Endovascular Solutions Provider EnduraMed Breaks Through 'Bottleneck' in Balloon and Catheter Raw Material Supply with In-House High-Performance Polymer Development

Driven by technological innovation, economic development, and policy support, China’s polymer materials industry is experiencing a period of rapid growth. In the medical field, polymer materials are utilized in the manufacturing of medical equipment, implantable medical devices, and artificial organs due to their low density, safety, and ease of processing. Currently, polymer materials have become one of the key raw materials for medical devices.

Medical polymer materials in Europe and the United States started earlier, forming a stable market of considerable scale. In contrast, the development of polymer materials in China has been primarily concentrated in the petrochemical, consumer appliance, and aviation sectors, with limited progress in medical-grade polymers. Most domestic medical device manufacturers are unable to produce polymer materials independently; instead, they rely on imported raw materials for product research, development, and manufacturing.

For domestic medical device companies, in-house development of polymer materials requires substantial investment, yet the ultimate demand for such materials is relatively limited. Raw materials that meet medical-grade standards are already available overseas. Although imported materials come at a higher price, the cost impact per unit product is negligible. Moreover, regarding medical balloons, China’s manufacturing processes and market are already quite mature, making it straightforward to produce balloons using imported raw materials.

However, long-term reliance on imported raw materials will subject China’s balloon catheter R&D to the “chokehold” dilemma. Once the supply of upstream raw materials is disrupted, the R&D and production processes of medical institutions may come to a standstill.

In the medical industry, commonly used polymer materials include polyurethane (PU), polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), nylon (PA), block polyether amide (Pebax), and polyethylene terephthalate (PET).The technology and quality of the polymer materials industry directly determine the R&D progress and product performance of downstream medical enterprises.。

For medical device companies, the journey from product development to regulatory approval is inherently time-consuming. Delays in raw material supply further slow down the pace of product development. According to Frost & Sullivan, domestic manufacturers of balloons and catheters generally rely on imported polymer materials. When developing products involving balloons and catheters, they typically require eight to ten weeks or even longer for product adjustments and prototype design.

Furthermore, major overseas material manufacturers may not dedicate time to customizing materials specifically for enterprises to meet the clinical requirements of different products. Moreover, quality variations across different batches of materials can occur, making it impossible to guarantee consistent final product performance. Although some companies maintain fixed relationships with a few imported raw material suppliers,The development of suppliers, production processes, delivery cycles, and quality are all uncontrollable.。

In the current global market, companies such as BASF, Bayer, Arkema, DuPont, and Kraton are dedicated to the research, development, production, and manufacturing of polymer materials. Although these enterprises have long established their presence in the field of polymer materials, the transition from industrial applications to medical use has been a protracted process. For instance, Solvay’s PEEK (polyether ether ketone) required overcoming challenges related to biocompatibility and stringent regulatory oversight to move from its use in aircraft components and automobiles to the medical implant market. Currently, the primary application of this material is in spinal fusion cages.

Turning our attention to the domestic market, China’s medical polymer materials, especially high-performance polymers, remain heavily reliant on imports, with some medical device companies maintaining stable overseas raw material suppliers.Due to technology embargoes, funding constraints, and other factors, domestic enterprises have yet to establish an independently developed ecosystem in the field of medical polymer materials.. Yet we have been discussing domestic substitution; if the issue of customized raw material supply is not resolved, how can we achieve self-sufficiency or deliver superior product quality?

The medical polymer materials industry featuresSmall Volume、High Requirementscharacteristics. In China, there are few large enterprises specializing in the research and development of polymer materials; such activities are predominantly concentrated among small and medium-sized enterprises (SMEs). Chinese companies seeking to independently develop polymer materials first face significant technical challenges. To meet clinical demands, raw materials for medical devices must not only address biocompatibility issues but also comply with standards for heat resistance, wear resistance, and high elasticity.Involving multiple disciplines, including biology, clinical medicine, physics, and chemistry。

Meanwhile, domestic enterprises are confronted not only with shortages of basic raw materials and technical challenges, but also with issues related to R&D costs and scale. Targeted R&D of medical-grade polymer materials is highly challenging, requiring substantial upfront investment. Furthermore, companies must break through the commercial dominance of imported raw materials to achieve successful commercialization. In the high-standard medical device sector, some material manufacturers may fail to establish advantages in quality and scale, thereby hindering their ability to implement effective commercial strategies.

