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Jun 30, 2024
InspireMD Q2 2024 Earnings Report
InspireMD reported financial results for Q2 2024 and provided a business update.
Key Takeaways
InspireMD announced positive outcomes from the C-GUARDIANS IDE clinical trial and is on track to submit a PMA application to the FDA. Revenue increased by 5.4% to $1,739,000, but gross profit decreased by 32.6% to $331,000. Net loss totaled $7,909,000, or $0.22 per share. The company raised $17.9 million from the full exercise of Series H warrants.
Announced positive outcomes from the C-GUARDIANS IDE clinical trial, demonstrating a one-year primary endpoint event rate of 1.95%.
On track to submit a Premarket Approval (PMA) application to the FDA this quarter.
Raised gross proceeds of $17.9 million from the full exercise of Series H warrants.
Revenue increased by 5.4% compared to the same period last year.
InspireMD
InspireMD
Forward Guidance
InspireMD is focused on submitting a PMA application to the FDA and continuing development of its pipeline.
Positive Outlook
- Advancing development of carotid intervention and stroke prevention tools.
- Initiating CGUARDIANS II clinical trial in the back half of the year.
- Well positioned for the ongoing paradigm shift toward an endovascular ‘stent first’ approach.
- Building out a world-class US commercial infrastructure.
- Expecting FDA approval in the first half of 2025.
Challenges Ahead
- History of recurring losses and negative cash flows from operating activities.
- Uncertainty regarding the adequacy of liquidity to pursue business objectives.
- Need to raise additional capital.
- Market acceptance of products.
- Inability to secure and maintain regulatory approvals.