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