Medeon

SEQ_NO	1	Date of announcement	2025/10/08	Time of announcement	22:16:51
Subject	Urocross Retrieval Sheath Receives FDA 510(k) Clearance as the First Approved Accessory to the Urocross Expander System
Date of events	2025/10/08	To which item it meets	paragraph 10
Statement	1.Date of occurrence of the event:2025/10/08 2.New drug name or code: Urocross Retrieval Sheath (Prodeon Urethral Sheath System) 3.Indication: The Urocross Retrieval Sheath is an accessory device designed for use with the Urocross Expander System. It is compatible with standard flexible cystoscopes and enables the safe retrieval of the implant approximately six months after placement. The device can also be used to establish a conduit as an operative passage during the treatment of urinary stones or other urinary diseases during endoscopic urological procedures. (Note: The Urocross Expander System is a removable, 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. The implant is intended to be removed after six months with the aforementioned Retrieval Sheath, ensuring that no permanent implant remains.) 4.Planned development stages: Urocross Retrieval Sheath has obtained an independent FDA 510(k) clearance as the retrieval accessory for the Urocross Expander System, and will be marketed for use in conjunction with the Urocross Expander System. The Urocross Expander System is planned to be formally submitted to the US FDA for market clearance in 2025Q4, as previously communicated. 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: Urocross Retrieval Sheath Receives FDA 510(k) Clearance as the First Approved Accessory to the Urocross Expander System (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: 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: The main system, Urocross Expander System, is planned to be formally submitted to the US FDA for market clearance in 2025Q4, and the development progress remains on track as originally planned. 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.) This announcement is to inform that Urocross Retrieval Sheath, designed for use with the Urocross Expander System, has successfully received US FDA 510(k) clearance as the first approved accessory. The Urocross Expander System is scheduled for formal submission to the US FDA in 2025Q4, with development progressing as planned. The Company will continue to make relevant disclosures in compliance 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.