Atlantic Therapeutics Wins FDA Clearance for INNOVO Non-Invasive Wearable for Stress Urinary Incontinence

INNOVO Wearable for Stress Urinary Incontinence
Image: Business Wire

Atlantic Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter clearance to INNOVO, a non-invasive, clinically proven and wearable device to treat stress urinary incontinence (SUI). INNOVO® was previously available in the U.S. by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide.

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“INNOVO is a revolutionary device that offers women a safe, clinically effective and truly non-invasive choice to treat the root cause of bladder leaks rather than just the symptoms,” said Ruth M. Maher, Ph.D., D.P.T., co-inventor of INNOVO® and Professor, Department of Physical Therapy, Philadelphia College of Osteopathic Medicine (PCOM) Georgia. “Simple to use and wearable, INNOVO® fits into a busy lifestyle. In the privacy of their own home, women can simply pull on a pair of shorts for a 30-minute INNOVO® pelvic floor workout. By strengthening and re-educating their pelvic floor muscles, they have the opportunity to live a leak-free life in as little as three months.”

SUI refers to accidental leakage of urine from the bladder when coughing, sneezing, laughing or exercising. These simple movements put pressure on the bladder and, if the pelvic floor muscles are unable to tighten sufficiently, an involuntary leak occurs. This common condition affects one in three women at some point in their lives, according to the Urology Care Foundation. SUI is often managed with pads, liners and absorbable underwear, but these products only mask the problem, reports Business Wire.

Women wearing wearable device
Image: INNOVO (Twitter)

“With INNOVO now approved for over-the-counter use, women suffering from urinary incontinence, a common but stigmatized condition, have easy access to this convenient, effective and safe product, which is backed by science,” said Steve Atkinson, Chief Executive Officer of Atlantic Therapeutics. “No longer requiring a prescription for INNOVO® means women can take back control of their personal health in the safest and most convenient way possible with this effective at-home treatment. They no longer need to suffer in silence and make do with temporary fixes, such as pads, to manage their condition.”

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Atlantic Therapeutics develops professional and consumer medical devices, related software, apps and connected health technologies to treat all types of incontinence, sexual health dysfunctions, and other associated disorders by strengthening muscles and modulating nerves of the pelvic floor.