<p>ProSense® 系統正在北美的新地點銷售和安裝，包括一些美國最受尊敬的醫療機構。</p>
<p>, /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM)（&#34;IceCure&#34;、&#34;IceCure Medical&#34; 或 &#34;公司&#34;）是開發微創冷凍消融技術的公司，該技術通過冷凍摧毀腫瘤，作為外科腫瘤切除的替代方案，預計將在北美第四季度銷售中報告顯著增長，與去年同期相比。根據目前可用的初步信息，銷售增長將代表公司在北美的銷售創下新紀錄。公司在 2025 年 10 月獲得美國食品藥品監督管理局（&#34;FDA&#34;）對 ProSense®用於 70 歲及以上女性低風險乳腺癌局部治療的市場授權後，ProSense® 控制枱及其一次性冷凍探頭的興趣激增。</p>
<p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg"/></p>
<p>&#34;在 FDA 對 ProSense®在低風險乳腺癌方面的市場授權僅兩個月後，我們對醫生和醫療機構的強烈和快速興趣感到非常鼓舞，&#34; IceCure 首席執行官 Eyal Shamir 表示。&#34;我們相信，與 FDA 最近的有利決定相關的幾個因素正在推動需求，例如 ProSense®在醫療會議上的高曝光率，包括實踐培訓課程，我們與乳腺專科醫療協會的互動，越來越多的獨立研究和同行評審數據，以及媒體報道和對我們非手術選擇的認識日益增加所支持的患者驅動需求。&#34;</p>
<p>北美銷售副總裁 Shad Good 評論道：&#34;我們的銷售團隊正在與全國越來越多的醫院、診所、乳腺外科醫生和放射科醫生接洽，他們正在評估 ProSense®並下訂單。正如預期的那樣，FDA 的市場授權是我們銷售管道增長的主要催化劑。美國的患者現在有了微創的選擇，提供者希望將這一選擇提供給他們的患者。我們非常高興，我們最近的一筆訂單來自一家在全球排名前列的醫院網絡，該網絡在美國有多個地點。我們相信，這些具有高度影響力的機構的訂單可能進一步推動更廣泛市場的需求。&#34;</p>
<p>IceCure 計劃在 2026 年 1 月報告初步的頂線收入結果，並在 2026 年 4 月提交完整的 20-F 年度報告。</p>
<p>ProSense®用於低風險乳腺癌治療的相關信息出現在越來越多的主流媒體、女性雜誌、醫療行業貿易出版物和消費者醫療新聞中，包括：Essense、Cancer Health、Authority Magazine、Arizona Family、Fierce Biotech、Medscape、KFF Health News、MedPage Today 和 Medical Device Network。</p>
<p><strong>關於 ProSense®</strong></p>
<p>ProSense® 冷凍消融系統是首個也是唯一一個獲得 FDA 市場授權的醫療設備，用於 70 歲及以上女性低風險乳腺癌的局部治療，適用於不適合乳腺癌手術替代方案的患者。有關益處和風險的完整列表可以在公司網站上找到。</p>
<p>ProSense® 是一種微創冷凍外科工具，提供通過冷凍摧毀腫瘤的選項。該系統獨特地利用液氮的力量，在良性和惡性病變（包括乳腺、腎臟、肺部和肝臟）中創造大範圍的致死區域，以實現最大效果。</p>
<p>ProSense® 通過加速恢復、減少疼痛、手術風險和併發症，提升患者和提供者的價值。憑藉其易於運輸的設計和液氮的使用，ProSense® 為乳腺腫瘤的快速和便捷的門診程序打開了大門。</p>
<p><strong>關於 IceCure Medical</strong></p>
<p>IceCure Medical（Nasdaq: ICCM）開發和銷售基於液氮的先進冷凍消融治療系統，通過冷凍摧毀腫瘤（良性和惡性），主要關注領域為乳腺、腎臟、骨骼和肺癌。其微創技術是安全有效的外科腫瘤切除替代方案，能夠在相對較短的程序中輕鬆執行。公司的旗艦產品 ProSense®系統在美國、歐洲和亞洲等地進行市場銷售，適用於迄今為止獲得批准的適應症。</p>
<p><strong>前瞻性聲明</strong></p>
<p>本新聞稿包含根據 1995 年《私人證券訴訟改革法案》和其他聯邦證券法的 “安全港” 條款的前瞻性聲明。諸如 “預計”、“預期”、“意圖”、“計劃”、“相信”、“尋求”、“估計” 等詞語及其類似表達或變體旨在識別前瞻性聲明。例如，IceCure 在本新聞稿中使用前瞻性聲明時討論了：其對北美第四季度銷售顯著增長的預期；其相信此類增長將代表公司創紀錄的銷售水平；在 FDA 市場授權後對 ProSense®系統持續需求的預期；其相信各種因素正在推動並將繼續推動產品的採用；其美國銷售管道的增長；以及其相信來自高度影響力醫院網絡的訂單可能進一步推動更廣泛的市場需求。科學研究和臨牀及前臨牀試驗的歷史結果並不能保證未來研究或試驗的結論會得出相同或甚至相似的結論。可能導致實際結果、發展和商業決策與這些前瞻性聲明中預期的結果顯著不同的重要因素包括但不限於：公司的預期收入和資本支出水平；公司可用現金及其獲得額外資金的能力；公司市場營銷和銷售產品的能力；美國及其他國家的法律和監管發展；公司與供應商、分銷商及其他合作伙伴維持關係的能力；公司維護或保護其專利及其他知識產權有效性的能力；公司向醫療專業人士展示和教育其產品的能力；中東地區，特別是以色列的政治、經濟和軍事不穩定；以及在 2024 年 12 月 31 日結束的年度公司 20-F 表格年報的風險因素部分中列出的其他因素，以及向 SEC 提交或提供的其他文件，這些文件可在 SEC 網站 www.sec.gov 上獲得。除法律要求外，公司沒有義務在本聲明發布後更新這些聲明以進行修訂或更改。</p>
<p><strong>投資者關係聯繫方式：</strong> 郵箱：investors@icecure-medical.com</p>
<p>邁克爾·波利維歐</p>
<p>電話：732-232-6914</p>
<p>Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg</p>
<p>來源：IceCure Medical</p>

