- FDA approved Axonics Modulation Technologies' implantable, rechargeable sacral neuromodulation (SNM) system to treat clinical indications of overactive bladder (urinary urge incontinence and urinary urge frequency) as well as urinary retention, the company said Thursday.
- The latest approval allows Axonics, which raised $120 million in an IPO last fall, to compete with Medtronic for both the fecal and urinary incontinence markets. The new indications follow the Irvine, California-based Axonics' approval in September for its SNM system to treat fecal incontinence.
- Earlier this month, Medtronic sued Axonics in the U.S. District Court for the Central District of California, alleging the small medtech's rechargeable sacral neuromodulation system infringes four Medtronic patents covering the implantation method, lead fixation, and recharging technology.
Medtronic has dominated the sacral neuromodulation space with its InterStim product marketed for bowel and urinary control. Axonics' rechargeable sacral neuromodulation r-SNM system product touts a longer product life, full body MRI compatibility and a wireless charging system optimized for infrequent charging, the company said.
"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," CEO Raymond Cohen said in a statement Thursday.
The new approval positions Axonics to beat consensus throughout 2020 because the additional urinary indications means a domestic market opportunity three times the size of the fecal indication, Needham analysts wrote in a note to investors Thursday.
Analysts estimated approximately 3 million patients in the U.S. and Europe with overactive bladder, and about 1 million in the U.S. and Europe with fecal incontinence. The latest OAB "launch should catalyze expansion of the SNM market," they wrote.
The company plans to begin shipping products in the U.S. in the fourth quarter. Its domestic sales force numbers 145 sales reps, regional managers and clinical specialists, according to Cohen.
Axonics received a CE mark for its device to treat overactive bladder, fecal incontinence and urinary retention in June 2016. It received a marketing license from Health Canada in January 2017 and was approved by Australian regulators in January 2018. Last year, the company recorded a $32.5 million net loss as sales of the SNM system in Europe and Canada generated $700,000 in revenue for the year.
Medtronic executives said on an Aug. 20 earnings call the company plans to launch a smaller, rechargeable version of InterStim II in the U.S. in late fiscal year 2020 or early fiscal year 2021.