The U.S. patents issued range in subject matter and include coverage of the Axonics clinician programmer, patient remote control, and internal system electronics. The issued U.S. patents are: 10,029,090; 9,855,436; 10,092,762; 9,855,423; 9,895,546; 10,105,542; 9,925,381.
“Axonics is committed to rapidly bringing innovative technology to market in order to serve the unmet needs of the millions of patients suffering from urinary and bowel dysfunction and the healthcare providers who serve them. We believe that the continued growth of our patent portfolio demonstrates how serious we are in our efforts,” said Raymond W. Cohen, Axonics CEO. “With these seven additional U.S. utility patents, we presently have 108 granted and 105 pending patent applications in our portfolio in various jurisdictions around the world.”
The Axonics patent portfolio represents technology internally developed by Axonics and technology developed under license from the Alfred Mann Foundation.
The Axonics r-SNM System has obtained European CE mark approval, Health Canada approval, and Australian Therapeutic Goods Administration approval for the treatment of overactive bladder, urinary retention, and fecal incontinence.
Currently, Axonics is in the follow-up phase of its 129-patient pivotal clinical study, ARTISAN-SNM, designed to gain U.S. Food and Drug Administration (FDA) approval in the United States for urinary urgency incontinence. All patients in the ARTISAN-SNM clinical study were scheduled to reach their six-month post-implant endpoint on or about, the end of 2018.
Overactive bladder affects an estimated 85 million adults in the United States and Europe. Another 40 million are reported to suffer from fecal incontinence. SNM 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. SNM is the only treatment with proven clinical superiority to standard medical therapy and patients receiving SNM report significantly higher quality of life than patients undergoing drug treatment.
Axonics, based in Irvine, Calif., develops and commercializes an implantable SNM system for patients with urinary and bowel dysfunction, which is designed to disrupt the SNM market currently dominated by one large provider. The Axonics r-SNM system offers a temporary disposable external trial system, a miniaturized and rechargeable long-lived neurostimulator that is qualified to function for at least 15 years, a tined lead as well as patient-friendly accessories such as a charging system optimized for minimal charge time without overheating, a small, easy to use patient remote control and an intuitive clinician programmer that facilitates lead placement and programming.