Cerus Corporation (NASDAQ:CERS) has announced that the US FDA has approved the INTERCEPT Blood System for Cryoprecipitation.The system is vital in the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex in treating and controlling bleeding including fibrinogen deficiency associated with massive hemorrhage.
The system improves hemorrhage treatment
Pathogen Reduced Cryoprecipitated Fibrinogen Complex will remain transfusion ready for five days at room temperature after thawing. Most importantly it remains available for administration over an extended period. The product received FDA Breakthrough Device designation because of its potential to improve massive hemorrhage treatment.
William ‘Obi’ Greenman, the company’s CEO, said that the approval of the INTERCEPT Blood System for Cryoprecipitation is a huge milestone in establishing pathogen reduction as a transfused blood components standard of care globally. He said that this is a significant win for patients, clinicians, and hospitals which also represents a new business model for the company. Greenman said that the company will start selling the Pathogen Reduced Crypopreciptiated Fibrinogen Complex in Texas, California, Wisconsin, and Louisiana in 2021. The company will expand distribution nationwide in 2022 after expected manufacturing site Biologics Licences Applications approval.
INTERCEPT Blood System for Cryopreciptoation supports other indications
Besides treating and controlling massive bleeding, the product has been indicated for bleeding control there is no recombinant or specific virally inactivated factor XII preparation sot von Willebrand factor. It can also be used as a von Willebrand disease second-line therapy and in controlling uremic bleeding where other treatment modalities don’t work.
Dr. Philip Spinella, Paediatrics Professor and Critical Care Blood Research Program Director at Washington University, said that fibrinogen is vital in controlling bleeding. However, it has been difficult to provide it quickly for patients that experience massive bleeding. Spinella said that Pathogen Reduced Cryoprecipitated Fibrinogen Complex offers extended shelf life at room temperature after thawing allowing preparation. This is vital because immediate availability will enhance coagulopathy reversal time. Spinella added that he is optimistic that the product will be a valuable addition to therapies necessary in supporting damage control resuscitation for patients experiencing life-threatening bleeding.