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Hibernaid's lead product, HBN-1, is a pharmaceutical preparation that combines several drugs in a single formulation. It is administered intravenously to critically ill patients to induce clinically relevant regulated hypothermia.

Based on extensive and highly predictive translational animal model research conducted at the University of North Carolina, the degree and duration of the HBN-1 induced hypothermic response will be sufficient to elicit a neuroprotective physiological response in man that is of clinical benefit.

'Regulated hypothermia' is a unique feature of HBN-1 in that the drug acts by resetting the body's temperature set point in the hypothalamus area of the brain, as opposed to temperature reduction by current 'mechanical' and 'forced' hypothermia methodologies, all of which produce severe shivering that requires sedation, induced coma and ventilatory assistance to control, and which are often associated with other serious side effects. 'Forced' hypothermia's complex procedural and support elements can involve considerable expense and require specialized training.

HBN-1 produces an unexpected synergy of combined drug components that induces regulated hypothermia without shivering during cooling. The drug displays rapid onset and unlimited duration without tolerance or hypotension, as well as significantly improved neurological and survival outcomes when compared to forced methodologies in preclinical studies.

To date, the Company has completed a comprehensive and highly predictive preclinical and translational research program, has had several of its studies published in peer-reviewed journals, and received a major award from NIH (through the agency’s BrIDGs program) that fully supported CMC and toxicology work for FDA that will enable the Company to conduct a Phase I - II study in post-cardiac arrest patients.