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- **FDA-Approved Growth Driver**: ProSense now addresses ~200,000 U.S. patients annually, with exclusive market position due to FDA barriers.
- **Global Momentum**: Brazil deal ($6.6M over 5 years) and Switzerland approval expand international reach; Japan submission planned for H1 2026.
- **Financial Resilience**: $11.8M cash on hand post-rights offering, supporting U.S. rollout despite short-term revenue decline.
- **Clinical Validation**: 13 studies published in Q3, reinforcing ProSense's safety and efficacy in breast, lung, and endometrial cancer.

**【CEO Opening Remarks】**
- **FDA Authorization Milestone**: ProSense cryoablation system received FDA marketing authorization for low-risk breast cancer in women ≥70 years old, addressing ~46,000 annual patients. An additional 88,000 patients not eligible for surgery and 63,000 with benign breast tumors could benefit, totaling ~200,000 U.S. addressable patients annually.
- **Market Leadership**: ProSense is the only cryoablation system with FDA clearance for breast cancer, with a 5-year data barrier for competitors. 20 U.S. commercial sites are active, with plans to expand organically and through 30 clinical sites for a post-market study.
- **Global Expansion**: ProSense approved in Switzerland and Brazil (via $6.6M 5-year distribution deal). Upcoming regulatory submissions in Japan (Terumo partnership) and training programs in Europe and Asia.
- **Innovation & IP**: New cryoablation system approved in Israel; patent allowances secured in the U.S. and Japan. ProSense featured at major medical conferences, with 13 independent studies published in Q3.

**【CFO Financial Commentary】**
- **Revenue Performance**: Q3 2025 revenue $2.1M (down 12% YoY) due to decreased sales in Japan, North America, and Asia, partially offset by Latin America growth. Gross profit $626K (30% margin) vs. $1.03M (43% margin) YoY, reflecting commercial scale-building costs.
- **Cost Optimization**: Operating expenses reduced to $11.5M (down 6% YoY). Net loss $10.8M ($0.18/share), stable vs. prior year. Cash position strengthened to $10M (vs. $7.6M at year-end 2024) via $10M rights offering and $5.87M share sales.
- **Liquidity**: $11.8M cash as of October 2025, supporting U.S. commercialization and global expansion.

**【Q&A Highlights】**
- **Post-Market Study Update**: FDA protocol submission complete; expect final approval by early 2026. 20 clinical sites identified, targeting 80 patients by end-2026.
- **FDA Communication**: Interactive discussions ongoing; no timeline provided but prioritization expected due to breakthrough device designation.
- **Market Expansion**: Brazil delegation visit highlights strong interest in Latin America. Japan submission planned for H1 2026 via Terumo partnership.
- **Pricing**: CPT code coverage increased to ~$4,000 in January 2026, supporting reimbursement and adoption.


IceCure Medical Ltd (ICCM) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

ICCM

ICCM fundamentals

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