Atlantic Therapeutics Receives FDA Clearance for Over-the-Counter Use of INNOVO

Atlantic Therapeutics 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 United States by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide.
 
“INNOVO is a 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, CEO 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 is a transcutaneous muscle electrical stimulator that uses unique Multipath technology to target the weakened pelvic floor muscles. Women with stress urinary incontinence are recommended to use INNOVO for 30 minutes a day, five days a week for three months. They can then follow a maintenance routine of one to two 30-minute sessions per week to maintain pelvic floor strength. INNOVO delivers 180 perfect and complete pelvic floor contractions, equivalent to Kegel exercises, during each 30-minute session. With every gentle pulse, a woman feels her pelvic floor muscles lifting and releasing—strengthening and rebuilding the muscles and helping regain bladder control one session at a time.
 
Results of a clinical study demonstrated that 80 percent¹ of INNOVO users experienced significant improvements after four weeks, and 87 percent² were considered “dry” or “near dry” after three months. In a separate clinical study, 98 percent³ of healthcare professionals said they would recommend INNOVO, and 90 percent¹ of users said they would recommend the therapy to others. INNOVO has an excellent safety record to date, with more than 3.5 million therapy sessions delivered worldwide, and no reported device-related complications.
 
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. SUI is common, affecting one in three women at some point in their lives, according to the Urology Care Foundation.² SUI can occur at any age but is most common during pregnancy, menopause and post-childbirth. SUI often interferes with social activities and can diminish a woman’s quality of life. Because there are many misconceptions about SUI, women with the condition often feel embarrassed and find it difficult to be open and honest about their symptoms. SUI is often managed with pads, liners and absorbable underwear, but these products only mask the problem.

References 
¹ Soeder S, et al, A randomised, controlled, double-blind, clinical study to compare two neuromuscular stimulator devices in female stress urinary incontinence: Effects on symptoms and quality of life. IUGA Conference 2018
² Dmochowski R, Lynch CM, Efros M, Cardozo L. External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial. Neurourol Urodyn. 2019 Sep;38(7):1834-1843. doi: 10.1002/nau.24066. Epub 2019 Jul 3
³ Observational study on the treatment of stress urinary incontinence with Innovotherapy, April 2014