FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO® Therapy Device to Treat Stress Urinary Incontinence

Atlantic Therapeutics, will soon be releasing the first ever transcutaneous electrical stimulator cleared by the FDA, offering US women a safe, clinically effective and non-invasive choice to treat stress urinary incontinence. The device was FDA approved late last year and delivers electric current through the body toward muscles that control the pelvic floor, which in turn can help maintain continence.

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In its pivotal multi-centre randomized controlled clinical trial, 87.2% of INNOVO® users were dry or mild after a 12-week treatment period. INNOVO® is a novel wearable device, that may be prescribed as a front-line therapy to those suffering stress urinary incontinence, or as a second line therapy to those that have previously failed physical therapy (in the form of supervised or unsupervised pelvic floor exercises, also known as Kegel exercises).

INNOVO® is the only non-invasive pelvic floor exerciser that treats the root cause of bladder weakness – a weak pelvic floor, rather than just managing the symptoms. INNOVO®’s unique Multipath technology uses electrical muscle stimulation (EMS) to deliver 180 perfect and complete pelvic floor contractions to the entire network of pelvic floor muscles in every 30 minute session. It is a proven technology designed to optimally strengthen the pelvic floor and re-educate the muscles that control bladder function.

The new & improved INNOVO® is super simple to use, patients just pull it on like a pair of cycling shorts and let INNOVO® do the hard work. A hand-held controller connects to the shorts and allows the user to increase the intensity of the stimulations - feel the entire pelvic floor lifting & releasing!

INNOVO® treats Stress, Urge & Mixed Incontinence in both women and men, and is used in the comfort of your home. Best of all, INNOVO® is clinically proven to work, with results in as little as 4 weeks!

“For the first time, physicians in the U.S. can offer their patients a safe, clinically effective, noninvasive home-based treatment” said Steve Atkinson, CEO, Atlantic Therapeutics.

"INNOVO® is a major breakthrough for the millions of women who have to deal with the emotional and physical daily burden of incontinence,” said Gordie Nye, Chairman of Atlantic Therapeutics, “INNOVO® is the active solution for U.S. women who otherwise face a life wearing absorbent pads.”

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 Press Release

About Atlantic Therapeutics

Our vision is to enable millions of people each year to restore their pelvic floor, and thereby restore their control, confidence and active lifestyle.

We manufacture innovative pelvic floor muscle strengthening and nerve stimulation products of medical device quality, supported by strong clinical evidence and subjected to controlled product trials. We are at the leading edge of technological developments in muscle rehabilitation and conditioning and are pioneering clinically proven pelvic floor health solutions. Thousands of clinicians and customers rely on Atlantic Therapeutics products such as INNOVO® (www.myinnovo.com) every day, and our products improve many thousands of lives every year. We continue to carry out rigorous clinical trials to support the use of Innovotherapy to treat bladder weakness.

Since launching in March 2016, Innovotherapy has become the leading choice for a safe, effective, home-based treatment for the causes, not just the symptoms, of bladder weakness. Innovotherapy is already available in the UK, France, Germany, Ireland and the Middle East with further launches planned in the near future.

Atlantic Therapeutics’ offices are located in Galway, on the Atlantic coast of Ireland, London, Paris and Salem, close to Lake Constance in Germany.