IceCure Medical Ltd.
Climate Impact & Sustainability Data (2023, January 2025)
Reporting Period: 2023
Environmental Metrics
Climate Goals & Targets
Medium-term Goals:
- Complete development of MultiSense system and obtain regulatory approval for commercialization.
Short-term Goals:
- Obtain FDA approval for commercialization of products for treatment of malignant tumors in breast.
Environmental Challenges
- Limited operating history and significant operating losses since inception.
- Minimal revenues from product sales.
- Need to raise substantial additional funding.
- Conditions raise substantial doubts about the Company’s ability to continue as a going concern.
- Highly dependent on successful development, regulatory clearances, and marketing of ProSense, XSense, and MultiSense systems.
- Dependence on third-party manufacturers and suppliers.
- Small number of employees and key consultants.
- Intense competition in the market.
- Dependence on third-party payors for insurance coverage and reimbursement.
- Limited experience managing a U.S. reporting company.
- Vulnerability to security breaches and cybersecurity incidents.
- Impact of changes in general economic conditions.
- Political, economic, and military instability in Israel.
- Enforcement of civil liabilities against the company and its officers may be difficult.
Mitigation Strategies
- Expense reduction plan to reduce non-revenue generating and clinical efforts costs.
- Plans to raise funds from existing shareholders and potential investors.
- Continued investment in research and development.
- Seeking additional distributors.
- Monitoring inventory levels and maintaining recovery plans to address potential disruptions from suppliers.
- Expanding commercial operations and entering new markets.
- Efforts to obtain regulatory approvals for additional indications and in new jurisdictions.
- Collaborating with key opinion leaders and medical associations.
- Negotiating reimbursement with government and private insurers and payers.
- Implementing security measures to prevent and minimize the impact of IT-related interruptions.