InspireMD revenue doubles on U.S. launch, but voluntary recall triggers $1.4M charge

Filed May 7, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 8, 2025 · ~2 min read

Key Changes

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  Company announced voluntary recall of CGuard Prime delivery system in May 2026 after technical performance fell short during controlled launch; expects $1.4M in reserves for returns, inventory impairment, and remediation. Recall limited to delivery system, not stent implant.

  MD&A: CGuard Prime Recall verify on EDGAR →
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  Revenue surged 122% to $3.4M in Q1 2026 vs. 1.2% growth prior year, driven by U.S. commercial launch of CGuard Prime following June 2025 FDA approval. Direct U.S. sales contributed $1.2M of the increase.

  MD&A: Revenue Growth verify on EDGAR →
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  NIH-sponsored CREST-2 study (Nov 2025) showed carotid stenting plus medical therapy significantly reduced stroke risk vs. medical management alone in asymptomatic patients; carotid endarterectomy showed no significant benefit, validating company's stent-first approach.

  MD&A: CREST-2 Results verify on EDGAR →