Icecure Medical Ltd (ICCM) 2025 Q2 法說會逐字稿

(Operator Instructions)

（操作員指示）

I would now like to hand over the call to Michael Polyviou. Please go ahead.

現在我想把電話交給 Michael Polyviou。請繼續。

Thank you, Janni, and welcome to Icecure Medical's conference call to review the financial results as of and for the six months ended June 30, 2025 and provide an update on recent operational highlights.

謝謝 Janni，歡迎參加 Icecure Medical 的電話會議，回顧截至 2025 年 6 月 30 日的六個月的財務業績，並提供近期營運亮點的最新資訊。

You may refer to the earnings press release that we issued earlier this morning.

您可以參考我們今天早上發布的收益新聞稿。

Participating on today's call are Icecure Medical CEO, Eyal Shamir and the company's CFO and COO Ronen Tsimerman.

參加今天電話會議的有 Icecure Medical 執行長 Eyal Shamir 和公司財務長兼營運長 Ronen Tsimerman。

Before we begin, I'll not take a moment to read a statement about statements. This call in the question and answer session that follows it contains photo statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.

在我們開始之前，我不會花一點時間來閱讀有關聲明的聲明。本次電話會議及其後的問答環節中包含了符合 1995 年《私人證券訴訟改革法案》和其他聯邦證券法的安全港條款含義的照片聲明。

Words such as expects, anticipates, intents, plans, beliefs, seeks, estimates, and similar expressions or variations of such words are intended to identify the statements.

諸如預期、預期、意圖、計劃、信念、尋求、估計等詞語以及類似的表達或此類詞語的變體旨在識別這些陳述。

For example, we are using following statements in this presentation when we discussed that the company is optimistic that regulatory approval for process will be granted before year-end 2025. The expectation that there is more clinical data forthcoming from independent researchers.

例如，當我們討論公司對在 2025 年底之前獲得該流程的監管批准持樂觀態度時，我們在本次演示中使用了以下陳述。期望獨立研究人員提供更多臨床數據。

The belief that the recent rights offering is a strong indicator in a vote of confidence from the company's shareholders and that it will provide a sufficient cash runway for the anticipated FDA marketing authorization decision.

人們相信，最近的配股發行是公司股東信任投票的有力指標，並將為預期的 FDA 行銷授權決定提供充足的現金流。

The expectation that revenue and gross profits may continue to vary quarter to quarter as the company focuses on building commercial sales, commercial scale sales. The belief that the company's growth trajectory could meaningfully accelerate upon receiving the FDA's decision.

由於公司專注於建立商業銷售和商業規模銷售，因此預計收入和毛利可能會繼續逐季度變化。人們相信，在收到 FDA 的決定後，該公司的成長軌跡可能會顯著加速。

The company's upcoming presentation at the HC Wainwright and Company conference participation Maxim Group LLC's conference, and the belief that the company's cash equivalent and short-term deposits positions it in a strong financial position to continue executing across regulatory, clinical, and commercial initiatives.

該公司即將在 HC Wainwright and Company 會議參與 Maxim Group LLC 的會議上進行演示，並且相信該公司的現金等價物和短期存款使其處於強大的財務狀況，可以繼續執行監管、臨床和商業計劃。

The further look at statements contained or replied during this call is 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 20-F for the year in December 31, 2024, filed Securities and Exchange commission on March 27, 2025, which is available on the SEC's website at www.SEC.gov.

對本次電話會議中包含或回應的聲明的進一步審查受到其他風險和不確定因素的影響，其中許多風險和不確定因素超出了公司的控制範圍，包括公司於 2025 年 3 月 27 日向美國證券交易委員會提交的截至 2024 年 12 月 31 日的 20-FSEC 年度報告中查看該交易委員會不確定.gov.

The company disclaims any intention or obligation except as required by law to update or revise any further statements, whether because of new information, future events, or otherwise. This conference call contains time sensitive information and speaks only as of the live broadcast today, August 13, 2025. In addition, during the course of the call, we will discuss certain metrics that are non-gap measures and refer you to the creation 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 Al Shamir. Eyal, please go ahead.

