The latest earnings report from Irvine-based Axonics Modulation Technologies Inc. (Nasdaq: AXNX) provided a slight boost to the maker of devices to treat urologic conditions.
The company is awaiting FDA approval for the commercial sale in the U.S. for its sacral neuromodulation system, which provides stimulating electrical impulses in the pelvis area, which are used to correct faulty nerve activity.
The device has been shown to decrease overactive bladder activity by 50% in two-thirds of the patients enrolled in the company’s studies to date.
The company, which went public last year, in July joined the ranks of OC companies with $1 billion market values, after seeing its stock price more than double in a few months. Shares subsequently fell some 10%.
Aug. 6 earnings pushed its shares a bit higher again; it now has a market value of about $975 million.
The company’s new r-SNM (sacral neuromodulation) system sales totaled $1.5 million in Europe and Canada last quarter. That’s a 38% increase from the prior quarter.
The boost “demonstrates continued progress and satisfaction with our product from patients and physician implanters,” Chief Executive Raymond Cohen said.
FDA Wait
An FDA approval is expected later this year.
Prior feedback from the FDA permits Axonics’ r-SNM device to enter a full-body MRI—other SNM devices must be “explanted” prior to an MRI.
Unlike other SNM devices, Axonics’ r-SNM device also can be charged via wand extrinsically.
“Some patients choose to charge it every Sunday night because that’s easier for them,” but the battery lasts longer than a week, Cohen said.
The “wand” is a pod-like battery that can be secured to a patient much like a fanny pack, which allows them to move around while it charges.
