Commercial Development of Stabilized Cellular Diagnostics and Therapeutics to Lessen Logistical Burden on the Battlefield

Massive blood loss is the most common cause of death in potentially survivable battlefield casualties, yet no definitive medical innovations have been made for reducing these deaths in the past several decades. It is still highly impractical to carry large volumes of refrigerated blood into battle, and substantial research for developing blood substitutes and extending the durability and portability of whole blood has not yet been successful. A practical means of addressing life-threatening hemorrhaging is still needed. Our objective is to develop and commercialize a novel binary drug therapy that serves as a temporary (3-4 hours), life-saving alternative to volume resuscitation and whole blood transfusions. Phase I proved feasibility using the rat hemorrhagic shock model. In addition to elevating low arterial pressure to vital organs, hypovolemic rats treated with the binary agents exhibited a statistically significant indication that the drug therapy has a potent “insulating” effect in protecting vital organs from the effects of advanced hemorrhagic shock. In Phase II, we will research the binary therapy’s efficacy in a pig hemorrhagic shock model, evaluate vital organ protective properties discovered in Phase I, optimize formulation and dosage, and initiate commercialization via the FDA approval process for an Orphan Drug fast-track designation.