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.
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.