Q3 2025 Icecure Medical Ltd Earnings Call

November 19, 2025

Speaker #1: Good morning and thank you for standing by . Currently , all of the participants are in listen only mode . After management's discussion , there will be a question and answer session .

Speaker #1: Please be advised that today's conference call is being recorded . I would now like to turn the conference over to Michael . Please go ahead .

Speaker #2: Thank you . Ella , and welcome to IceCure Medical Ltd. Conference call to review the financial results . As of and for the nine months ended September 30th , 2025 and provide an update on recent operational highlights .

Speaker #2: You may refer to the earnings press release that we issued earlier this morning . Participating on today's call are IceCure Medical Ltd. CEO .

Speaker #2: Al Shamir , and the CFO , company Ronen Zimmerman . Before we begin , I'll now take a moment to read a statement about forward looking statements .

Michael Polyviou: Thank you, Ella, and welcome to IceCure Medical's conference call to review the financial results as of and for the nine months ended 30 September 2025, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning. Participating on today's call are IceCure Medical CEO, Eyal Shamir, and the company CFO, Ronen Tsimerman. Before we begin, I will now take a moment to read a statement about forward-looking statements.

Speaker #2: This call and the question and answer that follows it session forward contains looking statements within the meaning of the safe harbor provisions of the private securities .

Speaker #2: Securities Litigation Reform Act of 1995 and other federal securities laws . Words such as expects , anticipates , intends , plans , believes , seeks and similar , estimates expressions or variations of such words are intended to identify forward looking statements .

Speaker #2: For example , we are using forward looking statements in this presentation when we discuss that the FDA's marketing authorization process will drive meaningful growth for us and support broader access for patients .

Operator: This call and the question-and-answer session that follows it contains forward-looking statements within the meaning of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as expects, anticipates, intends, plans, believes, seeks, estimates, and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements in this presentation when we discuss that the FDA's marketing authorization for ProSense will drive meaningful growth for us and support broader access for patients. The belief that global interests follow the FDA authorization will support international adoption. The belief that ProSense will be the only cryoablation system cleared in the US for breast cancer in the foreseeable future. Terumo Corporation will submit a regulatory application for ProSense in Japan in the first half of 2026.

This call and the question-and-answer session that follows it contains forward-looking statements within the meaning of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as expects, anticipates, intends, plans, believes, seeks, estimates, and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements in this presentation when we discuss that the FDA's marketing authorization for ProSense will drive meaningful growth for us and support broader access for patients. The belief that global interests follow the FDA authorization will support international adoption. The belief that ProSense will be the only cryoablation system cleared in the US for breast cancer in the foreseeable future. Terumo Corporation will submit a regulatory application for ProSense in Japan in the first half of 2026.

Speaker #2: The belief that global interest following the FDA authorization will support international adoption . The belief that process will be the only cryoablation system cleared in the US for breast cancer in the foreseeable future .

Speaker #2: The Terumo will submit Corporation a regulatory application for presence in Japan in the first half of 26 . The expectation that revenue and gross profits may continue to vary quarter to quarter , as the company focuses on building commercial scale sales and the belief that the company's cash cash equivalents and short term deposits positions puts it in a stronger financial position to continue executing across regulatory , clinical and commercial initiatives .

Speaker #2: The forward looking statements contained or implied during this call are subject to other risks and uncertainties , many of which are beyond the control of the company , including those set forth in the Risk Factors section of the company's annual Report on Form 20 .

Operator: The expectation that revenue and gross profits may continue to vary quarter to quarter as the company focuses on building commercial scale sales. The belief that the company's cash, cash equivalents, and short-term deposits positions puts it in a stronger financial position to continue executing across regulatory, clinical, and commercial initiatives. The forward-looking statements contained or implied during this call are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the risk factor section of the company's annual report on Form 20F for the year ended 31 December 2024, filed with the Securities and Exchange Commission on 27 March 2025, which is available on the SEC's website at www.sec.gov. The company disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements, whether because of new information, future events, or otherwise.

Speaker #2: F for the year ended December 31st , 2020 . For filed with Securities and Exchange Commission on March 27th , 2025 , which is available on the SEC's website at .

Speaker #2: The company disclaims any intention or obligation except as required by law , to update or revise any forward looking statements , whether because of new information , future events or otherwise .

Speaker #2: This conference call contains time sensitive information and speaks only as of the live broadcast today , November 19th , 2025 . In addition , during the course of this call , we'll metrics that are discuss certain non-GAAP measures and refer you to the reconciliation tables and other information about these non-GAAP included in the earnings measures press release that we issued earlier this morning .

Speaker #2: I will now turn the call over to IceCure Medical Ltd. CEO at . Please go ahead .

