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SAN FRANCISCO, Dec. 28, 2017 -- 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
About Streetwise Reports – The Life Sciences Report
Investors rely on The Life Sciences Report to share investment ideas for the biotech, pharmaceutical, medical device, and diagnostics industries. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
DISCLOSURES:
The following company mentioned in this article is a sponsor of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclosures about sponsor fees. The following company paid Streetwise Reports to issue a press release on their behalf relating to this article: CytoSorbents Corp. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
Please see the end of the article for the complete disclosures: Immunotherapy Firm Gets Green Light for Pivotal Trial From FDA
Contact Information: Carrie Beal Amaro- Publisher ([email protected])
