NSPR Q1 2025: FDA Delay Sets CGuard Prime Approval for Q3 2025
- Regulatory Engagement and Adjusted Timelines: Management has proactively engaged with the FDA, clearly explaining the timeline adjustments (e.g., CGuard Prime approval now targeted for Q3 2025) and demonstrating a methodical approach to meeting statutory review deadlines, which showcases strong regulatory oversight.
- Robust Clinical Enrollment: The pace of enrollment in pivotal trials is robust with 8 active sites already onboard, underlining strong physician and institutional confidence in the product’s potential, which bodes well for commercial success post-approval.
- Strong Commercial Foundation: The company has built an experienced commercial team and is strategically scaling hires to prepare for an aggressive U.S. launch, indicating readiness to capture market demand while keeping a disciplined approach to operating expenses.
- Regulatory approval delays: The team indicated that compressed timelines—stemming from the facility audit being completed just one month before the statutory deadline—could lead to additional time needed for FDA feedback and responses, potentially delaying the CGuard Prime approval and U.S. launch.
- Uncertainty in clinical trial outcomes: There is uncertainty in the enrollment and patient selection of pivotal trials (e.g., CGuardians II), which could result in ambiguous clinical outcomes that may not sufficiently shift clinical practice, thereby dampening market excitement and future revenue prospects.
- Revised timeline for SwitchGuard clearance: The revised expectation for SwitchGuard clearance shifting from mid-2026 to late 2026, due partly to enrollment uncertainties and regulatory feedback, poses additional risk of delayed market entry for the complementary TCAR solution.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
CGuard Prime FDA Approval | Q1 2025 | no prior guidance | Anticipated FDA approval for CGuard Prime in Q3 2025 | no prior guidance |
CGuardians II Trial | Q1 2025 | no prior guidance | Enrollment progressing with 8 active sites; FDA approval expected in the first half of 2026 | no prior guidance |
SwitchGuard Neuroprotection System | Q1 2025 | no prior guidance | IDE resubmitted; approval expected next month; clearance anticipated in late 2026 (adjusted from mid‑2026) | no prior guidance |
Crest 2 Trial | Q1 2025 | no prior guidance | Readout expected in the second half of 2025 | no prior guidance |
Financial Milestones | Q1 2025 | no prior guidance | Receipt of FDA premarket approval triggers milestone financing of $17.9 million; additional tranches tied to future milestones (SwitchGuard clearance and U.S. sales) | no prior guidance |
Commercial Team Expansion | Q1 2025 | no prior guidance | Approximately 20 sales and marketing professionals onboarded | no prior guidance |
Market Opportunity | Q1 2025 | no prior guidance | If Q1 2025 international volume of 2,611 stents were realized in the U.S. at current market ASPs, it would generate roughly $12 million in revenue | no prior guidance |
CGuard Prime Approval and Launch | FY 2025 | Optimistic view: FDA approval for CGuard Prime expected in the first half of 2025 with a foundational commercial launch in the second half of 2025 | no current guidance | no current guidance |
Commercial Infrastructure Growth | FY 2025 | Building the U.S. commercial team with 13 personnel onboarded (including 4 sales directors) and plans to hire additional managers | no current guidance | no current guidance |
Operating Expenses (OpEx) | FY 2025 | Significant growth expected due to sales organization expansion, increased clinical trial costs and PMA submission expenses | no current guidance | no current guidance |
Clinical Trials and Product Development | FY 2025 | Enrollment for the C-GUARDIANS II study progressing; commercial launch of the TCAR-indicated CGuard Prime expected early 2026; C-GUARDIANS III study to begin in Q2 2025; SwitchGuard approval and launch expected in the second half of 2026 | no current guidance | no current guidance |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
Regulatory Approval Process and FDA Engagement | Earlier periods indicated optimism for achieving FDA approval in the first half or early 2025 with an efficient, modular submission process. | Q1 2025 now reflects a slight delay with CGuard Prime expected in Q3 2025 due to audit timing and compressed review periods, with prudently built-in extra time. | Slightly delayed timelines and increased caution in FDA engagement. |
