US Army, Helius modify CRADA to speed PoNS device development

Helius Medical Technologies [through its wholly owned division NeuroHabilitation Corporation (NHC)], and the US 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) 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 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 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 CRADA modifications also allows the USAMRMC to research other potential uses of the device relevant to injured service members, such as whether the PoNS 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.

The Portable Neuromodulation Stimulator (PoNS) device is an investigational medical device being studied for the treatment of neurological symptoms caused by disease or trauma.

The PoNS 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).