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  • 6 December 2016
    Axonics Announces First Fecal Incontinence Patients Implanted with its Miniaturized Rechargeable Sacral Neuromodulation System

    Axonics Modulation Technologies, Inc., the developer of the first rechargeable Sacral Neuromodulation (r-SNM™) System for the treatment of urinary and fecal dysfunction, announced today that the first Fecal Incontinence patients were successfully implanted at the University Hospital Southampton NHS Foundation Trust in Southampton, United Kingdom.

    Two patients were implanted by Thomas Dudding M.D., FRCS, Consultant, Colorectal & Pelvic Floor Surgeon. Dr. Dudding is internationally recognized as an expert in the use of neurostimulation for bowel control and the treatment of Fecal Incontinence and has extensive research publications in the field.

    The implants are part of a 12 patient evaluation designed to confirm the performance of the Axonics rechargeable SNM System as an aid in the treatment of the symptoms of Fecal Incontinence.

    “In just a few weeks since the implants, my patients are experiencing a significant  improvement in their condition. The implant procedure for the Axonics device is consistent with our current practices, which eliminates any learning curve. Given its long life in the body and ease of recharging, the Axonics r-SNM system represents a major step forward for patients with Fecal Incontinence,” said Dr. Dudding, based at Southampton General Hospital.

    The Axonics SNM System received CE Mark in early June 2016.  To date, over 25 patients have been successfully implanted at leading medical centers in the Netherlands, Belgium, France and the UK as part of a post-market clinical follow-up study (RELAX-OAB) designed to confirm the performance of the Axonics SNM System as an aid in the treatment of the symptoms of Overactive Bladder.

    The Axonics miniaturized implantable neurostimulator is 60 percent smaller than what is currently available and expected to be functional for at least 15 years in the body, which is more than three times longer than the competitors currently marketed non-rechargeable neurostimulator for SNM.

    Fecal Incontinence affects an estimated 40 million adults in the U.S. and Europe with an estimated 10 million adults suffering from Dual Incontinence, a combination of Urinary Incontinence and Fecal Incontinence. Sacral Neuromodulation therapy is an effective and durable treatment that has been widely used and reimbursed in Europe and the U.S. for the past two decades. Fecal Incontinence is characterized by the involuntary loss of solid or liquid feces. It is a multifactorial symptom which benefits from limited treatment options as of today. Sacral Neuromodulation has proven to be effective in about 90% of patients who receive the therapy.