FDA upholds DrugSorb-ATR De Novo denial but offers path forward

Cytosorbents Corp

FDA appeal decision found no safety issues with DrugSorb-ATR but upheld the prior De Novo denial.
FDA proposed a potential path to market authorization; Company discussing details with the Agency.
Another appeal avenue with CDRH Director is available within 30 days; Company evaluating.
CEO states resolution of majority of outstanding issues; device remains an FDA Breakthrough Device.

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