The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence.
The FDA approval was supported by the results of a detailed review of technical data and the positive results of the Axonics ARTISAN-SNM 129-patient pivotal clinical study that met all primary and secondary endpoints and demonstrated 90 percent efficacy for all implanted urinary incontinence patients at six months, as well as published clinical literature.
The Axonics r-SNM System is the first rechargeable SNM system approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device approved for patients to undergo full-body MRI scan without the necessity of having the device explanted. The FDA approval includes the claim of a 15-year functional life, which is in contrast to the incumbent company’s legacy device which requires replacement on average every four years. In addition to many other differentiating attributes, the system includes a patented tined lead, user-friendly accessories, such as a wireless charging system optimized for infrequent charging, a small easy-to-use key-fob patient remote control and an intuitive clinician programmer that facilitates lead placement and stimulation programming. The long-lived miniaturized neurostimulator is approximately the size of a USB stick.
“If we consider the millions of women who have tried and discontinued OAB pharmaceuticals, the market opportunity for Axonics goes well beyond the approximate $700 million of revenue that is currently being generated by the incumbent’s non-rechargeable SNM device,“ said Raymond W. Cohen, CEO of Axonics. ”Based on feedback from U.S. physicians, we believe the SNM market is poised to dramatically expand over the next few years given our fuss-free, highly efficacious, long-lived, full-body MRI compatible device. Our U.S. commercial team of 146 territory managers, clinical support specialists and sales managers rivals the size of the incumbent’s field staff, and is focused on calling on the top 1,000 urologists, urogynecologists and colorectal surgeons who account for approximately 80 percent of the SNM implants in the U.S.”