What is IceCure Medical's latest dividend and current dividend yield?

What were the key takeaways from IceCure Medical’s earnings call?

What factors drove the changes in IceCure Medical's revenue and profit?

What is IceCure Medical's gross profit margin?

What guidance did IceCure Medical's management provide for the next earnings period?

What is the revenue and EPS growth rate for IceCure Medical year over year?

What does IceCure Medical do and what are its main business segments?

What is the market's earnings forecast for IceCure Medical next quarter?

- **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

- **FDA Approval Optimism**: ProSense on track for potential U.S. approval by year-end 2025, with post-market study details finalized.
- **Clinical Excellence**: 17-year Japan data shows 99% recurrence-free rate, reinforcing cryoablation's efficacy.
- **Financial Resilience**: $10M rights offering strengthens cash position, supporting regulatory and commercial efforts.
- **Global Expansion**: Europe and Japan show growing adoption, with key conferences and regulatory submissions driving momentum.
- **Commercial Readiness**: Preparing for rapid launch post-approval, including sales team hiring and site training.

**【CEO Opening Remarks】**
- **FDA Regulatory Progress**: ProSense for early-stage breast cancer in women ≥70 years completed a productive FDA meeting. The FDA requested a post-market study (400 patients across 30 sites) and additional site qualification details, with potential approval by year-end 2025.
- **Clinical Momentum**: Highlighted 17-year follow-up data from Japan showing a 99% recurrence-free rate for 600+ breast cancer patients treated with cryoablation. ProSense was featured at major conferences (e.g., American Breast Surgeons, European Conference on Interventional Oncology), with 91% patient preference for ablation over lumpectomy.
- **Financial Strength**: Completed a $10M rights offering (oversubscribed), providing sufficient cash runway for FDA decision and commercial preparation.

**【CFO Financial Commentary】**
- **Revenue**: $1.25M (H1 2025) vs. $1.75M (H1 2024), down 29% due to $200K shipment delays from the Israel-Iran conflict.
- **Gross Margin**: 28% (H1 2025) vs. 46% (H1 2024), driven by lower sales volume.
- **Operating Expenses**: $7.39M (H1 2025) vs. $7.68M (H1 2024), reflecting cost optimization.
- **Cash Position**: $5.38M as of June 30, plus $10M from the rights offering, supporting regulatory and commercial activities.

**【Q&A Highlights】**
- **FDA Post-Market Study**: Submission complete; awaiting FDA approval. Budget under review, with potential CRO involvement and site recruitment plans.
- **Commercial Strategy**: Post-FDA approval, plans to hire a sales team and train sites for both commercial use and post-market study participation. CPT1 code application to AMA expected post-approval, with 12-18 months for approval.
- **European Growth**: Increased interest in breast cryoablation, driven by clinical data and conference presentations. Upcoming European Society of Breast Imaging and CIRSE conferences expected to accelerate utilization.
- **Japan Regulatory Update**: Partner Terumo preparing to submit ProSense for breast cancer approval in Japan.
- **Cash Sufficiency**: Current funds sufficient for FDA-related expenses, with ongoing cost monitoring.


IceCure Medical Ltd (ICCM) Q2 2025 Earnings Call Transcript

- **FDA Approval Imminent**: Post-market study plan submitted; 400-patient recruitment over 3 years required. ASBrS 2025 show strong clinical interest.
- **US Revenue Growth**: Q1 2025 US/North America sales +11% YoY; commercial launch poised for 2025H2.
- **Financial Stability**: $6.2M cash; $2M loan provides runway for FDA decision.
- **Global Expansion**: Japan filing Q3 2025; Europe targeting 50+ age cohort.
- **Pricing Strategy**: 50-50 split between system sales and 2-3yr probe commitments.

