Helius Medical Technologies recently announced NeuroHabilitation Corporation, which it owns in total, will join with the Feinstein Institute for Medical Research to conduct a Clinical Experience Program (CEP), studying its Portable Neuromodulation Stimulator (PoNS). The Southside Hospital in Bay Shore is one of the locations chosen to participate in the study.
The PoNS is a device that is currently being studied by the U.S. Food & Drug Administration to determine if it can be released to the market. In Canada, the stimulator is already marketed as a class II medical device.
CEPs such as the one planned enable Helius to investigate how well PoNS treatment works in patients who have balance difficulties due to a traumatic brain injury (TBI). The study is restricted to those whose injuries are mild to moderate. Companies developing products such as this can work with a brochure printing company to explain them.
The PNS device is noninvasive, and is used in conjunction with targeted physical therapy. Neuromodulation is delivered via the tongue to stimulate nerves in the brain, to help restore neurological functioning. The tongue is chosen as the site of the delivery because of its large number of sensory nerve receptors, as well as the fact that saliva is electrolyte-rich. The nerve endings are on the surface of the organ, which is why the device is noninvasive.