Operator: This conference call contains time-sensitive information and speaks only as of the live broadcast today, 19 November 2025. In addition, during the course of this call, we'll discuss certain metrics that are non-GAAP measures and refer you to the reconciliation tables and other information about these non-GAAP measures included in the earnings press release that we issued earlier this morning. I will now turn the call over to IceCure Medical CEO, Ayal Shamir. Ayal, please go ahead. Thanks, Michael, and hello everyone, and thank you for joining us today to review the results for the first nine months of 2025. During the third quarter, we remained focused and executed across multiple fronts, including commercial operations, technology, intellectual property, and regulatory matters. In October, we announced the most significant milestone in IceCure history thus far when the FDA granted marketing authorization for our ProSense cryoablation system to treat low-risk breast cancer.

Speaker #3: Thanks , Michael . And hello , everyone , and thank you for joining us today to review the results of the first nine months of 2025 .

Speaker #3: During the third quarter , we remained focused on executed the gross multiple front , including commercial operations , technology , intellectual property , and regulatory matters .

Speaker #3: In October, we announced the most significant milestone in ICU history thus far, when the FDA granted marketing authorization for our presence Cryoablation system to treat low-risk breast cancer.

Eyal Shamir: Thanks, Michael, and hello everyone, and thank you for joining us today to review the results for the first nine months of 2025. During the third quarter, we remained focused and executed across multiple fronts, including commercial operations, technology, intellectual property, and regulatory matters. In October, we announced the most significant milestone in IceCure history thus far when the FDA granted marketing authorization for our ProSense cryoablation system to treat low-risk breast cancer.

Speaker #3: This authorization validates the clinical research we have invested in over many years and positions ICU at the forefront of minimally invasive breast cancer care.

Speaker #3: As a reminder , the authorization is for women aged 70 and older with tumors up to 1.5cm or receiving endocrine adjuvant therapy , including women who are not eligible for surgery .

Operator: This authorization validates the clinical research we have invested in over many years and positions IceCure at the forefront of minimally invasive breast cancer care. As a reminder, the authorization is for women aged 70 and older with tumors up to 1.5cm who are receiving adjuvant endocrine therapy, including women who are not eligible for surgery. The indication covers a population of roughly 46,000 women in the US over 70 years of age diagnosed each year, plus an estimated 88,000 patients who are not candidates or willing to go through surgery, and patients that can be treated for palliative purposes. By addressing the needs of patients we cannot or choose not to undergo surgery, ProSense offers an important alternative to treat cancer that was not previously available to those patients. Additionally, 10% of women are diagnosed with benign breast tumors annually, and of those, approximately 63,000 US.

This authorization validates the clinical research we have invested in over many years and positions IceCure at the forefront of minimally invasive breast cancer care. As a reminder, the authorization is for women aged 70 and older with tumors up to 1.5cm who are receiving adjuvant endocrine therapy, including women who are not eligible for surgery. The indication covers a population of roughly 46,000 women in the US over 70 years of age diagnosed each year, plus an estimated 88,000 patients who are not candidates or willing to go through surgery, and patients that can be treated for palliative purposes. By addressing the needs of patients we cannot or choose not to undergo surgery, ProSense offers an important alternative to treat cancer that was not previously available to those patients. Additionally, 10% of women are diagnosed with benign breast tumors annually, and of those, approximately 63,000 US.

Speaker #3: They indication covers a population of roughly 46,000 women in the US . Over 70 years , of age , diagnosed each year , plus an estimated who 88,000 patients candidates or willing to go through surgery and patients that can be treated for palliative purposes by addressing the needs of patients , we cannot or choose not to undergo surgery .

Speaker #3: Crossens offer an important alternative to treat cancer that was not previously available to those patients . Additionally , 10% of women are diagnosed with benign breast tumors annually and of these , approximately 63,000 US women operated to remove the benign breast tumors via a surgery treatment which called lumpectomy .

Speaker #3: Collectively , this is a significant addressable market for presence of roughly 200,000 patients annually , representing a significant opportunity ahead for high skill .

Speaker #3: The response the FDA decision has been extremely encouraging . We are seeing growing interest from the US clinicians , including breast surgeons , interventional radiologists and breast radiologists , many of whom are requesting demonstration and installation .

Operator: Women operated to remove the benign breast tumors via a surgery treatment, which is called lumpectomy. Collectively, this is a significant addressable market for ProSense of roughly 200,000 patients annually, representing a significant opportunity ahead for IceCure. The response to the FDA decision has been extremely encouraging. We are seeing growing interest from US clinicians, including breast surgeons, interventional radiologists, and breast radiologists, many of whom are requesting demonstration and installation. Our US commercial team is focused on expanding ProSense installation, treatment volume, and utilization. We believe IceCure is well positioned at this time for reasons including the fact that the FDA marketing authorization established that any other company wishing to file for a 510(k) marketing authorization for a different cryoablation system to treat breast cancer will be required to submit five years of follow-up data, use a liquid nitrogen-based system, and use probes that are 10 gauge.

