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FDA Approves the ProVee System - the First of a New Generation of Prostatic Urethral Stents for Treatment of BPH

On December 9, 2025, the U.S. Food and Drug Administration approved the ProVee System, a prostatic urethral stent, now available for sale in the United States, and CEO Paul Bateman said it's "a major step forward for ProVerum and for men living with BPH."
The ProVIDE randomized double-blind sham-controlled trial met all endpoints, showing durable symptom relief and improved urinary flow through 12 months in men with moderate-to-severe benign prostatic hyperplasia.
The ProVee System works without cutting, burning, tearing or piercing prostatic tissue, and trial safety data showed no serious adverse events, no catheterization, and preserved sexual function.
More than 12 million men in the United States are actively managed for BPH, and without treatment, symptoms tend to worsen and impair quality of life.
ProVerum Ltd., Dublin-based medical-device company focused on minimally invasive BPH technologies, directs clinicians to proverummedical.com and its X and LinkedIn channels for more information.

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FDA Approves the ProVee System - the First of a New Generation of Prostatic Urethral Stents for Treatment of BPH

DUBLIN, Dec. 9, 2025 /PRNewswire/ -- ProVerum Limited, a medical device company focused on innovative, safe and effective solutions for treating benign prostatic hyperplasia (BPH), today announced it has received FDA approval for its ProVee® System for BPH.

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