<p>ProSense® 系统正在北美的新地点销售和安装，包括一些美国最受尊敬的医疗机构。</p>
<p>, /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM)（&#34;IceCure&#34;、&#34;IceCure Medical&#34; 或 &#34;公司&#34;）是开发微创冷冻消融技术的公司，该技术通过冷冻摧毁肿瘤，作为外科肿瘤切除的替代方案，预计将在北美第四季度销售中报告显著增长，与去年同期相比。根据目前可用的初步信息，销售增长将代表公司在北美的销售创下新纪录。公司在 2025 年 10 月获得美国食品药品监督管理局（&#34;FDA&#34;）对 ProSense®用于 70 岁及以上女性低风险乳腺癌局部治疗的市场授权后，ProSense® 控制台及其一次性冷冻探头的兴趣激增。</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 对 ProSense®在低风险乳腺癌方面的市场授权仅两个月后，我们对医生和医疗机构的强烈和快速兴趣感到非常鼓舞，&#34; IceCure 首席执行官 Eyal Shamir 表示。&#34;我们相信，与 FDA 最近的有利决定相关的几个因素正在推动需求，例如 ProSense®在医疗会议上的高曝光率，包括实践培训课程，我们与乳腺专科医疗协会的互动，越来越多的独立研究和同行评审数据，以及媒体报道和对我们非手术选择的认识日益增加所支持的患者驱动需求。&#34;</p>
<p>北美销售副总裁 Shad Good 评论道：&#34;我们的销售团队正在与全国越来越多的医院、诊所、乳腺外科医生和放射科医生接洽，他们正在评估 ProSense®并下订单。正如预期的那样，FDA 的市场授权是我们销售管道增长的主要催化剂。美国的患者现在有了微创的选择，提供者希望将这一选择提供给他们的患者。我们非常高兴，我们最近的一笔订单来自一家在全球排名前列的医院网络，该网络在美国有多个地点。我们相信，这些具有高度影响力的机构的订单可能进一步推动更广泛市场的需求。&#34;</p>
<p>IceCure 计划在 2026 年 1 月报告初步的顶线收入结果，并在 2026 年 4 月提交完整的 20-F 年度报告。</p>
<p>ProSense®用于低风险乳腺癌治疗的相关信息出现在越来越多的主流媒体、女性杂志、医疗行业贸易出版物和消费者医疗新闻中，包括：Essense、Cancer Health、Authority Magazine、Arizona Family、Fierce Biotech、Medscape、KFF Health News、MedPage Today 和 Medical Device Network。</p>
<p><strong>关于 ProSense®</strong></p>
<p>ProSense® 冷冻消融系统是首个也是唯一一个获得 FDA 市场授权的医疗设备，用于 70 岁及以上女性低风险乳腺癌的局部治疗，适用于不适合乳腺癌手术替代方案的患者。有关益处和风险的完整列表可以在公司网站上找到。</p>
<p>ProSense® 是一种微创冷冻外科工具，提供通过冷冻摧毁肿瘤的选项。该系统独特地利用液氮的力量，在良性和恶性病变（包括乳腺、肾脏、肺部和肝脏）中创造大范围的致死区域，以实现最大效果。</p>
<p>ProSense® 通过加速恢复、减少疼痛、手术风险和并发症，提升患者和提供者的价值。凭借其易于运输的设计和液氮的使用，ProSense® 为乳腺肿瘤的快速和便捷的门诊程序打开了大门。</p>
<p><strong>关于 IceCure Medical</strong></p>
<p>IceCure Medical（Nasdaq: ICCM）开发和销售基于液氮的先进冷冻消融治疗系统，通过冷冻摧毁肿瘤（良性和恶性），主要关注领域为乳腺、肾脏、骨骼和肺癌。其微创技术是安全有效的外科肿瘤切除替代方案，能够在相对较短的程序中轻松执行。公司的旗舰产品 ProSense®系统在美国、欧洲和亚洲等地进行市场销售，适用于迄今为止获得批准的适应症。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含根据 1995 年《私人证券诉讼改革法案》和其他联邦证券法的 “安全港” 条款的前瞻性声明。诸如 “预计”、“预期”、“意图”、“计划”、“相信”、“寻求”、“估计” 等词语及其类似表达或变体旨在识别前瞻性声明。例如，IceCure 在本新闻稿中使用前瞻性声明时讨论了：其对北美第四季度销售显著增长的预期；其相信此类增长将代表公司创纪录的销售水平；在 FDA 市场授权后对 ProSense®系统持续需求的预期；其相信各种因素正在推动并将继续推动产品的采用；其美国销售管道的增长；以及其相信来自高度影响力医院网络的订单可能进一步推动更广泛的市场需求。