Cerus Submits the Medical Device License Application to Health Canada for
CONCORD, Calif. -- April 7, 2014
Cerus Corporation (NASDAQ: CERS) announcedtoday that it has submitted its
Medical Device license application to Health Canada for review of the
INTERCEPT Blood system for plasma. This follows an agreement reached with
Health Canada in November of last year to pursue regulatory submissions for
both INTERCEPT platelets and plasma. Cerus plans to file its regulatory
submission for platelets in the second quarter of 2014.
“The parallel regulatory submissions in the US and Canada have enabled us to
be efficient in our filings by leveraging common elements in both submissions,
including the existing dossier of clinical and routine use data accumulated
over ten years in Europe,” said Carol Moore, Cerus’ senior vice president of
regulatory, quality and clinical affairs. “We are excited about our continued
regulatory progress in North America, and look forward to the subsequent
regulatory filing for INTERCEPT platelets to Health Canada.”
Canada is supported by two blood services, Hema Quebec for the province of
Quebec and Canadian Blood Services for the remainder of the country. Hema
Quebec and Canadian Blood Services produce approximately 55,000 and 70,000
units of plasma for transfusion per year, respectively.
Cerus Corporation is a biomedical products company focused in the field of
blood safety. Cerus currently markets and sells the INTERCEPT Blood System for
both platelets and plasma in Europe, the Commonwealth of Independent States,
the Middle East and selected countries in other regions around the world. In
the United States, Cerus is seeking regulatory approval of the INTERCEPT Blood
System for plasma and platelets. The INTERCEPT red blood cell system is in
See http://www.cerus.com for more information.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
This press release contains forward-looking statements. Any statements
contained in this press release that are not statements of historical fact may
be deemed to be forward-looking statements, including, without limitation,
statements relating to the regulatory submission to Health Canada for
INTERCEPT platelets, including the timing thereof. These forward-looking
statements are based upon Cerus’ current expectations. Actual results could
differ materially from these forward-looking statements as a result of certain
factors, including, without limitation, risks related to the uncertain and
time-consuming regulatory process, the fact that Cerus may encounter
unanticipated difficulties complying with the regulatory requirements for a
Canadian product approval, the fact that Cerus may not have the resources to
support multiple regulatory submissions, and other risks detailed in the
Cerus' filings with the Securities and Exchange Commission (SEC), including in
Cerus' annual report on Form 10-K for the quarter ended December 31, 2013,
filed with the SEC on March 7, 2014. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Cerus does not undertake any obligation to update any
forward-looking statements as a result of new information, future events,
changed assumptions or otherwise.
Lainie Corten, 925-288-6319
Sr Director, Global Marketing & Investor Relations
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