Medeon

SEQ_NO	1	Date of announcement	2025/05/08	Time of announcement	02:37:18
Subject	Medeon announced the preliminary clinical results for the Expander-2 IDE Study in evaluating its BPH minimally invasive treatment device Urocross.
Date of events	2025/05/07	To which item it meets	paragraph 10
Statement	1.Date of occurrence of the event:2025/05/07 2.New drug name or code: Urocross Expander System and Urocross Retrieval Sheath 3.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 (Benign Prostatic Hyperplasia) 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. 4.Planned development stages: While the data collection and evaluation of the primary endpoint is completed, the clinical study details will be reviewed by the U.S. FDA prior to the official submission of the market approval application. 5.Current development stage: The preliminary analysis of clinical results for the Expander-2 IDE Study in evaluating the BPH minimally invasive treatment device Urocross has been completed. Pivotal, multi-national and multi-center, randomized, sham-controlled, blinded study Evaluate the safety and efficacy for the Urocross Expander System and Retrieval Sheath treating lower urinary tract symptoms (LUTS) associated with BPH Pivotal IDE Study Urocross Expander System and Urocross Retrieval Sheath Treating lower urinary tract symptoms (LUTS) associated with BPH Primary Outcome Measures: i.Safety: The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void. ii.Efficacy: The average improvement in IPSS among the experimental group is more than 25% greater than the average improvement in IPSS among the sham control group at 3 months post-procedure. Secondary Outcome Measures Percent change in IPSS from baseline (i.e., pre-procedure) to 3 months post-procedure for subjects randomized to the Urocross Implant group is greater than 30%. A total of 240 patients were randomized 2:1 to the Urocross experimental group and the sham control group (intervene by cystoscopy without further treatment). Safety Endpoint: According to the statistical results of the study, no serious adverse events related to the procedure or device. The percentage of subjects who were left with catheter for more than 7 days due to difficulty in urination was 0.6%. Efficacy Endpoint: The trial results showed that the treatment group achieved average improvements in the International Prostate Symptom Score (IPSS) of 25.7%, 32.6%, 44.5%, and 52.1% at 3 months (N=158), 6 months (N=129), 7 months (N=107), and 12 months (N=68) post-treatment, respectively, with all p-values less than 0.0001. The IPSS improvement in the Urocross treatment group reached the 30% benchmark outlined in the FDA’s guidance for BPH treatments at 6 months post-procedure. Additionally, the treatment group showed a 25% greater improvement than the sham control group at the six-month period. Once the full clinical study report is finalized, the trial data will undergo inspection by the U.S. FDA to ensure its accuracy and reliability. Concurrently, additional clinical data will continue to be collected, with plans to formally submit a marketing application to the FDA by the end of 2025. During its review, the FDA will evaluate the application based on the requirements outlined in its guidance for BPH treatments, as well as the safety and efficacy profiles of comparable products already on the market, to determine whether Urocross offers meaningful clinical benefit to patients. While the data collection and evaluation of the primary endpoint is completed, the clinical study details will be reviewed by the U.S. FDA prior to the official submission of the market approval application. Due to the involvement of information pertaining to future international licensing negotiations, and to avoid impacting the licensing amount while safeguarding the rights and interests of investors, the details will not be disclosed at this time. 6.Upcoming development plan: Officially submit the market approval application to the US FDA. 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 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%. 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.): While the data collection and evaluation of the primary endpoint is completed, the clinical study details will be reviewed by the U.S. FDA prior to the official submission of the market approval application. Relevant information will be disclosed from time to time in accordance with applicable laws and regulations. 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.: