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Press Releases

Urotronic Announces Publication of Data in Journal of Urology from PINNACLE Clinical Trial Evaluating Optilume® BPH Catheter System’s Effectiveness and Durability

Study demonstrates Optilume BPH treatment results in significant improvements immediately post procedure through one year; highest reported Qmax in BPH MIST trials

MINNEAPOLIS – (Aug. 30, 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 publication of positive data from its PINNACLE clinical trial evaluating the Optilume® BPH Catheter System’s safety, effectiveness and durability in treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Twelve-month data from the PINNACLE clinical trial was published in the September 2023 edition of the Journal of Urology and featured on the cover.

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Urotronic Announces Completion of the World’s First Optilume® BPH Catheter System Commercial Procedure in Toronto

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.

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Urotronic Announces FDA Approval of Optilume® BPH Catheter System, Pioneering the Next Generation of Minimally Invasive Solutions for Enlarged Prostate Symptom Relief

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.

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

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.

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