Bioness last week said it’s making progress with a Canadian study of its StimRouter neuromodulation device designed to expand the number of conditions for which it can be used for treatment.
The California company said 4 patients were successfully implanted with the StimRouter device in an ongoing pilot trial exploring its use as a treatment for overactive bladder.
In February, Bioness won U.S. FDA clearance for StimRouter as a treatment of chronic peripheral pain.
"The StimRouter is a platform technology with a design we believe has applications outside of its current indication," president & CEO Todd Cushman said in prepared remarks. "This pilot study demonstrates the first of several investigations with the goal of expanding StimRouter use in markets of unmet need or existing markets that seek the appropriate neuromodulation solution.”
Patients with documented refractory overactive bladder will be eligible for the 6-month Canadian study, Bioness said. The StimRouter implantable lead and external, hand-held pulse transmitter will give them tibial nerve stimulation. Subjects will manage their treatment at home, according to study protocol, broken up by periodic clinic visits.