “living vessels” that connect “Chinese innovation” with hemodialysis patients!

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.

Professor Qiu Xuefeng, Founder, Chairman, and CEO of Humstrix

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 hemodialysis, 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 develops and manufactures 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 list of enterprises in the Suzhou Unicorn Cultivation Program. 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 included in the Suzhou Key Core Technology Breakthrough Projects and won first place in the finals of the Passive Medical Devices Category at 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 built and put into operation a 2,243-square-meter GMP production workshop and quality inspection center of Class C+A grade, with an annual production capacity exceeding 30,000 units. LineMatrix Naimaitong, the first domestically produced bio-based artificial blood vessel.^®Completed the FIM clinical trial 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.