Brain SHIELD: A Field-Deployable Hydrogel Drug Delivery System for Localized Treatment of TBI

Over 500,000 cases of traumatic brain injury (TBI) have been reported among U.S. military service members over the past two decades, which can lead to severe edema and hemorrhage. Open TBIs such as open skull fractures and penetrating brain injuries historically have a poor prognosis, with an overall mortality rate of 21% found in a recent study of active-duty U.S. military personnel with combat-related penetrating brain injuries. While management of mild TBI can often be performed in the field, open TBIs typically require evacuation to Combat Support Hospitals for advanced medical intervention. As the U.S. prepares for peer and near-peer conflict in which air superiority is not guaranteed, it is paramount that therapeutic measures are put in place to prevent the development of life-threatening complications and bridge the gap between prehospital and hospital care. To address the need for an effective neuroprotective drug product suitable for use in austere settings, Luna Labs USA, LLC is developing Brain SHIELD™, a field-deployable hydrogel-based drug delivery platform for the treatment of open TBI. Neuroprotective drugs are first loaded into a thermoresponsive liquid hydrogel precursor. Upon injection into the wound cavity, the precursor will be thermally triggered to gel and seal the wound. Coverage with a bandage will further secure the gel in place and stabilize the system. Over time, the hydrogel will degrade through bulk erosion for the localized release of neuroprotective drugs directly into brain tissue. The developed product will be designed for easy implementation in combat settings and leverage FDA-approved components to de-risk development and regulatory pathways. In Phase I, Luna Labs demonstrated feasibility of an injectable thermosensitive hydrogel formulation to provide unidirectional drug release of multiple neuroprotective agents. Preliminary biocompatibility and degradability were also verified. Phase II will include formulation optimization and multiple in vivo studies aimed at demonstrating safety and efficacy to support preclinical validation.