Patient Treatment Completed in Synthetic Blood Traumatic Brain Injury Trial; Oxycyte Administration Increases Brain Oxygen Tension in All Trial Patients; Announcement of Preliminary Analysis of Trial Data Expected in 4th Quarter.COSTA MESA, Calif. -- Synthetic Blood International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :SYBD) today announced the completion of treatment in the Company's Phase IIa open-label, proof-of-concept Oxycyte(TM) study in traumatic brain injury Traumatic brain injury (TBI), traumatic injuries to the brain, also called intracranial injury, or simply head injury, occurs when a sudden trauma causes brain damage. TBI can result from a closed head injury or a penetrating head injury and is one of two subsets of acquired brain . Oxycyte administration increased oxygen tension over baseline in all eight evaluable trial patients. The Company expects to announce results of preliminary data analysis from this trial in the 4th quarter. The primary purpose of the Phase IIa 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 from severe head injury. The safety of delivering Oxycyte via intravenous infusion is also being assessed. Patients qualifying for Oxycyte treatment in this study suffered from severe traumatic brain injury and a Glasgow Coma Scale Glas·gow Coma Scale n. A scale for measuring level of consciousness, especially after a head injury, in which scoring is determined by three factors: amount of eye opening, verbal responsiveness, and motor responsiveness. score of 3-9. The first four study patients breathed 50% oxygen for four hours before and 12 hours following Oxycyte administration. The final five treated study patients were stabilized on 100% inspired oxygen on the same schedule. Data on brain oxygen and metabolite metabolite, organic compound that is a starting material in, an intermediate in, or an end product of metabolism. Starting materials are substances, usually small and of simple structure, absorbed by the organism as food. levels will be compared to baseline before Oxycyte administration in patients from both groups. Due to a data monitoring malfunction in one treated patient, nine patients were treated during this study to provide the required eight-patient trial data. "Early data indicating increased oxygen tension in the brain following Oxycyte administration suggests Oxycyte's ability to oxygenate oxygenate /ox·y·gen·ate/ (-je-nat) to saturate with oxygen. ox·y·gen·ate or ox·y·gen·ize v. To treat, combine, or infuse with oxygen. tissues with narrow or occluded capillaries, such as those that occur in brain injury, and suggest Oxycyte's promise as a therapy in human severe traumatic brain injury," said Robert Nicora, Synthetic Blood President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We look forward to reporting additional data from this proof-of-concept study that could provide the foundation for further clinical development of Oxycyte for this indication." About Traumatic Brain Injury A traumatic brain injury is caused by a blow or jolt to the head or a penetrating head injury A penetrating head injury, or open head injury, is a head injury in which the dura mater, the outer layer of the meninges, is breached.[1] Penetrating injury can be caused by high-velocity projectiles or objects of lower velocity such as knives, or bone fragments that disrupts the normal function of the brain. Among the indications of severe traumatic brain injuries are extended periods of unconsciousness or amnesia after the injury. Approximately 1.4 million Americans each year sustain traumatic brain injury for which there is no direct therapy. Approximately one-third of severe head injury patients show reduced oxygen tension during the first six to 12 hours following traumatic brain injury, and this may be predictive of poor clinical outcome. The Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ) estimates that at least 5.3 million Americans, approximately 2% of the U.S. population, currently have a long-term or lifelong need for help to perform activities of daily living as a result of a traumatic brain injury with direct medical costs and indirect costs, such as lost productivity, totaling an estimated $60 billion in the U.S. in 2000. 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 bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. applications for perfluorocarbons, and medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including acute respiratory distress syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. , stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes. For further information, visit www.sybd.com. Safe Harbor Statement The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 provides a safe harbor for forward-looking information made on the Company's behalf. All statements, other than statements of historical facts which address the Company's expectations of sources of capital or which express the Company's expectation for the future with respect to financial performance or operating strategies, can be identified as forward-looking statements. Such statements made by the Company are based on knowledge of the environment in which it operates, but because of the factors previously listed, as well as other factors beyond the control of the Company, actual results may differ materially from the expectations expressed in the forward-looking statements. |
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