Atlantic Therapeutics, a provider of medical therapeutics, has secured the US Food and Drug Administration (FDA) over-the-counter (OTC) approval of its INNOVO, intended for stress urinary incontinence (SUI).

INNOVO is a non-invasive wearable device designed to treat the SUI, which is the root cause of bladder weakness, causing accidental leakage of urine during coughing, sneezing, laughing or exercising.

In addition, the device has been previously commercialised in the US as prescription device, and has delivered more than 3.5million therapy sessions across the globe.

Atlantic Therapeutics chief executive officer Steve Atkinson said: “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.

“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 provides 180 perfect and complete pelvic floor contractions

INNOVO is a transcutaneous muscle electrical stimulator that deploys Multipath technology to target the weakened pelvic floor muscles. The device delivers 180 perfect and complete pelvic floor contractions.

Women suffering from SUI are recommended to use the INNOVO for 30 minutes a day, five days a week for three months, followed by a maintenance routine of one to two 30-minute sessions per week to strengthen pelvic floor.

The company has conducted a clinical study of INNOVO, and the results of which demonstrated that 80% of users experienced improvement after four weeks, and 87% after three months.

In addition, the device has demonstrated a superior safety record, without any device-related complications reported.

INNOVO co-inventor Ruth M Maher said: “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.

“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.”