Balance Medical(SH:688198) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-08-18 23:59Core Viewpoint - Beijing Bairen Medical Technology Co., Ltd. has had its application for the registration of a patent foramen ovale (PFO) occluder accepted by the National Medical Products Administration, indicating a significant step in the development of this medical device [1][3]. Group 1: Product Information - The PFO occluder is a self-expanding, mushroom-shaped implant made from nickel-titanium alloy wire, designed to close the abnormal shunt caused by a patent foramen ovale [3]. - The device is intended to prevent complications associated with PFO, such as unexplained strokes and migraines, by effectively blocking the passage between the heart's atria [2][3]. - Clinical studies have shown that the PFO occluder can significantly reduce or eliminate migraine attacks, highlighting its therapeutic potential [2]. Group 2: Market Potential - The incidence of PFO in the general population ranges from 22% to 38%, with rates as high as 32% to 50% in patients with unexplained ischemic strokes, indicating a substantial patient base for the PFO occluder [2]. - The market for PFO occluders is expected to continue growing, with the number of implants increasing from 21,000 in 2021 to an estimated 54,000 by 2024, reflecting a strong demand for this treatment option [2]. Group 3: Regulatory Status - The acceptance of the registration application for the PFO occluder does not guarantee approval, and the company acknowledges the uncertainty regarding the impact of this product on its future performance [3].