Women operated to remove the benign breast tumors via a surgery treatment, which is called lumpectomy. Collectively, this is a significant addressable market for ProSense of roughly 200,000 patients annually, representing a significant opportunity ahead for IceCure. The response to the FDA decision has been extremely encouraging. We are seeing growing interest from US clinicians, including breast surgeons, interventional radiologists, and breast radiologists, many of whom are requesting demonstration and installation. Our US commercial team is focused on expanding ProSense installation, treatment volume, and utilization. We believe IceCure is well positioned at this time for reasons including the fact that the FDA marketing authorization established that any other company wishing to file for a 510(k) marketing authorization for a different cryoablation system to treat breast cancer will be required to submit five years of follow-up data, use a liquid nitrogen-based system, and use probes that are 10 gauge.

Speaker #3: Our US commercial team is focused on expanding , on expanding presence , installation , treatment , volume and utilization . We believe ICU is well positioned at this time for reasons including the fact that the FDA marketing authorization established that any other company wishing to file for a marketing authorization for a different cryoablation system to treat breast cancer will be required to submit five years of follow up data , use a liquid liquid nitrogen based system , and use probes that are ten gauge .

Speaker #3: So our knowledge no other company is currently conducting a breast cryoablation study in the US . Giving this We entry . barrier to believe presents will be the only cryoablation cleared in the US for breast cancer in foreseeable the future .

Speaker #3: the In US , we have over commercial over 20 commercial sites using presence prior to the FDA marketing authorization . We expect the number of commercial sites will increase organically in addition to the 30 clinical sites plan for our upcoming post-market study , we have submitted the study design to the for FDA review and will provide an update when we receive the FDA approvals to move forward with the post-market study .

Operator: To our knowledge, no other company is currently conducting a breast cryoablation study in the US. Given this significant barrier to entry, we believe ProSense will be the only cryoablation cleared in the US for breast cancer in the foreseeable future. In the US, we have over 20 commercial sites using ProSense prior to the FDA marketing authorization. We expect the number of commercial sites will increase organically, in addition to the 30 clinical sites planned for our upcoming post-market study. We have submitted the study design to the FDA for review and will provide an update when we receive the FDA approvals to move forward with the post-market study. As a reminder, the FDA approval to move—sorry, as a reminder, the clinical site while treating study patients with the benefit of reimbursement will also be available for any appropriate patients seeking ProSense cryoablation commercially.

To our knowledge, no other company is currently conducting a breast cryoablation study in the US. Given this significant barrier to entry, we believe ProSense will be the only cryoablation cleared in the US for breast cancer in the foreseeable future. In the US, we have over 20 commercial sites using ProSense prior to the FDA marketing authorization. We expect the number of commercial sites will increase organically, in addition to the 30 clinical sites planned for our upcoming post-market study. We have submitted the study design to the FDA for review and will provide an update when we receive the FDA approvals to move forward with the post-market study. As a reminder, the FDA approval to move—sorry, as a reminder, the clinical site while treating study patients with the benefit of reimbursement will also be available for any appropriate patients seeking ProSense cryoablation commercially.

Speaker #3: As a reminder , the FDA approval to move . Sorry . As a reminder , the clinical site , while treating study patients with the benefit of free of reimbursement , will also be available for appropriate patients seeking process .

Speaker #3: Cryoablation commercially , we expect this rollout to drive meaningful growth in both clinical use and product adoption . Presence . Currently benefit from a cyp3 code covering approximately 3800 In-facility costs .

Speaker #3: This is expected to increase to just over $4,000 in early January 2026 . That's improvement combined with the FDA authorization should support broader access to patients beyond the US .

Operator: We expect this rollout to drive meaningful growth in both clinical use and product adoption. ProSense currently benefits from a CPT-3 code covering approximately $3,800 in facility cost. This is expected to increase to just over $4,000 in early January 2026. This improvement, combined with the FDA authorization, should support broader access for patients. Beyond the US, we are experiencing a high level of global interest from clinicians in response to the FDA decision in markets where ProSense is already approved for breast cancer. Just a few days ago, we added Switzerland to our growing list of countries in which ProSense has been approved. At our office in Israel, we are currently hosting a visit from a distinguished Brazilian medical delegation. Their visit encompassed a clinical overview and a roundtable discussion featuring meeting with key opinion leaders and presentation regarding ongoing clinical trials for breast cryoablation.

We expect this rollout to drive meaningful growth in both clinical use and product adoption. ProSense currently benefits from a CPT-3 code covering approximately $3,800 in facility cost. This is expected to increase to just over $4,000 in early January 2026. This improvement, combined with the FDA authorization, should support broader access for patients. Beyond the US, we are experiencing a high level of global interest from clinicians in response to the FDA decision in markets where ProSense is already approved for breast cancer. Just a few days ago, we added Switzerland to our growing list of countries in which ProSense has been approved. At our office in Israel, we are currently hosting a visit from a distinguished Brazilian medical delegation. Their visit encompassed a clinical overview and a roundtable discussion featuring meeting with key opinion leaders and presentation regarding ongoing clinical trials for breast cryoablation.

Speaker #3: We are experiencing a high level of global interest from clinicians in response to the FDA decision in markets where presence is already approved for breast cancer .

