Urotronic Announces Presentation of Data from Two Clinical Trials Evaluating Optilume® BPH System’s Effectiveness and Durability

 // News

May 1  

Dr. Steven A. Kaplan presented positive 4-year and 12-month clinical outcomes during the American Urological Association’s Annual Meeting

MINNEAPOLIS – (May 1, 2023) – Urotronic, Inc., a Minnesota-based medical device company pioneering the application of its drug-coated balloon technology for use in interventional urology, today announced the presentation of positive data from two clinical trials evaluating the Optilume® BPH System’s effectiveness and durability in treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Four-year and 12-month data from the EVEREST and PINNACLE clinical trials were presented by Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York and the principal investigator of the two studies, during the American Urological Association’s (AUA) Annual Meeting in Chicago.

“The positive data from the PINNACLE and EVEREST trials – including the highest reported Qmax in BPH MIST trials to date – demonstrates clear and compelling sustained clinical outcomes through four years post-treatment,” said Dr. Kaplan. “Optilume BPH is not your grandfather’s BPH balloon – it’s the next generation of minimally invasive technology, creating a new drug device space among BPH therapies.”

Optilume BPH is 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 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. 

“The PINNACLE Trial: 12-Month Report from a Randomized, Double-Blind, Sham Controlled Study” and “At 4 Years, Optilume BPH Has the Highest Sustained Improvement in Peak Flow (Qmax) of Any Minimally Invasive BPH Therapy,” both presented by Dr. Kaplan during the AUA Annual Meeting, demonstrated positive outcomes including:

  • Treatment with Optilume BPH resulted in significant, immediate symptomatic and functional improvements, including improvement in International Prostate Symptom Score (IPSS).
  • The highest average peak urinary flow rate (Qmax) at 12 months reported in randomized MIST trials for BPH. In the PINNACLE trial, Qmax more than doubled from 8.9 mL/second at baseline to 19.0 mL/second at 12 months after treatment with Optilume BPH (+113%). 
  • Durability of symptom and flow rate improvement was shown through four years follow-up in the EVEREST trial.
  • Erectile and ejaculatory function scores were not significantly changed from baseline through follow up in either study.

“Backed by positive clinical data, ease of use and ability to be performed in an office setting, we believe this groundbreaking therapy has the potential to change the way BPH is treated, establishing a new standard of care to improve the quality of life for millions of men struggling with LUTS caused by BPH,” said David Perry, Urotronic president and CEO. 

The PINNACLE trial is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System with 148 patients randomized in a 2:1 fashion at 18 centers in the U.S. and Canada. Subjects and evaluating personnel were blinded to the treatment received through 12 months. The EVEREST trial is a prospective, single arm, multicenter study evaluating functional improvement in urine flow and improvement in LUTS after treatment with the Optilume BPH System. Eighty patients were enrolled at six centers with four-year follow-up complete. 

Optilume BPH is an investigational device in the U.S. and is pending Food and Drug Administration (FDA) premarket approval; the device is approved for sale in Canada and Israel. The Optilume Urethral Drug Coated Balloon for use in male urethral strictures, which applies the same technology, was granted U.S. FDA approval in December 2021 and received CE Mark in September 2020.

About Urotronic, Inc.

Urotronic, Inc., headquartered in Plymouth, Minnesota, is a medical device company currently conducting clinical trials to support global commercialization of their products. The Optilume® drug-coated balloon technology provides a minimally invasive treatment option for men suffering from urinary tract conditions like urethral strictures and benign prostatic hyperplasia (BPH). The prevalence of BPH and lower urinary tract issues rises markedly with increased age. BPH affects 70% of men 60-69 years of age and 80% of those 70 years of age or older. 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 our products, please visit urotronic.com. 


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