CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (Nasdaq:CERS) announced today that the U.S. Food and
Drug Administration (FDA) has granted Breakthrough Device designation
for the Company’s pathogen-reduced cryoprecipitate product candidate.
The basis of the designation is improved treatment of massive
hemorrhage, a life-threatening medical condition.
"The proposed label indication for pathogen-reduced cryoprecipitate
would be to control massive bleeding associated with fibrinogen
deficiency,” said Dr. Laurence Corash, Cerus’ chief scientific officer.
“We are eager to work with the FDA throughout this process to
potentially accelerate the regulatory review process for
pathogen-reduced cryoprecipitate."
The Breakthrough Device Program was created in response to the 21st
Century Cures Acts. Regulatory submissions for devices designated as
Breakthrough Devices receive priority review status and the FDA works
with the sponsor to expedite the review and approval process. According
to the FDA, Breakthrough designation is granted for devices “that
provide more effective treatment or diagnosis of life-threatening or
irreversibly debilitating human disease or conditions.”
“This designation reaffirms and validates our belief that
pathogen-reduced cryoprecipitate addresses a clear, unmet clinical
need,” said William ‘Obi’ Greenman, president and chief executive
officer of Cerus. “Control of massive bleeding is a significant
challenge in U.S. hospitals today, especially for patients with
traumatic injury or maternal hemorrhage, which are among the leading
causes of death in the U.S. for patients under the age of 45.
Pathogen-reduced cryoprecipitate is being developed to potentially
confer important features, such as an extended thawed shelf-life and
improved product standardization, which could markedly improve the time
it takes physicians to control bleeding in these patients."
Cryoprecipitate or cryo, a concentrate of cold insoluble high molecular
weight plasma proteins, is made when frozen plasma is slowly thawed. It
is rich in clotting factors such as fibrinogen, Factor VIII and Factor
XIII. Conventional cryo is stored frozen and must be used within four to
six hours after thawing or be discarded. Cryoprecipitate use has been
increasing in the U.S. based on advances in trauma learned from the
military and the broader utilization of coagulation monitoring in
hospitals to diagnose coagulopathy and associated fibrinogen deficiency.
The proposed shelf-life for the Breakthrough Device designation is
5-days at room temperature and that could enable greater availability of
cryoprecipitate and facilitate ease of use.
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 the INTERCEPT Blood System are trademarks of Cerus
Corporation.
Forward Looking Statements
Except for the historical statements contained herein, this press
release contains forward-looking statements concerning Cerus’ planned
PMA supplement for extended storage pathogen-reduced cryoprecipitate;
the impact of Breakthrough Device designation on the timing of
regulatory review and approval; anticipated regulatory approval of
INTERCEPT-treated cryoprecipitate, and the potential claims thereof; and
other statements that are not historical facts. Actual results could
differ materially from these forward-looking statements as a result of
certain factors, including, without limitation, risks associated with:
the uncertain and time-consuming development and regulatory process,
including with respect to the label claims ultimately approved for
INTERCEPT-treated cryoprecipitate; that Cerus may be unable to submit
its planned PMA supplement to the FDA for INTERCEPT-treated
cryoprecipitate from plasma on the anticipated timeframe or at all, and
even if submitted, Cerus may be unable to obtain FDA approval, or any
other regulatory approvals, of INTERCEPT-treated cryoprecipitate in a
timely manner or at all; that applicable regulatory authorities may
disagree with Cerus‘ interpretations of the data from its clinical
studies and/or may otherwise determine not to approve Cerus’ regulatory
submissions in a timely manner or at all, as well as other risks
detailed in Cerus’ filings with the Securities and Exchange Commission,
including Cerus’ Quarterly Report on Form 10-Q for the quarter ended
June 30, 2018, filed with the SEC on August 2, 2018. Cerus disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release.
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https://www.businesswire.com/news/home/20181031005267/en/
Cerus Corporation
Tim Lee, 925-288-6137
Investor Relations
Director
Source: Cerus Corporation