Axonics Sacral Neuromodulation System Receives Marketing Approval in Australia

Axonics Modulation Technologies Inc. has received marketing approval from the Australian Department of Health, Therapeutic Goods Administration (TGA) for the first rechargeable Sacral Neuromodulation (r-SNM) System to treat overactive bladder (OAB), fecal incontinence and urinary retention.
 
This approval confirms that the Axonics r-SNM System meets all of the Australian Medical Devices Regulations for Active Implantable Medical Devices and enables commercialization throughout Australia.
 
“Australian TGA approval provides Axonics with another important marketing approval. Along with our European CE mark and Health Canada approval, this gives us the ability to sell our product in three significant international territories while we complete our U.S. pivotal study,” said Raymond W. Cohen, CEO of Axonics.
 
More than 5 million people, or approximately 20 percent of the Australian population, experience bladder or bowel control problems, many of which are not provided with a suitable therapeutic option. Urinary incontinence tops the list with up to 37 percent of women affected (Australian Institute of Health and Welfare report, 2006).
 
In the United States and Europe, OAB affects an estimated 85 million adults with another 40 million reported to suffer from fecal incontinence. SNM therapy is an effective and durable treatment that has been widely used and reimbursed for the past two decades accounting for an estimated $700 million in revenue in 2017. SNM is the only OAB treatment with proven clinical superiority to standard medical therapy and OAB patients who receive SNM report significantly higher quality of life than patients undergoing drug treatment.
 
Axonics, based in Irvine, Calif., is a privately-held venture backed company that has developed an implantable neuromodulation technology for patients with urinary and bowel dysfunction and can be further directed towards other clinical indications. The Axonics r-SNM system includes a miniaturized rechargeable implantable stimulator qualified to function at least 15 years, a charging system optimized for reduced charge time without overheating, a patient-friendly remote control and an intuitive clinician programmer that facilitates the lead placement procedure and programming.
 
During 2016, the Axonics r-SNM system gained regulatory approval in Europe and Canada for the treatment of overactive bladder, urinary retention, and fecal incontinence. In November 2017, the U.S. Food & Drug Administration (FDA) granted an Investigational Device Exemption to allow Axonics to conduct a pivotal study designed to gain FDA pre-market approval in the United States.