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| > medical applications | additional applications | ||
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| PHER O2 is
a second-generation formulation of the perfluorocarbon (PFC) emulsion, Fluosol, a product
developed, FDA approved and marketed under the direction of Dr. Thomas Drees, current
Chairman and CEO of Sanguine. As a second generation PFC, PHER O2 was designed to overcome
some of the deficiencies of the original Fluosol product; i.e., need for frozen storage,
low (20%) PFC content and short intra-vascular residency time. Fluosol was chemically
derived and is a combination of the carbohydrate decalin (C10 H18) that replaces the
hydrogen atoms with flourine atoms, resulting in a fluorocarbon. It is the pioneering PFC
in the field of synthetic substitutes for blood. Although refuted by the U. S. Food and
Drug Administration (FDA) as a blood substitute, it remains the first and only blood
substitute approved to date by the FDA for medical use in connection with blood
supplementation. The U.S.FDA and eight other countries approved Fluosol for use in cardiac
angioplasty to “reduce the amount of allogeneic blood units transfused.” After
FDA approval, Fluosol was welcomed by surgeons and successfully used for angioplasties; in
addition, it was found to be useful in other “off label” applications. Approximately 50% of the cases involving Fluosol use was in such “off label” applications. In the three years of its widest use, Fluosol was transfused into approximately 15,000 human patients each year. Because of the non-medical difficulties associated with Fluosol use (frozen storage and consequent need for adaptation to human temperature), its popularity declined and its production ended. Dr. Drees, Chairman and CEO of Sanguine, convinced of the value of perfluorocarbon blood supplementation, was determined to develop and produce a second generation PFC product. He therefore organized Sanguine Corporation to conduct the Research and Development to perfect an improved PFC blood supplement, which he named PHER O2. In the years since the PHER O2 |
concept
was first advanced, PFCs have become very much in the forefront of blood substitute
activity. One other new formulation is currently being retested. For Sanguine, therefore,
it may be advantageous to skip the second generation of PFC formulations (now in repeated
tests and evaluation by a number one company), and proceed directly to a more advanced,
third generation formulation. A number of PFC articles in recent technical journals have
addressed the subject of blood substitutes, such as one published in October 1999, which
states:
“Perfluorocarbons are a promising new class of molecules without direct toxicity, and possessing interesting properties on the respiratory gasses as well as on the other inert gasses. Their principal indications are related to their oxygen carrying capacity.”
PFCs are frequently referred to as “blood substitutes” or “synthetic blood.” This is technically incorrect, since they are intended only to supplement the oxygen-conveying red blood cells.They do not replace, enhance, or supplement the coagulation or immunity capabilities of blood, and therefore are more accurately described as oxygen carriers or blood supplements. Modern transfusion is only red cells, whose main function is oxygination. PHER-O2 does not need to be typed and cross matched, has a long shelf life, no risk of AIDS, Hepatitis, nor mad cow disease. PHER-O2 is designed to carry more oxygen than blood and to be much smaller than a red blood cell. It should be useful in transfusions, heart attack, stroke cancer and many other hypoxic and ischemic diseases, such as burns, shock, eye surgery, transplant organ perfusion, sickle cell anemia and many others... read more about the |
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