除法律要求更新或修改任何進一步聲明外，本公司不承擔任何意圖或義務，無論是由於新資訊、未來事件或其他原因。本次電話會議包含時間敏感訊息，僅代表截至今天（2025 年 8 月 13 日）現場直播的內容。此外，在通話過程中，我們將討論某些非差距衡量指標，並請您參閱我們今天早上發布的收益新聞稿中包含的有關這些非 GAAP 衡量指標的創建表和其他資訊。現在我將電話轉給 Icecure Medical 執行長 Al Shamir。埃亞爾，請繼續。

Thanks, Michael, and hello everyone, and thank you for joining us today to review our results for the first half of 2025.

謝謝，邁克爾，大家好，感謝您今天加入我們，回顧我們 2025 年上半年的業績。

This is a pivotal time for ICU as we are experiencing momentum building across several fronts, including regulatory, clinical, and commercial.

這是 ICU 的關鍵時刻，因為我們正在監管、臨床和商業等多個方面經歷勢頭的增強。

Let me begin with our regulatory progress in the US for persons for the very important indication of early stage low risk breast cancer in women aged 70 and over combined with adjuvant endocrine therapy. We believe that this is a significant opportunity to change the paradigm of breast cancer care for the estimated of 46,000 women in the US annually with the alternative to a lumpectomy.

首先，我要介紹美國針對 70 歲及以上女性早期低風險乳癌合併輔助內分泌治療這一非常重要的適應症的監管進展。我們相信，這是一個重要的機會，可以透過乳房腫瘤切除術的替代治療來改變美國每年約 46,000 名女性的乳癌治療模式。

In the second quarter, we concluded a productive meeting with leadership at the FDA Center of Devices and Radiological Health regarding our De Novo marketing authorization request. Importantly, the FDA requested a post-market study to be conducted after marketing authorization has been granted.

在第二季度，我們與 FDA 設備和放射健康中心的領導層就我們的 De Novo 行銷授權請求進行了富有成效的會議。重要的是，FDA 要求在授予行銷授權後進行上市後研究。

The post-market study has been fully submitted to the FDA. We believe the plan reflects a comprehensive and well structured approach. We were asked to provide additional information which we are actively working to complete. Assuming the FDA funds the supplemental data satisfactory, we remain optimistic that approval will be granted before year end 2025.

上市後研究已全部提交給 FDA。我們相信該計劃體現了一種全面且結構良好的方法。我們被要求提供更多信息，我們正在積極努力完成。假設 FDA 對補充數據的資助令人滿意，我們仍然樂觀地認為該藥物將在 2025 年底前獲得批准。

Meanwhile, we are also experiencing a positive shift in adoption in Europe, especially in breast cancer cryoablation.

同時，我們也經歷了歐洲採用的正向轉變，特別是在乳癌冷凍消融領域。

While pros is already approved in Europe, several indications including breast cancer, we believe the increase in usage for breast cancer is being driven by the ICE3 results and the growing body of independent. Clinical evidence. We are aware of many more studies and expect more clinical data will be forthcoming from independent researchers that our commercial team is prepared to leverage to drive further adoption and utilization.

雖然 pros 已在歐洲獲得批准，用於治療包括乳癌在內的多種疾病，但我們認為，乳癌用藥量的增加是由 ICE3 結果和越來越多的獨立機構推動的。臨床證據。我們了解到還有更多的研究，並期望獨立研究人員能夠提供更多的臨床數據，我們的商業團隊準備利用這些數據來推動進一步的採用和利用。

ProSense were featured prominently during the second quarter and several high impact medical forums, including the American Breast Surgeon's annual conference, Society of Breast Imaging Symposium, and the European Conference on Interventional Oncology, demonstrating the growing interest in process during the Society of Breast Imaging symposium, both ends on breast cryoablation training courses were sold out.

ProSense 在第二季和幾個高影響力的醫學論壇上表現出色，包括美國乳房外科醫生年會、乳房影像學會研討會和歐洲介入性腫瘤學會議，顯示人們對乳房影像學會研討會期間的流程的興趣日益濃厚，乳房冷凍消融訓練課程的門票也已售罄。

At the European Conference on Interventional encouraging, our technology was featured in a separate events, including data showing that 91% of patients would choose ablation over breast conserving surgery. Earlier in this quarter ,ProSense was featured at the Japanese Breast Cancer Society conference, which during the conference, a respected expert and ProSense user, Professor Fukuma, presented 17 years of data from over 600 breast cancer patients showing a 99% recurrence free rate with cryoablation. We'd like to repeat this message of this amazing follow up and results. 17 years of follow up for over 600 breast cancer patients showing only 1% recurrence, which means 99% recurrence rate, which is the biggest global clinical evidence using our technology.

