FDA clears Prodeon Medical’s Urocross expander for non-permanent BPH Treatment

USA—The US Food and Drug Administration (FDA) has cleared Prodeon Medical’s implantable technology for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

The California-based company’s Urocross expander system offers a non-permanent implant designed to remodel obstructed prostatic tissue, which is then retrieved within six months.

Once implanted, the nitinol-based structure initiates reshaping of the prostatic urethra.

During this process, the implant applies constant, gentle pressure to the obstructive prostatic lobes, effectively pushing them aside and opening the urethral lumen.

This approach differs from traditional treatments that permanently alter or remove tissue.

Clinical trial results support approval

FDA approval for Urocross drew support from data in Prodeon’s Expander-2 pivotal trial (NCT05400980).

Among 240 patients enrolled in the study, 48.1% demonstrated a mean improvement in the International Prostate Symptom Score (IPSS) at 12 months post-implant, corresponding to 6 months after retrieval.

IPSS serves as a seven-question tool designed to assess the severity of LUTS, with higher scores reflecting more severe symptoms.

The trial showed that Urocross achieved a procedural responder rate of 74.5%.

The FDA defines this metric as the percentage of patients experiencing IPSS improvement above 30% at 12 months.

Prodeon now plans to initiate a controlled US release of Urocross later this year.

Innovative treatment category

Thomas Palermo, Prodeon’s president, highlighted the device’s unique position in the market.

“Unlike existing minimally invasive therapies that rely on permanent implants or irreversible tissue ablation, Prodeon Medical introduces a new category of non-permanent, retrievable intervention for BPH, designed to remodel obstructive tissue while leaving no permanent foreign material behind,” he stated.

Growing market opportunity

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) reports that approximately 14 million men in the US live with BPH.

The condition appears most commonly in men aged 60 and above, creating substantial demand for effective treatments.

GlobalData analysis projects that the global nephrology and urology device market, which includes BPH treatments, will reach almost USD12 billion in 2035, up from around USD8.6 billion in 2024.

Major medtech players increasingly view this space as a significant revenue driver.

Industry investment signals market potential

At the J.P. Morgan Healthcare conference in January 2026, Medtronic CEO Geoff Martha emphasized the billion-dollar market opportunity for Altaviva, the company’s urge urinary incontinence (UUI) treatment device that gained FDA clearance in September 2025.

Boston Scientific’s recent acquisitions demonstrate prioritization of the urology-nephrology space.

During the J.P. Morgan conference, the company announced the acquisition of Valencia Technologies for an undisclosed sum, adding an implantable tibial nerve stimulation (ITNS) treatment for UUI to its urology portfolio.

This deal followed Boston Scientific’s acquisition of Axonics and its urinary and faecal incontinence solutions portfolio for USD 3.7 billion in November 2024.