U.S. Army and Helius Technologies Speed Up Neuromodulation Device Development

Newtown, Pa.-based Helius Medical Technologies Inc. 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) 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 (TBI). The PoNS is an investigational medical device designed to induce neuromodulation by stimulating the cranial nerves found in the tongue.

In the modified agreement, Helius’ division NeuroHabilitation Corporation (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 moderate TBI. 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 Kenneth Bertram, M.D., principal assistant for acquisition, USAMRMC. “This shift in strategy will enable us to potentially get this technology through advanced development and U.S. Food and Drug Administration 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 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.