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FDA approves Axonics sacral neuromod for FI

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Axonics Modulation TechnologiesAxonics Modulation Technologies (NSDQ:AXNX) today said it received FDA approval for its rechargeable sacral neuromodulation device.

The rechargeable SNM device is designed to treat urinary and bowel dysfunction in adults and features a neurostimulator about the size of a USB drive that lasts 15 years in the body.

Irvine, Calif.-based Axonics also has a pre-market approval filed with the FDA for the clinical indications of overactive bladder and urinary retention.

“If we consider the millions of women who are suffering in silence with bladder and bowel dysfunction, we believe the market opportunity for Axonics goes well beyond the existing approximately $650 million of revenue that is currently being generated by the incumbent’s non-rechargeable SNM device,” CEO Raymond Cohen said in a press release. “We believe the number of patients seeking SNM treatment will expand dramatically over the next few years given our fuss-free, long-lived, full-body MRI-compatible device”

“In the months prior to FDA approval, we invested significant time and resources in building inventory to support our fully trained, U.S. commercial team which now includes 145 territory managers, clinical support specialists and sales managers strategically located around the country,” Cohen said. “We plan to begin shipping product to U.S. physicians and hospitals during the fourth quarter of 2019, following the fulfillment of customary, pre-launch regulatory requirements.”

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