ProVerum Announces Completion of Enrollment for the ProVIDE Clinical Study for BPH and First-use of its New Flexible, Steerable Delivery System

2024-03-20

临床研究

DUBLIN, March 20, 2024 /PRNewswire/ -- ProVerum Limited, an Irish medical device company developing a minimally invasive solution to treat benign prostatic hyperplasia (BPH) in the doctor's office, today announced completion of enrollment of the ProVIDE pivotal clinical trial to evaluate the safety and effectiveness of the ProVee System, a 'stent-like' expander designed to gently 'open-up' the obstructed urethra and alleviate the symptoms caused by BPH.

Steve Kaplan, M.D., Professor of Urology at the Icahn School of Medicine at Mount Sinai in New York is the Global Lead Investigator for the ProVIDE study. "The ProVee System has the potential to be a first-line interventional therapy (FIT) for BPH that can be safely and reliably performed in the office setting" said Dr. Kaplan. "This large international, multi-center clinical study, which is now fully enrolled, thoroughly evaluates the safety, efficacy and long-term durability of the ProVee device and I look forward to presenting the data."

ProVerum Announces First Enrollment in the ProVIDE II: Bridging Study

The company also announced the commencement of the ProVIDE II: Bridging Study to evaluate the performance of its new low profile flexible, steerable delivery system for deploying the ProVee expander. This second-generation delivery system is the same diameter as a diagnostic cystoscope and ideally suited to an office or out-patient setting. Given its flexible and steerable nature, it also facilitates patients to lay flat during the procedure rather than having to have their legs in stirrups, which some men find uncomfortable. There is no change to the ProVee expander. The first procedure was successfully performed by Brian Mazzarella, M.D., Principle Investigator at Urology Austin, Texas. According to Dr Mazzarella, "The new delivery system is straightforward to use and works similarly to a flexible cystoscope that all urologists use routinely in the office setting." He continued, "I see many dissatisfied patients whose BPH symptoms are not resolved by medication yet they are unwilling to undergo more invasive surgical procedures. The atraumatic nature of ProVee may make it an option that patients would actually choose to have and thus improve their lives and avoid further bladder damage."

About the ProVIDE Study

The ProVIDE clinical trial is a prospective, multi-center, double-blind controlled study to evaluate the safety, performance, and effectiveness of the ProVee System in patients with lower urinary tract symptoms secondary to BPH. 221 subjects have been enrolled across 15 investigational sites in the US and 2 international sites.

About the ProVIDE II: Bridging Study

The ProVIDE II: Bridging Study is a prospective, multi-center, open-label, non-randomized bridging study to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with lower urinary tract symptoms secondary to BPH. Up to 50 subjects will be enrolled across 7 investigational sites in the US and 1 international site.

About ProVerum Ltd

ProVerum Ltd. is an innovative Dublin based SME focused on the development of novel minimally invasive technologies to treat BPH. The ProVee System is an investigational device and is not approved for commercial sale. For more information, please visit www.proverummedical.com

SOURCE ProVerum

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