NMPA Accepts First Domestic ePTFE Pericardial Membrane for Review, Developed by Bairong Medical

On November 20, Balance Medical announced that its registration application for pericardial membrane (ePTFE) had been formally accepted by the NMPA.

Currently, the domestic market for pericardial patches (ePTFE) is monopolized by foreign companies, with long-term reliance on imports. If this product is successfully approved, it will end the history of total import dependence on ePTFE implantable materials for cardiac surgery in China.

The human heart is enveloped by a thin membrane known as the pericardium or pericardial sac, which protects the surface tissues of the heart, particularly the coronary vessels. Cardiac surgery inevitably damages the native pericardium, resulting in postoperative exposure of the heart surface and adhesion to sternal tissue, thereby increasing the risk of complications during secondary or multiple re-sternotomies. Therefore, routine implantation of pericardial substitutes is required in cardiac surgery to repair or reconstruct the damaged pericardium and protect the heart.

The pericardial membrane (ePTFE) accepted for review is an expanded polytetrafluoroethylene (ePTFE) membrane manufactured through specialized processing techniques, intended for the repair or reconstruction of the pericardium during cardiac surgical procedures.

PTFE is a linear polymer composed of fluorine and carbon atoms, with its most common application being the Teflon coating on cookware. ePTFE is its expanded form and is widely used in medical devices and tissue fillers due to its strong biocompatibility, high heat resistance, low friction, long-term stability, and chemical inertness. ePTFE features a microporous structure that facilitates the ingrowth of human tissue cells and blood vessels into its pores, forming tissue integration; the resulting integrated tissue closely resembles autologous tissue.

ePTFE can be used for stent covering in applications such as self-expanding gastric stents and endovascular devices for abdominal aortic aneurysms, as well as in the treatment of structural heart diseases including heart valves, ventricular septal defect occluders, left atrial appendage implants, and mitral valve clips. Meanwhile, ePTFE material can be stretched and deformed, and fabricated into product forms such as sutures, patches, films, and tubes.

Biocompatibility is one of the key factors in the selection of pericardial materials. Medical-grade implantable ePTFE exhibits excellent biocompatibility, meaning it elicits minimal host response in specific applications. To avoid rejection by the implanted body, medical-grade implantable ePTFE demands extremely high uniformity in microporous porosity and pore size, presenting significant technical barriers.

However,The production and R&D of medical-grade ePTFE materials in China are relatively lagging, with supply monopolized by a few foreign companies, leading to high costs, long lead times, and significant supply chain risks.. This monopolistic status quo has also severely constrained the research, development, and production of coated medical implants and artificial vascular grafts in China.

Balance Medical is a domestically leading, technology-driven innovation platform for animal-derived implantable and interventional medical devices. Its products are primarily applied in the fields of structural heart diseases, such as valvular heart disease and congenital heart disease, as well as soft tissue repair. If successfully approved, this product will effectively complement Balance Medical’s existing congenital heart disease portfolio and is expected to address the long-standing bottleneck of import monopoly on ePTFE implantable and interventional devices and materials in China, thereby achieving domestic self-sufficiency and control.

The market for medical-grade implantable ePTFE is highly competitive, with numerous domestic and international companies actively participating. Major foreign players include ZEUS, Paradyne Medical, Medical Murray, and Donaldson.

Among them, ZEUS is a global leader in advanced polymer solutions, with its core business focused on the research, development, and production of new medical materials. Its product portfolio includes tubing, catheter components, heat-shrink tubing, bioabsorbable and implantable medical products, sutures, and more. In December 2023, the Swedish private equity firm EQT announced the acquisition of ZEUS. At that time, ZEUS was valued at $4 billion (approximately RMB 28.5 billion).

There are not many domestic companies, but they are also continuously growing and expanding.

According to Balance Medical's announcement, its ePTFE technology originated from an acquisition. In April 2023, Balance Medical acquiredSkyDome Innovations, and leveraging over a decade of R&D foundation in the latter, it has further developed ePTFE series implantable devices and materials, including pericardial patches, cardiovascular patches, and artificial blood vessels, that benchmark against those from foreign enterprises.

Shanghai Jinyou Fluorine MaterialsIt is a national high-tech enterprise specializing in the industrialization of ePTFE materials, with an annual production capacity of 10 million square meters of ePTFE membranes. Its products are applied in fields such as medical devices, baghouse dust collection, and air purification. In the field of dental medicine, its brand JINYOU has become one of the most important raw material suppliers in this market.

Suzhou Meichuang MedicalIt is an innovative platform dedicated to the research and development of interventional and implantable medical devices in the fields of peripheral vascular, tumor intervention, and vascular access. The company aims to overcome the reliance on imported materials by leveraging its self-developed medical-grade ePTFE material platform. In March 2024, Meichuang Medical announced that its Suzhou factory had officially commenced production of ePTFE Membrane. Previously, in December 2023, it had successfully started production of ePTFE Tubing.

With the improvement of domestic healthcare standards and the rising incidence of heart disease, the volume of cardiac surgical procedures continues to increase, driving up the demand for pericardial materials and expected to further expand the market size.