Healthcare Industry News: perfluorocarbon
News Release - August 12, 2008
Oxygen Biotherapeutics Develops Gel Version of Oxycyte(R) for Treating Surface WoundsCOSTA MESA, Calif.--(HSMN NewsFeed)--Oxygen Biotherapeutics, Inc. (OTCBB:OXBO ) today announced that the company has developed a gel-like form of Oxycyte® that it intends to investigate as a topical application for open wounds, abrasions and burns. Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
The innovation is based on technologies in-licensed earlier this year from Virginia Commonwealth University. In combination with a hydrogen peroxide pouch, researchers believe the compound could have superior abilities to deliver a high concentration of oxygen directly to the wounded tissue. The combination of Oxycyte gel and H2O2 is believed to be the key to its possible efficacy. The company intends to submit to the FDA a protocol for a proposed clinical investigation before the end of the calendar year.
“Unlike the intravenous drug application of Oxycyte in traumatic brain injury, this would be a topical application, applied to the skin or to the surface of wounds. So we’re hopeful that the clinical review process would be as a medical device, which can be shorter and faster than review as a drug,” said company chairman and CEO Chris J. Stern, DBA. “If the safety/efficacy cycle is indeed shorter, as I believe it can be, then it suggests that substantive partnering models could be launched shortly after safety and efficacy are proven. Sales of ointments, dressings, bandages, etc are counted in the high billions of dollars each year. I think that every one of these products could prove to be a candidate to carry a form of Oxycyte.
“While I’m excited about this new potential use for Oxycyte, I know that the big question on our shareholders’ minds right now is the status of our Phase IIb protocol for Oxycyte in TBI. We’re not going to get into the details of our communications with the FDA. That would not be in the best interests of the company or the process. I’ll just say that positive communications are continuing and that when there is news, we’ll announce it,” said Stern.
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 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 acute respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes. For further information, visit 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 references to potential wound care applications of Oxycyte in treating open wounds, abrasions and burns and to expectations that the FDA will allow clinical trials and reviews to be conducted as a medical device rather than a drug. Forward-looking statements in this release also include those that suggest markets in which a wound care version of Oxycyte could be used and estimates of the cumulative size of those markets. Actual events or results may differ from the company's expectations. There can be no assurance that the FDA will approve a protocol to conduct clinical trials for these applications, that it will allow testing and review as a medical device, and that if conducted, any clinical trials will be successful or that the FDA will approve use of Oxycyte in any formulation in the uses described in this release. Furthermore, there can be no assurance that if the FDA does approve such uses that the product will compete successfully or that sales at any meaningful levels will be reached. There can be no assurance also that the company will be able to reach or launch any partnering agreements to develop and/or market these applications of Oxycyte. 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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