Clinical Trial Enrollment and Outcome Confidence | Q2, Q3, and Q4 demonstrated robust enrollment campaigns and consistent, record-low adverse event data with high confidence in trial outcomes. | Q1 2025 shows continued strong enrollment for CGuardians II and reiterates excellent trial results, though adding nuance regarding CREST 2 outcomes based on patient severity. | Consistent high confidence with increased nuance around clinical outcome implications. |
U.S. Commercial Launch Readiness and Execution | Previous periods highlighted steady sales team build-out (13 personnel with directors, hiring in Q3, targeted outreach and training for VAC reviews). | Q1 2025 features an even larger sales force (about 20 professionals) and solid operational readiness via a state‑of‑the‑art Miami facility, though FDA approval delays affect the timeline. | Expanded sales and operational readiness with refined strategic hiring momentum. |
Operating Expenses and Cost Management | Q2, Q3, and Q4 showed rising expenses (increases of 46–56%) driven primarily by higher compensation, share‐based costs, and investments in commercialization and R&D. | Q1 2025 continues this trend with a 52.5% increase in operating expenses driven by the costs of scaling the U.S. sales force, facility rent, and launch preparation. | Continued rising expenses reflecting aggressive commercialization and R&D investments. |
Supply Chain and Manufacturing Strategy | In Q2 and Q3, the focus was on establishing U.S. headquarters with production capacity, a multi‑pronged supply strategy involving the Tel Aviv facility, contract manufacturing, and a new Miami headquarters; Q4 had no specific mention. | Q1 2025 emphasizes a domestic production facility in Miami aimed at diversifying the supply chain amid macroeconomic uncertainty. | Strengthening domestic production capability and supply chain diversification with added emphasis. |
Product Pipeline Innovation and SwitchGuard Clearance Timelines | Q2 and Q3 discussions outlined the development of CAS and TCAR solutions through C‑GUARDIANS II and III studies, with anticipated clearance for SwitchGuard in the second half of 2026. | Q1 2025 reiterates development progress with a resubmitted IDE for SwitchGuard and a revised expectation for FDA clearance in late 2026, reflecting a slight delay from previous mid‑2026 expectations. | Ongoing innovation with revised (slightly delayed) clearance timelines for SwitchGuard. |
Hospital and Physician Adoption Dynamics | Q2 detailed proactive outreach to hospitals and VAC committees and strong physician advocacy; Q3 and Q4 emphasized targeted specialty engagement and robust training initiatives. | Q1 2025 does not provide as detailed discussion on hospital approval processes, though it notes strong physician enthusiasm and sales team expertise in garnering interest. | Consistent physician enthusiasm persists, but the detailed discussion on hospital adoption dynamics is less prominent. |
CREST 2 Trial Engagement and Differentiation | In Q2 2024, detailed discussion covered trial enrollment across multiple sites, rapid adoption of CGuard, and potential impact on treatment paradigms. | Q1 2025 includes a nuanced discussion highlighting that patient selection in CREST 2 may lead to outcomes that do not significantly change clinical practice. | Diminished emphasis with more nuanced differentiation regarding trial outcomes, reflecting reduced focus compared to earlier detailed discussions. |
-
Regulatory Timeline
Q: FDA approval delay reasons?
A: Management explained that a deferred facility site audit and its compressed feedback period have extended the timeline, with approval now expected in Q3 2025. -
SwitchGuard Timing
Q: When will SwitchGuard clear FDA?
A: They expect clearance in late 2026 after re-submitting the IDE and initiating enrollment, reflecting a cautious timeline. -
Clinical Enrollment
Q: How is CGuardians II enrollment progressing?
A: Enrollment is robust, with 8 active sites and strong surgeon enthusiasm, keeping the clinical milestones on track for first‐half 2026 approval. -
CAS2 Impact
Q: What market impact from CAS2 trial readout?
A: Management believes the readout will largely confirm current practices, as outcomes will depend on the enrolled patients’ risk profiles, implying minimal change in market practice. -
FDA Interaction
Q: Any issues with team and FDA interaction?
A: They reported consistent and positive engagement with the FDA, with no changes in the team’s approach or structure. -
Hiring Pace
Q: Will hiring slow down pre-approval?
A: The organization has built a strong foundation and plans to scale further post-approval, maintaining a prudent hiring pace in the meantime.
Research analysts covering InspireMD.