Axonics Announces First Patients Treated in Sacral Neuromodulation Study

Axonics Modulation Technologies Inc., developer of the first rechargeable implantable Sacral Neuromodulation (SNM) System for the treatment of urinary and fecal dysfunction, announced that its first patients were successfully implanted at both the National Hospital for Neurology and Neurosurgery in London and Maastricht University Medical Centre in the Netherlands.
 
The patients were treated as part of a 65-patient 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 (OAB).
 
The Axonics SNM System received CE Mark in early June 2016 and patients are currently being enrolled in the study at leading medical centers in England, Belgium, the Netherlands and France. The first implant procedure was performed in London by Sohier Elneil, M.D., Ph.D., and three additional implants were performed by Professor Philip van Kerrebroeck, M.D., Ph.D., in Maastricht.
 
“This miniaturized rechargeable SNM System represents a major step forward for patients seeking a long-term solution to relieve overactive bladder symptoms and improve their quality of life. The implant is expected to be functional for at least 15 years in the body, which is more than three times longer than current non-rechargeable systems,” said van Kerrebroeck.
 
OAB affects an estimated 85 million adults in the United States and Europe. Sacral Neuromodulation therapy is an effective and durable treatment that has been widely used and reimbursed in Europe and the United States for the past two decades. More than 200,000 patients have benefited from the therapy to date. Sacral Neuromodulation is the only OAB treatment with proven clinical superiority to standard drug therapy.
 
“The implantation procedure of the Axonics System was quick and easy and consistent with our current Sacral Neuromodulation implant practices,” said Elneil. “Our patients are excited to have the option of an implant with such a small size and long life. We will closely follow the patients and are confident they will experience significant relief of their overactive bladder symptoms.”
 
Earlier this month, Axonics announced that Neurourology and Urodynamics published the results of a peer-reviewed study titled, “Cost Profiles and Budget Impact of Rechargeable Versus Non-Rechargeable Sacral Neuromodulation Devices in the Treatment of Overactive Bladder Syndrome.” The study findings determined that compared to non-rechargeable Sacral Neuromodulation systems for the treatment of OAB, a rechargeable system with a long-lived battery could save healthcare systems billions over the next 15 years. Physicians and researchers who collaborated on the study included Karen L. Noblett, M.D., University of California, Riverside; Roger R. Dmochowski, M.D., Vanderbilt University; Sandip P. Vasavada, M.D., Cleveland Clinic, Abigail M. Garner, M.S.; Shan Liu, Ph.D., and Jan B. Pietzsch, Ph.D., of Wing Tech Inc., Menlo Park, Calif.
 
The Axonics SNM System is a rechargeable implantable neuromodulation system that modulates sacral nerve activity for the management of urinary and fecal dysfunction. The System includes, among other innovations, a miniaturized implantable pulse generator that is 60 percent smaller and is qualified to last at least 15 years in the body—more than three times longer than currently marketed non-rechargeable Sacral Neuromodulation technology. In addition, the Axonics SNM System features both a key-fob sized patient-friendly remote control and an intuitive clinician programmer that guides physician implanters throughout the procedure, from lead placement to programming.
 
Axonics, based in Irvine, Calif., is a privately held venture-backed company developing implantable neuromodulation technology directed toward a number of clinical indications. Investors include Edmond de Rothschild Investment Partners, Advent Life Sciences, NeoMed Management, Legend Capital, Cormorant Asset Management and The Alfred E. Mann Foundation.