| SEQ_NO | 1 | Date of announcement | 2026/08/26 | Time of announcement | 12:48:47 |
| Subject | Explanation of Media Reports | ||||
| Date of events | 2026/08/26 | To which item it meets | paragraph 53 | ||
| Statement | 1.Date of occurrence of the event:2026/08/26 2.Company name:Medeon Biodesign, Inc. 3.Relationship to the Company (please enter ‘head office’ or ‘subsidiaries’):head office 4.Reciprocal shareholding ratios:N/A 5.Name of the reporting media: Economic Daily News, Page C05 / Commercial Times, Page B06 6.Content of the report: August 26, 2026, Economic Daily News reported: ‘Urocross, a minimally invasive BPH treatment device developed by the innovative medical device company Medeon (6499), successfully received 510(k) clearance from the U.S. FDA in March this year. Chairman Dr. Yue-Teh Jang stated yesterday (the 25th) that the company has submitted an application for market approval in Taiwan to the relevant regulatory authorities, with the goal of obtaining approval by the end of the year.’ August 26, 115, Commercial Times report: ‘Medeon (6499) is entering a critical turning point in its operations. Chairman Dr. Yue-Teh Jang stated that, following U.S. FDA approval of Urocross, the minimally invasive BPH treatment device, the company is moving into the commercialization phase and will adopt a dual-track strategy of ‘commercialization and out- licensing’ at this stage. Meanwhile, its application for market approval in Taiwan is currently under review, with the company striving to obtain approval this year.’ 7.Cause of occurrence:Explanation of Media Reports 8.Countermeasures: The Company has submitted the application for market approval in Taiwan for Urocross, the minimally invasive BPH treatment device. Further progress will be made in accordance with the review procedures of the Taiwan Food and Drug Administration (TFDA). 9.Any other matters that need to be specified:None |
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