Medeon

SEQ_NO	1	Date of announcement	2024/12/05	Time of announcement	18:28:04
Subject	PMC, a subsidiary of Medeon, announced the US Expander-2 Pivotal Study for its minimally invasive BPH treatment Urocross has completed the subject enrollment.
Date of events	2024/12/05	To which item it meets	paragraph 53
Statement	1.Date of occurrence of the event:2024/12/05 2.Company name: PMC 3.Relationship to the Company (please enter ‘head office’ or ‘subsidiaries’):Subsidiary 4.Reciprocal shareholding ratios: Medeon holds a 89.3% ownership stake in PMC. 5.Cause of occurrence: PMC, a subsidiary of Medeon, has completed subject enrollment in its US Expander-2 Pivotal Study for its minimally invasive BPH treatment device Urocross, with a total of 240 patients. This multi-center, randomized, blinded, controlled study is designed to evaluate the safety and efficacy of Urocross in treating symptomatic benign prostatic hyperplasia (BPH). The primary endpoint is the efficacy at 3 months post-procedure, specifically whether it meets the U.S. FDA’s guidance for BPH product, which requires an improvement of more than 30% in the IPSS (International Prostate Symptom Score). 6.Countermeasures:None 7.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 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.): I. New drug name or code: Urocross Expander System and Urocross Retrieval Sheath II. Indication: Urocross is a retrievable and non-permanent implant based treatment, which is placed within the prostatic urethra using a standard flexible cystoscope commonly used for urological cystoscopy. The procedure is performed under mild sedation while the implant to be gently placed into the prostate-urethra. This provides immediate relief of BPH symptoms while modifying the obstruction. After six months, Urocross can be removed using the standard flexible cystoscope, ensuring that no permanent implant is left behind. III. Planned development stages: According to the U.S. FDA-approved clinical study protocol, data collection and evaluation of the primary endpoint could begin three months after the last patient enrolled. The clinical study details will be reviewed by the U.S. FDA prior to the official submission of the market approval application. IV. Current development stage: (1) Application submission/Approval/disapproval/each clinical trials (including interim analysis): The US Expander-2 Pivotal Study for Urocross has completed the subject enrollment. (2) Risks and mitigation measures to be taken by the company upon disapproval of the competent authority or inconclusive results from each clinical trial (including interim analyses): Not applicable. (3) Strategies to be taken by the company upon approval the competent authority or statistically significant results from each clinical trial (including interim analyses): Not applicable. (4) Accumulated investment expenditure is incurred: Due to the involvement of upcoming international licensing negotiations, and to protect the interests of investors, this information will not be disclosed at this time. V. Upcoming development plan: (1) Estimate Date of Completion: According to the U.S. FDA-approved clinical study protocol, data collection and evaluation of the primary endpoint could begin three months after the last patient enrolled. The clinical study details will be reviewed by the U.S. FDA prior to the official submission of the market approval application. (2) Estimated Responsibilities: None. VI. 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 published in 2023, the global market for medical devices treating BPH reached USD 1.42 billion in 2022. It is projected that from 2023 to 2030, the BPH-related market will grow at a compound annual growth rate (CAGR) of 8.9%. VII. Advanced innovative medical device development requires a 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.