Regenerative Medicine Rebuilds 'Living' Blood Vessels: Roumai Medical Aims to Break International Gap in Small-Diameter Artificial Vascular Grafts

A Single Blood Vessel Traps a Large Population.

Since the outbreak of the pandemic, the shortage of artificial blood vessels in China has gradually come to light. During the recent lockdown in Shanghai amid the pandemic, the supply of artificial blood vessels was cut off, leaving vascular surgeons unable to proceed with their work and causing immense suffering for patients.

China’s artificial blood vessel market has long been dominated by imports, with international giants such as Maquet, Terumo, Gore, and Bard capturing the vast majority of the market share. Due to various factors including factory relocations and changes in suppliers, production volumes from two major players have been disrupted, thereby impacting China’s supply chain for artificial blood vessels.

Artificial blood vessels are regarded as the "lifeline."Clinically, synthetic vascular grafts are primarily used for aortic replacement or bypass, peripheral vascular bypass grafting, repair of vascular trauma, hemodialysis vascular access, and coronary artery bypass grafting.For some patients with acute aortic diseases and coronary artery disease, a single blood vessel serves as the critical pathway between life and death. Reliance on imported products for such cases strips vascular surgeons of their autonomy in treatment decision-making.

In China, the per capita accessibility of artificial blood vessels is poor, nearly two orders of magnitude lower than that in developed countries.

Abroad, patients with vascular trauma can be transported to nearby hospitals for bypass surgery or repair. In China, however, because artificial blood vessels have not yet become widely available at the primary care level, patients in county-level hospitals may not survive long enough to be transferred; consequently, most are left with no choice but to undergo amputation. Patient purchasing power is another major factor constraining the development of the artificial blood vessel market. Artificial blood vessels carry a high unit price, yet a significant proportion of patients suffering from vascular trauma result from car accidents or construction incidents. These patients often have limited financial resources and struggle to afford the high cost of artificial blood vessels.

According to Roupai Medical, while tertiary hospitals in first- and second-tier cities may maintain stockpiles of vascular grafts, prefecture- and county-level hospitals generally lack mature vascular surgery departments, let alone substantial reserves of vascular grafts, leaving the majority of patient needs unmet. Among tertiary hospitals across China, fewer than one-quarter have established vascular surgery as an independent specialty.

The development of vascular surgery as a discipline is not only contingent upon multidisciplinary collaboration within hospitals but also closely tied to the application of innovative products such as synthetic blood vessels. Furthermore, national efforts to improve citizens’ quality of life depend on breakthroughs in clinically essential products like synthetic blood vessels.With the improvement of primary healthcare capabilities and changes in medical insurance policies in China, the artificial vascular graft market is expected to see an order-of-magnitude increase in volume, offering promising prospects.

Based on diameter, vascular grafts are classified into three specifications: large, medium, and small. Generally, grafts with a diameter greater than 10 mm are referred to as large-diameter vascular grafts, those between 6 mm and 10 mm as medium-diameter, and those less than 6 mm as small-diameter. Currently, medium- and large-diameter vascular grafts are widely used in clinical practice. Domestic companies have gradually overcome technical barriers, leading to continuous positive developments in the localization of vascular graft production in China.

However, small-diameter artificial blood vessels remain scarce worldwide, with no clinically available products yet; most domestic and international efforts are still in the research phase. In contrast, clinical demand is growing steadily. According to the "Report on Cardiovascular Health and Diseases in China 2020," there are currently 330 million patients with cardiovascular diseases in China.

Small-diameter arterial diseases, particularly coronary artery occlusion, are associated with high morbidity and mortality rates worldwide, necessitating bypass surgery in some patients. Currently, clinical practice relies on the patient’s autologous internal thoracic artery and great saphenous vein; however, these grafts carry a high risk of postoperative restenosis. Once restenosis occurs, the autologous vessels are no longer viable for reuse, posing a life-threatening risk to the patient.

Materials such as polytetrafluoroethylene (PTFE) and polyester are widely used in large-diameter synthetic vascular grafts; however, their application in small-diameter grafts is associated with complications including thrombosis, intimal hyperplasia, and infection, resulting in suboptimal clinical outcomes. As artificial organs intended for long-term implantation and function within the human body,Small-diameter synthetic vascular grafts demand high performance, requiring an optimal balance of biocompatibility, anticoagulant properties, and mechanical strength to achieve ideal long-term patency.。

So, what if we could cultivate a living blood vessel outside the human body? Roumai Medical has provided an answer through regenerative medicine technology. Roumai Medical stated, “The tissue-engineered small-diameter artificial blood vessels we develop are essentially equivalent to living human blood vessels. Upon implantation, these vessels undergo rapid endothelialization, with the patient’s autologous cells gradually infiltrating the scaffold, leading to self-driven remodeling and regeneration of the vascular tissue over time.”

Roumai Medical’s vascular technology leverages microfluidics, innovative materials, and tissue engineering to overcome the technical barriers associated with small-diameter artificial blood vessels.

This process involves multiple steps, each requiring precise control. The core team at Roumai Medical has been deeply engaged in this field for many years and has developed two globally leading technologies in small-diameter vascular regenerative medicine and human-machine interface, includingSmall-Diameter Tissue-Engineered Artificial Blood Vessels and Tissue-Integrated Electronic Blood Vessels。

Roumai Medical’s second-generation small-diameter tissue-engineered vascular grafts offer resistance to infection, calcification, and hyperplasia, along with high long-term patency rates. Moreover, unlike the first-generation grafts made from inert materials, the second-generation products feature a higher degree of production automation.The weaving process for first-generation artificial blood vessels is complex and requires a large number of experienced workers. In contrast, the production of second-generation artificial blood vessels is fully automated and can be completed by machines; once the production line is established, no manual labor is required.

Building on the foundations of tissue engineering and human-computer interaction technology, Roumai Medical is dedicated to creating a technological platform.The company’s future growth potential extends far beyond artificial blood vessels, encompassing regenerative medicine fields such as artificial skin, tendons, cartilage, complex organs, and organ-on-a-chip technologies. These advancements aim to achieve human tissue replacement and functional enhancement, enabling comprehensive management across prevention, treatment, and monitoring through diverse technological approaches.

In recent years, China has vigorously encouraged domestic innovation, with high-tech devices such as thrombectomy stents and defibrillators gradually achieving localization. However, small-diameter synthetic vascular grafts remain a significant challenge, leaving this market largely untapped.

Globally, the U.S. company Humacyte is at the forefront in the development of regenerative medicine-based bioengineered vascular grafts. Humacyte is developing Human Acellular Vessels (HAV), which leverage tissue engineering technology to generate “living” human blood vessels ex vivo. HAV is the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA and has also been granted FDA Fast Track designation for the establishment of hemodialysis access.

As of the end of 2021, the Human Acellular Vessel (HAV) had been implanted in approximately 471 patients. As early as 2018, Fresenius and Humacyte signed a strategic cooperation agreement valued at $150 million for the commercialization rights of HAV technology. Humacyte estimates that if its HAV product ultimately receives FDA approval, the potential peak annual sales of its pipeline products will reach $12.1 billion.

The rapid development of Humacyte and its products offers a glimpse into the superiority of the tissue-engineered pathway for artificial blood vessels, as well as the vast market potential they hold. This untapped market awaits more participants and original technologies to fill the void, with Rourai Medical poised to enter the top international tier.

A multidisciplinary talent pool is the foundation of corporate development.The founding team and core R&D team of Roumai Medical are composed of world-leading scientists, clinical experts, and industry experts, all hailing from top-tier universities and research institutions such as ETH Zurich, Harvard University, the Chinese Academy of Sciences, Novartis, and Roche. Their research interests and professional expertise span more than a dozen disciplines, including materials science, biology, mechanical engineering, electronic engineering, systems engineering, software engineering, industrial design, cell engineering, genetic engineering, and chip design.

Leveraging a team of highly educated and experienced professionals,Roumai Medical has mastered cutting-edge technologies, including stent manufacturing processes, cell culture techniques, and bioreactors, and has implemented a forward-looking patent layout.. The company collaborates with universities and research institutions such as Southern University of Science and Technology, École Polytechnique Fédérale de Lausanne (EPFL), Swiss Center for Electronics and Microtechnology (CSEM), and the Chinese Academy of Sciences, as well as hospitals including Fuwai Hospital, the National Center for Cardiovascular Diseases, and PLA General Hospital (301 Hospital), boasting abundant expert resources.

Roumai Medical was founded with the aim of enhancing the quality and performance of artificial blood vessels, truly addressing clinical treatment challenges for patients, and extending human lifespan. With a focus on regenerative medicine, artificial blood vessels hold promising prospects for the future.

Reference: “Artificial Blood Vessels (Part 4): Trends in Products Under Development—Small-Diameter Grafts Show Promising Prospects, and New Technologies Are Flourishing” — Heyi Guangye Innovation Platform