Cerus’ Intercept blood system receives Swiss approval
1 September 2009
Cerus Corporation (NASDAQ:CERS) has announced that the Swiss
regulatory body, Swissmedic, has approved the use of platelet components
treated with Cerus’ Intercept Blood System. The approval extends
permitted storage time for platelets to seven days with Intercept
treatment, compared to five days without treatment.
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 have been
approved as a biologic for patient use. Cerus has previously received CE
mark approval for its Intercept platelet and plasma systems, which
allows Cerus to sell the systems in the European Union.
The Intercept platelet system has been piloted in Basel over the past
three years and also has been used in clinical studies elsewhere in
Switzerland. It is estimated that Switzerland produces approximately
20,000 platelet doses and 75,000 plasma units for transfusion annually.
The plasma system is under review by Swissmedic.
Bookmark this page