亚虹医药:产品APLD - 2304申报欧洲医疗器械注册获接收

Core Viewpoint - The company has submitted a medical device registration application for its product APLD-2304 to the EU regulatory body, which has been accepted, but it still requires further review and approval before market launch [1] Group 1: Product Information - APLD-2304 is the first portable single-use blue light bladder endoscope, which, when combined with blue light imaging agents, can improve bladder cancer detection rates and reduce recurrence rates [1] - The annual new cases of bladder cancer in Europe exceed 130,000, indicating a high market potential for the product [1] Group 2: Financial Impact and Risks - The acceptance of the application will not have a significant impact on the company's recent performance [1] - There are uncertainties associated with product development and approval, which investors are advised to consider [1]

Asieris-亚虹医药:产品APLD - 2304申报欧洲医疗器械注册获接收 - Reportify