First procedure at The Hospital at Westlake Medical Center in Austin, Texas, marks the beginning of the company’s controlled U.S. commercial release
SAN JOSE, Calif., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Prodeon Medical, a medical device company advancing minimally invasive therapies for urologic disease, today announced the first commercial case using its Urocross® Expander System. Tyler McClintock, MD, performed the procedure at The Hospital at Westlake Medical Center in Austin, Texas, marking an important milestone in bringing a new treatment option to men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Dr. Tyler McClintock at Midtown Urology and staff from The Hospital at Westlake Medical Center in Austin, Texas, performed the first commercial procedure of Urocross Expander System
Urocross enables Prostatic Urethral Remodeling (PURE), a minimally invasive procedure to place a non-permanent implant to gently open and remodel the obstructed prostatic urethra. This implant is removed after six months, leaving no permanent foreign material behind. Clinical studies have demonstrated sustained improvement in urinary symptoms after retrieval, with preservation of erectile and ejaculatory function.
"What distinguishes Urocross is its design intent: it's placed through a flexible cystoscope, remodels the prostatic urethra over six months, and is then retrieved - leaving nothing permanent behind and preserving future diagnostic and treatment options," said Dr. McClintock. "In the pivotal trial, symptom improvement continued after the device was removed, and sexual function was not adversely affected. That combination makes Urocross a compelling addition to the therapies we can offer men seeking meaningful relief from LUTS associated with BPH."
The first commercial procedure builds on the company’s clinical development program, including the Expander-2 pivotal randomized controlled trial involving 240 patients at 23 sites across the United States and Canada. Sustained symptom improvement was observed, with a mean 49.0% improvement in the International Prostate Symptom Score at 12 months after implantation (6 months after planned retrieval), with minimal risk of needing catheterization and de novo sustained sexual dysfunction. “Our priority is to offer our community access to state-of-the-art alternatives that address patients’ needs and improve their quality of life,” said Jerry Jasper, Chief Administrative Officer of The Hospital at Westlake Medical Center. He continued, “We are pleased to work with Dr. McClintock and Prodeon Medical to bring Urocross to our community.”
The procedure marks the beginning of Prodeon’s controlled U.S. commercial release, with an emphasis on physician training and clinical support, while building experience in commercial practice.
“This first commercial case puts Prodeon’s mission into practice: advancing minimally invasive therapies that deliver meaningful symptom relief while respecting the priorities of patients and physicians,” said Tom Palermo, President & COO of Prodeon Medical. “Urocross is designed to provide sustained symptom improvement while preserving sexual function and future treatment flexibility. Unlike permanent urethral implants, which carry long-term risks such as migration, encrustation, tissue reaction or urinary tract infection, Urocross is intentionally retrieved after six months. We believe this combination of durable tissue remodeling without a permanent implant represents an important advancement in the treatment of LUTS associated with BPH.”
“This milestone reflects years of dedication from our clinical investigators and their teams,” said Timothy Buckley, Executive Vice President, Business Development & Commercial Strategy at Prodeon Medical. “We are deeply grateful to the physicians, research coordinators and clinical staff whose passion for developing new therapies helped bring Urocross to this point. We also thank the patients who participated in our studies and made this progress possible.”
About Prodeon Medical
Prodeon Medical is a U.S.-based medical device company focused on developing innovative, minimally invasive treatments for urologic disease. Its mission is to advance new therapeutic approaches that expand patient choices and improve quality of life.
About the Urocross® Expander System
The Urocross® Expander System is a technology for treating lower urinary tract symptoms associated with BPH. Through a minimally invasive cystoscopic procedure, a non-permanent implant opens and remodels the obstructed prostatic urethra. The implant is intentionally retrieved within six months, leaving no permanent foreign material behind and preserving future treatment options.
About Benign Prostatic Hyperplasia (BPH)
Benign prostatic hyperplasia, or BPH, is a common condition of the prostate that affects men increasingly as they age. Associated urinary symptoms can include a weak stream, urgency, frequent urination and waking at night to urinate. These symptoms can disrupt sleep and daily activities, creating a need for effective treatment options that provide sustained relief while supporting patients’ quality of life.
Media Contact
Timothy Buckley
Executive Vice President
Prodeon Medical
tim.buckley@prodeonmedical.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c1752c95-ef40-400e-8285-e819e7162767
