Medeon

SEQ_NO	1	Date of announcement	2026/03/13	Time of announcement	16:44:17
Subject	Urocross Expander System Officially Obtained U.S. FDA 510(k) Clearance
Date of events	2026/03/13	To which item it meets	paragraph 10
Statement	1.Date of occurrence of the event:2026/03/13 2.New drug name or code:Urocross Expander System 3.Indication: The Urocross Expander System is a retrievable, non-permanent implant system developed to improve lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). The system gently expands the prostatic urethral tissue through a minimally invasive procedure performed under mild anesthesia, thereby relieving obstruction and improving urinary flow. 4.Planned development stages: The Urocross Expander System has officially obtained the 510(k) Clearance from the U.S. FDA on 2026/03/13 (Taipei Time). 5.Current development stage: (1) Submission of application / approval granted / approval not granted / results of each phase of clinical trials (including interim analysis) / occurrence of other material events affecting new drug development: The Urocross Expander System has officially obtained the U.S. FDA for 510(k) Clearance (2) In the event that approval is not granted by the competent authority for the intended use, or the results of any phase of clinical trials (including interim analysis) fail to reach statistical significance, or other material events occur that may affect new drug development, the risks faced by the Company and corresponding countermeasures: Not Applicable (3) In the event that approval has been granted by the competent authority for the intended use, or the results of any phase of clinical trials (including interim analysis) reach statistical significance, or other material events occur that may affect new drug development, the Company’s future business plans and directions: Not Applicable (4) Cumulative research and development expenses incurred?G Due to the involvement of information pertaining to future international licensing negotiations, and to avoid impacting the deal amount while safeguarding the rights and interests of investors, the details will not be disclosed at this time. 6.Upcoming development plan: Subsequent efforts will continue to advance preparations for product launch while simultaneously conducting international strategic collaboration discussions. 7.Market situation: The probability of men suffering from BPH increases with age. The estimated population in only the United States with BPH is reaching 40 million. As the population continues to age, the number of BPH patients is expected to grow accordingly. According to a market research report by Grand View Research, the global market for medical devices treating BPH reached USD 1.67 billion in 2024. It is projected that from 2025 to 2033, the BPH-related market will grow at a compound annual growth rate (CAGR) of 9.4%, reaching USD 3.71 billion in 2033. 8.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.): The Company has successfully obtained 510(k) clearance, enabling it to legally commence sales activities in the U.S. market. Commercialization plans and mass production initiatives will be rolled out in phases. Concurrently, the Company has initiated market entry plans for Taiwan, including applying for Taiwanese regulatory approval and progressively establishing sales channels. Market entry efforts will be dynamically adjusted in alignment with global licensing negotiations and overall strategic priorities, with the core objective of maximizing the project’s overall value. 9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.: