InspireMD Earnings Call Transcripts
Fiscal Year 2026
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Q2 2026 results were impacted by a voluntary recall, leading to negative U.S. revenue and gross margin, but international sales grew 21% year-over-year. Regulatory progress continues, with key FDA approvals expected in late 2026 and cost-saving measures set to fully impact by Q4.
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Stroke prevention is shifting rapidly toward endovascular stenting, driven by strong clinical evidence and expanded coverage. The flagship stent demonstrates best-in-class outcomes and is now being commercialized in the U.S., with significant market growth expected.
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Q1 2026 revenue surged 122% year-over-year to $3.4M, driven by strong global demand, but U.S. commercialization paused due to technical issues with the CGuard Prime 135 delivery system. Full-year guidance was withdrawn, with FDA approval for relaunch targeted for Q3 2026.
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A novel carotid stent with MicroNet mesh is driving a shift from surgery to stenting, supported by strong clinical outcomes, CMS reimbursement changes, and a robust commercial strategy. Financially, the company is well-capitalized through 2027, with plans for further expansion and new product launches.
Fiscal Year 2025
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Q4 2025 revenue grew 62% year-over-year to $3.1M, driven by U.S. CGuard Prime launch and international growth. 2026 revenue is projected at $13–$15M, with acceleration expected in H2 from new indications and enhanced delivery systems. Cash reserves rose to $54.2M.
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CREST-2 trial results and CMS policy changes are accelerating the shift to endovascular stenting for carotid disease, with strong physician support and early commercial traction in the U.S. The company is executing a controlled launch, reporting strong Q3 results and advancing its pipeline with key trials targeting 2026–2027 regulatory milestones.
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Q3 2025 revenue grew 39% year-over-year to $2.5M, driven by the U.S. launch of CGuard Prime and international demand. Gross margin improved to 34.2%, while net loss widened to $12.7M due to commercial expansion. Q4 revenue is expected at $2.5–$3.0M.
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At the HC Wainwright conference, a new FDA-approved carotid stent with proprietary mesh technology was introduced, targeting a rapid shift from surgery to stenting in a $1B U.S. market. Strong clinical data, robust patent protection, and significant capital support underpin a focused commercial expansion.
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FDA approval of CGuard Prime enabled a U.S. launch, with early commercial traction and strong physician interest. Q2 revenue grew 2% year-over-year, but net loss widened due to higher operating expenses from U.S. expansion. Over $58 million in new financing supports growth and commercial scale.
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A next-generation carotid stent with MicroNet mesh is set for imminent FDA approval, supported by strong clinical data and recent CMS coverage expansion. The company is well-funded and positioned to capitalize on a $1 billion U.S. market as endovascular procedures become the new standard of care.
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Q1 2025 revenue grew 1.2% year-over-year, driven by international CGuard sales, while operating expenses rose sharply due to U.S. launch preparations. FDA approval for CGuard Prime is expected in Q3 2025, with significant revenue growth anticipated post-launch.
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Expanded CMS reimbursement is driving a shift from open surgery to stenting in carotid interventions, with the company poised for U.S. market entry and FDA approval expected in the first half of 2024. Clinical data shows superior outcomes for its MicroNet mesh stent, and a robust financial position supports commercialization and growth.
Fiscal Year 2024
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Q4 2024 revenue grew 10.6% year-over-year to $1.9M, with full-year revenue up 13% to $7M. U.S. approval and launch of CGuard Prime is expected in the first half of 2025, with significant commercial buildout underway and strong international performance continuing.
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Q3 2024 revenue grew 16% year-over-year, driven by strong CGuard implant sales and expanding international market share. Anticipates U.S. approval and launch in early 2025, with significant investments in commercial infrastructure and clinical programs.
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Q2 2024 revenue grew 5.4% year-over-year to $1.74M, with 2,969 CGuard implants sold and a net loss of $7.91M. Pivotal trial data showed best-in-class outcomes, supporting a planned U.S. launch in H1 2025. Cash position improved to $47.2M after warrant exercise.