Cerus Receives FDA Breakthrough Device Designation for Pathogen-Reduced Cryoprecipitate

- October 31st, 2018

Cerus (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. As quoted in the press release: “The proposed label indication for pathogen-reduced cryoprecipitate would be to … Continued

Cerus (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.

As quoted in the press release:

“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 21stCentury 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.”

Click here to read the full press release.

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