| SEQ_NO | 1 | Date of announcement | 2025/05/07 | Time of announcement | 18:20:57 |
| Subject | Announcement of the material information released at the press conference | ||||
| Date of events | 2025/05/07 | To which item it meets | paragraph 53 | ||
| Statement | 1.Date of occurrence of the event:2025/05/07 2.Company name:Medeon Biodesign, Inc. 3.Relationship to the Company (please enter ‘head office’ or ‘subsidiaries’):head office 4.Reciprocal shareholding ratios:NA 5.Cause of occurrence: Medeon Biodesign Announces Positive Preliminary Results from Urocross’ Pivotal Trial 6.Countermeasures: Medeon held a material information press conference at the Taipei Exchange (TPEx) at 17:00, 7 May, 2025. The content of the press release from the conference is as follows: Medeon Biodesign announced that its pivotal IDE study for Urocross, conducted across the United States and Canada, delivered positive results. The treatment group demonstrated mean improvements in 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?Xall with p-values below 0.0001. These findings indicate that therapeutic effects were not only sustained but continued to improve significantly after implant retrieval, reaching the 30% improvement benchmark outlined in the FDA’s guidance for BPH treatment by the six-month mark. The study group also outperformed the sham control group by 25%, with this difference becoming evident at six months. Additional efficacy endpoints showed similarly strong results, including significant improvements in quality of life (QOL) and peak urinary flow rate (Qmax), while sexual function, as measured by the MSHQ-EjD score, remained well preserved. Notably, Urocross demonstrated an exceptional safety profile, with no procedure or device related serious adverse events (SAEs) reported, and the rates of other adverse events were either comparable to or significantly lower than those seen with similar products. Pain?Xoften a top concern for patients?Xwas minimal, with VAS scores of just 2.5 for the implantation procedure and 2.0 for retrieval, markedly better than the typical score of 4-6 reported for comparable treatments. Additionally, only 0.6% of patients require catheterization for more than seven days, a safety indicator that also outperforms competing therapies. These results further highlight Urocross’ minimally invasive nature and superior patient comfort, reinforcing its differentiated market positioning. Subgroup analysis showed that Urocross demonstrated particularly strong efficacy in patients with moderate to severe symptoms (baseline IPSS of 20?V35), with IPSS improvements of 35.8%, 48.9%, and 52.7% observed at 6 months (N=108), 7 months (N=90), and 12 months (N=57), respectively. The treatment was especially effective in patients who had not used medication prior to enrollment, had no bladder-related symptoms (Void/Storage >1), and had prostate volumes between 30?V50 grams. Additionally, 85% of patients in the sham control group opted to cross over to receive treatment after three months. This crossover group achieved a 39.8% improvement in IPSS at the three-month mark (N=50), representing a patient population that closely reflects real-world clinical scenarios. Dr. Dan Rukstalis, a world-renowned Urologist at Virginia Tech Carilion Clinic and Co-Principal Investigator of the Expander-2 Trial, added ‘The removable design of the Urocross Expander as a non-permanent prostatic implant creates a new paradigm for the treatment of men with BPH who want to avoid tissue resection and sexual dysfunction. The fact that this system works without cutting, burning, ablating, or leaving a permanent foreign body inside the prostate is truly revolutionary and it serves as the least invasive treatment option as compared to other tissue-respecting technologies. Urocross opens up a whole new world of possibilities for how we approach treatment, offering patients effective sustained symptom relief with minimal intervention.’ 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. BPH affects a large population, with over 40 million men impacted in the United States alone. Due to concerns over postoperative discomfort, long recovery times, and the risk of sexual dysfunction, only about 1% of patients opt for traditional surgical resection each year. As a result, many patients continue to endure a decline in quality of life while delaying treatment. In recent years, emerging minimally invasive therapies have provided more options for patients. However, some procedures still require postoperative catheterization, and those involving permanent metallic implants may interfere with MRI imaging or require invasive removal. These clinical pain points highlight the unmet need for safer, more comfortable, and flexible treatment options, creating a significant market opportunity for Urocross. Chairman and CEO of Medeon, Dr. Yue-Teh Jang stated that the development of Urocross was driven by the goal of striking a balance between treatment comfort and clinical efficacy, aiming to offer a new option with greater comfort than existing minimally invasive therapies. Building on the positive results from earlier Expander-1 feasibility studies, this trial further validated Urocross’ performance through large-scale data. The improvement in IPSS was comparable to that of similar products, while Urocross stood out for its significantly superior safety profile, demonstrating an exceptional overall performance and fulfilling its original development vision. The team remains fully committed to accelerating the path to regulatory approval, with market clearance as the top priority. 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.):None |
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