ICCM

<p>IceCure Medical Ltd. 預計在北美的第四季度銷售將創下紀錄，這得益於其 ProSense® 冷凍消融系統獲得 FDA 批准用於低風險乳腺癌。該系統提供了一種微創的手術替代方案，正在醫療機構中獲得越來越多的關注。FDA 的批准激發了頂級醫院的興趣和訂單，增強了公司的銷售管道。IceCure 計劃在 2026 年 1 月發佈初步收入結果，並在 2026 年 4 月發佈完整報告</p>

<p><em>ProSense® systems are being sold and installed at new locations across North America, including some of the most highly regarded medical institutions in the United States</em></p>
<div class="lb-trans"><p>ProSense® 系統正在北美的新地點銷售和安裝，包括一些美國最受尊敬的醫療機構。</p>
</div><p>, /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (&#34;IceCure&#34;, &#34;IceCure Medical&#34; or the &#34;Company&#34;), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, is expecting to report a significant increase in fourth quarter sales in North America compared to the same period last year. Based on currently available preliminary information, the increase in sales would represent record North American sales levels for the Company. The Company is experiencing a surge of interest for the ProSense® console and its disposable cryoprobes following the U.S. Food and Drug Administration's (&#34;FDA&#34;) marketing authorization of ProSense® for the local treatment of low-risk breast cancer in women aged 70 and above in October 2025.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM)（&#34;IceCure&#34;、&#34;IceCure Medical&#34; 或 &#34;公司&#34;）是開發微創冷凍消融技術的公司，該技術通過冷凍摧毀腫瘤，作為外科腫瘤切除的替代方案，預計將在北美第四季度銷售中報告顯著增長，與去年同期相比。根據目前可用的初步信息，銷售增長將代表公司在北美的銷售創下新紀錄。公司在 2025 年 10 月獲得美國食品藥品監督管理局（&#34;FDA&#34;）對 ProSense®用於 70 歲及以上女性低風險乳腺癌局部治療的市場授權後，ProSense® 控制枱及其一次性冷凍探頭的興趣激增。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg" alt="" original-src="https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg"/></p>
<p>&#34;We are highly encouraged by the strong and rapid interest from doctors and medical institutions just two months after the FDA's marketing authorization for ProSense® in low-risk breast cancer,&#34; said Eyal Shamir, IceCure's Chief Executive Officer. &#34;We believe several factors correlated with the FDA's recent favorable decision are driving demand, such as ProSense®'s high visibility at medical conferences including hands-on training sessions, our engagement with breast-focused medical societies, the growing body of independent studies and peer reviewed data, and patient-driven demand supported by increasing media coverage and awareness of our non-surgical option.&#34;</p>
<div class="lb-trans"><p>&#34;在 FDA 對 ProSense®在低風險乳腺癌方面的市場授權僅兩個月後，我們對醫生和醫療機構的強烈和快速興趣感到非常鼓舞，&#34; IceCure 首席執行官 Eyal Shamir 表示。&#34;我們相信，與 FDA 最近的有利決定相關的幾個因素正在推動需求，例如 ProSense®在醫療會議上的高曝光率，包括實踐培訓課程，我們與乳腺專科醫療協會的互動，越來越多的獨立研究和同行評審數據，以及媒體報道和對我們非手術選擇的認識日益增加所支持的患者驅動需求。&#34;</p>
