Healthcare Industry News: sickle cell
News Release - March 17, 2009
Oxygen Biotherapeutics, Inc. to Launch Product Line of Oxycyte(R) Gels for the Over-the-Counter Market
COSTA MESA, Calif.--(HSMN NewsFeed)--Oxygen Biotherapeutics, Inc. (OTCBB:OXBO ) today announced that the company will move ahead with a line of gels based on Oxycyte®. The first and most basic gel based on Oxycyte will be formulated to enhance its topical cosmetic properties. Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier.The company intends to market the first Oxycyte Gel as a cosmetic which provides a moist, oxygen-rich environment for the skin. No therapeutic claim for healing will be made for this baseline, cosmetically-formulated Oxycyte Gel.
“Our first product is now very close to market readiness,” said Chris J. Stern, company chairman and CEO. “The regulatory process for such products is uncomplicated and straightforward. Laboratory testing of the cosmetic formulation should be completed in the second quarter along with the packaging design. We are now ready to start the processes of identifying and signing license and distribution partners. The progress we’re making with the topical gel should give us good momentum to launch our more complex over-the-counter product initiatives.”
Simultaneously, the company is pushing development of the second OTC product, which will be designated as a topical, therapeutic, non-prescription drug intended to provide a moist, oxygen-rich environment to promote healing of minor skin wounds. While it will require safety and clinical testing, the pre-IND (Investigational New Drug) process has already been initiated, and a detailed critical path will be decided after the pre-IND exchange with the FDA. “We should have the best of both worlds, a fast-track marketable product and, in its footsteps, a highly effective wound treatment with superb potential,” Stern stated further. “We will be working towards exploring this further and, with a third product line, try to reach deep into the highly profitable surgical environment.”
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. More information is available at www.oxybiomed.com.
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 plans for the development and marketing of an Oxycyte-based gel as an over-the-counter topical cosmetic and for other over-the-counter uses as a drug. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that the product will be ready for licensing or market in the estimated time frame, that FDA will give final approval to the marketing of the product in any use or form, or that any other company will be interested in licensing or distributing any Oxycyte-based product in the over-the-counter markets. 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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