Therapy Areas: Cardiovascular
CytoSorbents' REFRESH 2-AKI Protocol revisions wins US FDA's approval
5 September 2018 -

Immunotherapy company CytoSorbents Corporation (NASDAQ:CTSO) reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for the REFRESH 2-AKI CytoSorb trial protocol amendment to improve patient enrolment as well as trial site screening process.

The company's pivotal REFRESH 2-AKI trial is a multi-centre, randomized controlled, clinical trial intended to support US regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb has been used in more than 46,000 human treatments to date.

Based on the recommendations of key clinical advisors, the changes were back-tested against patient screening logs and were designed to facilitate enrollment and broaden the applicable market for CytoSorb. The US FDA approved amendment has now been distributed to nine active clinical trial sites, seven additional sites nearing budget and contract finalization and nine additional sites completing start-up activities, awaiting individual ethics committee review, added the company.

According to the company, CytoSorb is an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses.

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