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    InspireMD (NSPR)

    NSPR Q4 2024: Confident in H1 2025 FDA Approval, OpEx to Rise

    Reported on Aug 4, 2025 (Before Market Open)
    Pre-Earnings Price$2.79Last close (Mar 11, 2025)
    Post-Earnings Price$3.34Open (Mar 12, 2025)
    Price Change
    $0.55(+19.71%)
    • Optimistic U.S. Approval Outlook: Management remains confident in obtaining FDA approval for CGuard Prime in the first half of 2025, reinforcing a bullish view on future U.S. market expansion.
    • Robust Sales and Commercial Infrastructure: The company is actively strengthening its sales organization—onboarding sales directors, territory, and clinical specialists—to secure early positioning with hospitals and VAC committees, which supports accelerated market adoption upon approval.
    • Positive Clinical Data and Pipeline Progress: Ongoing favorable feedback from pivotal studies, including robust enrollment in C-GUARDIANS II and III and strong clinical outcomes, underpins confidence in the product’s efficacy and anticipated market traction.
    • Regulatory Approval Uncertainty: Despite optimism for a first-half 2025 U.S. approval of CGuard Prime, challenges in the FDA’s complex review process—as evidenced by detailed Q&A discussions on timing—could lead to delays that negatively affect revenue expectations.
    • Rising Operating Expenses: The anticipated significant growth in operating expenses due to increased commercial hiring and R&D investments (as mentioned regarding ongoing and future expenditures) could further pressure margins if revenue growth does not accelerate as planned.
    • Variable Hospital Adoption: There is uncertainty regarding the pace at which hospitals will adopt the product post-approval; differing local decision dynamics and cautious value analysis committee reviews may result in slower-than-expected revenue uptake.
    1. U.S. Approval
      Q: US approval timing for CGuard Prime?
      A: Management remains optimistic for approval and launch in the first half of 2025, emphasizing productive, interactive engagement with FDA and an efficient modular PMA submission approach.

    2. Pipeline Timing
      Q: Timeline for C-GUARDIANS and SwitchGuard?
      A: Enrollment for C-GUARDIANS II is strong with an anticipated supplement approval early '26, while SwitchGuard's trial initiation and subsequent approval are expected in the second half of 2026, keeping plans on track.

    3. OpEx Outlook
      Q: What is the expected OpEx growth in 2025?
      A: Management expects significant increases in operating expenses driven by additional sales hiring and higher R&D costs for clinical trials, reflecting robust investment in U.S. expansion.

    4. Market Outlook
      Q: How will U.S. vs. OUS business perform in 2025?
      A: While the OUS business remains strong, the U.S. is set for a foundational building phase in the second half of 2025 to transition into accelerated growth in 2026.

    5. Commercial Readiness
      Q: How are hospitals being prepped via VAC committees?
      A: Their newly trained sales force is positioning itself effectively by leveraging robust claims data and existing relationships to secure favor in upcoming value analysis committee reviews.

    6. Sales Personnel
      Q: What is the current sales team structure?
      A: The team includes 13 onboarded professionals—among them 4 sales directors—with plans to further expand territory manager and clinical specialist roles as the launch approaches.

    7. Goal Confidence
      Q: How confident are they on meeting annual goals?
      A: Management confidently rated their goal attainment at a 10, underscoring a strong sense of momentum and clarity in execution.

    Research analysts covering InspireMD.