在歐洲介入會議上，我們的技術在單獨的活動中得到了展示，令人鼓舞，其中的數據顯示 91% 的患者會選擇消融而不是乳房保留手術。本季度早些時候，ProSense 在日本乳癌協會會議上亮相，會議期間，受人尊敬的專家和 ProSense 用戶福間教授展示了來自 600 多名乳癌患者的 17 年數據，顯示冷凍消融的無復發率為 99%。我們想重申這驚人的追蹤和結果。對超過 600 名乳癌患者進行 17 年的跟踪，結果顯示僅有 1% 的復發率，這意味著 99% 的復發率，這是使用我們的技術獲得的最大的全球臨床證據。

In summary, we are executing and laying the groundwork for future success.

總而言之，我們正在執行並為未來的成功奠定基礎。

Recently we strengthened our financial position with the closing of our $10 million rights offering that was significantly oversubscribed. We believe that this is a strong indicator and a vote of confidence from our shareholder. We expect this to provide a sufficient cash runway for the anticipated FDA marketing authorization decision. Our largest shareholder and a board member, Mr. Li Heijiang of Epoch Partner Investment Limited, participated in the rights offering. I will now turn the call over to Ronen.

最近，我們完成了 1000 萬美元的配股發行，獲得了大幅超額認購，從而增強了我們的財務狀況。我們相信這是一個強而有力的指標，也是股東對我們的信任投票。我們預計這將為預期的 FDA 行銷授權決定提供充足的現金流。我們的最大股東和董事會成員，Epoch Partner Investment Limited 的李黑江先生參與了此次配股。現在我將電話轉給羅南。

Thank you, Eyal.

謝謝你，埃亞爾。

For the six months ended June 30, 2025, revenue was about $1.25 million compared to $1.75 million for the same period in 2024. As previously disclosed, over $200,000 in product shipments originally scheduled for Q2 were delayed due to the Israeli-run conflict in June.

截至 2025 年 6 月 30 日的六個月，收入約為 125 萬美元，而 2024 年同期的收入為 175 萬美元。如前所述，由於 6 月以色列引發的衝突，原定於第二季度發貨的價值超過 20 萬美元的產品被推遲。

These will be recognized in the third quarter.

這些將在第三季度得到確認。

Gross profit for the first half of 2025 was $349,000 compared to $799,000 in the prior year period.

2025 年上半年毛利為 349,000 美元，去年同期為 799,000 美元。

This resulted in gross margin of 28% versus 46% in the first half of 2024.

這使得毛利率為 28%，而 2024 年上半年為 46%。

As we previously communicated, we expect revenue and gross profit may continue to vary quarter to quarter as the company focuses on building commercial scale sales.

正如我們之前所傳達的，由於公司專注於建立商業規模銷售，我們預計收入和毛利可能會繼續逐季度變化。

Overall, total operating expenses decreased to $7.39 million for the six month period compared to $7.68 million a year ago. This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution.

總體而言，六個月的總營運費用從一年前的 768 萬美元下降至 739 萬美元。這反映了我們在不犧牲商業或監管執行的情況下優化支出的努力。

Net loss for the first half of 2025 was $6.95 million or $0.12 per share compared to a net loss of $6.69 million or $0.14 per share in the same period last year.

2025 年上半年淨虧損為 695 萬美元，即每股 0.12 美元，而去年同期淨虧損為 669 萬美元，即每股 0.14 美元。

As of June 30, 2025 we had $5.38 million in cash equivalent and short term deposits which included a $2 million dollar loan from our major shareholder.

截至 2025 年 6 月 30 日，我們擁有 538 萬美元的現金等價物和短期存款，其中包括來自大股東的 200 萬美元貸款。

This excludes the $10 million in gross proceeds raised from our freights offering which closed at August 1, 2025.

這還不包括我們於 2025 年 8 月 1 日結束的貨運發行所籌集的 1,000 萬美元總收益。

During the first half of 2025, I raised $2.65 million in net proceeds from the sales of 2,127,961 ordinary shares under our the market offering facility.

2025 年上半年，我透過市場發行方式出售 2,127,961 股普通股，籌集了 265 萬美元的淨收益。

We believe this puts us in a stronger financial position to continue executing across our regulatory, clinical and commercial activities.

