Synthetic Blood International Announces Phase II Protocol Submission
COSTA MESA, Calif.--(BUSINESS WIRE)--Sept. 7, 2004--Synthetic Blood International, Inc. (OTCBB:SYBD), announced today that it has submitted the first of a series of Phase II clinical trial protocols for Oxycyte(TM) to the Food and Drug Administration (FDA). Oxycyte is the company's perfluorocarbon (PFC) based blood substitute and therapeutic oxygen carrier. The company also submitted the final Phase I safety study report for Oxycyte.
Enrollment in this first Phase II trial is expected to begin this month, assuming the required institutional review board approvals are obtained. This study will involve orthopedic surgery patients who experience mild to moderate blood loss during surgery. While blood transfusions are usually not required in these cases, the amount of blood loss may result in post-operative complications caused by tissue hypoxia (loss of oxygen). This study will focus on using Oxycyte to prevent tissue hypoxia.
"We are pleased to have reached this important milestone on our way to the start of Phase II clinical trials," said Robert Nicora, SYBD President. "We are especially excited at the prospect of showing that Oxycyte may improve the care and outcome for these patients by carrying and offloading oxygen to the tissues to prevent hypoxia. This could reflect itself in a shorter hospital stay, which we believe would be enthusiastically received by both patients and the medical community."
The company is traded under the symbol SYBD on the OTC Electronic Bulletin Board. SYBD is headquartered in Costa Mesa, Calif. The Company's website is www.sybd.com.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
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