FemPulse Trajectory
FemPulse ScienceNeuromodulation, using low-level electrical current, is a common therapy to treat medical conditions. It is believed to work by altering aberrant nerve behavior. Electrical impulses are delivered to positively influence nerve communication and muscle and end-organ sensation and function. FemPulse wearable technology is based on the neuroanatomy and neurophysiology of bladder control.
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AUA GuidelineFemPulse’s mission is to offer non-implanted electrical stimulation (neuromodulation) as first-line treatment for OAB and the additional indications addressed by the FemPulse neuromodulation platform. The American Urological Association (AUA) 2014 OAB guideline recommends noninvasive first-line treatment to all patients with OAB and outlines that these treatments can include electrical stimulation. Medication is classified second-line and more invasive neuromodulation third-line. To read the full AUA guideline click here.
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FDA GuidanceFemPulse will seek initial FDA 510(k) clearance as a “nonimplanted electrical continence device”. This class of devices has generally carried the nonsignificant risk (NSR) designation, and often not required clinical trials for FDA 510(k) clearance. FDA guidance listing nonimplanted electrical continence devices as an example of NSR devices is available here. The FDA provides guidance documents for incontinence device trials. FemPulse has completed both in-clinic and in-home OAB trials and plans to study other indications, for which it may then seek additional 510(k) clearance.
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