我們相信，這將使我們擁有更強大的財務狀況，從而繼續進行監管、臨床和商業活動。

We believe our growth trajectory could meaningfully accelerate upon receiving the FDA decision.

我們相信，在收到 FDA 的決定後，我們的成長軌跡可能會顯著加速。

To help raise awareness of IQ story and broaden investor engagement, Eyal and I will be presenting at the next month's HC Wainwright conference and we'll be participating at Maxim Conference in October.

為了幫助提高人們對 IQ 故事的認識並擴大投資者參與度，Eyal 和我將在下個月的 HC Wainwright 會議上發表演講，並將於 10 月參加 Maxim 會議。

Operator will now open the call for Q&A.

接線員現在將開啟電話問答環節。

(Operator Instructions)

（操作員指示）

Kemp Dolliver of Brookline Capital Markets.

布魯克林資本市場的 Kemp Dolliver。

Hi, good day.

你好，你好。

What's the nature of the additional information that FDA requested?

FDA 要求的補充資訊是什麼性質的？

Hi, Kemp. Good morning and thank you for your question. This is Eyal, the CEO. The FDA would like to get, quite important information around the post-market study.

你好，坎普。早安，感謝您的提問。這位是首席執行官 Eyal。FDA 希望獲得有關上市後研究的相當重要的資訊。

As we announced it's supposed to be, after granting the approval, it's going to be 400 patients in 30 sites, and we need to conclude the participation of the patient, recruitment of the patients within 3 years. So they would like to get some list of potential participating sites, some kind of qualification form of the site and to see the recruitment plan that we will be able to conclude and to run the post-market study after they will grant us the letter so to build the confidence and the information that ICO will be able like other companies that got the novo approval that need to run this post-market study.

正如我們宣布的那樣，獲得批准後，將在 30 個地點招募 400 名患者，我們需要在 3 年內完成患者的參與和患者招募。因此，他們希望獲得一些潛在參與站點的列表、某種站點資格表格，並查看我們能夠完成的招募計劃，並在他們授予我們信函後運行上市後研究，從而建立信心和信息，使 ICO 能夠像其他獲得 novo 批准的公司一樣運行這項上市後研究。

Just to be sure that we will be able to conduct it.

只是為了確保我們能夠進行它。

Right, and just going through this exercise.

對，只是進行這個練習。

Lead you to increase your budget for Recruiting for the trial, for instance, or do you expect the cost of the trial to be about the same as you've previously suggested.

例如，導致您增加試用招募的預算，或者您是否預計試用費用與您先前建議的大致相同。

Yeah, we are working now, we are working now to update, the budget. Maybe Ronen could give some more light on it. But, we work with the site, of course, we need to have some support like any study from the COO. And basically, it's a normal post-market study. And we have also the current TPT3 code that will be able to cover the cost of the probe and more for the sites and we will work according a normal course of a study.

是的，我們現在正在努力，我們正在努力更新預算。也許 Ronen 可以對此做出更多的解釋。但是，我們與該網站合作，當然，我們需要得到一些支持，就像首席營運長的任何研究一樣。基本上，這是一項正常的上市後研究。我們還有目前的 TPT3 代碼，可以涵蓋探測成本以及站點的更多費用，我們將按照正常的研究進程開展工作。

Yeah, the final budget will be decided when we have the full, let's call it understanding with the FDA regarding all the requests.

是的，當我們與 FDA 就所有請求達成全面諒解時，我們將決定最終預算。

They also the CRO, the costs of the follow up and the payments to the facilities.

他們還負責 CRO、後續費用和設施付款。

Great, thank you. And then question on the separate topic and that is given the expected timetable for an approval.

太好了，謝謝。然後針對單獨的主題提出問題，並給出預計的批准時間表。

Are you still expecting, for instance, late 2026 for CPT1 code from AMA possibly sooner from the other specialist societies and are there any changes in how you're thinking about the Build out of your commercial efforts as a result.

