Helius Medical Technologies and the U.S. Army Medical Research and Material Command have modified an existing Cooperative Research and Development Agreement to speed up the development of the company's Portable Neuromodulation Stimulator 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. The PoNSTM 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 PoNSTM 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 CRADA modifications also allows the USAMRMC to research other potential uses of the device relevant to injured service members, such as whether the PoNSTM device is effective at treating tinnitus, post-traumatic stress, or sleep disturbances.