Uromedica, Inc. Announces Launch Of Proact Adjustable Continence Therapy For Men With FDA Approval And Reimbursement Coding

PLYMOUTH, Minn.--(BUSINESS WIRE)--Uromedica, Inc., today announced that its FDA approved product, ProACT™ Adjustable Continence Therapy for Men, has received a reimbursement code from the Center of Medicare Services and is now commercially available in the United States. The code, C9746, is associated with a national average payment of $14,363 in the Hospital Outpatient setting and $10,527 in Ambulatory Surgery Centers. “The issuance of these codes will allow Uromedica to deliver its safe and effective therapy to improve the quality of life for men struggling with Stress Urinary Incontinence,” said Tim Cook, PhD, President and CEO of Uromedica.

About Post-Prostatectomy Stress Urinary Incontinence and the ProACT Therapy

Men who have undergone radical prostatectomy or transurethral resection of the prostate (TURP) are at risk of Stress Urinary Incontinence (SUI). “Twelve months after a prostatectomy, one in four men will still have their lives disrupted by SUI,” said Tim Cook, “ProACT is an adjustable balloon device designed to treat all severities of SUI in men. Given the minimally invasive nature of the procedure and the low risk profile, ProACT provides a therapeutic alternative to more invasive alternative procedures.” Specifically, the ProACT system is indicated by the FDA for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or TURP and who have failed to respond adequately to conservative therapy.

The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a filling port. The implantation procedure lasts approximately 30 minutes and can be performed in Ambulatory Surgical Centers or in the Hospital Outpatient setting. The balloons are surgically placed in the area where the prostate was removed or resected and the ports are placed underneath the skin. The fluid-filled balloons provide pressure and support at the bladder neck which protects against accidental leaking of urine that can occur during a sneeze, cough, or physical activity. When there is a need to urinate, passing urine requires only a normal amount of bladder effort. The balloon volume can be adjusted at any time to achieve optimal continence.

About Uromedica
Uromedica, Inc. is a privately held, Minnesota-based medical device company that has developed and manufactures a long-term implantable balloon device for the treatment of stress urinary incontinence in men and women. ProACT has been implanted in over 8,000 patients worldwide since 2002. Interested physicians or patients may visit www.proact-for-men.com.