Speaker #3: Just a few days ago , we added Switzerland to our growing list of countries in which presence has been approved . As for our office in Israel , we are currently hosting visit a from a distinguished Brazilian medical delegation .

Speaker #3: Their visit encompassed a clinical overview and a roundtable discussion featuring meeting with a key opinion leaders and presentation regarding ongoing clinical trials for breast cryoablation .

Speaker #3: The delegation , which includes five interventional radiologists and breast surgeons , also observed live clinical cases in Zion and Beilinson Medical Centers in Israel .

Speaker #3: In Brazil , the largest healthcare market in South America . Presence is approved for breast cancer as well as other indications , and we have a distribution agreement with a 6.6 million in sales expected over the next five years .

Operator: The delegation, which includes five interventional radiologists and breast surgeons, also observed live clinical cases in Nate Sion and Bailey Medical Centers in Israel. In Brazil, the largest healthcare market in South America, ProSense is approved for breast cancer as well as other indications, and we have a distribution agreement with $6.6 million in sales expected over the next five years. Furthermore, our global marketing and clinical team have been approached by numerous medical societies to ensure our participation in upcoming conferences in 2026. European and Asian medical societies are specifically adding breast cancer cryoablation master classes with ProSense. On the innovation front, we continue to make strong progress. In September 2025, our next-generation cryoablation system received regulatory approval in Israel for breast cancer and other indications. We recently secured a notice of patent allowance for Accent and its cryo probe in the US.

The delegation, which includes five interventional radiologists and breast surgeons, also observed live clinical cases in Nate Sion and Bailey Medical Centers in Israel. In Brazil, the largest healthcare market in South America, ProSense is approved for breast cancer as well as other indications, and we have a distribution agreement with $6.6 million in sales expected over the next five years. Furthermore, our global marketing and clinical team have been approached by numerous medical societies to ensure our participation in upcoming conferences in 2026. European and Asian medical societies are specifically adding breast cancer cryoablation master classes with ProSense. On the innovation front, we continue to make strong progress. In September 2025, our next-generation cryoablation system received regulatory approval in Israel for breast cancer and other indications. We recently secured a notice of patent allowance for Accent and its cryo probe in the US.

Speaker #3: Furthermore , our global our global marketing and clinical team have been approached by numerous medical societies to ensure our participation is in in upcoming conferences .

Speaker #3: In 2026 , European and Asian medical societies are specifically adding breast cancer Cryoablation masterclasses with present on the on the innovation front . We continue to make strong progress in September 2025 , our next generation Cryoablation system received regulatory approval in Israel for breast cancer and other indication .

Speaker #3: We recently secured a patent notice of allowance for accents and it's cryoprobe in the US and in Japan . Further strengthen the intellect , intellectual property portfolio persons continue to gain significant visibility and at leading medical conferences around the world .

Speaker #3: Since the beginning of the third quarter , it was featured at 2025 , the Japanese Breast Cancer Society conference , the European Society of Breast Imaging Congress , and the aptitude , Health Stake .

Operator: In Japan, further strengthening the intellectual property portfolio. ProSense continued to gain significant visibility at leading medical conferences around the world. Since the beginning of the third quarter, it was featured at CIRSA 2025, the Japanese Breast Cancer Society Conference, the European Society of Breast Imaging Congress, and the Aptitude HealthStake: The Lead in the Breast Cancer Care Fold Summit in New Orleans. In addition, we are partnered with Cariggi Hospital in Florence, Italy, and conducted a two-day course of theoretical and hands-on training for physicians from across the globe, helping to broaden adoption and expertise for breast cancer cryoablation. Finally, an ongoing clinical validation continues to reinforce the safety and the effectiveness of our technology.

In Japan, further strengthening the intellectual property portfolio. ProSense continued to gain significant visibility at leading medical conferences around the world. Since the beginning of the third quarter, it was featured at CIRSA 2025, the Japanese Breast Cancer Society Conference, the European Society of Breast Imaging Congress, and the Aptitude HealthStake: The Lead in the Breast Cancer Care Fold Summit in New Orleans. In addition, we are partnered with Cariggi Hospital in Florence, Italy, and conducted a two-day course of theoretical and hands-on training for physicians from across the globe, helping to broaden adoption and expertise for breast cancer cryoablation. Finally, an ongoing clinical validation continues to reinforce the safety and the effectiveness of our technology.

Speaker #3: The lead in the Breast Cancer Care Fall Summit in New Orleans . In addition , we are partnered with Carnegie Hospital in Florence , Italy , and conducted a two day course of theoretical and hands on training for physicians from across the globe , helping to broaden adoption and expertise for breast cancer .

Speaker #3: Cryoablation . Finally , an ongoing clinical validation continues to reinforce the safety and the effectiveness of our technology during and following the end .

Speaker #3: The the end of the third quarter alone . 13 independent studies in breast cancer were presented and published , as well as data in encouraging lung cancer and endometriosis .

