FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO Therapy Device

Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced that the U.S. Food and Drug Administration (FDA) has granted a DeNovo clearance for its INNOVO therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in adult females.

INNOVO is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following results of two randomized controlled trials (RCTs) demonstrating it to be an effective and low-risk device for the treatment for stress urinary incontinence (SUI) in adult females. Atlantic Therapeutics presented key data from its pivotal U.S. trial showing 87.2 percent of patients were dry or mild of after a 12-week treatment period,¹ with 93 percent of patients experiencing improvement in just four weeks.¹ This follows the presentation of data from an earlier sham-controlled RCT conducted in Europe that demonstrated significant improvement across all study endpoints.²

“For the first time, physicians in the U.S. can offer their patients a safe, clinically effective, non-invasive home-based treatment,” said Steve Atkinson, CEO of Atlantic Therapeutics.
“INNOVO therapy is a compelling treatment option for all those women who today simply suffer in silence from stress urinary incontinence.”

With an estimated one third of all U.S. females affected by SUI3, the market potential for INNOVO is significant, making this big news for the Galway, Ireland, based medical device manufacturer. With recent widespread reports of mesh surgery complications, this is an ideal time to offer a non-invasive option. INNOVO has an excellent safety record to date, with over 1.5 million therapy sessions delivered by INNOVO in Europe and no reported device related complications.

“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 of The Simon Foundation for Continence.

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 a unique, 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.

References
1. ICS 2018, POSTER NO. 235, Roger Dmochowski, Vanderbilt University, Catherine M. Lynch, University of South Florida, Mitchell Efros, AccuMed Research Associates, Linda Cardozo, King’s College Hospital, London.
2. IUGA 2018, Poster NO. 135, S.Soeder, German pelvic Floor Center Berlin, T. Fink, Pelvic floor Center, Berlin–Lichtenberg, M. Goetze, Hospital Brandenburg, G. Neymeyer, Charite Medical University, Berlin R.Tunn German pelvic Floor Center Berlin
3. The Urology Care Foundation (2018) Available at: [http://www.urologyhealth.org/] (Accessed: 24th August 2018)