-- New Label Claim Expands the Market for Cerus' INTERCEPT Blood
System in the United States--
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS), a biomedical products company focused
on improving blood transfusion safety, today announced U.S. Food and
Drug Administration (FDA) approval of the INTERCEPT Blood System for
treatment of platelets suspended in 100% plasma. This extended label
claim further enhances compatibility with commonly used platelet
collection methods.
The INTERCEPT Blood System was initially approved by the FDA in December
2014 for treatment of platelets collected in a commercially available
platelet additive solution, InterSol. Use of InterSol is already
widespread in Europe; in the U.S., platelet additive solutions have been
approved more recently and are still being introduced into blood center
and hospital operations.
“This additional approval demonstrates further progress toward optimal
collection platform compatibility, as we have had in Europe for a number
of years. The label claim expansion will be valuable for blood centers
as they consider how to address the revised draft guidance document for
bacterial safety standards just issued this week by the FDA, as well as
the proposed revised standards set forth in the Code of Federal
Regulations,” said William ‘Obi’ Greenman, Cerus’ president and chief
executive officer. “A significant number of our customers have been
waiting for this approval in order to begin their implementation process
for INTERCEPT platelets. We look forward to working with these centers
in the coming months to make INTERCEPT platelets more widely available
to U.S. hospitals.”
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood transfusion safety. The INTERCEPT Blood System is designed to
reduce the risk of transfusion-transmitted infections by inactivating a
broad range of pathogens such as viruses, bacteria and parasites that
may be present in donated blood. The nucleic acid targeting mechanism of
action of the INTERCEPT treatment is designed to inactivate established
transfusion threats, such as Hepatitis B and C, HIV, West Nile Virus and
bacteria, as well as emerging pathogens such as chikungunya, malaria and
dengue. Cerus currently markets and sells the INTERCEPT Blood System for
both platelets and plasma in the United States, Europe, the Commonwealth
of Independent States, the Middle East and selected countries in other
regions around the world. The INTERCEPT red blood cell system is in
clinical development. See http://www.cerus.com
for information about Cerus.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.
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Source: Cerus Corporation