Speaker #3: Further demonstrating the versatility and clinical value of present in addition to the recent approval in Switzerland , we are also advancing our global regulatory strategy .

Operator: During and following the end of the third quarter alone, 13 independent studies in breast cancer were presented and published, as well as encouraging data in lung cancer and endometriosis, further demonstrating the versatility and clinical value of ProSense. In addition to the recent approval in Switzerland, we are also advancing our global regulatory strategy. Our partner in Japan, Terumo Corporation, planned to submit a regulatory application for ProSense in the treatment of breast cancer in the first half of 2026, marking an important step in expanding access to ProSense in new international markets. In summary, we believe IceCure is entering an exciting growth phase. We are implementing our sales and marketing strategy in the US to target a patient population of about 200,000 women annually. To drive and accelerate growth, we will continue to expand clinical evidence, improve reimbursement, and enter new markets.

During and following the end of the third quarter alone, 13 independent studies in breast cancer were presented and published, as well as encouraging data in lung cancer and endometriosis, further demonstrating the versatility and clinical value of ProSense. In addition to the recent approval in Switzerland, we are also advancing our global regulatory strategy. Our partner in Japan, Terumo Corporation, planned to submit a regulatory application for ProSense in the treatment of breast cancer in the first half of 2026, marking an important step in expanding access to ProSense in new international markets. In summary, we believe IceCure is entering an exciting growth phase. We are implementing our sales and marketing strategy in the US to target a patient population of about 200,000 women annually. To drive and accelerate growth, we will continue to expand clinical evidence, improve reimbursement, and enter new markets.

Speaker #3: Our partner in Japan , Terumo Corporation , plans to submit a regulatory application for the presence in the treatment of breast cancer in the first half of 2026 , marking an important step expanding access to presence in New international markets .

Speaker #3: In summary , we believe Ecco is entering an exciting growth phase . We are implementing our sales and marketing strategy in the US to target patient population of about 200,000 women annually to drive an accelerate growth , we will continue to expand clinical evidence , improve reimbursement and enter new markets .

Speaker #3: We are confident in both patients and shareholders . I will now turn the call over to Ronan .

Speaker #4: Ian , Thank you . for the nine months ended September 30th , 2025 . Revenue was $2.1 million compared to $2.4 million for the same period in 2020 .

Speaker #4: For revenue for the first nine months of 2024 , included $100,000 from our exclusive distribution agreement and other services with Terumo . Our distributor in Japan .

Operator: We are confident in both patients and shareholders. I will now turn the call over to Ronen. Thank you, Ayal. For the nine months ended 30 September 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024. Revenue for the first nine months of 2024 included $100,000 from our exclusive distribution agreement and other services with Terumo, our distributor in Japan, while no Terumo revenue was booked during the first nine months of 2025. We had a $316,000 decrease in sales during the nine months ended 30 September 2025, due to a decrease in sales in Japan, other territories in Asia, and North America, partially offset by an increase in sales in Latin America. As we have said in the past, we expect fluctuations in quarterly revenue as commercial activities ramp in the US.

We are confident in both patients and shareholders. I will now turn the call over to Ronen.

Speaker #4: While not a revenue , was booked during the first nine months of 2025 . We had $316,000 decrease in sales during the nine months ended September 30th , 2025 , due to a decrease in sales in Japan .

Ronen Tsimerman: Thank you, Ayal. For the nine months ended 30 September 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024. Revenue for the first nine months of 2024 included $100,000 from our exclusive distribution agreement and other services with Terumo, our distributor in Japan, while no Terumo revenue was booked during the first nine months of 2025. We had a $316,000 decrease in sales during the nine months ended 30 September 2025, due to a decrease in sales in Japan, other territories in Asia, and North America, partially offset by an increase in sales in Latin America. As we have said in the past, we expect fluctuations in quarterly revenue as commercial activities ramp in the US.

Speaker #4: Other territories in Asia and North America , partially offset by an increase in sales in Latin America . As we have said in the past , we expect fluctuations in quarterly revenue as commercial activities ramp in the US and .

Speaker #4: globally Following the FDA's marketing clearance for process in low risk breast cancer , gross profit for the nine months ended September 30th , 2025 was $626,000 , compared to $1,034,000 in the prior year period .

Speaker #4: This resulted in a gross margin of 30% versus 43% in the same period in 2024, as we previously communicated. We expect gross profit may continue to improve quarter to quarter as the company focuses on building scale in commercial sales.

Operator: Globally following the FDA's marketing clearance for ProSense in low-risk breast cancer, gross profit for the nine months ended 30 September 2025 was $626,000 compared to $1,034,000 in the prior year period. This resulted in a gross margin of 30% versus 43% in the same period in 2024. As we previously communicated, we expect gross profit may continue to vary quarter to quarter as the company focuses on building commercial-scale sales. Overall, total operating expenses decreased to $11.5 million for the nine months ended 30 September 2025, compared to $12.2 million a year ago. This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution. Net loss for the nine months ended 30 September 2025 was $10.8 million or $0.18 per share, relatively the same as net loss of $10 million or $0.22 for the same period last year.

