Cerus Corporation Announces FDA Approval for INTERCEPT Blood System for Cryoprecipitation

Cerus Corporation (Nasdaq: CERS) today announced that the US Food and Drug Administration (FDA) has granted approval of the INTERCEPT Blood System for Cryoprecipitation. The system is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.

After thawing, Pathogen Reduced Cryoprecipitated Fibrinogen Complex remains transfusion-ready at room temperature for up to 5 days, continuously available for administration over this extended period. This product has been granted FDA Breakthrough Device designation based on the potential to improve treatment of massive hemorrhage, a life-threatening medical condition.

“FDA approval of the INTERCEPT Blood System for Cryoprecipitation is an important step forward in our mission to establish pathogen reduction as the standard of care for transfused blood components globally,” said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. “This is an important win for hospitals, clinicians and patients and also represents a new business model for Cerus. We plan to begin selling Pathogen Reduced Cryoprecipitated Fibrinogen Complex in California, Texas, Louisiana and Wisconsin in 2021, with expansion to national distribution in 2022 following anticipated approval of manufacturing site Biologics License Applications.”

In addition to use for treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex is also indicated for control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor are not available, for second-line therapy for von Willebrand disease, and for control of uremic bleeding after other treatment modalities have failed.

“Fibrinogen plays a critical role in controlling bleeding, but it has been difficult to provide quickly to massively bleeding patients. The extended room temperature shelf life, after thawing, of pathogen reduced cryoprecipitated fibrinogen complex allows it to be prepared in advance, which is essential because immediate availability will improve time to reversal of coagulopathy,” said Dr. Philip C. Spinella, Professor of Pediatrics and Director of the Critical Care Blood Research Program at Washington University in St. Louis. “I am optimistic that pathogen reduced cryoprecipitated fibrinogen complex will be a valuable tool to add to the tool box of therapies that are needed to support damage control resuscitation for patients with life threatening bleeding.”