Synthetic Blood to initiate trial in Mexico

US firm Synthetic Blood International has announced the execution of a letter of intent with an official from the Mexican government Institute of Social Security, the IMMS, confirming its agreement in principle to conduct a clinical study in cardiopulmonary bypass surgical procedures with Oxycyte, its proprietary perfluorocarbon therapeutic oxygen carrier and blood substitute, to support market approval in Mexico.

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 US 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-Mexico-based companies establish a partnership with a Mexican entity to conduct clinical trials and obtain product approval in the country. Synthetic Blood has identified a potential Mexican partner to obtain approval and distribute Oxycyte for use in cardiopulmonary bypass surgery in Mexico.