Rich Here is a couple of answers to your questions, taken from press release.
1. Universal Compatibility: Because the cell tissue is removed from the solution, no typing or cross-matching is required, eliminating transfusion reactions and making PolyHeme a universal donor solution.
2. Extended Shelf Life: While human blood has a useful shelf life of 28-42 days, PolyHeme has a shelf life in excess of 12 months.
In 1996, Northfield Labs completed the first prospective, randomized, large volume Phase II trauma trial, directly comparing the use of a blood substitute to blood. After having transfused patients at dosages up to six units of PolyHeme, Northfield received FDA clearance to conduct an additional Phase II trauma study at dosages up to ten units.
Later in the year, the company entered into an agreement with Hemerica, Inc., a subsidiary of Blood Centers of America, under which Hemerica would supply Northfield with 82,500 units per year of packed red cells, the source material for PolyHeme, at a price of $26 per unit, over a three-year period.
In addition, Northfield and Hemerica agreed to a joint effort to increase the amount of raw material available in excess of the contracted amount. It requires approximately two units of red cells to create one unit of PolyHeme, according to the company. Outdated red cells, unfit for transfusion, can be used as a raw material for PolyHeme, however, giving these cells a ''second life'' as a transfusion medium.
Looks like Hemerica will supply 27,500 units per year over the next 3 years, (they will try and get more). So if you take one half of 27,500(takes 2 units of blood to make one unit of Northfield product) = 13,750 units that Northfield can make per year. 13,750 units times $450 per unit = $6,187,000 per year in sales, unles they can get get more outdated blood.
Currently, the company is completing plans for a commercial-scale production facility with a capacity of approximately 300,000 units of PolyHeme. That would generate 135 milion in sales, assuming this is a yearly figure.
To do this they would need 600,000 units of blood, approximately 20 times more than Hermica on average is supplying. Do not know where it will come from.
Don't forget there is 60million transfusions done per year in the world, average transfusion takes 2 units. So there is a need for 120million units per year. At $300.00
per unit that comes to 36BILLION dollars. I think there is room for more than one company in this market.
All in all I think this is positive for the industry, because there has been so many failures in other companys, it is nice to see something positive for a change and bring more awareness to this critical needed technology.
R>G>
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