( label Phase II proof-of-concept eight...)Positive Statistical Analysis from Synthetic Blood's Oxycyte,Traumatic Brain Injury Trial Indicates Achievement of Primary,Endpoint,Health

label, Phase II proof-of-concept, eight-patient study conducted at Virginia Commonwealth University, Oxycyte was administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9. The study protocol includes two groups. The first four study patients were stabilized with 50% oxygen for four hours before and 12 hours following Oxycyte administration. The remaining four study patients breathed 100% oxygen on the same schedule. Clinical data on brain oxygen and metabolite levels are compared in patients from both groups. The primary purpose of this study is to demonstrate Oxycyte's ability to increase brain oxygen tension and favorably affect other brain chemistries that impact clinical outcome in patients suffering severe head injury. Additionally, the study will further assess the safety of Oxycyte when given by intravenous infusion.

Due to a technical malfunction whereby a complete measurement of oxygen levels in the brain of one treated patient was not made, nine patients were treated during this study to meet the eight-patient enrollment goal. While survival was not a trial endpoint, seven patients in the trial survived their brain trauma. Neither of the two mortality cases was related to the safety of Oxycyte. One patient suffered massive injury and was not expected to survive. Another patient was withdrawn from the trial upon the voluntary decision to remove life-support.

About Synthetic Blood International

Synthetic Blood International is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring. The Company has under development a blood substitute, a liquid ventilation product and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for perfluorocarbons, and medical and industrial applications for biosensors. Each of the product candidates is designed with ad
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