IceCure Medical Ltd (ICCM) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call summary presents a positive outlook with record revenue, FDA marketing authorization, and strategic growth plans. The Q&A section highlights the company's efforts to improve reimbursement and expand into new markets, with some uncertainty in timelines. Despite challenges in scaling and market penetration, the strong financial performance and optimistic guidance suggest a positive stock price movement.
Key Financial Performance
Fourth Quarter Sales Approximately $1.3 million, leading to a record revenue from sales of $3.4 million for the full year ended December 31, 2025. Growth driven by record U.S. sales reflecting the positive effect of the U.S. FDA clearance in low-risk early-stage breast cancer and continued growth adoption of ProSense in key markets.
Revenue from Sales (Full Year 2025) $3.4 million, a record high. Growth attributed to U.S. FDA clearance for ProSense and its adoption in key markets.
ProSense System Installations Increased installations in prominent hospitals, including a large university hospital in the Southeast and a highly regarded medical institution with ProSense systems at two of its largest facilities. Growth driven by FDA clearance and ASBrS recommendation for cryoablation.
Peer-reviewed Publications and Presentations (2025) Record number achieved, with 63 principal investigators presenting data at 10 conferences globally. Growth attributed to increased global exposure and demand for ProSense systems.
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Operating Highlights
ProSense FDA Clearance: ProSense received FDA clearance in October 2025 for treating low-risk breast cancer in women aged 70 and over, as well as patients unsuitable for surgery. It is the first and only FDA-cleared device for breast cancer treatment.
ASBrS Recommendation: The American Society of Breast Surgeons (ASBrS) recommended cryoablation as an option for selected patients with low-risk early-stage breast cancer, validating ProSense's role in modern breast cancer care.
Global Clinical Studies: ProSense is supported by global clinical studies, including the SIX study in Brazil and the PRECICE study in Italy, which are expected to provide meaningful clinical evidence.
U.S. Market Expansion: ProSense installations are increasing in prominent U.S. hospitals and clinics, with a growing pipeline of customers converting to signed contracts. The company plans to triple its U.S. commercial team by the end of 2026.
International Market Growth: FDA clearance has driven demand in international markets, particularly in Europe. IceCure has also submitted an application to Health Canada to expand ProSense's approval for breast cancer treatment.
Record Sales: IceCure achieved record sales of $3.4 million in 2025, driven by U.S. FDA clearance and adoption of ProSense.
Post-Marketing Study: A post-marketing study for ProSense is set to commence, with 30 sites identified and onboarding expected within 3-6 months. This study will accelerate national rollout and availability.
Reimbursement Strategy: IceCure is working on obtaining CPT 1 reimbursement to cover physician costs by early 2028 and has applied for transitional pass-through payment, potentially adding $900 per procedure by early 2027.
Increased Awareness: IceCure is leveraging medical conferences, peer-reviewed publications, and social media to enhance ProSense's visibility and adoption globally.
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Risk or Challenges
Regulatory and Reimbursement Challenges: The company is awaiting decisions on transitional pass-through payment (TPP) and CPT 1 reimbursement, which are critical for covering procedure and physician costs. Delays or unfavorable outcomes could impact financial performance and adoption rates.
Market Penetration and Sales Cycle: The sales cycle for ProSense systems ranges from a few months to nine months, depending on the size of the customer. This extended timeline could delay revenue realization and market penetration.
Post-Marketing Study Requirements: The FDA requires 30 sites for the post-marketing study, with onboarding expected to take 3-6 months and full site activation by the end of next year. Delays in this process could hinder the national rollout and availability of ProSense.
Competitive Landscape: Although ProSense is currently the only FDA-cleared device for breast cancer cryoablation, any future competitors would need to meet stringent FDA requirements. However, the emergence of competitors could pose a risk in the long term.
Operational Scaling: The company plans to triple its U.S. commercial team by the end of the year to meet growing demand. Challenges in scaling operations effectively could impact customer acquisition and service quality.
Economic and Market Conditions: Economic uncertainties and market conditions could affect customer budgets and willingness to invest in new medical technologies, impacting sales and revenue.
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Guidance & Outlook
FDA Marketing Authorization for ProSense: Expected to drive meaningful growth, with increased interest and installations in medical clinics and hospitals.
Post-Marketing Study for ProSense: Anticipated to accelerate national rollout and availability, with 30 sites expected to be onboarded by the end of next year and patient enrollment commencing in late summer.
ASBrS 2026 Recommendation: Cryoablation recommended for selected patients with low-risk early-stage breast cancer, expected to act as a significant catalyst for adoption and reimbursement expansion.
Global Sales Momentum: FDA clearance in the U.S. is increasing confidence and adoption internationally, particularly in Europe and Canada. A decision from Health Canada on expanded approval is expected in the second half of 2026.
