Cerus Corporation (NASDAQ:CERS) announced today that the Swiss regulatory body, Swissmedic, has approved the use of plasma components treated with Cerus' INTERCEPT Blood System.
The INTERCEPT platelet system was approved by Swissmedic in August of 2009, and is currently being implemented by the Swiss Red Cross in 12 of their 13 centers. The approval of the INTERCEPT plasma system provides Swiss blood centers the option to treat both platelets and plasma using the INTERCEPT Blood System, taking advantage of the natural synergy between the two processes. Switzerland produces approximately 30,000 platelet doses and 65,000 plasma units for transfusion annually. To date, the INTERCEPT Blood System is the only technology approved in Switzerland for pathogen inactivation treatment of platelet and plasma components on a single platform.
The regulatory review process by Swissmedic is similar to the regulatory processes in France (Afssaps) and Germany (Paul Ehrlich Institute), in which INTERCEPT-treated blood components are approved as a biologics for patient use. Cerus previously received CE mark approval for the INTERCEPT platelet and plasma systems, which allows Cerus to sell the systems in the European Union.
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