您是否仍預計，例如，AMA 的 CPT1 代碼將在 2026 年底發布，而其他專業協會可能會更早發布，並且您對建立商業努力的想法是否有任何變化。

Yeah, I will start from the last part of your questions. As soon as we will get the clearance, we have Mr. Shad Good as our VP sales for North America who is bringing. Over 20 years of experience in breastfeeds from JJ Mamaov and other leading companies, and we have a current small team. As soon as we will have the clearance, we will start the recruitment in order to start a commercialization in 2026 under the assumption of getting the the clearance. The grant letter and then after the clearance we will be able also to apply to AMA in order to move to CPT1. We have support from about 5 society that we are going to support us for this application to move to CPT1. There is a process in place which is 12 to 18 months in order to get the approval, some kind of a survey that the AMA is doing, and then we will get the code and the reimbursement attached to it and in parallel we will work with the other society and some other payers.

是的，我將從你問題的最後一部分開始。一旦我們獲得許可，我們將聘請 Shad Good 先生擔任我們北美銷售副總裁。JJ Mamaov 和其他領先公司在母乳餵養方面擁有超過 20 年的經驗，我們目前擁有一支小型團隊。一旦獲得批准，我們將開始招募，以便在獲得批准的假設下於 2026 年開始商業化。獲得授權書後，我們也可以向 AMA 申請轉入 CPT1。我們得到了大約 5 個協會的支持，他們將支持我們將此申請轉移到 CPT1。為了獲得批准，有一個需要 12 到 18 個月的流程，AMA 正在進行某種調查，然後我們將獲得代碼和附帶的報銷，同時我們將與其他協會和其他一些付款人合作。

Great, thank you.

太好了，謝謝。

Anthony Vendetti of Maxim Group.

Maxim Group 的 Anthony Vendetti。

So just to follow up on the post-market study. So, that's been submitted and accepted by the FDA in terms of the submissions been accepted, and now they're reviewing the protocol before making a final decision. Is that correct?

因此只是為了跟進上市後研究。因此，就提交內容而言，FDA 已經接受了該方案，現在他們正在審查該方案，然後做出最終決定。對嗎？

Yeah, we provided any information that they ask, even including the intended use, the IFU, as well as the indication they will require, they require a patient leaflet with all the information. So everything in the package that's related to the A post-market study the recruitment plan as well as all the package to build the final decision letter and grant letter we provided all the required information and they reviewed them. We have a continuously discussions and we are giving them information on any time they ask.

是的，我們提供了他們要求的任何信息，甚至包括預期用途、IFU 以及他們需要的適應症，他們需要一份包含所有信息的患者手冊。因此，我們提供了與上市後研究招聘計劃相關的所有內容以及構建最終決定書和授權書的所有必要信息，並對其進行了審查。我們一直在進行討論，並且會在他們詢問的任何時候向他們提供資訊。

So you've submitted everything you're just waiting for them to either make a decision or see if they have any other Information request at this point.

因此，您已提交了所有內容，只是在等待他們做出決定或查看他們此時是否還有其他資訊請求。

Yeah.

是的。

And leadership, which is extremely important, Antony, that leadership that participated in the last two months or whatever, they still shown in any meeting that we have with them in order to be a positive decision.

安東尼，領導力非常重要，過去兩個月或更長時間參與的領導力，在我們與他們的任何會議中仍然表現出來，以便做出積極的決定。

Leadership of the of the FDA, not for sure leadership of IT, but leadership of the FDA management of FDA that participated in the last round and working closely with us in order to get this positive decision.

FDA 的領導層，肯定不是 IT 的領導層，而是參與了上一輪審查並與我們密切合作以做出這一積極決定的 FDA 管理層的領導層。

Okay, great. And then just in terms of how Icecure is preparing for the potential acceptance of the post-market study and therefore FDA approval. I know you've already implemented some steps and hired a few people. Is there anything else, that you feel Icecure needs to do to prepare to hit the ground running, once the decision's been made?

好的，太好了。然後就 Icecure 如何為上市後研究的潛在接受以及 FDA 批准做準備。我知道您已經採取了一些措施並僱用了一些人員。一旦做出決定，您認為 Icecure 還需要做哪些準備才能順利開始運作？

I think that after we had the meeting with the FDA and we already agreed with them on the indication for patients who are 70 years and over, and they asked us to work on the post-market study and we were able to announce it.

