Helius Medical Technologies said this week it expanded a source cost sharing contract with the U.S. Army Medical Research and Materiel Command, while its CEO Phil Deschamps is looking to the future of its Portable Neuromodulation Stimulator.
The contract extension moves the ending date to December 31, 2017 and allows for additional study sites in a trial testing the use of the PONS device for treating chronic balance deficits in patients with mild to moderate traumatic brain injury.
Traumatic brain injury is the 1st focus for the company’s PONS system, which is designed to treat neurological symptoms caused by disease or trauma. The neurostimulation is delivered non-invasively through the tongue, which Helius said can be used as ‘a gateway to the brain,’ specifically the pons area.
Treating movement and balance disorder issues caused by traumatic brain injury is only the 1st stop for the device, according to CEO Phil Deschamps, who sees the device as a platform that could be used to treat a wealth of other indications.
“The reason that we chose traumatic brain injury as the 1st indication is that we have a development partnership with the Department of Defense. Of course, the Department of Defense has a huge humanitarian and PR issue with respect to traumatic brain injury in the active duty forces. Out of the 2 million soldiers in the active duty force, unfortunately, 30 thousand of them suffer a traumatic brain injury every year,” CEO Deschamps told MassDevice.com in an interview.
Deschamps said the system has been studied more in treatments for balance and movement issues related to multiple sclerosis, which the company plans on seeking an indication from the FDA for in the future.
“We actually have more clinical experience with the MS model and that will certainly be the 2nd indication that we’ll be taking. In fact, we’ve already applied for a pre-submission meeting with the FDA to review the risk assessment based on us treating neurological disease and are awaiting that feedback, hopefully before the end of this year,” Deschamps said. “Immediately upon collecting that information, we would like to start our MS clinical trial. That will take us a year to prosecute, so sometime in 2018.”
But Deschamps sees the indications as merely as the 1st of many for the platform, which he believes will be able to treat number of chronic neurological issues, and possibly even holds some ability to boost human performance.
“If the therapeutic model is shown to work during the clinical trials, that definitely could add value in to human performance aspects, because there’s no reason to believe that in the future we won’t be able to use the same technology to help people improve their golf swing or better study for exams or things like that. Because ultimately, it’s always the same thing, whether you’re doing an exercise, whether cognitively or physically, combining with the stimulation, seems to trigger the brain’s reorganization process to be able to enhance the plasticity,” Deschamps said.
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