Globally following the FDA's marketing clearance for ProSense in low-risk breast cancer, gross profit for the nine months ended 30 September 2025 was $626,000 compared to $1,034,000 in the prior year period. This resulted in a gross margin of 30% versus 43% in the same period in 2024. As we previously communicated, we expect gross profit may continue to vary quarter to quarter as the company focuses on building commercial-scale sales. Overall, total operating expenses decreased to $11.5 million for the nine months ended 30 September 2025, compared to $12.2 million a year ago. This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution. Net loss for the nine months ended 30 September 2025 was $10.8 million or $0.18 per share, relatively the same as net loss of $10 million or $0.22 for the same period last year.

Speaker #4: Overall, total operating expenses decreased to $11.5 million for the nine months ended September 30, 2025, compared to $12.2 million a year ago.

Speaker #4: This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution. Net loss for the nine months ended September 30, 2025, was $10.8 million, or $0.08 per share.

Speaker #4: Relatively the same as net loss of $10.8 million , or $0.22 , for the same period last year . As of September 30th , 2025 , we had $10 million in cash .

Speaker #4: Cash equivalents and short term deposits , compared to $7.6 million as of December 31st , 2024 . In July 2025 , we completed a rights offering which was approximately two times oversubscribed , raising $10 million in gross proceeds to support commercialization of process and systems .

Speaker #4: During the first ten months of 2025 , we raised approximately $5.87 million in net proceeds from the sales of 5.4 million ordinary shares through an eight market offering facility , bringing our cash balance as of October 31st , 2025 to $11.8 million .

Operator: As of 30 September 2025, we had $10 million in cash, cash equivalents, and short-term deposits compared to $7.6 million as of 31 December 2024. In July 2025, we completed a rights offering, which was approximately two times oversubscribed, raising $10 million in gross profit to support commercialization of the ProSense system. During the first 10 months of 2025, we raised approximately $5.87 million in net profits from the sales of $5.4 million ordinary share through an at-the-market offering facility, bringing our cash balance as of 31 October 2025 to $11.8 million. We believe this puts us in a stronger financial position to continue executing across our regulatory, clinical, and commercial initiatives. Operator, we will now open the call for Q&A. Thank you. We have time for a couple of questions. If you have a question, please press Star 1. If you wish to cancel your request, please press Star 2.

As of 30 September 2025, we had $10 million in cash, cash equivalents, and short-term deposits compared to $7.6 million as of 31 December 2024. In July 2025, we completed a rights offering, which was approximately two times oversubscribed, raising $10 million in gross profit to support commercialization of the ProSense system. During the first 10 months of 2025, we raised approximately $5.87 million in net profits from the sales of $5.4 million ordinary share through an at-the-market offering facility, bringing our cash balance as of 31 October 2025 to $11.8 million. We believe this puts us in a stronger financial position to continue executing across our regulatory, clinical, and commercial initiatives. Operator, we will now open the call for Q&A.

Speaker #4: We believe this puts us in a stronger financial position to continue executing across our regulatory , clinical and commercial and initiatives . Operator we will now open the call for Q&A .

Speaker #1: Thank you . We have time for a couple of questions . If you have a question , please press star one . If you wish to cancel your request , please press star two .

Speaker #1: If you are using speaker equipment , kindly leave the handset before pressing the numbers . Your questions will be pulled in the order they are received .

Speaker #1: Please stand by while we call for your questions . The first question is from Anthony Vendetti of Maxim Group . Please go ahead

Operator: Thank you. We have time for a couple of questions. If you have a question, please press Star 1. If you wish to cancel your request, please press Star 2.

Speaker #1: .

Speaker #5: Thank

Speaker #5: you . Y'all running ? I just want to just find out where where it's with the at FDA for approval . The post-market study .

Operator: If you are using speaker equipment, kindly lift the hands before pressing the numbers. Your questions will be called in the order they are received. Please stand by while we pull for your questions. The first question is from Anthony Vendetti of Maxim Group. Please go ahead. Thank you, Ayal. Ronan, I just want to just find out where it's at with the FDA for approval of the post-market study. I know you're awaiting that final approval. Has there been any communication with them, or are you just kind of in a wait-and-see mode? Hi, Anthony. Good morning. As I described in my part, we submitted the protocol to the FDA, and we started interactive communication with them in order to finalize it. The official protocol, with all other elements, is already submitted to the FDA. Okay.

If you are using speaker equipment, kindly lift the hands before pressing the numbers. Your questions will be called in the order they are received. Please stand by while we pull for your questions. The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Speaker #5: I know you're awaiting that final approval . Has there been any communication with them , or are you just . You're just kind of in a wait and see mode .

Speaker #3: Hi , Anthony . Good morning . As as I describe in my part , we submitted the protocol to the FDA and we started interactive communication with them in order to finalize it .

