says it expects to seek approval of its artificial-blood product PolyHeme during the first half of next year.
The filing of an application with the Food and Drug Administration depends on how quickly the company can evaluate clinical trial data involving 720 patients, Northfield says. The company expects to announce the initial results during the final months of this year.
The company has been working on a blood-substitute since it was incorporated in 1985. Through Aug. 31 of this year, it has recorded nearly $180 million in operating losses.
For the most recent quarter, the first of Northfield's fiscal year, it lost $7.6 million, or 28 cents a share. A year ago, it lost $5.8 million, or 22 cents a share.
At the moment, Northfield has no products, and it says it cannot estimate projected sales for its blood substitute. Northfield completed enrollment in a late-stage clinical trial on July 31, which examined how well the blood substitute aided patients who had severe trauma injuries and blood loss.
"Since blood is not routinely carried in ambulances, the use of PolyHeme in this setting has the potential to improve patient survival and address a critical, unmet medical need," the company says in a quarterly report filed with the
Securities and Exchange Commission
. The report was filed Tuesday after markets had closed.
The clinical-trial guidelines enabled PolyHeme to be given to patients at the scene of an accident or in an ambulance. The product could be given during transportation to a hospital and for up to 12 hours after the injury occurred.
PolyHeme is a solution of chemically modified human hemoglobin, the protein in red blood cells that carries oxygen from the lungs to the rest of the body. Northfield says its product is compatible with all blood types, adding that it has a shelf-life of more than 12 months.
Northfield's stock finished the day down 46 cents, or 3%, at $14.68.