Medeon Biodesign announced on the 7th that its minimally invasive treatment device for benign prostatic hyperplasia (BPH), Urocross, has demonstrated positive results in the Expander-2 pivotal clinical trial conducted in the U.S. and Canada. The results show that the experimental group experienced significant improvements in the International Prostate Symptom Score (IPSS) at 3 months (N=158), 6 months (N=129), 7 months (N=107), and 12 months (N=68), with average improvements of 25.7%, 32.6%, 44.5%, and 52.1%, respectively. The P-values were all less than 0.0001, indicating that the therapeutic effect not only persisted after device removal but also continued to significantly improve. After 6 months of treatment, the improvement reached the 30% threshold required by the FDA for BPH treatments.
Medeon Biodesign stated that the treatment effect in the experimental group was 25% better than the control group, observed at the 6-month mark. Other efficacy indicators also showed excellent results, including significant improvements in quality of life (QOL), urinary flow rate (QMax), and maintained good sexual function (MSHQ-EjD).
Notably, the safety data for Urocross was outstanding, with no major adverse events (SAEs) related to surgery or the device. Other adverse reactions were either similar to or much lower than those of comparable products. The pain scores (VAS Pain Score) during the implantation and device removal surgeries were 2.5 and 2.0, respectively, much lower than the 4-6 points observed for other products in the same category. Additionally, the percentage of patients requiring a catheter for more than 7 days was only 0.6%, far better than other similar products, further proving Urocross's low invasiveness and high patient comfort in its market positioning.
Group analysis showed that Urocross had particularly significant effects in the moderate-to-severe group (pre-treatment IPSS=20-35), with improvements in IPSS of 35.8%, 48.9%, and 52.7% at 6 months (N=108), 7 months (N=90), and 12 months (N=57), respectively. The device also showed excellent efficacy in patients who were drug-naïve, had no bladder lesions (Void/Storage >1), and had prostate sizes between 30-50g. Furthermore, 85% of patients in the control group chose surgical treatment after 3 months, and the IPSS improvement in this crossover group reached 39.8% (N=50) after 3 months, which better reflects the real-world clinical effect.
Dr. Dan Rukstalis, Vice Chair of Surgery at Virginia Tech Carilion School of Medicine and co-principal investigator of this trial, stated that Urocross, with its non-permanent, removable design, offers a revolutionary treatment option for BPH patients who wish to avoid tissue resection and sexual dysfunction. The treatment process does not require cutting, burning, or ablation of tissue, nor does it leave permanent foreign objects in the body. Compared to existing BPH treatments and products, Urocross is the least invasive solution currently available, opening new possibilities in BPH treatment with minimal intervention while delivering continuous and significant symptom improvement.
After receiving the final report, the clinical trial data will undergo FDA inspection to ensure accuracy and reliability. Ongoing clinical data collection will continue, with plans to formally submit a market approval application to the U.S. FDA by the end of 2025. The FDA's review will consider the requirements of BPH treatment guidelines and the safety and efficacy data of similar products on the market, evaluating whether Urocross can provide significant clinical benefits for patients.
There are over 40 million men affected by benign prostatic hyperplasia in the U.S. alone. Traditional resection surgeries, due to post-operative discomfort, long recovery periods, and sexual dysfunction, result in only about 1% of patients opting for surgery each year. In recent years, minimally invasive treatments have offered more options for patients, though some procedures still require catheter use post-surgery, and permanent metal implants may affect MRI scans or require invasive removal.
Chairman Yu-te Chang stated that this trial continues the success of the previous Expander-1 feasibility trial and, through large-scale data verification, Urocross’s efficacy has been reaffirmed. Its IPSS improvement is comparable to other products in the same category, while its safety profile significantly outperforms others, showcasing outstanding overall performance and fully achieving its initial development goals. The team’s primary goal is to obtain market approval as quickly as possible and continue pushing forward with related work.
Resource: 益安攝護腺醫材樞紐試驗初步結果具顯著療效，年底向美申請上市
