{"filing":{"accession_number":"0001104659-26-077584","cik":"0001175151","ticker":"CTSO","company_name":"Cytosorbents Corp","form":"8-K","filing_date":"2026-06-25","report_date":null,"primary_document":"tm2618977d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1175151/000110465926077584/tm2618977d1_8k.htm"},"events":[{"id":13779,"run_id":12240,"accession_number":"0001104659-26-077584","anchor_item_number":"7.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"CytoSorbents disclosed that it has scheduled two pre-submission meetings with the FDA in August 2026 to discuss its ticagrelor and DOAC programs, presented at the Life Sciences Forum on June 24, 2026. This is a material operational and regulatory milestone for a medical device company pursuing FDA approval of investigational products (DrugSorb-ATR). The pre-submission meetings represent a significant step in the regulatory pathway toward potential U.S. market approval, which would materially affect the company's future revenue prospects and strategic direction.","company_name":"Cytosorbents Corp","ticker":"CTSO","filing_date":"2026-06-25","form":"8-K","submitted_at":null,"items":[{"id":11018,"accession_number":"0001104659-26-077584","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"CytoSorbents disclosed that it has scheduled two pre-submission meetings with the FDA in August 2026 to discuss its ticagrelor and DOAC programs, presented at the Life Sciences Forum on June 24, 2026. This is a material operational and regulatory milestone for a medical device company pursuing FDA approval of investigational products (DrugSorb-ATR). The pre-submission meetings represent a significant step in the regulatory pathway toward potential U.S. market approval, which would materially affect the company's future revenue prospects and strategic direction.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-25T13:28:37.666165+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":11018,"accession_number":"0001104659-26-077584","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"CytoSorbents disclosed that it has scheduled two pre-submission meetings with the FDA in August 2026 to discuss its ticagrelor and DOAC programs, presented at the Life Sciences Forum on June 24, 2026. This is a material operational and regulatory milestone for a medical device company pursuing FDA approval of investigational products (DrugSorb-ATR). The pre-submission meetings represent a significant step in the regulatory pathway toward potential U.S. market approval, which would materially affect the company's future revenue prospects and strategic direction.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-25T13:28:37.666165+00:00","company_name":"Cytosorbents Corp","ticker":"CTSO","filing_date":"2026-06-25"}]}