科学研究和临床及前临床试验的历史结果并不能保证未来研究或试验的结论会得出相同或甚至相似的结论。可能导致实际结果、发展和商业决策与这些前瞻性声明中预期的结果显著不同的重要因素包括但不限于：公司的预期收入和资本支出水平；公司可用现金及其获得额外资金的能力；公司市场营销和销售产品的能力；美国及其他国家的法律和监管发展；公司与供应商、分销商及其他合作伙伴维持关系的能力；公司维护或保护其专利及其他知识产权有效性的能力；公司向医疗专业人士展示和教育其产品的能力；中东地区，特别是以色列的政治、经济和军事不稳定；以及在 2024 年 12 月 31 日结束的年度公司 20-F 表格年报的风险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，这些文件可在 SEC 网站 www.sec.gov 上获得。除法律要求外，公司没有义务在本声明发布后更新这些声明以进行修订或更改。</p>
<p><strong>投资者关系联系方式：</strong> 邮箱：investors@icecure-medical.com</p>
<p>迈克尔·波利维欧</p>
<p>电话：732-232-6914</p>
<p>Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg</p>
<p>来源：IceCure Medical</p>

ICCM

<p>IceCure Medical Ltd. 预计在北美的第四季度销售将创下纪录，这得益于其 ProSense® 冷冻消融系统获得 FDA 批准用于低风险乳腺癌。该系统提供了一种微创的手术替代方案，正在医疗机构中获得越来越多的关注。FDA 的批准激发了顶级医院的兴趣和订单，增强了公司的销售管道。IceCure 计划在 2026 年 1 月发布初步收入结果，并在 2026 年 4 月发布完整报告</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® 系统正在北美的新地点销售和安装，包括一些美国最受尊敬的医疗机构。</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;）是开发微创冷冻消融技术的公司，该技术通过冷冻摧毁肿瘤，作为外科肿瘤切除的替代方案，预计将在北美第四季度销售中报告显著增长，与去年同期相比。根据目前可用的初步信息，销售增长将代表公司在北美的销售创下新纪录。公司在 2025 年 10 月获得美国食品药品监督管理局（&#34;FDA&#34;）对 ProSense®用于 70 岁及以上女性低风险乳腺癌局部治疗的市场授权后，ProSense® 控制台及其一次性冷冻探头的兴趣激增。</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 对 ProSense®在低风险乳腺癌方面的市场授权仅两个月后，我们对医生和医疗机构的强烈和快速兴趣感到非常鼓舞，&#34; IceCure 首席执行官 Eyal Shamir 表示。&#34;我们相信，与 FDA 最近的有利决定相关的几个因素正在推动需求，例如 ProSense®在医疗会议上的高曝光率，包括实践培训课程，我们与乳腺专科医疗协会的互动，越来越多的独立研究和同行评审数据，以及媒体报道和对我们非手术选择的认识日益增加所支持的患者驱动需求。&#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>北美销售副总裁 Shad Good 评论道：&#34;我们的销售团队正在与全国越来越多的医院、诊所、乳腺外科医生和放射科医生接洽，他们正在评估 ProSense®并下订单。正如预期的那样，FDA 的市场授权是我们销售管道增长的主要催化剂。美国的患者现在有了微创的选择，提供者希望将这一选择提供给他们的患者。我们非常高兴，我们最近的一笔订单来自一家在全球排名前列的医院网络，该网络在美国有多个地点。我们相信，这些具有高度影响力的机构的订单可能进一步推动更广泛市场的需求。&#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 计划在 2026 年 1 月报告初步的顶线收入结果，并在 2026 年 4 月提交完整的 20-F 年度报告。</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®用于低风险乳腺癌治疗的相关信息出现在越来越多的主流媒体、女性杂志、医疗行业贸易出版物和消费者医疗新闻中，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>关于 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® 冷冻消融系统是首个也是唯一一个获得 FDA 市场授权的医疗设备，用于 70 岁及以上女性低风险乳腺癌的局部治疗，适用于不适合乳腺癌手术替代方案的患者。