CytoSorbents Corporation (CTSO)

[TwoNE1]

That said, we recently just met again with the Agency and believe that we are now aligned on the positive benefit-risk profile of the therapy and the additional clinical data needed to support approval.
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There is another point that makes U.S. FDA Breakthrough Designation even more meaningful. Last month, the Centers for Medicare & Medicaid Services (CMS) announced the Medicare Coverage of Innovative Technology pathway that will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough medical devices, where coverage would last 4 years. This program is expected to speed adoption of CytoSorb, if approved, across the U.S. for this application.