Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®, A Wearable, Non-Invasive, Clinically Proven Solution for Stress Urinary Incontinence

13 Feb

Atlantic Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO®, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as 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.

“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.”

“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.”

INNOVO® can be purchased without a prescription at starting February 6, 2020.

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