Core Insights - IceCure Medical Ltd. specializes in minimally-invasive cryoablation technology for low-risk breast cancer treatment, providing an alternative to traditional surgical methods [1] - The company is expanding its market presence in the U.S. and internationally following FDA marketing authorization for its ProSense cryoablation system [1] Financial Performance - For the earnings report on November 19, 2025, the company reported an EPS of -$0.056, which was below the estimated EPS of -$0.05 [2][6] - Revenue for the same period was $725,000, surpassing the estimated $714,000, indicating stronger-than-expected sales performance [2][6] Market Demand and Growth Potential - The earnings call highlighted increasing demand for ICCM's ProSense systems, with expectations for acceleration in 2026, targeting a U.S. patient population of approximately 200,000 [3] Financial Metrics - The company has a price-to-sales ratio of 17.31, suggesting that investors are willing to pay a premium for its sales [4] - The enterprise value to sales ratio stands at 16.23, indicating similar high expectations from an enterprise perspective [4] - ICCM's debt-to-equity ratio is 0.82, reflecting a moderate level of debt management [5] - A current ratio of 1.18 indicates a reasonable level of short-term financial health, with current assets slightly exceeding current liabilities [5]

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million, a decrease from $2.4 million in the same period of 2024, primarily due to a lack of revenue from Terumo, the distributor in Japan [16] - Gross profit for the same period was $626,000, down from $1,034,000 in the prior year, resulting in a gross margin of 30% compared to 43% in 2024 [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively unchanged from a net loss of $10 million or $0.22 per share in the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million at the end of 2024, with a cash balance of $11.8 million as of October 31, 2025 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other Asian territories, and North America, partially offset by an increase in Latin America [16] - The company expects fluctuations in quarterly revenue as commercial activities ramp up following the FDA's marketing clearance for ProSense [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, targeting a population of approximately 200,000 patients annually in the U.S. [6][8] - The ProSense system is expected to benefit from a CPT-3 code covering approximately $3,800 in facility costs, which is anticipated to increase to just over $4,000 in early January 2026 [10] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. and globally, with plans for a post-market study involving 30 clinical sites [9][10] - IceCure aims to drive growth by expanding clinical evidence, improving reimbursement, and entering new markets, particularly in Brazil and Japan [12][15] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has significantly changed the company's growth trajectory and is optimistic about the future [27] - The company is entering an exciting growth phase, with expectations for increased adoption of ProSense in both clinical and commercial settings [15] Other Important Information - The company has received regulatory approval for its next-generation cryoablation system in Israel and secured a notice of patent allowance for its cryo probe in the U.S. and Japan [12][14] - IceCure is experiencing high global interest from clinicians following the FDA decision, with plans for participation in upcoming medical conferences [12] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and they are in communication to finalize it, with expectations for approval by early next year [20][21] Question: Clarification on the addressable patient population - Management elaborated that the addressable market includes approximately 46,000 low-risk patients over 70, 88,000 patients not eligible for surgery, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024, reflecting a decrease due to the absence of revenue from Terumo in 2025 [16] - Gross profit for the nine months ended September 30, 2025, was $626,000, resulting in a gross margin of 30%, down from 43% in the prior year [17] - Total operating expenses decreased to $11.5 million for the nine months ended September 30, 2025, compared to $12.2 million a year ago [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively the same as the net loss of $10 million or $0.22 for the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million as of December 31, 2024 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other territories in Asia, and North America, partially offset by an increase in sales in Latin America [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, which is expected to address a population of approximately 200,000 patients annually in the U.S. [8][25] - The indication covers about 46,000 women aged 70 and older diagnosed each year, plus an estimated 88,000 patients who are not candidates for surgery [8][24] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. following FDA authorization, with plans to increase the number of commercial sites [9][10] - IceCure aims to implement its sales and marketing strategy targeting a patient population of about 200,000 women annually, while also expanding clinical evidence and improving reimbursement [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the FDA marketing authorization has dramatically changed the company's growth trajectory and is optimistic about the future [27] - The company is in a strong financial position to continue executing across regulatory, clinical, and commercial initiatives, with a cash balance of $11.8 million as of October 31, 2025 [18] Other Important Information - The company has secured a distribution agreement in Brazil with expected sales of $6.6 million over the