COSTA MESA, Calif., May 1 /PRNewswire-FirstCall/ -- Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has filed a Cosmetic Product Ingredient Statement (CPIS) with the FDA for Dermacyte(TM) Gel, its new Oxycyte(R)-based cosmetic product. Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier.
"This voluntary filing with the FDA is a sign that we are a big step closer to bringing our first product to market," said Chris Stern, chairman and CEO of Oxygen Biotherapeutics. "This new gel, which we've named Dermacyte, is an oxygen-rich formulation of Oxycyte which we believe will promote skin health and other desirable cosmetic benefits when applied to the skin. Our gel shows amazing effects and it is just a foundation for us to morph gradually into more complex and clinical environments. It has achieved excellent test results in cytotoxicity, bacteriostasis, fungistasis, sterility and skin irritations studies. As subsequent steps, we intend to file Investigational New Drug applications with the FDA for over-the-counter drug applications both in the wound and acne sectors and go on with clinical trials as warranted."
A CPIS is a voluntary registration with the FDA recommended for a cosmetic product's commercial introduction. The acne product will be called Acnecyte(TM), and the wound product Wundecyte(TM).
"This gel is just the base of what I believe can become an extensive product line that will lead us deep into the topical sector," said Joe Tai, the newly-appointed director of Oxygen Biotherapeutics' topical division. "I dare to say that the market has not yet seen such a product."
Said Stern, "This marks another milestone in our company's development. We are now ready to shore up our efforts to enter into distribution license agreements with potential partners and emerge from a research company to a commercial enterprise."
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(R)) 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 and expectations for use of Dermacyte(TM) Gel in over-the counter cosmetic applications and other indications, Wundecyte(TM) in wound care, Acnecyte(TM) in acne as well as statements regarding distribution license agreements. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that the company will be able to license or partner Dermacyte Gel, Wundecyte, Acnecyte, or Oxycyte for any indications or that such licensees will generate profits for the company. Nor can there be any assurance that any Oxycyte-based products will reach the market. 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, Inc.|
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