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First Patients Enrolled in Uromedica’s Adjustable Continence Therapy (ACT®) for Female Stress Urinary Incontinence (SUI) Trial

Uromedica, Inc. announces the initiation of its FDA Investigational Device Exemption trial for ACT® to evaluate its safety and efficacy for treatment of female SUI.  Stress urinary incontinence is the accidental leakage of urine that can occur when sneezing, coughing, or performing physical activity. The investigational intent of the ACT trial, a post-operatively adjustable, minimally invasive outpatient procedure, is to assess safety and efficacy for women who suffer from moderate or severe SUI. Read more.

Source: Business Wire, March 10, 2021

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Uromedica Wins CMS Coverage for ProAct Continence Therapy Device

Uromedica said today it won a reimbursement code from the Centers for Medicaid and Medicare Services for its ProAct adjustable continence therapy for men, and that it launched the device in the US.  The ProAct system has FDA approval and is indicated for treating adult men with stress incontinence from intrinsic sphincter deficiency of at least 12 months following radical prostatectomy or TURP who have failed ot respond to conservative therapy, the Plymouth, Minn.-based company said. “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,” prez & CEO Tim Cook said in a press release. Read more.

Source: MassDevice Today, July 12, 2017