Anthony Vendetti: Thank you, Ayal. Ronan, I just want to just find out where it's at with the FDA for approval of the post-market study. I know you're awaiting that final approval. Has there been any communication with them, or are you just kind of in a wait-and-see mode?

Speaker #3: But the official protocol with all other elements already submitted to the FDA .

Speaker #5: Okay , so there's they have indicated or there's not necessarily a an expected timeline of when they'll officially sign off on it , but you've identified 30 sites and , well , there's 30 sites that you need .

Eyal Shamir: Hi, Anthony. Good morning. As I described in my part, we submitted the protocol to the FDA, and we started interactive communication with them in order to finalize it. The official protocol, with all other elements, is already submitted to the FDA.

Speaker #5: I believe in the last quarter, you said 20 have been identified. Could you give us an update on those numbers, please?

Anthony Vendetti: Okay. They haven't indicated, or there's not necessarily an expected timeline of when they'll officially sign off on it. You've identified 30 sites, and, well, there's 30 sites that you need. I believe in the last quarter, you said 20 have been identified. Can you give us an update on those numbers, please?

Speaker #3: Yeah , yeah , we have about 20 sites that are identified . We are adding adding more of that . But it's mainly around the clinical protocol .

Operator: They haven't indicated, or there's not necessarily an expected timeline of when they'll officially sign off on it. You've identified 30 sites, and, well, there's 30 sites that you need. I believe in the last quarter, you said 20 have been identified. Can you give us an update on those numbers, please? Yeah. Yeah. We have about 20 sites that are identified. We are adding more of that, but it's mainly around the clinical protocol, the statistical analysis plan, and the claim database. We are working on all elements. I believe that more or less by the end of the year, maybe the shutdown delay a bit, but by the end of the year, very early next year, we will get the final approval.

Speaker #3: The statistical analysis plan and the claim database . So we are working on all elements . And I believe that more or less by the end of the year , you know , maybe the shutdown delay a bit , but by the end of the year , very early next year , we will get the final approval .

Eyal Shamir: Yeah. Yeah. We have about 20 sites that are identified. We are adding more of that, but it's mainly around the clinical protocol, the statistical analysis plan, and the claim database. We are working on all elements. I believe that more or less by the end of the year, maybe the shutdown delay a bit, but by the end of the year, very early next year, we will get the final approval.

Speaker #3: And then by summer 26 , we will need to or maybe before , but not later than summer 26 . We need to recruit the first patient 20% , which is 80 patients by end of 2026 .

Speaker #5: That that certainly seems like a very easy hurdle in this in this press release , you mentioned that there might be even more patients that that could benefit from Cryoablation because the ones that are low risk , over 70 .

Operator: By summer 2026, we will need to, or maybe before, but not later than summer 2026, we need to recruit the first patient, 20%, which is 80 patients by end of 2026. That certainly seems like a very easy hurdle. In this press release, you mentioned that there might be even more patients that could benefit from cryoablation because the ones that are low risk, over 70, I think was originally identified as around 46,000. In this press release, you said there's 88,000 additional patients that could benefit, as well as another 63,000 that could be treated for benign tumors as well. Is that new information? Maybe just elaborate on that, please. Thanks. Yeah. Anthony, if you remember, part of our grant letter authorization letter that we got from the FDA contained two parts.

By summer 2026, we will need to, or maybe before, but not later than summer 2026, we need to recruit the first patient, 20%, which is 80 patients by end of 2026.

Speaker #5: You know , I think was we originally I think was originally identified as around 46,000 , but in this press release , you said there's 88,000 additional patients that could benefit as well as another 63,000 that could be treated for benign tumors , as well .

Anthony Vendetti: That certainly seems like a very easy hurdle. In this press release, you mentioned that there might be even more patients that could benefit from cryoablation because the ones that are low risk, over 70, I think was originally identified as around 46,000. In this press release, you said there's 88,000 additional patients that could benefit, as well as another 63,000 that could be treated for benign tumors as well. Is that new information? Maybe just elaborate on that, please. Thanks.

Speaker #5: Is that is that new information and maybe just elaborate on that , please . Thanks .

Speaker #3: Yeah . So part Anthony , if you remember , part of our grant letter , authorization letter that we got from the FDA contained like two parts , one of them is a low risk early stage for patients who are 70 and older , up to 1.5cm .

Speaker #3: This , as you mentioned , represents about 46,000 new patients every year in the US . And the second part , which is due also to the breakthrough device designation that I got in 2021 , is patients who are not eligible for surgery .

Eyal Shamir: Yeah. Anthony, if you remember, part of our grant letter authorization letter that we got from the FDA contained two parts.

Operator: One of them is a low-risk early stage for patients who are 70 and older, up to 1.5cm. This, as you mentioned, represents about 46,000 new patients every year in the US. The second part, which is due also to the breakthrough device designation that IceCure got in 2021, is patients who are not eligible for surgery. It could be patients with comorbidities that they cannot take them to the OR and put them under general. Patients who are not willing to do surgeries. Patients that maybe even they are in a stage that it's less curable, but more as a palliation treatment. According to all the evidence from CIRS and other evidence, we believe that the number is 88,000 new patients every year in the US for those who are nonsurgical or not willing to do.

