The US Food and Drug Administration (FDA) has cleared Prodeon Medical’s implantable technology for treating lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
The California-based company’s Urocross expander system is a non-permanent implant that is designed to remodel obstructed prostatic tissue before retrieval within six months.
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Once implanted, the nitinol-based structure initiates a process called prostatic urethral reshaping, in which the implant applies constant, gentle pressure to the obstructive prostatic lobes, effectively pushing them aside and opening the urethral lumen.
FDA approval for Urocross was supported by data from Prodeon’s Expander-2 pivotal trial (NCT05400980). Among 240 patients enrolled in the study, 48.1% demonstrated a mean improvement in International Prostate Symptom Score (IPSS) at 12 months post-implant (six months post-retrieval). IPSS is a seven-question tool designed to address the severity of LUTS, with a higher score reflecting more severe symptoms. Meanwhile, Urocross achieved a procedural responder rate of 74.5%, defined by the FDA as the percentage of patients with IPSS improvement above 30% at 12 months.
Prodeon now plans to initiate a ‘controlled’ US release of Urocross later this year.
Prodeon’s president, Thomas Palermo, commented: “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.”
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By GlobalDataAccording to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), approximately 14 million men in the US are affected by BPH, with the condition’s prevalence most common in men aged 60 and above.
Big players focusing on urology space
GlobalData analysis reveals that the global nephrology and urology device market, of which BPH treatments are a part, will be worth almost $12bn in 2035, up from around $8.6bn in 2024. Within this space, recent moves by some of the biggest players in the medtech industry suggest it is coming to be viewed as a significant revenue driver.
Speaking at the J.P. Morgan Healthcare conference in January 2026, Medtronic’s CEO Geoff Martha touted the billion-dollar market opportunity for Altaviva, the medtech giant’s urge urinary incontinence (UUI) treatment device that gained FDA clearance in September 2025.
Boston Scientific’s recent dealmaking suggests a prioritisation of the urology-nephrology space, too. During the J.P. Morgan conference, the company announced the acquisition of Valencia Technologies at an undisclosed sum, adding an implantable tibial nerve stimulation (ITNS) treatment for UUI treatment to Boston’s urology portfolio. This acquisition followed Boston’s acquisition of Axonics and its portfolio of urinary and faecal incontinence solutions for $3.7bn in November 2024.
