Optilume BPH is expected to have a significant global impact in urology, offering a novel alternative treatment option for enlarged prostate

MINNEAPOLIS – July 18, 2023 – Urotronic, Inc., a Minnesota-based medical device company pioneering the application of its drug-coated balloon technologies for use in interventional urology, today announced the world’s first commercial procedure of the Optilume BPH® Catheter System to treat benign prostatic hyperplasia (BPH) was completed by Dr. Dean Elterman, urologist at University Urology Associates, in Toronto, Canada.

“We are proud at University Urology Associates to be pioneering this novel, minimally invasive technology. The procedure was a success and was completed as planned under conscious sedation with the patient leaving our clinic the same day,” said Dr. Elterman. “The patient had a history of problematic urinary symptoms caused by benign prostatic enlargement and Optilume BPH represented a suitable option offering symptomatic and functional relief via a minimally invasive treatment method. Optilume BPH provides a new standard of care to improve the quality of life for millions of men suffering from LUTS caused by BPH.”

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 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.

“This world’s first commercial procedure of Optilume BPH is a significant milestone,” said David Perry, Urotronic president and CEO. “The technology provides urologists and their patients with an alternative for the treatment of BPH that does not require heating, cutting, steaming, or implants, as seen with other existing treatment methods. It delivers immediate symptomatic and functional improvements while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.”

Positive data from two clinical trials evaluating Optilume BPH effectiveness and durability in treating LUTS secondary to BPH was recently presented during the American Urological Association (AUA) annual meeting in Chicago. The PINNACLE trial 12-month report suggests Optilume BPH has the highest average peak urinary flow rate (Qmax) at 12-months reported in any randomized MIST trials for BPH. In the 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.

About Urotronic, Inc.

Urotronic, Inc., headquartered in Plymouth, Minn., 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 methods currently used by urologists to treat these conditions. For more information on Urotronic and its products, please visit urotronic.com.

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