next five years [12] - ProSense has received regulatory approval in Israel for breast cancer and other indications, and the company has a strong intellectual property portfolio [12] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and they are in interactive communication to finalize it, with expectations for approval by early next year [20] Question: Update on clinical sites for the post-market study - Management indicated that about 20 sites have been identified, with plans to finalize the protocol and recruit patients by summer 2026 [21] Question: Clarification on the addressable market for cryoablation - Management elaborated that the addressable market includes 46,000 low-risk patients over 70, 88,000 non-surgical candidates, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024, reflecting a decrease due to lower sales in Japan and other territories [16] - Gross profit for the same period was $626,000, resulting in a gross margin of 30%, down from 43% in the prior year [17] - Total operating expenses decreased to $11.5 million from $12.2 million a year ago, indicating efforts to optimize spending [17] - Net loss for the nine months was $10.8 million or $0.18 per share, relatively unchanged from a net loss of $10 million or $0.22 for the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million at the end of 2024 [18] Business Line Data and Key Metrics Changes - The company experienced a $316,000 decrease in sales during the nine months ended September 30, 2025, primarily due to reduced sales in Japan and North America, partially offset by an increase in Latin America [16] - The FDA granted marketing authorization for the ProSense cryoablation system, which is expected to drive growth and support broader access for patients [6][10] Market Data and Key Metrics Changes - The addressable market for ProSense includes approximately 200,000 patients annually in the U.S., consisting of 46,000 women aged 70 and older diagnosed with low-risk breast cancer, 88,000 patients not eligible for surgery, and 63,000 women with benign breast tumors [7][26] - The company has over 20 commercial sites using ProSense prior to FDA authorization, with expectations for organic growth and additional clinical sites planned [10] Company Strategy and Development Direction - The company aims to implement a sales and marketing strategy targeting a patient population of about 200,000 women annually, focusing on expanding clinical evidence and improving reimbursement [15] - The company is also advancing its global regulatory strategy, with plans for ProSense to be submitted for regulatory approval in Japan in the first half of 2026 [14] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has dramatically changed the company's growth trajectory and is optimistic about the future [28] - The company is confident in its financial position, supported by recent fundraising efforts, which will enable continued execution across regulatory, clinical, and commercial initiatives [18] Other Important Information - The company has received a notice of patent allowance for its cryo probe in the U.S. and Japan, strengthening its intellectual property portfolio [12] - ProSense has gained visibility at leading medical conferences, enhancing its reputation and adoption among clinicians [13] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and that they are in communication to finalize it, with expectations for approval by early next year [20][22] Question: Clarification on the addressable market for cryoablation - Management elaborated that the addressable market includes 46,000 low-risk patients, 88,000 non-surgical candidates, and 63,000 benign tumor cases, totaling over 200,000 potential patients annually [24][26]

Core Insights - IceCure Medical (ICCM) has received FDA marketing authorization for its ProSense cryoablation system, the first minimally invasive treatment for low-risk breast cancer in women aged 70 and above, positioning it as an alternative to lumpectomy [1][8] - The approval opens commercial opportunities in the U.S. and validates IceCure's leadership in cryoablation technology, with established reimbursement pathways enhancing adoption prospects [2][4] Company Summary - Following the FDA announcement, ICCM shares rose by 12% in after-market trading, although the stock has seen a year-to-date decline of 12.4% compared to the industry’s 5.2% growth and the S&P 500's 15.2% gain [3] - ICCM's market capitalization stands at $66.2 million, with an expected earnings growth of 26.7% in 2025 [5] Competitive Position - The FDA authorization significantly enhances IceCure's commercial outlook by granting access to the U.S. breast cancer treatment market, establishing a competitive moat against rivals who will face higher clinical data requirements for entry [4][10] - ProSense benefits from a CPT III reimbursement code covering $3,800 of facility costs, with potential for expanded coverage as adoption increases, positioning IceCure for accelerated revenue growth and market penetration [10] Clinical Validation - The FDA's decision was supported by robust clinical data from the ICE3 trial, demonstrating outcomes comparable to traditional surgical methods while offering a quicker, minimally invasive procedure [9] - IceCure plans to conduct a post-market study involving around 400 patients across 30 sites in the U.S. to further validate long-term efficacy, which will also serve as commercial centers for efficient rollout [9] Industry Outlook - The global cryoablation for cancer market was valued at $3.5 billion in 2024 and is projected to grow at a CAGR of 6.1%, reaching $5.8 billion by 2033, driven by rising cancer incidence and an aging population [11][12] - The increasing adoption of cryoablation for smaller tumors is a major driver of market expansion, as it offers fewer side effects compared to traditional treatments [12]