Currently, most medical device companies in China are focusing on product innovation, lacking control over the entire production chain. However, materials can directly affect the performance stability and quality of products, which should not be underestimated. To gain a first-mover advantage, medical device companies such as MicroPort, Sino Medical Sciences Technology, and acotec have established material research and development platforms to independently develop polymer raw materials. Among them, acotec has built its own polymer material R&D center,Breaking the reliance on the original single R&D and production model of "imported raw materials + domestic manufacturing"。

Generally, medical balloons are made from polymer materials. To adapt to the intravascular environment of patients, medical balloons must be thin and soft while maintaining high pressure resistance, which necessitates the careful selection of base raw materials. Initially, polyvinyl chloride (PVC) and later polyethylene terephthalate (PET) were used to manufacture medical balloons due to their favorable chemical stability and mechanical properties; however, they exhibit poor light resistance and insufficient flexibility. Polyurethane offers good biocompatibility and wear resistance but suffers from poor water resistance. Nylon provides high strength and excellent wear resistance but has high water absorption and poor light resistance. Thus, base raw materials alone cannot meet the complex clinical requirements of medical balloons. Modification of these materials is required to achieve a balance among the three key characteristics: thinness, softness, and pressure resistance.

In the peripheral interventional drug-coated balloon (DCB) market, acotec undoubtedly holds a first-mover advantage. In terms of product R&D, acotec possessesAcoArt Orchid & Dhalia: The First Peripheral Interventional DCB Product Approved by the NMPA for Market LaunchandAcoArt Tulip & Litos, the Currently Only Approved DCB Product for Treating Below-the-Knee Atherosclerotic Disease (BTK)，24 Balloon, Catheter, and Aspiration Products Under Development，Covering five major fields: vascular surgery, cardiology, nephrology, neurology, and andrology.; In terms of market performance, Acotec’s first approved product, AcoArt Orchid & Dhalia, captured 86.9% of the Chinese peripheral DCB market.

With respect to its core products, drug-coated balloons and angioplasty balloons, Acotec primarily utilizes raw materials including balloons, lumens, and markers. According to Acotec’s prospectus, the company previously sourced its balloons and catheters mainly from two suppliers in the United States.

In May 2020, acotec injected RMB 18.5 million to acquire Weitai Medical.Establishment of a Polymer Materials Center in Shenzhen, to complement the innovation of its balloon catheter products. At a critical stage prior to its planned public listing, Acotec chose to invest a substantial amount of capital in polymer material research and development, thereby establishing a technological moat across its upstream and downstream value chains.

Currently, Acotec’s polymer materials R&D team is led by Lu Lizhong, who has 16 years of experience in the medical industry and possesses extensive expertise in polymer materials and polymer extrusion technology.Balloons, catheters, and drug-device combination products co-designed by him/her have been exported to the United States, Europe, Japan, and other countries.. He has led several graduate students specializing in polymer materials and, together with an overseas consultant who has decades of experience in the modification and processing of polymer materials, initially formed a research and development team for polymer materials.

By establishing its own customized raw material production line, leveragingMaterial ModificationandPrecision Micro-Extrusion Molding Technology, acotec is capable of manufacturing high-end microcatheters and balloons, significantly reducing product iteration time and production costs. Previously, this polymer material centerA composite radiopaque material has been developed based on block polyether amide elastomers to replace existing platinum-iridium alloy radiopaque materials.。

Platinum-iridium alloy, a radiopaque metal material currently used for balloons and catheters, is characterized by high hardness and limited flexibility. In contrast, the novel composite radiopaque material developed by acotec’s Material Science Center offers superior radiopacity while maintaining softness and elasticity, thereby enhancing the clinical usability of the final product. This composite material is poised for imminent clinical application.

In addition to modifying base raw materials, the Polymer Materials Center can also adjust product structures to develop multi-lumen balloon catheters, enabling the placement of additional control units within the lumens and thereby enhancing the catheter’s adjustable strength, tip visibility, and overall controllability.

Furthermore, different raw materials can better perform their functions within a multilayer structure to meet product requirements. For instance, catheter products require a smooth inner surface and external pressure resistance. Researchers incorporate materials such as PTFE and HDPE into the catheter lumen to enhance lubricity, facilitating guidewire passage. Meanwhile, one or more composite materials can be added to the outer layer of the catheter, endowing the device with excellent pressure resistance, kink resistance, radiopacity, drug-loading stability, and torque transmission, thereby meeting customized clinical usage requirements.

In addition toPolymer Materials TechnologyIn addition, acotec has also developedDrug Coating Technology、Radiofrequency Ablation Technology、Aspiration Platform Technology, the four technologies can work synergistically. By combining polymer material technology with drug-coating technology, acotec can develop new drug-coated balloon (DCB) products and expand the indications for its two core products. Meanwhile, polymer material technology can also be integrated with radiofrequency ablation technology and aspiration platform technology to facilitate the development of other therapeutic devices, such as acotec’s radiofrequency ablation system for varicose veins and thrombus aspiration system, both of which have already entered clinical trials.

By independently producing polymer materials to accelerate the R&D of innovative products and fostering synergistic development across the upstream and downstream sectors, acotec is building a moat encompassing the entire industry chain. Today, medical-grade polymer materials have permeated every aspect of the healthcare sector. Domestic medical device companies must aim for high-quality, high-performance products to overcome supply chain bottlenecks in raw materials and achieve domestic substitution from upstream materials to downstream products.