One of them is a low-risk early stage for patients who are 70 and older, up to 1.5cm. This, as you mentioned, represents about 46,000 new patients every year in the US. The second part, which is due also to the breakthrough device designation that IceCure got in 2021, is patients who are not eligible for surgery. It could be patients with comorbidities that they cannot take them to the OR and put them under general. Patients who are not willing to do surgeries. Patients that maybe even they are in a stage that it's less curable, but more as a palliation treatment. According to all the evidence from CIRS and other evidence, we believe that the number is 88,000 new patients every year in the US for those who are nonsurgical or not willing to do.

Speaker #3: It could be patients with comorbidities that that they cannot take them to the Or and put them under general patients who are not willing to do surgeries , and patients that that may be even they are in a stage that is a less curable but more as a palliation treatment .

Speaker #3: According all the evidence from seals and other other evidence , we believe that the number is 88,000 new patients every year in the US .

Speaker #3: For those who are non-surgical or not willing to do and the and benign breast tumors that now new our users that the most drive is of course breast cancer .

Speaker #3: But those hospitals clinics , breast surgeons and breast radiologists seeing also younger patients again a 1 million new patients every year , mainly from the age of 21 to 35 , suffering from benign tumors and about 63,000 of them are surgically removed .

Operator: The benign breast tumors that now our new users, the most drive is, of course, breast cancer. Those hospitals, clinics, breast surgeons, and breast radiologists are seeing also younger patients. Again, 1 million new patients every year, mainly from the age of 21 to 35, suffering from benign tumors. About 63,000 of them are surgically removed. We believe that part of this addressable market could be replaced by cryoablation as a minimally invasive because those younger patients, body image, bikini line is extremely important for them. From the outpatient facility fee, it's the same coverage, which in January will be about $4,000. For that, we have a specific indication and also a specific, even CPT-1 code for benign breast tumors. All of that giving us a potential addressable market of over 200,000 new patients every year just in the US.

The benign breast tumors that now our new users, the most drive is, of course, breast cancer. Those hospitals, clinics, breast surgeons, and breast radiologists are seeing also younger patients. Again, 1 million new patients every year, mainly from the age of 21 to 35, suffering from benign tumors. About 63,000 of them are surgically removed. We believe that part of this addressable market could be replaced by cryoablation as a minimally invasive because those younger patients, body image, bikini line is extremely important for them. From the outpatient facility fee, it's the same coverage, which in January will be about $4,000. For that, we have a specific indication and also a specific, even CPT-1 code for benign breast tumors. All of that giving us a potential addressable market of over 200,000 new patients every year just in the US.

Speaker #3: So we believe that part of this addressable market could be replaced by cryoablation as a minimally invasive option, because for younger patients, both the image and the bikini line are extremely important for them from the outpatient facility fee.

Speaker #3: It's the same coverage which in general will be about $4,000 . And for that we have a specific indication and also a specific even CPT one code for for benign breast tumor .

Speaker #3: So, all of that gives us a potential addressable market of over 200,000 new patients every year, just in the U.S.

Speaker #1: Are there any additional questions? Please press star one if you wish to cancel your request; please press star two. Please stand by while we pull for more questions.

Speaker #1: There are no further questions at this time . I will turn the call over to a Shamir . For concluding remarks .

Speaker #3: Thank you for joining our call today and for the great questions. We believe the FDA marketing authorization has dramatically changed our growth trajectory.

Operator: If there are any additional questions, please press Star 1. If you wish to cancel your request, please press Star 2. Please stand by while we pull for more questions. There are no further questions at this time. I will turn the call over to Ayal Shamir for concluding remarks. Thank you for joining our call today and for the great questions. We believe the FDA marketing authorization has dramatically changed our growth trajectory. We look forward to keeping you all updated as we continue to execute on our commercial rollout of ProSense in the US and globally. Have a great day, everyone. For those in the US, have a happy Thanksgiving. Thank you. This concludes the IceCure Q3 2025 results conference call. Thank you for your participation. You may go ahead and disconnect.

Speaker #3: We look forward to keeping you all updated as we continue to execute on our commercial rollout of presence in the US and globally .

Speaker #3: great Have a day . Everyone . And for those in the US . Have a Happy Thanksgiving . Thank you .

Eyal Shamir: Thank you for joining our call today and for the great questions. We believe the FDA marketing authorization has dramatically changed our growth trajectory. We look forward to keeping you all updated as we continue to execute on our commercial rollout of ProSense in the US and globally. Have a great day, everyone. For those in the US, have a happy Thanksgiving. Thank you.

Operator: This concludes the IceCure Q3 2025 results conference call. Thank you for your participation. You may go ahead and disconnect.

Q3 2025 Icecure Medical Ltd Earnings Call

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