secwatch.observer — SEC 8-K summary
======================================

Issuer:     Cytosorbents Corp (CTSO)
CIK:        0001175151
Form:       8-K
Filed at:   2025-09-16T23:59:59+00:00
Accession:  0000929638-25-003494
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CytoSorbents to file new DrugSorb-ATR De Novo application after FDA appeal upholds denial but offers expedited path
--------------------------------------------------------------------------------

- FDA appeal upheld prior De Novo denial for DrugSorb-ATR, citing need for additional label-indication data; no safety issues found.
- Company will file new De Novo application with new real-world data; expects expedited review under Breakthrough Device designation.
- Pre-submission meeting request to FDA next month; formal meeting anticipated in Q4 2025; standard decision expected mid-2026.
- Withdrew Health Canada Request for Reconsideration; will submit new application after FDA clarity.
- Management focuses on core business growth, cost control, and near breakeven by end of 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1175151/000092963825003494/0000929638-25-003494-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1175151/000092963825003494/a8k.htm
  HTML page:      https://secwatch.observer/filing/0000929638-25-003494

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer