EMKinetics has started the TranStim Transdermal Neuromodulation System pivotal trial to treat urge incontinence and overactive bladder.
The trial enrolling 120 patients will be conducted at 10-15 US centers.
EMKinetics develops neuromodulation therapies based on its Transdermal Stimulation (TranStim) technology to treat overactive bladder and other maladies.
EMKinetics’ TranStim therapy is builtm on the evidence that posterior tibial nerve stimulation (PTNS) can generate improvement in patients suffering from urge incontinence and overactive bladder.
The company said after it completes the study, it plans to submit for CE mark and 510(k) clearance.