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.

The ProVee System is a next-generation prostatic urethral stent designed to gently open up the obstructed prostate and relieve lower urinary tract symptoms associated with BPH. It works without cutting, burning, tearing, or piercing of prostatic tissue, offering the potential for an improved safety profile and faster recovery compared to other interventions.    

FDA approval was supported by results from the ProVIDE study, a randomized, double-blind, sham-controlled trial evaluating the safety and effectiveness of the ProVee System in men with moderate-to-severe BPH. The study met all primary and secondary endpoints, demonstrating significant and durable symptom relief and improvements in urinary flow through 12 months. No device- or procedure-related serious adverse events were observed, no patients required catheterization following the procedure, and sexual function was preserved throughout the follow-up period.

"The data from the ProVIDE clinical study are very impressive and make a strong case for the ProVee System to become a first-line interventional therapy to treat BPH," said Steven A. Kaplan, M.D., Professor of Urology at the Icahn School of Medicine at Mount Sinai and Global Lead Investigator for the study.

BPH is the most common reason why men visit their urologist, with more than 12 million men in the United States actively managed for the condition. Symptoms include frequent or urgent need to urinate, urinating more often at night, weak urine streams and not being able to empty the bladder fully. Without treatment, symptoms tend to worsen and have a significant impact on quality of life.

"FDA approval of the ProVee System marks a major step forward for ProVerum and for men living with BPH," said Paul Bateman, CEO of ProVerum. "With the ProVee System, urologists have a safe, effective and straightforward procedure that can deliver meaningful symptom relief and improvement in quality of life."

About ProVerum

ProVerum Ltd. is an innovative Dublin- based company focused on the development of novel minimally invasive technologies to treat BPH.  Our first product offering, the ProVee System, is FDA-approved and available for sale in the United States. For more information, visit proverummedical.com or connect with us on X or LinkedIn.

Contact:

Matt Monarski

VP, Marketing

matt.monarski@ProVerumMedical.com

 

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SOURCE ProVerum Limited