有关益处和风险的完整列表可以在公司网站上找到。</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® 是一种微创冷冻外科工具，提供通过冷冻摧毁肿瘤的选项。该系统独特地利用液氮的力量，在良性和恶性病变（包括乳腺、肾脏、肺部和肝脏）中创造大范围的致死区域，以实现最大效果。</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® 通过加速恢复、减少疼痛、手术风险和并发症，提升患者和提供者的价值。凭借其易于运输的设计和液氮的使用，ProSense® 为乳腺肿瘤的快速和便捷的门诊程序打开了大门。</p>
</div><p><strong>About IceCure Medical</strong></p>
<div class="lb-trans"><p><strong>关于 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）开发和销售基于液氮的先进冷冻消融治疗系统，通过冷冻摧毁肿瘤（良性和恶性），主要关注领域为乳腺、肾脏、骨骼和肺癌。其微创技术是安全有效的外科肿瘤切除替代方案，能够在相对较短的程序中轻松执行。公司的旗舰产品 ProSense®系统在美国、欧洲和亚洲等地进行市场销售，适用于迄今为止获得批准的适应症。</p>
</div><p><strong>Forward Looking Statement</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</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>本新闻稿包含根据 1995 年《私人证券诉讼改革法案》和其他联邦证券法的 “安全港” 条款的前瞻性声明。诸如 “预计”、“预期”、“意图”、“计划”、“相信”、“寻求”、“估计” 等词语及其类似表达或变体旨在识别前瞻性声明。例如，IceCure 在本新闻稿中使用前瞻性声明时讨论了：其对北美第四季度销售显著增长的预期；其相信此类增长将代表公司创纪录的销售水平；在 FDA 市场授权后对 ProSense®系统持续需求的预期；其相信各种因素正在推动并将继续推动产品的采用；其美国销售管道的增长；以及其相信来自高度影响力医院网络的订单可能进一步推动更广泛的市场需求。科学研究和临床及前临床试验的历史结果并不能保证未来研究或试验的结论会得出相同或甚至相似的结论。可能导致实际结果、发展和商业决策与这些前瞻性声明中预期的结果显著不同的重要因素包括但不限于：公司的预期收入和资本支出水平；公司可用现金及其获得额外资金的能力；公司市场营销和销售产品的能力；美国及其他国家的法律和监管发展；公司与供应商、分销商及其他合作伙伴维持关系的能力；公司维护或保护其专利及其他知识产权有效性的能力；公司向医疗专业人士展示和教育其产品的能力；中东地区，特别是以色列的政治、经济和军事不稳定；以及在 2024 年 12 月 31 日结束的年度公司 20-F 表格年报的风险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，这些文件可在 SEC 网站 www.sec.gov 上获得。除法律要求外，公司没有义务在本声明发布后更新这些声明以进行修订或更改。</p>
</div><p><strong>IR Contact:</strong> Email: investors@icecure-medical.com</p>
<div class="lb-trans"><p><strong>投资者关系联系方式：</strong> 邮箱：investors@icecure-medical.com</p>
</div><p>Michael Polyviou</p>
<div class="lb-trans"><p>迈克尔·波利维欧</p>
</div><p>Phone: 732-232-6914</p>
<div class="lb-trans"><p>电话：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>来源：IceCure Medical</p>
</div>

IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast Cancer | ICCM Stock News

IceCure 预计将在北美报告创纪录的第四季度销售额，这主要得益于最近 FDA 批准 ProSense®冷冻消融用于低风险乳腺癌 | ICCM 股票新闻