</div><p>Shad Good, Vice President of Sales North America, commented, &#34;Our sales team is engaged with a growing number of hospitals, clinics, breast surgeons and radiologists nationwide who are evaluating ProSense® and placing orders. As expected, the FDA's marketing authorization is a major catalyst in the growth of our sales pipeline. Patients in the U.S. now have a minimally invasive option and providers want to offer this choice to their patients. We are very pleased that one of our most recent orders is from a hospital network that is ranked one of the top in the world, with multiple locations in the U.S. We believe orders from these kinds of highly influential institutions may further drive demand from the broader market.&#34;</p>
<div class="lb-trans"><p>北美銷售副總裁 Shad Good 評論道：&#34;我們的銷售團隊正在與全國越來越多的醫院、診所、乳腺外科醫生和放射科醫生接洽，他們正在評估 ProSense®並下訂單。正如預期的那樣，FDA 的市場授權是我們銷售管道增長的主要催化劑。美國的患者現在有了微創的選擇，提供者希望將這一選擇提供給他們的患者。我們非常高興，我們最近的一筆訂單來自一家在全球排名前列的醫院網絡，該網絡在美國有多個地點。我們相信，這些具有高度影響力的機構的訂單可能進一步推動更廣泛市場的需求。&#34;</p>
</div><p>IceCure plans to report preliminary top-line revenue results in January 2026 followed by its full annual report on Form 20-F in April 2026.</p>
<div class="lb-trans"><p>IceCure 計劃在 2026 年 1 月報告初步的頂線收入結果，並在 2026 年 4 月提交完整的 20-F 年度報告。</p>
</div><p>ProSense® for the treatment of low-risk breast cancer is featured in a growing number of mainstream media outlets, women's magazines, healthcare industry trade publications, and consumer healthcare news including: Essense, Cancer Health, Authority Magazine, Arizona Family, Fierce Biotech, Medscape, KFF Health News, MedPage Today, and Medical Device Network.</p>
<div class="lb-trans"><p>ProSense®用於低風險乳腺癌治療的相關信息出現在越來越多的主流媒體、女性雜誌、醫療行業貿易出版物和消費者醫療新聞中，包括：Essense、Cancer Health、Authority Magazine、Arizona Family、Fierce Biotech、Medscape、KFF Health News、MedPage Today 和 Medical Device Network。</p>
</div><p><strong>About ProSense®</strong></p>
<div class="lb-trans"><p><strong>關於 ProSense®</strong></p>
</div><p>The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.</p>
<div class="lb-trans"><p>ProSense® 冷凍消融系統是首個也是唯一一個獲得 FDA 市場授權的醫療設備，用於 70 歲及以上女性低風險乳腺癌的局部治療，適用於不適合乳腺癌手術替代方案的患者。有關益處和風險的完整列表可以在公司網站上找到。</p>
</div><p>ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.</p>
<div class="lb-trans"><p>ProSense® 是一種微創冷凍外科工具，提供通過冷凍摧毀腫瘤的選項。該系統獨特地利用液氮的力量，在良性和惡性病變（包括乳腺、腎臟、肺部和肝臟）中創造大範圍的致死區域，以實現最大效果。</p>
</div><p>ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.</p>
<div class="lb-trans"><p>ProSense® 通過加速恢復、減少疼痛、手術風險和併發症，提升患者和提供者的價值。憑藉其易於運輸的設計和液氮的使用，ProSense® 為乳腺腫瘤的快速和便捷的門診程序打開了大門。</p>
</div><p><strong>About IceCure Medical</strong></p>
<div class="lb-trans"><p><strong>關於 IceCure Medical</strong></p>
</div><p>IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.</p>
