Northfield Laboratories Inc., incorporated on June 19, 1985, develops hemoglobin-based, oxygen-carrying resuscitative fluid for the treatment of urgent, large-volume blood loss in trauma and resultant surgical settings. The Company's primary product is PolyHeme. PolyHeme is a human hemoglobin-based, oxygen-carrying resuscitative fluid used in the early treatment of urgent, life-threatening blood loss following trauma when donated blood may not be immediately available. Northfield is conducting a pivotal Phase III trial in the United States, in which a hemoglobin-based oxygen carrier is being used to treat severely injured and bleeding patients, beginning at the scene of injury and continuing during transport to the hospital and the early period of hospitalization. As of June 30, 2005, approximately 400 patients had been enrolled in the Phase III trial. PolyHeme is a solution of chemically modified human hemoglobin, which simultaneously restores lost blood volume and hemoglobin levels. Hemoglobin is the oxygen-carrying component of the red blood cell. PolyHeme is designed for rapid, massive infusion, which is the way blood is transfused in trauma patients. The Company purchases donated red blood cells from The American Red Cross and Blood Centers of America for use as the starting material for PolyHeme. It uses a process of separation, filtration, chemical modification, purification and formulation to produce PolyHeme. PolyHeme is designed to avoid potential undesirable effects, such as vasoconstriction, kidney dysfunction, liver dysfunction and gastrointestinal distress. Northfield's existing manufacturing facility has the capacity to produce 10,000 units of PolyHeme annually. The Company is enrolling patients in a pivotal Phase III trial, in which PolyHeme is being used for the first time in the United States to treat severely injured patients in hemorrhagic shock before they reach the hospital. Under this protocol, treatment with PolyHeme begins at the scene of the injury or in the ambulance and continues during transport and the initial 12 hour post-injury period in the hospital. As of August 1, 2005, 21 clinical sites in the United States were enrolling patients in Northfield's pivotal Phase III trial and six other sites had received final Institutional Review Board (IRB) approval and were preparing to begin patient enrollment. Multiple additional sites were engaged in the required public disclosure and community consultation process. Each of the sites participating in the trial is designated as a Level I trauma center, indicating its capacity to treat the most severely injured trauma patients. Northfield has reached an agreement with the United States Food and Drug Administration (FDA) on special protocol assessment (SPA) for its pivotal Phase III trial. The pivotal Phase III trial is being conducted under a federal regulation that permits research to be conducted in certain emergent, life-threatening situations using an exception from the requirement for prospective informed consent by individual patients. The trial is being conducted primarily in urban settings because urban Level I trauma centers have the patient volume, resources and sophistication to conduct a clinical trial of this complexity. In urban areas, however, transit times in the ambulance may be brief, and the control group will reach the hospital, where patients will have access to blood, in relatively short periods of time.

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