SAN FRANCISCO, Dec. 28, 2017 (GLOBE NEWSWIRE) -- Jason Kolbert, an analyst with Maxim Group, described the study, which enables this biotech's device to be used in patients undergoing heart surgery and will measure its effectiveness in reducing a common post-surgical side effect.
Included in this article is: CytoSorbents Corp. (NASDAQ:CTSO)
A Dec. 21 Maxim Group research report indicated the FDA has approved CytoSorbents Corp.'s investigational device exemption application (IDE) to conduct its REFRESH 2 trial. This milestone represents "a critical point for the company," noted analyst Jason Kolbert. "The trial by its nature (IDE) is 'pivotal,' designed to support the use of CytoSorb in cardiac surgery."
Kolbert explained that during surgery, CytoSorb can "capture and broadly reduce different kinds of cytokines and other inflammatory mediators that drive inflammation."
Now having a green light, REFRESH 2 in the United States should start soon, wrote Kolbert. Randomized, controlled and involving multiple centers, the trial aims to determine the effectiveness of CytoSorb blood treatment in reducing acute kidney injury following cardiac surgery, a common adverse side effect.
Continue reading this article: Immunotherapy Firm Gets Green Light for Pivotal Trial From FDA
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Please see the end of the article for the complete disclosures: Immunotherapy Firm Gets Green Light for Pivotal Trial From FDA