Former FierceMedTech Fierce 15 winner Axonics Modulation Technologies has received FDA approval for its rechargeable neuromodulation implant to treat bowel dysfunction.
According to the company, its r-SNM system has a functional life of 15 years and is compatible with full-body MRI scans.
The approval covers the sacral neuromodulation device’s use in treating fecal incontinence; Axonics has an additional premarket approval filing currently under review at the FDA for overactive bladder and urinary retention.
“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,” Axonics CEO Raymond Cohen said in a statement.
“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,” he added.
About the size of a USB stick, the system’s miniaturized neurostimulator can be recharged wirelessly through the skin, compared to a similar device from Medtronic that needs to be surgically replaced every three to five years.
It also includes a patient remote control and a programmer for clinicians to facilitate lead placement and stimulation. By delivering electrical stimulation to the body’s sacral nerve, the device aims to correct erroneous signals sent between the bowels, bladder and brain.
Last November, Axonics pulled off a $120 million IPO, following a $40 million funding round the April before. The company has already secured approvals for its device across Europe, Canada and Australia.