FDA突破性医疗器械认定

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赛诺医疗: 赛诺医疗科学技术股份有限公司关于股票交易异常波动的公告
Zheng Quan Zhi Xing· 2025-08-22 16:48
Core Viewpoint - The stock of Sino Medical Science and Technology Co., Ltd. has experienced abnormal trading fluctuations, with a cumulative decline of 30% over three consecutive trading days from August 20 to August 22, 2025, prompting a regulatory announcement regarding the situation [1][6]. Group 1: Stock Trading Abnormalities - The company's stock price closed at 32.70 yuan per share as of August 22, 2025, with significant volatility exceeding that of most peers and the Shanghai Composite Index [3][10]. - The rolling price-to-earnings (P/E) ratio of the company is reported at 2318.77, significantly deviating from the industry average P/E ratio of 34.84 [3][10]. - The trading turnover rates for August 20, 21, and 22, 2025, were 16.56%, 19.01%, and 14.54%, respectively, indicating a notable increase compared to previous levels [3][10]. Group 2: Company Disclosures and Operations - The company has not identified any significant media reports or market rumors that could impact its stock price, and it confirms that there are no undisclosed major events affecting stock trading [2][8]. - The company’s subsidiary, Sino Shenchang, received FDA breakthrough device designation for its COMETIU self-expanding intracranial drug-coated stent system and COMEX balloon microcatheter, which signifies recognition of its technological innovation [4][11]. - The breakthrough designation does not guarantee FDA approval for market entry, as further compliance with regulatory requirements is necessary [4][11]. Group 3: Financial Performance - For the fiscal years 2023 and 2024, the company reported net losses of 39.63 million yuan and 1.4978 million yuan, respectively, while the net profit for the first half of 2025 was 13.84 million yuan [5][12].