Expanded US label for Plethora's Osbon ErecAid

The UK's Plethora Solutions Holdings, a specialist developer of products for the treatment and management of urological disorders, says that its Osbon ErecAid product marketed through its US subsidiary, Timm Medical, has received permission from the Food and Drug Administration for extended labeling. This clarifies that the product may be used to create and maintain erections by providing arterial blood to the penis during recovery from prostatectomy and thus aid in maintaining preoperative sexual function. The Osbon ErecAid is the first device or drug to be cleared by the FDA for this specific indication, Plethora noted.

Men treated for localized prostate cancer by either radical prostatectomy or radiotherapy can expect some degree of erectile dysfunction and the condition may persist long into the recovery period. Prostate cancer screening has led to the detection of more cases in younger men and an increasing focus on restoring sexual activity after treatment. According to the American Cancer Society, around 230,000 new cases of prostate cancer were diagnosed in the USA during 2005. The majority had localized (Stage II) disease at diagnosis and between 25% and 30% of this patient group will be treated by radical prostatectomy, resulting in a potential penile rehabilitation treatment population of around 50,000 patients each year in the USA alone, the firm stated.