我認為，在我們與 FDA 會面之後，我們已經就針對 70 歲及以上患者的適應症與他們達成了一致，他們要求我們開展上市後研究，我們就可以宣布這一消息了。

It allowed us to have a discussion with some breast surgeons and breastioologists who like to participate to participate in the study, but also to be a commercial site. I'm not looking for sites just to join just to join the study, on average 400 patients to divide by 25 or 30. It's about 16 patients. All sites will be also a commercial site, so we've created a lot of traction of sites who are waiting for the FDA and they like to participate to be users and it will be part of the study, so it's creating a lot of excitement about site who we'd like to join both breasts and both radiologists, even some of them we would like to start to be fully trained and to be a commercial user purchasing the console. Even before officially the study we start for creating and we will look for a new team member that we will start to hire immediately after we will get the grant letter.

它使我們能夠與一些願意參與研究的乳房外科醫生和乳腺病學家進行討論，同時也將其作為一個商業網站。我尋找的網站不只是為了加入研究，而是平均 400 名患者除以 25 或 30。大約有16名患者。所有站點也將是商業站點，因此，我們已經吸引了大量等待 FDA 批准的站點，他們喜歡參與成為用戶，這將成為研究的一部分，因此，它為站點帶來了很多興奮，我們希望加入乳房和放射科醫生的隊伍，甚至希望他們中的一些人開始接受全面培訓，並成為購買控制台的商業用戶。甚至在正式開始研究之前，我們就開始進行創建，並且我們會尋找新的團隊成員，並在收到授權書後立即開始聘用。

So the sites have been selected, they will be both the sites that are part of the application for the post-market study. They'll also be commercial sites and you're already starting to train the interventional radiologist and the breast surgeons, or you're lining them up to be trained, immediately following, anticipated approval, correct?

因此，站點已經選定，它們將成為上市後研究申請的一部分。它們也將成為商業站點，並且您已經開始培訓介入放射科醫生和乳房外科醫生，或者您正在安排他們接受培訓，然後立即獲得預期的批准，對嗎？

Yeah.

是的。

They see it as a great opportunity to provide additional new data and to be a commercial user.

他們認為這是一個提供更多新數據和成為商業用戶的絕佳機會。

And be a commercial user as well, that's great okay and then and then just in terms of how are things progressing in Europe and just an update on the ex regulatory clearance in Israel.

並且也成為商業用戶，那很好，然後就歐洲的情況如何以及以色列前監管許可的最新情況而言。

Europe, we are seeing again a lot of influence around west.

歐洲，我們再次看到西方的巨大影響。

Even the coming, I think that I mentioned it, with the public information mid September we have the biggest, it's called CIA's Interventional Oncology and Cardiovascular event. This is the biggest European event this time in Barcelona. And usually in this conference regarding interventional oncology, in the past, you saw a lot of publication presentations regarding kidney, lung, bone, liver, and other organs, mainly soft tissue ablation.

甚至即將到來的，我想我提到過，根據公開訊息，我們將在 9 月中旬舉辦最大的活動，稱為 CIA 介入腫瘤學和心血管活動。這是此次在巴塞隆納舉辦的歐洲最大的盛會。通常在這次關於介入性腫瘤學的會議上，過去你會看到很多關於腎臟、肺、骨、肝臟和其他器官的出版報告，主要是軟組織消融。

And last year and mainly this year, the main topics and all the opening ceremony running by Professor Franco Osin and some of our other users, it's all around rest. So Interventional Oncology conference become mainly around breast. So this is creating around our many independent studies in Europe and other places. So breath become extremely important topic, and we have the biggest real world data that's going to present in this coming conference.

去年以及今年，主要議題以及由 Franco Osin 教授和我們的其他一些用戶主持的所有開幕式都與休息有關。因此介入性腫瘤學會議主要圍繞著乳房。這是圍繞著我們在歐洲和其他地方進行的許多獨立研究而創建的。因此呼吸成為極其重要的話題，我們擁有最大的真實世界數據，將在即將舉行的會議上展示。

So this is creating the much more activities.

因此，這將創造更多的活動。

Okay, so that conference in Barcelona, what's the date of that?

好的，那麼巴塞隆納的會議是什麼時候？

September 13th to 17th.

9月13日至17日。

Yeah, and even later in late September, we have the OSOBI, which is the European Conference for breast imaging, similar to the American FBI Society breast imaging.

是的，甚至在九月下旬，我們還會舉辦 OSOBI，即歐洲乳房影像會議，類似於美國 FBI 協會乳房影像會議。

So both conference, the topic will be breast cancer, and we have like 7 to 8 presentations of independent study, so quite a lot of new information on this top important topic, and this will drive utilization and additional new cells.

