InspireMD, Inc.
Climate Impact & Sustainability Data (2023)
Reporting Period: 2023
Environmental Metrics
Climate Goals & Targets
Medium-term Goals:
- Submission of a PMA application in the third quarter of 2024.
- Potential FDA approval of the CGuard Prime stent system in the first half of 2025.
Short-term Goals:
- Reporting primary endpoint results from the C-GUARDIANS trial in mid-2024.
Environmental Challenges
- Recurring losses and negative cash flows from operating activities.
- Need to raise additional capital.
- Market acceptance of products.
- Regulatory approvals for product sales.
- Competition from larger companies with greater resources.
- Dependence on a single manufacturing facility.
- Potential product liability claims.
- Insufficient reimbursement by third-party payers.
- Political, economic, and military instability in Israel.
- Fluctuations in currency exchange rates.
- Potential for misuse of complex medical devices.
- Product obsolescence or uncompetitiveness.
- Intellectual property infringement claims.
- Supply chain disruptions.
- Cybersecurity threats.
- ESG issues and evolving stakeholder expectations.
Mitigation Strategies
- Private placement offering to raise capital.
- Continued investment in clinical trials and product development.
- Focus on establishing CGuard as a viable alternative to existing therapies.
- Expansion into new markets.
- Development of new delivery systems and accessory solutions.
- Product liability insurance.
- Efforts to obtain reimbursement approvals.
- Cybersecurity risk management program.
- ESG risk assessment and mitigation strategies.
Supply Chain Management
Responsible Procurement
- Periodic audits of key suppliers to ensure product specifications are met.