Irvine-based medical device maker Axonics Modulation Technologies Inc. (Nasdaq: AXNX) saw its market value top $1 billion in late June, after the FDA said it was safe for trial patients using its products to get full-body MRIs.
Axonics is focused on making minimally invasive sacral neuromodulation devices that help treat overactive bladder and other urinary dysfunction issues.
It went public last October; shares initially traded around $15 and they’re now approaching $38 after steadily climbing over the course of this year.
The latest boost to its stock came after a positive report from the FDA, regarding MRI use on its patients.
The company’s initial product—a USB stick-sized neurostimulator designed to last at least 15 years in the body—is approved for sale in Europe, Canada, and Australia, but is still under review by the FDA.
June’s ruling on MRIs is a step in the right direction for ultimate approval by the U.S. agency.
“Allowing full-body MRI scans for our clinical study patients means that none will have to undergo an explant of their neurostimulator device should they require an MRI,” Chief Executive Raymond Cohen said in a statement.
Previously, patients would need to endure a surgery to remove the device prior to entering an MRI for examination.
Huge Market
The sacral neuromodulation, or SNM, device is said to decrease overactive bladder activity by 50% in two-thirds of the patients enrolled in the company’s studies to date.
One-third of patients saw a complete reduction in incontinence.
An estimated 3 million people suffering from urinary dysfunction could benefit from such a device, with more than 300,000 patients having benefited from sacral neurostimulation worldwide, the company estimates.
The SNM device works by stimulating electrical impulses in the pelvis area to correct faulty nerve activity. It is inserted through the skin into the sacrum, where four electrodes on a lead are implanted and subsequently connected to an implantable pulse generator that resides in the upper buttocks area.
The Axonics SNM device’s 15-year lifespan compares favorably to others now on the market; Medtronic lists their devices as needing replacement every 3 to 5 years.
