Medeon Biodesign, Inc. announced positive interim results of the EXPANDER-1 Clinical Study for its product the XFLO™ Expander System, an innovative, minimally invasive Benign Prostatic Hyperplasia (BPH) treatment solution. XFLO offers a reversible and office-based treatment option for patients who are seeking immediate relief from lower urinary tract symptoms (LUTS) caused by BPH without compromising sexual function. The XFLO Expander System is designed to provide patients with immediate relief BPH-related symptoms (LUTS) by placing an expander implant in the prostatic urethra using a low-profile delivery catheter and a standard flexible cystoscope. The XFLO Expander System opens the prostatic urethra that is narrowed due to the enlargement of the prostatic lobes. A unique feature of the XFLO Expander procedure is that it is designed to be completely reversible and preserves future treatment options, if needed. The XFLO Expander System may be easily retrieved in an office setting using standard flexible cystoscopes and the XPRO Retrieval Sheath. The EXPANDER-1 clinical study is an ongoing multinational study that is being conducted in Australia, Republic of Georgia, Canada, and Taiwan. To date, the study has enrolled and treated 32 patients using the XFLO Expander and the XPRO Retrieval sheath. Early data from this study has demonstrated the device can be safely deployed and retrieved after implantation following a dwell time of up to 6 months. The EXPANDER-1 study confirms that the procedure is a safe and minimally invasive BPH treatment that can potentially avoid post-procedure catheterization and preserves sexual function. In addition, the XFLO Expander System was demonstrated to be effective at providing immediate symptom relief (2 weeks post-implant) with 40% reduction in IPSS (International Prostate Symptom Score) for a 6 months dwell time (N=14). Efficacy continues to remain at least 6 months post-retrieval, indicating a promising minimally invasive solution to achieve patency effect of one year post-treatment. Long-term follow-up is on-going in order to obtain additional safety and efficacy outcome measures.
Medeon Biodesign, Inc. is a Taiwan-based company principally engaged in the research, development, manufacture and sales of medical equipment. The Company's main products include medical apparatus and instruments used in laparoscopic minimally invasive surgeries and cardiac catheter-related minimally invasive surgeries. The Company distributes its products in domestic market and to overseas markets.
MEDEON BIODESIGN, INC. 
