- Trial Phase
- Approved / Commercialized
- Time to Market
- Already on the market (CE-marked in Europe, FDA-cleared in US)
- Why 4/10
- CytoSorb is already approved and commercialized with no pending FDA regulatory decision for this specific product. The next hard binary catalyst is the Nasdaq compliance deadline on September 28, 2026 (stock price must sustain above $1.00), which is a corporate listing event rather than a drug catalyst. The DrugSorb-ATR De Novo decision has no announced date. Per the rubric, an approved marketed drug with no imminent new regulatory decision scores 3-5.
Watch the September 28, 2026 Nasdaq compliance deadline — if CTSO cannot sustain $1.00 for 10 consecutive trading days before then, delisting risk becomes acute. The DrugSorb-ATR FDA De Novo submission (submitted Q1 2026) is a potential positive catalyst but has no announced decision date. The stock is a high-risk micro-cap with limited cash runway and stagnant revenue.
Price Chart
Executive Summary
CytoSorb is a hemoadsorption (blood-purification) cartridge from Cytosorbents Corp (CTSO, ~$0.35/share, ~$24M market cap) that removes inflammatory cytokines and toxins from blood in ICU and cardiac-surgery settings. It is already CE-marked in Europe and FDA-cleared in the US for certain indications, generating ~$9.6M in quarterly revenue (flat YoY). The stock faces an existential near-term binary: a Nasdaq compliance deadline of September 28, 2026, to get the share price above $1.00 or face delisting. The company is burning cash ($5.9M remaining) with a GAAP net loss of $0.07/share that missed consensus by 75%. While CEO/CFO insider purchases of ~$149K in June signal management conviction, the analyst consensus is bearish (3 hold, 1 sell, 2 strong sell), the stock is down ~64% over 12 months, and the weighted short-volume ratio is elevated at 54.4%.
How It Works
CytoSorb is a cartridge that attaches to a standard blood-dialysis or heart-lung machine. As blood flows through the cartridge, special polymer beads inside act like a sponge to soak up inflammatory cytokines, toxins, and certain drugs. This "blood purification" process is intended to reduce the dangerous whole-body inflammation seen in sepsis, severe COVID-19, and after cardiac surgery.
Trial Status
CytoSorb is CE-marked in Europe and has FDA 510(k) clearance in the US for certain indications. It is commercially available and generates revenue (~$9.6M/quarter). A related product, DrugSorb-ATR (for removing blood thinners during cardiac surgery), received FDA Breakthrough Device Designation in November 2025 and May 2026, and a De Novo submission was made in Q1 2026. No pivotal trial readout is pending for CytoSorb itself.
The Two-Sided Case
Upcoming Catalysts
- September 28, 2026: Nasdaq minimum bid price compliance deadline (stock must close above $1.00 for 10 consecutive days to avoid delisting)
- DrugSorb-ATR FDA De Novo decision (submitted Q1 2026, no announced PDUFA date)
- Q3 2026 earnings report (likely late October/November 2026)
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Cytosorbents Corp PRESS-RELEASE CTSO ·Originating report