U.S. Commercial Expansion: Plans to triple the commercial team by the end of the year to address growing demand, with increasing system sales and installations expected in Q2 2026 and beyond.
Reimbursement Developments: Post-marketing study procedures are eligible for reimbursement. Applications for transitional pass-through payment and CPT 1 reimbursement are underway, with potential financial impacts by early 2027 and 2028, respectively.
Clinical Evidence and Studies: Ongoing international studies and peer-reviewed publications are expected to enhance ProSense's adoption and global exposure.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Could you walk through a little more detail with regard to your plans to get reimbursement coverage beyond Medicare?
A:The company currently operates under the CPT 3 code with a payment of $4,000. Post FDA approval, reimbursement has become more consistent. They have a payer outreach program targeting private payers and are focusing on the Medicare Advantage program due to the population on their FDA labeling. They are also working on increasing payments and transitioning to CPT 1.
Q:As you proceed with getting CPT 1 code in place, do you see that as spurring additional demand, significant additional demand? Or is it really just a matter of getting better reimbursement given what you've seen so far in the market?
A:The CEO stated that CPT 1 is part of the standard of care in the U.S. and will be a significant inflection point for growth, particularly in 2028. It will improve reimbursement and enable faster and higher growth for IceCure.
Q:On the 30 hybrid commercial clinical sites, more than half have been identified. Can you get a little more specific? Have you identified at least 20 or 25? How quickly do you think you can ramp that up?
A:The COO stated that all 30 sites required for the post-market study have been identified, but agreements are still in process. There is high interest from sites across the U.S., and the team is working with a CRO to ensure requirements are met and sites can be converted to both PMS and commercial use.
Q:You announced that you filed in Canada for regulatory approval, hoping to get that before the end of this year. Can you talk about the opportunity there? And then lastly, just an update on Japan.
A:In Canada, the company submitted for the ICE3 indication for patients aged 60 and above, representing over 10,000 new cases annually. In Japan, they are working with Terumo, which has started the process with the PMDA. Terumo had a positive first consultation with PMDA and plans to formally submit after addressing comments.
Q:Review of Unclear Management Responses
A:Management avoided providing specific timelines or detailed plans for ramping up the 30 hybrid commercial clinical sites. They also did not provide detailed timelines for the regulatory approval process in Canada or Japan, using general terms like 'in process' and 'moving forward fast.'
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Alabama
CEO Eyal
FDA clearance
Health Canada
ProSense breast
ProSense installation
ProSense system
activity
adoption ProSense
announcement
cancer cryoablation
cancer patient
clearance ProSense
clinic hospital
community
cryoablation system
customer
demand market
device
effect
evidence
exposure
importance
medium
momentum
patient doctor
peer
procedure
publication
radiologist surgeon
recommendation
record sale
reminder ProSense
sale record
segment
system breast
treatment risk
validation
ICCM Transcript
IceCure Medical Ltd (ICCM) Q4 2025 Earnings Call Transcript
Positive3-17
The earnings call summary presents a positive outlook with record revenue, FDA marketing authorization, and strategic growth plans. The Q&A section highlights the company's efforts to improve reimbursement and expand into new markets, with some uncertainty in timelines. Despite challenges in scaling and market penetration, the strong financial performance and optimistic guidance suggest a positive stock price movement.
IceCure Medical Ltd (ICCM) Q3 2025 Earnings Call Transcript
Unknown11-19
The company's financial performance shows declining revenue, gross profit, and margins, indicating challenges in maintaining profitability. Despite the optimism around FDA approval and market potential, the lack of a concrete timeline for regulatory approvals and the unclear management responses in the Q&A create uncertainty. The ongoing net losses and limited cash position add to financial strain. These factors, combined with supply chain and sales variability, suggest a negative market reaction, likely in the -2% to -8% range, especially given the lack of market cap information for a more precise prediction.
IceCure Medical Ltd (ICCM) Q2 2025 Earnings Call Transcript
Unknown8-13
The earnings call reveals several concerns: declining revenue and gross margin, increased net loss, and dependency on FDA approval for U.S. market growth. The Q&A highlighted uncertainties around the post-market study budget and lack of specific sales projections for Europe and Japan. While there is interest in ProSense and potential reimbursement, the financial metrics and market adoption risks overshadow these positives, suggesting a negative sentiment.
IceCure Medical Ltd (NASDAQ:ICCM) Q1 2025 Earnings Call Transcript
Unknown5-29
The earnings call presents several challenges: ongoing financial losses, dependency on FDA approval for revenue growth, and competitive pressures. Despite some positive developments like increased sales in North America and Europe, the decline in Asia and supply chain issues are concerning. The Q&A revealed uncertainties in regulatory timelines and management's unclear responses. The unsecured loan and share sales indicate financial strain. These factors, coupled with the lack of immediate revenue change expectation, suggest a negative sentiment, likely leading to a stock price decline in the next two weeks.
ICCM Report
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