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Sep 30, 2023
InspireMD Q3 2023 Earnings Report
InspireMD reported third quarter 2023 financial results, showing revenue increase and progress in clinical trials.
Key Takeaways
InspireMD reported an 8.7% increase in revenue for Q3 2023, driven by CGuard EPS sales, and highlighted positive safety data from the C-GUARDIANS U.S. IDE clinical trial. The company also noted the expansion of CAS coverage by CMS as a positive development.
CGuard EPS revenue reached $1.56 million in Q3 2023, an increase of nearly 9% year-over-year.
Presented positive 30-day follow-up results from the C-GUARDIANS U.S. IDE clinical trial.
CMS expanded coverage of CAS to include both asymptomatic and standard risk patients.
Gross profit increased by 19.7% to $438,000, with gross margin rising to 28.1%.
InspireMD
InspireMD
InspireMD Revenue by Segment
Revenue by Segment
CGuard EPS Revenue
CapyFin.com Forward Guidance
InspireMD is focused on obtaining potential approval and launching CGuard EPS in the U.S. in the first half of 2025 and believes the CMS coverage determination will catalyze a stent-first approach to the treatment of carotid disease.
Positive Outlook
- Potential approval and launch of CGuard EPS in the U.S. in the first half of 2025
- Compelling 30-day safety data from C-GUARDIANS presented at VIVA23
- CMS issued its final National Coverage Determination (NCD), expanding coverage of CAS to include both asymptomatic and standard risk patients
- Focus on developing products for both CAS and TCAR approaches
- Continued execution against 2023 objectives
Challenges Ahead
- History of recurring losses and negative cash flows from operating activities
- Need to raise additional capital to meet business requirements in the future
- Market acceptance of products
- Inability to secure and maintain regulatory approvals for the sale of products
- Negative clinical trial results or lengthy product delays in key markets