NSPR

InspireMD just cleared the gate that mattered — CGuard Prime won FDA PMA on June 23, 2025 and is now selling in the US through a direct salesforce, on top of CGuard EPS in 30+ countries. Revenue is compounding off a tiny base ($4.5M in FY2021 to $8.98M in FY2025, +28.1% last year) and gross margin is expanding fast (gross profit +75.9%, margin now 29.5%). The balance sheet looks superficially clean: liabilities/equity just 0.26x and only ~$3.8M of debt. On the surface, a de-risked device with a maiden US launch.

The filing dismantles that optimism. Management explicitly flags 'substantial doubt regarding our ability to continue as a going concern,' and the cash math is why: $8.94M of cash (down 52.7% YoY) against operating cash flow of -$35.1M. That is roughly three months of runway at the FY2025 burn rate. The net loss widened to -$48.8M (from -$32.0M) while revenue added under $2M — this business consumes ~$5–6 of cash for every $1 of revenue (operating margin -552.6%). The 'clean' equity is an accounting artifact of serial equity raises, not earned capital: accumulated deficit is -$302M.