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- **Revenue Milestone**: Full-year 2025 revenue of $3.4 million, driven by U.S. FDA clearance and ASBrS recommendation.
- **Market Validation**: ProSense is the only FDA-cleared breast cancer device, with ASBrS endorsement accelerating adoption.
- **Growth Catalysts**: 30 PMS sites identified, CPT 1 reimbursement expected 2028, and international expansion in Canada and Japan.
- **Operational Scale**: U.S. sales team to triple by end-2026, targeting 3-9 month sales cycle conversion.

**【CEO Summary Section】**
- **Record Revenue Growth**: Q4 2025 sales reached $1.3 million, driving full-year revenue to $3.4 million, fueled by U.S. FDA clearance for ProSense in low-risk breast cancer.
- **FDA and Professional Society Validation**: ProSense is the first FDA-cleared device for breast cancer, with the American Society of Breast Surgeons (ASBrS) recommending cryoablation for low-risk patients, enhancing market adoption.
- **Global Momentum**: Expanded installations in key U.S. hospitals (e.g., Thomas Hospital, Southeast university network) and international interest, including a Class III application to Health Canada for breast cancer indication.
- **Clinical Evidence**: 63 principal investigators presented data at 10 global conferences in 2025, with ongoing studies (SIX, PRECICE) in Brazil and Italy.

**【U.S. Commercial Activity】**
- **Post-Marketing Study (PMS)**: 30 sites required, with most identified; enrollment begins late 2026, targeting 20% completion by Q2 2027.
- **Reimbursement Progress**: CPT 3 code ($4,000) in place; applying for TPP ($900 additional) by early 2027 and CPT 1 (physician costs) effective 2028.
- **Sales Team Expansion**: Plan to triple U.S. commercial team by end-2026 to accelerate installations, with average sales cycle 3-9 months.

**【Q&A Highlights】**
- **Reimbursement Strategy**: Focused on Medicare Advantage and private payers, with CPT 1 expected to drive inflection in 2028.
- **International Expansion**: Canada application targets 60+ age group (10,000+ annual cases), while Japan partnership with Terumo progressing with PMDA submissions.
- **PMS Site Progress**: All 30 sites identified, with CRO support for regulatory compliance, ensuring dual commercial and study use.

IceCure Medical Ltd (ICCM) Q4 2025 Earnings Call Transcript

- **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.


Actual						-0.0785	-0.0883	-0.0883	-0.0589	-0.0785	-0.0589	-0.0785	-0.0785	-0.0589	-0.06	-0.06	-0.05
Forecast						-0.0916	-0.085	-0.0883	-0.0687	-0.0752	-0.0687	-0.0736	-0.0736	-0.0785	-0.0644	-0.05	-0.05
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	+14.30%	-3.88%	0.00%	+14.26%	-4.39%	+14.26%	-6.66%	-6.66%	+24.97%	+6.83%	-20.00%	0.00%

Actual	--	--	--	--	--	710.00K	937.00K	327.00K	1.26M	743.00K	1.01M	662.00K	875.00K	725.00K	525.00K	850.00K	1.30M
Forecast	--	--	--	--	--	950.00K	934.33K	1.02M	1.17M	1.02M	925.50K	708.50K	1.07M	750.00K	662.50K	714.00K	1.30M
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	-25.26%	+0.29%	-67.99%	+7.88%	-26.94%	+9.24%	-6.56%	-18.03%	-3.33%	-20.75%	+19.05%	0.00%

ICCM

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ICCM Q4 2025 Earnings

Earnings Call

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ICCM

ICCM fundamentals

ICCM Q4 2025 Earnings

Earnings Call

ICCM Earnings Call Summary for Q4/202511:00 AM on Mar 17, 2026

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ICCM Earnings Call Summary for Q2/202511:00 AM on Aug 13, 2025

ICCM Earnings Call Summary for Q1/202510:00 AM on May 28, 2025

ICCM Earnings Call Summary for Q4/202410:00 AM on Mar 27, 2025

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