INFORMATION ON SANGUINE'S PRODUCT -- SORRY FOR THE LONG POST
Lee
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Principal Products or Services and their Markets.
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The Company has only one product, PHER-O2, which is still in the
research and development stage. The Company's success hinges solely on the
success of this product, as to which no assurance can be given. PHER-O2 is
made up of perfluoro-decalin (a type of perfluorocarbon that is harmless to
the atmosphere), purified water and a proprietary surfactant to hold the
emulsion together. Perfluoro-decalin gives the product its oxygen carrying
ability. The surfactant is non-toxic and, being fluorinated, helps increase
PHER-O2's oxygen carrying capacity and emulsion stability. Sanguine believes
that the unique chemical nature of PHER-O2 will make it ideal for many medical
applications; each such application will be subject to the same types of
rigorous testing, clinical trials and regulatory approval process.
PHER-O2 is believed to have the following advantages over humanblood:
1. May carry three to four times the oxygen of human blood per
unit; 2. Free of HIV, hepatitis and other blood-borne disease;
3. Universal match for all blood types;
4. May be mass-produced; 5. Has a three-year shelf life;
6. May be stored at room temperature;
7. Has controllable circulatory half-life; and
8. 1/900th the size of a red blood cell.
9. PHER-O2 is a second generation drug from Fluosol-DA, the only
synthetic red blood cell approved by the Food and Drug Administration.
The Company believes that these unique qualities may make PHER-O2
ideal for blood transfusions and numerous other medical applications,
including nuclear magnetic resonance imaging, CAT scans, cardioplegia (i.e.,
the priming of heart-lung machines in open heart surgery) and treatment of
heart attacks, strokes, head and neck tumors and hemorrhagic shock. The
Company intends to fully exploit the immense worldwide market for these
applications.
Blood transfusion represents a vast market for synthetic blood. The
limited supply of donated blood is the largest constraint on the number of
transfusions given annually. If a blood substitute were widely available,
more transfusions could be given to those who desperately need them.
The Company hopes to fill this need with PHER-O2. The key
ingredients in PHER-O2 are readily available in the U.S. from many
manufacturers. When combined in the Company's proposed factory, using the
Company's proprietary emulsion process, the result will be a plentiful
alternative to donated human blood.
Another disadvantage to the use of human blood in transfusions is
the waiting period while the donor's blood is being matched to the
recipient's. Because it is believed PHER-O2 does not need to be matched to
the recipient's blood type, the use of PHER-O2 would eliminate this
potentially fatal wait.
As HIV, hepatitis and other diseases have infected the world's blood
supply, the need for an absolutely sterile blood product has become
increasingly apparent. There is currently no 100 percent effective method for
detecting blood-borne disease and sterilization of donated blood is not yet
possible. In light of these facts, PHER-O2's potential sterility makes it
especially attractive in comparison to donated blood.
PHER-O2's anticipated ability to carry up to four times the oxygen
of human blood makes it promising for many medical applications in which
increased oxygenation is vital. PHER-O2 molecules are up to 900 times smaller
than human red blood cells. The Company believes that this fact will make
PHER-O2 particularly useful for oxygenating organs through blocked arteries,
which are the primary cause of heart attack and stroke.
One of the Company's erstwhile competitors has obtained FDA approval
for the use of a similar product in angioplasty, the treatment of blocked
arteries with small inflated balloons. This application involves the
injection of the blood substitute into the artery past the inflated balloon.
As a result, the heart receives more oxygen, the treating physician can keep
the balloon inflated longer and the angioplasty is more effective than it
would otherwise be. This competitor has recently announced that it will no
longer manufacture its product, leaving Sanguine well-positioned in this
market segment. See the caption "Competition" of this Item.
Management also believes that PHER-O2 will be ideal for use in
open-heart surgery. Cardiac surgeons need an oxygen-carrying fluid that can
be used to prime the heart-lung bypass machines that are used to mechanically
pump and oxygenate heart patients' blood. This procedure is known as
"cardioplegia." Surgeons currently use saline, dextrose or hydroxyethyl
starch solutions for this purpose, but these fluids can dilute the red blood
cells in the body, and thus decrease the ability of the blood to carry oxygen.
Moreover, the risk of infection from whole blood or its derivatives makes them
undesirable for use as priming fluids. PHER-O2's significant oxygen-carrying
ability and its sterility address both of these concerns.
The treatment of head and neck tumors is another promising
application for PHER-O2. Increased oxygenation of these tumors makes them
more susceptible to the effects of chemotherapeutic drugs. Another potential
benefit of PHER-O2, though little understood, is the ability of oxygen-rich
blood to cause a tumor to produce hydrogen peroxide, which in turn tends to
shrink the tumor.
Finally, the perfluoro-decalin molecule in PHER-O2 works as a
radiopaque agent in X-ray imaging and as a contrast agent in nuclear magnetic
resonance (NMR) imaging and CAT scans. However, unlike many
currently-available imaging agents, PHER-O2 has no known side effects. |
