CytoSorbents Corporation (CTSO): Pearsby, Safety recalls of the drugs...

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Gman214

Re: A deleted message

Wednesday, 01/04/2017 1:15:32 PM

Wednesday, January 04, 2017 1:15:32 PM

Pearsby,

Safety recalls of the drugs you mentioned are immaterial and not relevant here and you know that.

It is up to you to provide links and evidence that support your claim that Cytosorbents' products are not safe.

I provide the following to support my position:

Thousands of treatments and no known safety issues have come to light that I am aware of.

CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial - a multi-center, randomized controlled study that has demonstrated the safety of intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery. In 2017, the company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval. CytoSorb® has been used safely in more than 17,000 human treatments to date.

Cytosorbents also was granted it's own reimbursement codes in Germany. This would never happen if safety issues existed.