<div class="lb-trans"><p>IceCure Medical（Nasdaq: ICCM）開發和銷售基於液氮的先進冷凍消融治療系統，通過冷凍摧毀腫瘤（良性和惡性），主要關注領域為乳腺、腎臟、骨骼和肺癌。其微創技術是安全有效的外科腫瘤切除替代方案，能夠在相對較短的程序中輕鬆執行。公司的旗艦產品 ProSense®系統在美國、歐洲和亞洲等地進行市場銷售，適用於迄今為止獲得批准的適應症。</p>
</div><p><strong>Forward Looking Statement</strong></p>
<div class="lb-trans"><p><strong>前瞻性聲明</strong></p>
</div><p>This press release contains forward-looking statements within the meaning of the &#34;safe harbor&#34; provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as &#34;expects,&#34; &#34;anticipates,&#34; &#34;intends,&#34; &#34;plans,&#34; &#34;believes,&#34; &#34;seeks,&#34; &#34;estimates&#34; and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: its expectation of a significant increase in fourth quarter North American sales; its belief that such increases would represent record sales levels for the Company; anticipated continued demand for the ProSense® system following FDA marketing authorization; its belief that various factors are driving and will continue to drive adoption; the growth of its U.S. sales pipeline; and its belief that orders from highly influential hospital networks may further drive broader market demand. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 27, 2025, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.</p>
<div class="lb-trans"><p>本新聞稿包含根據 1995 年《私人證券訴訟改革法案》和其他聯邦證券法的 “安全港” 條款的前瞻性聲明。諸如 “預計”、“預期”、“意圖”、“計劃”、“相信”、“尋求”、“估計” 等詞語及其類似表達或變體旨在識別前瞻性聲明。例如，IceCure 在本新聞稿中使用前瞻性聲明時討論了：其對北美第四季度銷售顯著增長的預期；其相信此類增長將代表公司創紀錄的銷售水平；在 FDA 市場授權後對 ProSense®系統持續需求的預期；其相信各種因素正在推動並將繼續推動產品的採用；其美國銷售管道的增長；以及其相信來自高度影響力醫院網絡的訂單可能進一步推動更廣泛的市場需求。科學研究和臨牀及前臨牀試驗的歷史結果並不能保證未來研究或試驗的結論會得出相同或甚至相似的結論。可能導致實際結果、發展和商業決策與這些前瞻性聲明中預期的結果顯著不同的重要因素包括但不限於：公司的預期收入和資本支出水平；公司可用現金及其獲得額外資金的能力；公司市場營銷和銷售產品的能力；美國及其他國家的法律和監管發展；公司與供應商、分銷商及其他合作伙伴維持關係的能力；公司維護或保護其專利及其他知識產權有效性的能力；公司向醫療專業人士展示和教育其產品的能力；中東地區，特別是以色列的政治、經濟和軍事不穩定；以及在 2024 年 12 月 31 日結束的年度公司 20-F 表格年報的風險因素部分中列出的其他因素，以及向 SEC 提交或提供的其他文件，這些文件可在 SEC 網站 www.sec.gov 上獲得。除法律要求外，公司沒有義務在本聲明發布後更新這些聲明以進行修訂或更改。</p>
</div><p><strong>IR Contact:</strong> Email: investors@icecure-medical.com</p>
<div class="lb-trans"><p><strong>投資者關係聯繫方式：</strong> 郵箱：investors@icecure-medical.com</p>
</div><p>Michael Polyviou</p>
<div class="lb-trans"><p>邁克爾·波利維歐</p>
</div><p>Phone: 732-232-6914</p>
<div class="lb-trans"><p>電話：732-232-6914</p>
</div><p>Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg</p>
<div class="lb-trans"><p>Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg</p>
</div><p>SOURCE IceCure Medical</p>
<div class="lb-trans"><p>來源：IceCure Medical</p>
</div>

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IceCure 預計將在北美報告創紀錄的第四季度銷售額，這主要得益於最近 FDA 批准 ProSense®冷凍消融用於低風險乳腺癌 | ICCM 股票新聞