Northfield Laboratories Inc. said it submitted a biologics license application for its blood substitute product, PolyHeme.
PolyHeme is intended to be an alternative to blood transfusions for patients with acute blood loss. The product carries oxygen, restores blood volume and is designed to treat hemorrhagic shock resulting from extensive bloodletting.
The BLA seeks approval to market PolyHeme as an oxygen-carrying resuscitative product to treat life-threatening blood loss.
Northfield officials could not be reached for comment.
PolyHeme is derived from human blood. Northfield, of Evanston, Ill., extracts hemoglobin from red blood cells, filters it to remove impurities, then chemically modifies it to create a polymerized form of hemoglobin. The modified hemoglobin is then incorporated into a solution that can be administered to patients.
Northfield said it believes PolyHeme has benefits that blood does not. Clinical tests have shown it does not pass along blood-borne diseases, is compatible across blood types, and can have a shelf life of 12 months, if refrigerated.
Northfield¿s stock (NASDAQ:NFLD) rose 22 cents on the news Tuesday to close at $17.30. ¿ Brady Huggett