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Oxygen Biotherapeutics submits results of requested nonclinical studies to FDA

Oxygen Biotherapeutics announced that it has submitted to the U.S. FDA results from two series of animal studies designed to address Agency concerns regarding the use of Oxycyte in treating traumatic brain injury patients. These studies were conducted to probe both the interactions between Oxycyte and the immune system as well as assess the PFC-based emulsion’s potential to increase the risk of intracerebral hemorrhage. This research was funded as part of a $2.07M grant that Oxygen Biotherapeutics has with the U.S. Army who is committed to developing treatments for TBI. “Submission to the FDA of these long-awaited studies represents another important step towards adding the United States to the growing list of countries participating in our current Phase IIb severe TBI trial,” said Oxygen Biotherapeutics.