Healthcare Industry News: sickle cell
News Release - January 27, 2009
Oxygen Biotherapeutics, Inc. Submits Request for Designation to FDA for Oxycyte(R)-based Wound Care Product
COSTA MESA, Calif.--(HSMN NewsFeed)--Oxygen Biotherapeutics, Inc. (OTCBB:OXBO ) today announced that the company has submitted a preliminary Request For Designation (RFD) to the FDA for its first wound care product. The RFD submission is part of a process with the FDA for determining which agency component will have primary jurisdiction for a drug, device or biological product.The product is Oxycyte® Gel in a single-dose packaging delivered as an ointment onto wounds and is protected by a standard bandage. The gel has a substantially higher oxygen permeability than most wound ointments currently on the market. Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier.
“Oxycyte Gel has wonderful capabilities and is a breakthrough product for the treatment of a large variety of wounds ranging from simple abrasions and minor burns to more complex, non-healing, chronic wounds,” says Bob Diegelmann, Ph.D., Professor of Biochemistry and Molecular Biology at Virginia Commonwealth University and advisor to Oxygen Biotherapeutics, Inc. “This first product is very simple, yet is a solid first step in a broad line of over-the-counter wound care products that employ the Oxycyte technology.”
Says the company’s Chairman and CEO, Chris Stern, “Biomedical companies should not just depend on one product area. This is part of our plan to apply Oxycyte broadly to multiple products for a range of indications. Our new wound product line is coming along just fine and actually is ahead of schedule. I am very proud of our researchers who have brought this new product line to the point where I believe it has the potential of generating ongoing revenues for the company in the not too distant future.”
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring. The Company has under development a perfluorocarbon therapeutic oxygen carrier and liquid ventilation product (Oxycyte®) and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for PFCs and medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including traumatic brain injury, sickle cell crisis pain, trauma, wound care, acute respiratory distress syndrome, stroke, myocardial infarction, surgery, and diabetes.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by Oxygen Biotherapeutics, Inc. that involve risks and uncertainties and reflect the company's judgment as of the date of this release. These statements include those referring to wound care products using Oxycyte. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that the FDA will respond positively to the company’s RFD submission. Nor can there be any assurance that Oxycyte in a wound care formulation or any company product will be approved for market for any indications or that such products will generate any revenues for the company. Additional information concerning these and other risk factors affecting Oxygen Biotherapeutics, Inc.'s business can be found in the company's public periodic filings with the Securities and Exchange Commission, which are available via www.oxybiomed.com. Oxygen Biotherapeutics, Inc. disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Source: Oxygen Biotherapeutics
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