In the market for bladder and bowel dysfunction devices that stimulate the sacral nerve, the world's largest medical-device maker Medtronic (MDT -0.57%) currently holds a leading share.
A good start
In November, the Food and Drug Administration (FDA) approved r-SNM, the first rechargeable sacral nerve stimulator cleared for full-body MRI scans, and sales results from the initial launch were surprisingly good. Sales of r-SNM reached $9.9 million before the end of 2019, and the company expects momentum to continue throughout 2020.
In 2020, over 300 U.S. institutions have already implanted an r-SNM system, compared to just 200 during the fourth quarter of 2019. At a recent conference, Axionics was able to show a crowd of physicians results from a clinical study that showed that implanting an r-SNM device helped 9 out of 10 patients achieve clinically meaningful improvement.
In the EU, Medtronic has already launched a device expected to pour water on Axonics' r-SNM launch. The InterStim Micro from Medtronic is a rechargeable implant designed to be safe during full-body MRI scans. In the U.S., Medtronic submitted an application for InterStim Micro last October, which means it could begin pressuring Axonics sales in the summer.
Luckily for Medtronic and Axonics, there's probably more-than-enough underserved patients with incontinence issues to fuel sales of at least two successful devices. Overactive bladder affects an estimated 87 million adults in the U.S. and EU, and another 40 million lack bowel control.