益安生醫

SEQ_NO	1	Date of announcement	2025/11/16	Time of announcement	22:19:22
Subject	Urocross Expander System Officially Submitted to the U.S. FDA for 510(k) Clearance
Date of events	2025/11/14	To which item it meets	paragraph 10
Statement	1.Date of occurrence of the event:2025/11/14 2.New drug name or code: Urocross Expander System 3.Indication: 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. 4.Planned development stages: The Urocross Expander System has been officially submitted for market clearance to the U.S. FDA on 2025/11/13 (California time). Subsequent actions will follow the FDA’s review procedures and timeline, with the review period expected to take approximately three to six months. 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 been officially submitted for market clearance to the U.S. FDA. (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 licensing amount while safeguarding the rights and interests of investors, the details will not be disclosed at this time. 6.Upcoming development plan: Subsequent actions will follow the FDA’s review procedures and timeline, with the review period expected to take approximately three to six months. 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.): The clinical data obtained aligns with the preliminary clinical results announced in May 2025, showing no change in the overall trend. Based on the typical review timeline for historical 510(k) applications, the review period is estimated to be approximately three to six months. However, the full impact of the schedule resulting from the resumption following the U.S. government shutdown is currently difficult to assess completely. The Company will make disclosure in the event of material changes to the review progress or outcome according to relevant laws and regulations. Should the review proceed smoothly, preparations for U.S. market commercialization can commence; however, the actual impact will ultimately depend on the FDA’s final review results and market adoption progress. 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.: