Bairen Medical (688198.SH): ePTFE pericardial product approved for registration

Zhitong Finance App News, Bairen Medical (688198.SH) issued an announcement. Recently, after review by the State Drug Administration, the pericardial membrane (ePTFE) product developed by the company was approved for registration.

This product is a 0.1 mm expanded polytetrafluoroethylene (ePTFE) film used to repair or rebuild the capsule in cardiac surgery centers. The surface of the human heart has a film covering the entire heart. This layer of film, called the pericardium or pericardium, protects the surface tissue of the heart, especially coronary blood vessels. Every time an extracardiac surgery is required, the pericardium must be cut. Due to surgical damage to the pericardium, the original pericardium is permanently lost after surgery, causing the surface of the heart to be exposed and adhering to the sternum tissue, causing the risk of serious complications such as bleeding during further thoracotomy surgery, making the operation more difficult. In particular, many patients with complicated congenital heart disease in children need to open the chest again. Therefore, open heart surgery usually requires pericardial implantation (ePTFE) to repair or rebuild the damaged pericardium to protect the heart. Currently, pericardial membranes used in the domestic market are monopolized by foreign companies and have relied on imports for a long time. The registration and marketing of this product will end the history of reliance on imports for extracardiac ePTFE pericardial membranes.

Based on huge treatment demand, the number of cardiovascular surgeries in China has continued to grow over the years. In 2024, the total number of cardiac surgeries nationwide is about 360,000. The company's ePTFE pericardial products have broad application prospects and will also benefit more patients. At the same time, the company's subsidiary, Sky Sky Innovation, will also apply for 510K registration from the US FDA and will sell it to the global market after approval.