Corporate Overview
We are a leader in developing a hemoglobin-based oxygen-carrying
red blood cell substitute. The initial indication we are seeking
for our product PolyHemeŽ is the treatment of life-threatening hemoglobin
levels when blood transfusion is indicated but red blood cells may
not be available, appropriate or acceptable.
PolyHeme® is a human hemoglobin-based temporary oxygen-carrying
red blood cell substitute. PolyHeme® simultaneously restores
lost blood volume and hemoglobin levels and is designed for rapid,
massive infusion. PolyHeme® requires no cross-matching. It is
compatible with all blood types and therefore immediately available
for infusion. It has an extended shelf life in excess of 12 months.
Patient enrollment was completed in July 2006 in a landmark Phase
III, randomized, controlled open-label, multicenter, parallel group
study to evaluate the safety and efficacy of PolyHeme® when
used to treat severely injured patients in hemorrhagic shock before
they reach a hospital. Under the protocol, treatment began at the
scene of the injury or in the ambulance, and continued during transport
and a 12 hour post-injury period in the hospital.
Northfield intends to submit a BLA for PolyHeme® to FDA with
a request for Priority Review, based on the potential of PolyHeme®
to address a critical, unmet medical need.
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