Newtown, PA / ACCESSWIRE / January 19, 2015 / Helius Medical Technologies ("Helius", or the "Company") [through its wholly owned division NeuroHabilitation Corporation ("NHC")], and the U.S. Army Medical Research and Material Command ("USAMRMC") have modified an existing Cooperative Research and Development Agreement ("CRADA") to speed up the development of the company's Portable Neuromodulation Stimulator ("PoNS(TM)") device, a non-invasive brain stimulation device that is being developed for the treatment of balance disorder in patients with mild-to-moderate Traumatic Brain Injury ("mTBI"). The PoNS(TM) is an investigational medical device that is designed to induce neuromodulation by stimulating the cranial nerves found in the tongue.
In the modified agreement, NHC takes over sponsorship of the regulatory pathway for the PoNS(TM) device, with support from the USAMRMC. NHC will also sponsor the initial registrational clinical trial to study use of the device, in conjunction with physical therapy, for treatment of mTBI. To support this effort, the USAMRMC has published a Notice of Intent to enter into a sole-source contractual agreement to support the execution of the registrational trial. The terms of the contract and the actual award of contract are not yet final.
The USAMRMC leadership emphasized that the amendment to the CRADA, which was originally signed in February 2013, does not change the USAMRMC's commitment to this important, high visibility project.
"The Army remains focused on finding evidence-based solutions for our wounded warriors," said Dr. Kenneth Bertram, Principal Assistant for Acquisition, USAMRMC. "This shift in strategy will enable us to potentially get this technology through advanced development and FDA clearance faster, so we can offer it to our service members who may benefit."
The CRADA modifications also allows the USAMRMC to research other potential uses of the device relevant to injured service members, such as whether the PoNS(TM) device is effective at treating tinnitus, post-traumatic stress, or sleep disturbances.
"This is a great example of innovation and a public/private collaboration with our USAMRMC partners and we are very pleased to take over some of the responsibility to get this technology studied, cleared and distributed to help patients," said the CEO of Helius, Philippe Deschamps.
About The PoNS(TM)
The Portable Neuromodulation Stimulator (PoNS(TM)) device is an investigational medical device being studied for the treatment of neurological symptoms caused by disease or trauma. The PoNS(TM) is currently being studied in the United States for the treatment of balance disorder related to mild to moderate Traumatic Brain Injury (mTBI), and in Canada for the treatment of gait and balance disorder for patients with Multiple Sclerosis (MS). It represents the first in a series of non-invasive devices - based on the patented PoNS(TM) platform - designed to amplify the brain's powerful ability to heal itself. This is part of a new approach being studied for "symptom treatment" for the rising number of patients who have experienced loss of function as a result of neurological disease or trauma.
About Helius Medical Technologies (HMT)
Helius Medical Technologies is a medical technology company focused on neurological wellness. HMT seeks to use unique and non-invasive platform technologies that amplify the brain's ability to heal itself. HMT intends to file for U.S. Food and Drug Administration clearance of the PoNS(TM) device. For more information, please visit www.heliusmedical.com.
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Contact:
Corporate Contact:
Phil Deschamps
614-596-2597
US Investor Relations Contact:
Todd James
646-378-2926
Canadian Investor Relations:
778-588-7144
Media Contact:
Becky Kern
914-772-2310
SOURCE: Helius Medical Technologies