MINNEAPOLIS – (July 11, 2023) – Urotronic, Inc. today announced it has received U.S. Food and Drug Administration (FDA) approval of its Optilume® BPH Catheter System, a unique minimally invasive surgical therapy (MIST) that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing.
“With the highest reported Qmax in BPH MIST trials to date, Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” said Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York. “The positive data from the PINNACLE and EVEREST trials demonstrates clear and compelling sustained clinical outcomes through four years post-treatment,” said Dr. Kaplan.,
“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming or implants,” said Urotronic President and CEO David Perry. “This advancement, backed by strong clinical outcomes, has the potential to improve the quality of life for millions of patients looking for a solution for BPH and its associated lower urinary tract symptoms. Drug-coated balloons are the future of interventional urology.”
Optilume BPH is a minimally invasive outpatient procedure engineered to alleviate urinary symptoms caused by BPH, a condition affecting 70% of men 60-69 years of age and 80% of those 70 or older. By combining mechanical dilation with the safe and proven drug paclitaxel, the Optilume BPH Catheter System achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing.
About Urotronic, Inc.
Urotronic, Inc., headquartered in Plymouth, Minnesota, is a medical device company developing and commercializing Optilume®, its proprietary drug-coated balloon technology that provides a minimally invasive treatment option for men suffering from urinary tract conditions like urethral strictures and benign prostatic hyperplasia (BPH). The drug-coated balloon technology creates a paradigm change from the methods currently used by urologists to treat these conditions. For more information on Urotronic and its products, please visit urotronic.com.
 Kaplan SA, Pichardo M, Rijo E, et al. MP76-02: At 4 Years, Optilume BPH has the Highest Sustained Improvement in Peak Flow (Qmax) of Any Minimally Invasive BPH Therapy. J Urol 2023;209(4S):e1090-91
 Kaplan SA, Moss J, Freedman S, et al. PD41-03: 12-Month Outcomes from a Randomized, Sham-Controlled Study Evaluating a Novel Drug Coated Balloon for the Treatment of BPH. J Urol. 2023;209(4S):e1059