InspireMD launches CGuard Prime in U.S. after FDA approval; revenue up 28% but loss widens 52%

Filed March 18, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 12, 2025 · ~2 min read

Key Changes

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  FDA approved CGuard Prime in June 2025; U.S. commercial launch began July 2025 through direct salesforce. Approval milestone triggered $16.9M from warrant exercises; August 2025 private placement raised additional $37M net.

  Business: FDA approval; MD&A: Financing verify on EDGAR →
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  Revenue grew 28% to $9.0M driven by U.S. launch, but net loss widened 52% to $48.8M as selling/marketing expenses nearly tripled to $16.6M from commercial staffing buildout. Operating cash burn jumped 61% to $35.1M.

  MD&A: Financial Results verify on EDGAR →
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  New 15% U.S. tariffs on Israeli-manufactured products effective February 2026 could materially increase cost of goods sold. All CGuard Prime currently manufactured in Israel and shipped to U.S. market.

  Risk Factors: Tariffs verify on EDGAR →