UROMEDICA, INC.

Uromedica, Inc. is a medical device manufacturer specializing in minimally invasive surgical therapies for the treatment of stress urinary incontinence (SUI). The company develops and markets two primary product lines: ProACT (adjustable continence therapy for men) and ACT (adjustable continence therapy for women). ProACT is indicated for treatment of male SUI resulting from radical prostatectomy or transurethral resection of the prostate and is commercially available in the United States. ACT is designed for treatment of female SUI resulting from intrinsic sphincter deficiency; it has received CE Mark approval for European markets, Canadian licensing, and Australian therapeutic goods registration, but is classified as investigational in the United States. Both systems utilize silicone balloon technology and are designed as passive therapies requiring no patient manipulation for normal voiding. Key differentiators include minimally invasive placement via small incisions, office-based adjustability without additional surgery, reversibility with office-based removal, and passive operation. The company emphasizes physician and patient education, maintains a physician locator network for treatment access, and provides safety information and regulatory documentation. Manufacturing and regulatory compliance align with medical device standards applicable to implantable urological products.