NSPR Q2 2024: US Launch Ready, Operating Costs to Rise 30–40%
- Consistent Clinical Outcomes & Positive Feedback: The Q&A highlighted that both 30-day and 1-year event rates for CGuard have been exceptionally low, with the data mirroring real-world outcomes and prior trial results, underscoring best-in-class safety and efficacy.
- Robust U.S. Commercial Readiness & Physician Interest: Management emphasized proactive steps for U.S. market entry—ramping up recruitment, establishing a headquarters in Southeast Florida, and receiving overwhelming interest from high-caliber physicians. This positions the company for an aggressive and well-supported U.S. launch.
- Favorable CREST 2 Engagement Impact: The Q&A discussion on CREST 2 noted low overall event rates and rapid uptake of CGuard by investigators. Although stent-specific data won’t be isolated early, this strong enrollment and potential for favorable trial outcomes may boost market confidence and support wider clinical adoption.
- Increasing operating expenses: There is a risk that the anticipated 30%-40% rise in operating expenses—driven by U.S. commercialization setup, recruiting, and building new facilities—could strain margins if revenue growth does not keep pace.
- Uncertainty in CREST 2 differentiation: With CGuard representing only about 4% of the overall stent enrollment in the CREST 2 trial and expectations of low overall event rates, there is a concern that the trial data may not significantly differentiate or validate the product's superiority.
- Challenges in U.S. market adoption: The need to navigate value analysis committees and secure swift U.S. market acceptance poses risks; delays or lower-than-expected uptake could impact the company’s anticipated robust U.S. launch post-approval.
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US Commercialization
Q: When will US commercialization start?
A: Management noted that with early physician enthusiasm and a small field team already in place, they are positioning themselves to quickly start engaging value analysis committees following FDA approval. -
US Operation Expenses
Q: What are US headcount and OpEx plans?
A: The team is ramping up hiring for the U.S. launch, with operating expenses anticipated to rise by 30–40% next year to support increased production and commercial readiness. -
CREST 2 Data
Q: How will CREST 2 data be presented?
A: Initial analysis will be aggregated without splitting by stent type; with only 4% of stents being CGuard, management expects no statistically significant differences, underscoring overall low event rates. -
Clinical Outcomes
Q: What are the key CGuardians 1-year results?
A: Management highlighted exceptionally low adverse event rates of 1.95% at one year, consistent with broader published studies, reinforcing confidence in safety and potential FDA approval. -
TCAR Study Details
Q: What can we expect from the TCAR trial?
A: There is significant enthusiasm from vascular surgeons, with plans to commence enrollment soon under FDA clearance, aiming for a favorable trial that supports both TCAR and CAS indications.
Research analysts covering InspireMD.