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Mar 31, 2023
InspireMD Q1 2023 Earnings Report
InspireMD reported Q1 2023 financial results, highlighted by a transformational private placement and increased CGuard EPS revenue.
Key Takeaways
InspireMD reported a 4.7% increase in revenue to $1.239 million for Q1 2023, driven by a 6.7% increase in CGuard EPS sales. The company also completed a transformational private placement for up to $113.6 million, including $42.2 million upfront. The company's CE mark was reinstated under the MDD directive allowing the company to resume sales and shipments to the EU countries.
Completed a transformational private placement for up to $113.6 million, including $42.2 million upfront.
Generated Q1 2023 CGuard EPS revenue of $1.2 million, an increase of 6.7% over Q1 2022.
Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework.
Continued enrollment in the C-Guardian US IDE trial; on track to complete enrollment by end of Q2 2023.
InspireMD
InspireMD
InspireMD Revenue by Segment
Revenue by Segment
CGuard EPS Revenue
CapyFin.com Forward Guidance
InspireMD anticipates recertification of its CE Mark under MDR, plans to grow market share in approved markets, and expects to complete enrollment in the U.S. IDE trial by the end of Q2 2023.
Positive Outlook
- Potential FDA approval and launch of CGuard EPS in the U.S.
- Initiation of new regulatory pathways for advanced applications of CGuard stent platform.
- Development of new products.
- Continuing to grow business outside of the United States.
- Likely recertification of CE Mark under MDR occurring imminently.
Challenges Ahead
- History of recurring losses and negative cash flows from operating activities.
- Significant future commitments and the uncertainty regarding the adequacy of liquidity to pursue complete business objectives.
- Need to raise additional capital to meet business requirements.
- Market acceptance of products.
- Inability to secure and maintain regulatory approvals for the sale of products.