Healthcare Industry News: BD
News Release - June 19, 2006
Synthetic Blood Receives Letter of Intent to Initiate Oxycyte Cardiopulmonary Bypass Surgery Registration Trial in MexicoCOSTA MESA, Calif.--(HSMN NewsFeed)--June 19, 2006--Synthetic Blood International, Inc. (OTCBB:SYBD ) today announced execution of a letter of intent with an official from the Mexican government Institute of Social Security (IMMS) confirming its agreement in principle to conduct a clinical study in cardiopulmonary bypass surgical procedures with Oxycyte(TM) to support market approval in Mexico. Oxycyte(TM) is Synthetic Blood's proprietary perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
This agreement calls for Synthetic Blood to work with the IMMS, through a Mexican partner, in conducting a 50-patient cardiopulmonary bypass surgery registration trial, including providing Oxycyte and overseeing a U.S. clinical research organization that will monitor the study. The IMMS will oversee the clinical study and prepare the required documentation for the application submission to the Mexican Ministry of Health. The IMMS has also indicated interest in exploring Oxycyte applications in additional medical procedures, including trauma and ischemia. Synthetic Blood is responsible for obtaining funding for the trial. No sources of funding have been identified yet.
The Mexican government requires that non-Mexican based companies establish a partnership with a Mexican entity to conduct clinical trials and obtain product approval in Mexico. Synthetic Blood has identified a potential Mexican partner to obtain approval and distribute Oxycyte for use in cardiopulmonary bypass surgery in Mexico.
"We are honored to have reached this agreement with the IMMS, which is recognized as Mexico's best public health services provider. IMMS is a leader in that country's medical research and the largest national institution for training and educating physicians," said Robert W. Nicora, Synthetic Blood President and CEO. "This clinical trial will be the first Oxycyte study in cardiopulmonary bypass surgery patients."
A first-generation PFC blood substitute manufactured in Russia, Perftoran, is currently approved for use in Mexico. Synthetic Blood believes that its third-generation PFC Oxycyte offers significant advantages over Perftoran, including superior safety, oxygen delivery and efficacy. The Company is reviewing key elements of the Perftoran cardiopulmonary bypass protocol in developing its protocol for the planned Oxycyte study. Synthetic Blood may also request input from the U.S. Food and Drug Administration (FDA) prior to protocol submission to the IMMS.
The Oxycyte trial in cardiopulmonary bypass surgical procedures is expected to be conducted at two large hospitals in Mexico City. Clinical endpoints for this trial will include safety, oxygen delivery, maintenance of good hemodynamics and avoidance of packed red cell administration.
"Obtaining market approval in Mexico could open significant commercial opportunities for Oxycyte in the future," Mr. Nicora added. "Approval in Mexico could also serve as the basis for Oxycyte registration in other Central and South American countries without the need for additional clinical trials."
About Synthetic Blood International
Synthetic Blood International 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 blood substitute, a liquid ventilation product and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for perfluorocarbons, 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.sybd.com.
Safe Harbor Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking information made on the Company's behalf. All statements, other than statements of historical facts which address the Company's expectations of sources of capital or which express the Company's expectation for the future with respect to financial performance or operating strategies, can be identified as forward-looking statements. Such statements made by the Company are based on knowledge of the environment in which it operates, but because of the factors previously listed, as well as other factors beyond the control of the Company, actual results may differ materially from the expectations expressed in the forward-looking statements.
Source: Synthetic Blood International
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