因此，兩次會議的主題都是乳癌，我們有 7 到 8 場獨立研究的報告，因此關於這個最重要的主題有很多新訊息，這將推動利用率和額外的新細胞。

Okay, great. So these conferences you expect to be able to drive new sales and utilization in Europe. Do you think that in addition to these conferences and the data that you have, do you think things will, sales will accelerate in your following potential FDA approval, do you think that will be an additional catalyst?

好的，太好了。因此，您期望這些會議能夠推動歐洲的新銷售和利用。您是否認為除了這些會議和您擁有的數據之外，您是否認為在您獲得 FDA 批准後，銷售將會加速成長，您是否認為這會成為額外的催化劑？

Yeah, absolutely saying, well, we had a very, I personally participated to the Japanese Breast Cancer Society. We had an excellent conference led by led by Dr. Fukuma and also Dr. Richard Fein, who was the main PI of our study.

是的，絕對是這樣，嗯，我們有一個非常，我個人參加了日本乳癌協會。我們召開了一場精彩的會議，由 Fukuma 博士和我們研究的主要 PI Richard Fein 博士主持。

Past President of the American society, so it was well accepted and in Japan also they are looking very much on the FDA and this will be extremely important catalyst, for Teo, but for the leadership of the Japanese society who would like to support us very much and also in other places. So even if you have a CE in breast cancer, everyone is looking on the FDA.

他曾擔任美國協會主席，因此這項計劃得到了廣泛認可。日本也非常關注 FDA，這對於 Teo 以及非常願意支持我們的日本協會領導層來說都是一個極其重要的催化劑。因此，即使您擁有乳癌 CE，每個人都會關注 FDA。

Okay, great. Thanks so much for all that color. I'll hop back in the queue.

好的，太好了。非常感謝這些顏色。我會重新回到隊列中。

Yi Chen of HC Wainwright.

HC Wainwright 的 Yi Chen。

Hello, this is Eduardo on for Yi.

大家好，我是易建聯的愛德華多。

Just maybe if I could ask a question regarding the seven-year follow-up study you alluded to previously. Could you add a little bit more detail about the specific patient population cancer type and how that, I think it was 1% recurrence rate you mentioned compares with the historical expectation for those patients.

也許我可以問一個有關您之前提到的七年跟踪研究的問題。您能否詳細介紹特定患者群體的癌症類型，以及您提到的 1% 復發率與這些患者的歷史預期相比如何。

Yeah, the standard of care in Japan is a bit different from the US. In Japan they are treating patients even from the age of 50 or basically officially they don't have or they are not going to have age limitation in Japan.

是的，日本的護理標準與美國有點不同。在日本，他們甚至為 50 歲以上的患者提供治療，或者基本上正式地說，日本沒有或不會有年齡限制。

Firstly, the first peak in Japan for breast cancer, it's mainly for patients who are 45 to 49, and then the second peak is 65 and up. In Japan they are giving all breast radiation to any patients. So this is why they have excellent results of a 1% recurrence, only 1% or 99% free from a local recurrence and in the ICE3 study or even a part of standards of care, especially elderly patients, they are now with the de-escalation. They try to omit radiation, for example, or at least it's not mandatory by the societies.

首先，日本乳癌的第一個高峰，主要集中在45至49歲的患者，第二個高峰是65歲以上的患者。在日本，他們為所有患者提供乳房放射治療。這就是為什麼他們取得了優異的療效，即復發率僅為 1%，局部復發率僅為 1% 或 99%，並且在 ICE3 研究中甚至在部分標準護理中，尤其是老年患者，現在他們的治療已經降級。例如，他們試圖消除輻射，或至少社會不強制要求這樣做。

Even in the ICE3 study, patients who got A cryoablation, adjuvant therapy, and radiation. We had a zero recurrence, but most or most parts of our patients in the ICE3 study didn't get radiation, and this is why we believe that this is part of why we got a 97%. We still have a very good results even to compare to the lumpectomy recurrence rate with the standard of care, but in Japan they have a better results.

即使在 ICE3 研究中，接受冷凍消融、輔助治療和放射治療的患者。我們的復發率為零，但 ICE3 研究中的大部分患者沒有接受放射治療，這就是我們認為我們獲得 97% 治癒率的部分原因。即使與標準治療的乳房腫瘤切除術復發率相比，我們仍然取得了非常好的成果，但在日本，他們取得了更好的結果。

Hard for me to evaluate if whole breast radiation to any patient it's good or not good, but this is the difference between two standards of care.

