Company’s prospective, multi-center 240-patient, pivotal randomized controlled trial (RCT) earns AUA “Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2s)” designation at conference’s Plenary Session
SAN JOSE, Calif., April 28, 2026 (GLOBE NEWSWIRE) -- Prodeon Medical, a medical device company developing minimally invasive treatments for benign prostatic hyperplasia (BPH), today announces that three scientific abstracts featuring the Urocross® Expander System will be presented at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C.
The Urocross Expander System is designed to provide immediate and durable relief for patients suffering from lower urinary tract symptoms (LUTS) due to BPH with a novel non-permanent implant. The procedure gently opens and remodels the obstructed prostatic urethra relieving urinary symptoms and is intentionally retrieved 6 months later, leaving no permanent foreign body behind. The Prostatic Urethral Remodeling (PURE) procedure, enabled by the Urocross Expander System, is designed to maximize procedural accessibility by utilizing physicians’ preferred brand of cystoscopes. Because the implant avoids piercing, cutting, tissue removal, and permanent implantation, the PURE procedure aims to maximize treatment adaptability and maintains all future options.
Scientific Presentations at AUA 2026:
The following abstracts have been accepted for presentation, showcasing the clinical progress and technical innovation of the Urocross Expander technology, including:
The P2s program is designed to showcase exceptional, groundbreaking studies that are expected to change the day-to-day practice of urology. Safety and effectiveness data from the Expander-2 RCT will be presented on the Plenary Stage on Saturday, May 16th by Dr. Kevin T. McVary, Professor of Urology at Loyola University Medical Center, and Co-Principal Investigator of the Expander-2 RCT.
The one hundred thirty-two (132) men in the Urocross arm that were sexually active at baseline were analyzed to determine overall effect of Urocross treatment on sexual function through 1 year post treatment. Results indicate both the erectile function (17.7 at 1 year vs 16.0 at baseline, p=.006) and ejaculatory function (10.1 at 1 year vs 8.2 at baseline, p<.0001) were preserved.
“The Expander-2 RCT data exhibits that the Urocross Expander, while in situ through 6 months and post retrieval, provides significant symptom relief with no negative impact on erectile and ejaculatory function. It’s a compelling option for men seeking early intervention to treat BPH without the sexual side effects common to certain medications or surgeries” says Dr. McVary.
Total of two hundred twenty-nine (229) men who completed their Urocross retrievals by the time of publication, were analyzed. Results indicate none of the Urocross retrievals require tissue resection prior to implant removal. Ninety-seven percent (97%) of the retrievals were successfully accomplished with flexible cystoscopy with Urocross Retrieval Sheath. Postoperative pain score (VAS) was 2.3/10 for implantation and 1.7/10 for retrieval at discharge and is comparable to standard flexible cystoscopy. Adverse events post-retrieval were mostly mild.
“Historically, a large percentage of prostatic urethral implants require subsequent removal due to patient intolerability and/or return of LUTS in the long-term. Most removal procedures are unplanned, complex, and may require excising the overlying urothelium prior to removal. As exhibited by the 229 patient experience, retrieval of the Urocross Expander is safe, well-tolerated, and predictable, supporting the concept of intentional retrieval as the optimal therapeutic strategy for BPH.” says Dr. Daniel B. Rukstalis, Chair of Urology at St. Catherine Hospital, Catholic Health System and co-principal investigator of the Expander-2 RCT.
Dr. Ricardo R. Gonzalez, Professor of Clinical Urology at Houston Methodist Hospital, investigator of the Expander-2 Trial commented: “The concept of First-Line Interventional Therapy (FIT) represents a paradigm-changing bridge between medical management and minimally invasive surgical treatment for BPH. An effective FIT should balance safety, efficacy, and tolerability while lowering the threshold for patients to pursue earlier intervention and preserve bladder function. The non-permanent, retrievable design of the Urocross Expander System, together with the data generated from the Expander-2 Trial, supports its candidacy as a FIT option for BPH.”
About the Urocross® Expander System
The Urocross® Expander System is designed to remodel the obstructed prostatic urethra through a minimally invasive cystoscopy procedure using a non-permanent, intentionally retrievable implant. The implant remains in place for up to six months and is then retrieved, leaving no permanent foreign material behind, preserving future treatment options.
About Prodeon Medical
Prodeon Medical is a U.S.-based medical device company dedicated to developing innovative, minimally invasive solutions for urologic disease. The company is focused on advancing therapies designed to challenge conventional treatment paradigms while improving quality of life for patients.
Media contact:
Tim Buckley, Executive Vice President
tim.buckley@prodeonmedical.com