**【CEO Opening Remarks】**
- **FDA Post-Market Study Submission**: ProSense cryoablation system for early-stage breast cancer in women ≥70 years submitted post-market study plan to FDA's CDRH. FDA expects marketing authorization decision upon plan approval.
- **Commercial Readiness**: US team prepared to launch commercial sales post-approval, targeting 46,000 annual US patients. Treatment reimbursed at $3,800 via CPT III code.
- **Market Momentum**: High interest at ASBrS 2025 Annual Meeting; 60%+ breast surgeons expressed intent to participate in post-market study.
- **Global Expansion**: Japan partner Terumo on track for 2025 H2 filing; Europe sees broader patient eligibility (50+ years, Luminal A/B).
- **Financial Flexibility**: $2M unsecured loan from largest shareholder Epoch provides liquidity ahead of FDA decision.

**【CFO Financial Highlights】**
- **Q1 2025 Revenue**: $725K (down 2.4% YoY) driven by 11% US/North America growth, offset by 60% decline in Japan.
- **Gross Margin**: 30% (vs. 36% YoY) due to low revenue scale; no material revenue change expected pre-FDA decision.
- **Operating Expenses**: $3.88M (flat YoY); net loss $3.59M ($0.06/share).
- **Cash Position**: $6.2M as of May 27, 2025 (includes $2M loan and $2.65M ATM proceeds).

**【Key Q&A Takeaways】**
- **FDA Timeline**: No specific approval timeline; CDRH reviewing ~400-page post-market study plan. Recruitment target: 400 patients over 3 years at 25+ sites.
- **Reimbursement Strategy**: 
  - Expand CPT III code coverage based on claims data.
  - Apply for CPT I code (physician fee) post-FDA approval.
- **Sales Model**: 50-50 split between system sales and placement agreements (2-3yr probe commitments).
- **Tariff Impact**: Subject to US-China tariffs; monitoring administration policy updates.
- **Japan Market**: ~100K annual breast cancer patients, 2/3 low-risk; no age/tumor size restrictions vs. US.

IceCure Medical Ltd (ICCM) Q1 2025 Earnings Call Transcript

- **North America Dominance**: 42% YoY sales growth in U.S. breast cancer market highlights ProSense adoption.
- **FDA Approval Critical**: Positive advisory panel vote in November, but FDA delay risks 2025 commercial launch.
- **Profitability Improving**: 42% non-GAAP gross margin shows operational efficiency gains.
- **New Product Pipeline**: XSense FDA-cleared, positioning for long-term growth post-ProSense transition.
- **Cash Position Stable**: $6M cash on hand with $2.6M raised via ATM to fund expansion.


**【CEO Opening Remarks】**
- **North America Sales Growth**: Product sales in North America increased by 42% YoY, driven by adoption of ProSense cryoablation for breast cancer treatment.
- **FDA Approval Momentum**: Waiting for FDA de novo marketing authorization for early-stage low-risk breast cancer; advisory panel voted in favor of ProSense's benefit-risk profile in November 2024.
- **Global Expansion**: 33 investigator-initiated studies conducted in 2024 across breast, kidney, lung, and soft tissue cancers; Terumo plans to submit ProSense for breast cancer in Japan by H2 2025.
- **New Product Development**: Next-gen XSense cryoablation system FDA-cleared in U.S.; soft launch in 2026 with plans to replace ProSense over time.

**【CFO Financial Highlights】**
- **Revenue Performance**: Total product sales $3.19M (8% YoY growth); North America sales up 42%, offsetting $100K decline in Japan revenue recognition.
- **Gross Margin Expansion**: Non-GAAP gross margin improved to 42% (from 35% YoY), driven by higher-margin product sales.
- **Cost Management**: Operating expenses stable at $17.15M; net loss $15.32M (-5% YoY) despite $2.6M raised via ATM offering.
- **Cash Position**: $6M cash as of March 2025; prioritizing investment in sales/marketing and R&D for XSense.

**【Q&A Key Takeaways】**
- **FDA Timeline Uncertainty**: FDA delays due to internal staffing challenges and stakeholder complexity; no specific decision date provided.
- **U.S. Commercial Readiness**: 4-person sales team in place; plans to expand upon FDA approval.
- **Japan Market Strategy**: Terumo to submit ProSense for breast cancer in H2 2025; no impact on existing product sales pending approval.
- **Product Transition**: XSense will coexist with ProSense initially, with full replacement over 2-3 years post-FDA clearance.


ICCM

ICCM fundamentals

Earnings Call

You can ask Aime