我很難評估全乳放射治療對任何患者是否有好處，但這是兩種護理標準之間的差異。

So I guess more aggressive maintenance with the radiation in in Japan could be driving some different.

因此，我猜測日本對輻射進行更積極的維護可能會帶來一些不同。

From the tumor biology or cancer grades, both Japan, US, and all the European or other independent study are go for the same group of patients low risk, early stage breast cancer usually up to 1.5 centimeters from the tumor site.

從腫瘤生物學或癌症分級來看，無論是日本、美國，或是所有歐洲或其他獨立研究都針對同一組患者，低風險早期乳癌通常距離腫瘤部位不超過 1.5 公分。

It's called luminal A is a low risk patient. So in Japan, ICE3 study, the PMS study for sure it will be according to the indication, and the European is the same group of patients, but Japan has, you could call it maybe a bit more precise or aggressive standard of care, and this is why they have better high rates of free from local recurrences.

被稱為管腔A的病人屬於低風險病人。因此，在日本，ICE3 研究、PMS 研究肯定會根據適應症進行，歐洲是同一組患者，但日本的治療標準可能更精確或更積極，這就是為什麼他們有更好的無局部復發率。

Got it. That's helpful.

知道了。這很有幫助。

I'm curious in terms of the commercial launch strategy that you have, and you're in the process of preparing in the contingency of the FDA approval. Would you, is your current task position sufficient to fund those operations through FDA clearance or are you planning you might need a little bit more funding for that?

我對您的商業發布策略很好奇，您正在為獲得 FDA 批准做準備。您目前的工作職位是否足以透過 FDA 審批來資助這些運營，或者您是否計劃為此需要更多一點的資金？

So, currently we have enough funding to get the FDA authorization and pass that. Of course when we will finalize the final cost of the and the budgeting of the expected post-marketing study, we will understand our full cash demands and management will operate accordingly.

因此，目前我們有足夠的資金來獲得 FDA 授權並通過該授權。當然，當我們最終確定預期上市後研究的最終成本和預算時，我們將了解我們的全部現金需求，管理層將據此開展工作。

Understood. All right, thanks for answering the questions.

明白了。好的，謝謝您回答這些問題。

There are no further questions at this time.

目前沒有其他問題。

Eyal, would you like to make your concluding statement?

埃亞爾，您願意做最後陳述嗎？

Thank you, thanks for joining our call today and great questions. We are excited about what is ahead. Some key value driving milestones that we expect in the second half of the year include, most importantly, a final FDA marketing authorization decision. Additionally, we expect our partner in Japan, Terumo, to submit a regulatory finding in Japan for present in breast cancer.

謝謝，感謝您今天參加我們的電話會議並提出很棒的問題。我們對未來充滿期待。我們預計下半年將出現一些關鍵的價值驅動里程碑，其中最重要的是 FDA 的最終行銷授權決定。此外，我們期望我們在日本的合作夥伴 Terumo 在日本提交有關乳癌的監管調查結果。

Also, our regulatory front, we expect a response from the Israeli Ministry of Health on our next generation actions.

此外，在我們的監管方面，我們期待以色列衛生部對我們的下一代行動作出回應。

We have continued to get strong commercial and practitioners traction at the medical conferences where data from independent study of persons are presented.

在展示針對個人的獨立研究數據的醫學會議上，我們繼續獲得強大的商業和從業者的關注。

We expect more broad exposure at major conferences in September, including at the European Society of Breast Imaging at theological and Interventional ideology Society of Europe, which I mentioned earlier Thursday, which is mid September. Additional data releases may be coming from independent study modeled on ICE, including from trials in Italy and Brazil. Thanks and have a great day, everyone.

我們期望在 9 月的大型會議上獲得更廣泛的曝光，包括歐洲乳房影像學會和歐洲神學與介入意識形態學會，我在周四早些時候提到過，那是在 9 月中旬。其他數據發布可能來自以 ICE 為模型的獨立研究，包括在義大利和巴西的試驗。謝謝大家，祝大家有個愉快的一天。

This concludes the Icecure second quarter 2025 results conference call.

Icecure 2025 年第二季業績電話會議到此結束。

Thank you for your participation. You may go ahead and disconnect.

感謝您的參與。您可以繼續並斷開連線。