Beijing Balance Medical Technology Co., Ltd. (688198.SH) announced that its expanded polytetrafluoroethylene (ePTFE) pericardial membrane product has recently been approved for registration by the National Medical Products Administration. The product, a 0.1mm ePTFE membrane, is designed for the repair or reconstruction of the pericardium during cardiac surgery.
The pericardium is a thin membrane enveloping the heart, providing protection to cardiac surface tissues, particularly the coronary arteries. During cardiac surgeries, the pericardium is often incised, leading to permanent loss of the original membrane due to surgical damage. This can result in adhesions between the heart surface and sternal tissues, increasing the risk of severe complications such as bleeding during subsequent thoracotomies—especially in pediatric patients with complex congenital heart diseases, many of whom require repeat surgeries.
Consequently, ePTFE pericardial membranes are routinely implanted to repair or reconstruct damaged pericardium post-surgery. Currently, the domestic market for pericardial membranes is dominated by foreign companies, with long-standing reliance on imports. The approval and commercialization of this product will mark the end of China's dependence on imported ePTFE pericardial membranes.
Given the substantial clinical demand, the volume of major cardiovascular surgeries in China has seen consistent growth over the years, with approximately 360,000 cardiac surgeries performed nationwide in 2024. The company's ePTFE pericardial membrane product holds significant market potential and is expected to benefit a large number of patients.
Additionally, the company's U.S. subsidiary, Tianqiong Innovation, plans to submit a 510K application to the U.S. FDA. Upon approval, the product will be marketed globally.
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