Pleasanton, CA.-- Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, will soon be releasing their newly approved wearable device, INNOVO®, in the United States.
INNOVO® was approved by the United States Food and Drug Administration (FDA) on November 13, 2018, and is the first and only, transcutaneous electrical stimulator cleared by the FDA, offering U.S. women a safe, clinically effective and truly non-invasive choice to treat stress urinary incontinence (SUI). In its pivotal multi-center randomized controlled clinical trial, 87% of INNOVO® users were dry or nearly dry after a 12-week treatment period, with 80% of patients experiencing improvement in just 4 weeks.[i]
“Many people find that SUI gets in the way of their daily and social activities, and INNOVO® is a breakthrough treatment option that can provide relief for millions of women who are living with the burden of incontinence," said Gordie Nye, Chairman of Atlantic Therapeutics. “We are excited to be showcasing our new wearable product here in the US after a successful track record in Europe and sharing it with the professional community at these important meetings.”
About one in three women suffer from SUI at some point in their lives.[ii] SUI occurs when urine leaks out from sudden pressure on the bladder from coughing, sneezing, laughing or exercising, causing the sphincter muscles to open briefly.2 SUI can happen at any age, but it is most common during pregnancy, post-childbirth and during stages of menopause.2
Mary Lynne Van Poelgeest-Pomfret, President of the World Federation of Incontinence Patients (WFIP) said, “WFIP is excited to hear that INNOVO® has received FDA clearance, enhancing treatment choice for U.S. patients. We are confident it will change people’s lives; INNOVO® therapy is fully supported by the WFIP."
“INNOVO® offers a new frontline therapeutic option for the millions of American women living with stress urinary incontinence, and in a significant group could delay or prevent the need for higher risk surgery or medical intervention,” said Elizabeth LaGro, Vice President, The Simon Foundation for Continence.
INNOVO® is a first-in-class, wearable and truly non-invasive solution that treats the root cause of stress urinary incontinence (SUI) or bladder weakness safely.1 Utilizing its innovative and patented Multipath™ technology, INNOVO sends 180 targeted and pain-free muscle stimulations through a pair of shorts, via neuromuscular electrical stimulation (NMES), to safely and effectively strengthen the muscles in the pelvic floor.
About Atlantic Therapeutics
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. INNOVO® from Atlantic Therapeutics is an FDA approved, externally applied, patented CE device that delivers a safe, clinically effective and comfortable therapy to treat reversible clinical conditions associated with pelvic floor weakness in the comfort of the user’s own home. Learn more at: www.myinnovo.com.