Northfield Laboratories, Inc. is gradually tackling one of the most challenging and long-standing problems in the medical field, the development of a hemoglobin-based oxygen-carrying red blood cell substitute, which some are simply calling artificial blood.
Imagine you or a family member is rushed to the hospital after a serious accident. Blood loss has robbed the body of oxygen, and an urgent, large-volume transfusion is needed. But there’s a problem. The hospital doesn’t have access to enough blood, at least of the type needed. It’s exactly the scenario Northfield Labs has been working on for many years to address.
Although attempts have been made to achieve this major medical goal, the process is tricky, and nothing has yet been approved in the United States. But Northfield, considered a leader in developing a hemoglobin-based oxygen-carrying red blood cell substitute, believes that will be changing.
PolyHeme®, Northfield’s product, is a human hemoglobin-based oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss when appropriate red blood cells are not available. It’s a solution of chemically modified human hemoglobin that requires no cross-matching, and is therefore compatible with all blood types. Plus it has an extended shelf life in excess of 12 months. It simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
The company, based in Evanston, Illinois, has nine U.S. patents and several pending U.S. patent applications, all relating to the use and production of PolyHeme®. It’s now actively working on clinical trials, along with production processes, necessary for FDA approval. Northfield intends to submit a BLA (Biologic License Application) for PolyHeme® to the FDA with a request for Priority Review, based on the potential of the product to address a critical, unmet medical need.
Northfield is already exploring sales and distribution possibilities, as well as manufacturing options. If things go as planned, hospitals across the country will have a life-saving tool they’ve never had before.
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