IceCure报告了与 FDA就 ProSense®冷冻消融在早期乳腺癌中的市场授权的更新时间表和进展-动脉网

IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer

CISION 等信源发布 2025-03-20 20:30

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IceCure working in close collaboration with FDA towards De Novo decision

IceCure与FDA紧密合作，朝着De Novo决定迈进

CAESAREA, Israel

以色列凯撒利亚

，

March 20, 2025

2025年3月20日

/PRNewswire/ --

/美通社/ --

IceCure Medical Ltd.

冰疗医疗有限公司

(Nasdaq:

（纳斯达克：

ICCM

国际计算机辅助制造会议

) ('IceCure', 'IceCure Medical' or the 'Company'), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it is in continued discussions with the U.S. Food and Drug Administration ('FDA') regarding its De Novo marketing authorization request for ProSense® in early-stage low risk breast cancer with endocrine therapy.

“IceCure”、“IceCure Medical”或“公司”，微创冷冻消融技术的开发者，该技术通过冷冻摧毁肿瘤，作为手术切除肿瘤的替代方案，今天宣布其正就ProSense®在早期低风险乳腺癌联合内分泌治疗的De Novo营销授权申请，继续与美国食品药品监督管理局（“FDA”）进行讨论。

The Company now expects the FDA's marketing authorization decision to be reached after the first quarter of 2025..

公司现在预计 FDA 的上市授权决定将在 2025 年第一季度之后做出。

'Given the novelty of our product and the importance of breast cancer in public health, the FDA has included many stakeholders in the discussion of the De Novo marketing clearance for ProSense® for the treatment of early-stage, low-risk breast cancer with endocrine therapy' stated IceCure's Chief Executive Officer, .

“鉴于我们产品的创新性以及乳腺癌在公共卫生领域的重要性，FDA已将许多利益相关者纳入ProSense®用于治疗早期、低风险乳腺癌的内分泌疗法的De Novo市场准入讨论中，”IceCure首席执行官表示。

Eyal Shamir

埃亚尔·沙米尔

。

'We appreciate the attention of many at the FDA despite the evolving situation at the agency as we work productively together towards a decision on marketing authorization,' Shamir added.

沙米尔补充说：“尽管FDA内部局势不断变化，但我们仍与许多FDA工作人员保持良好的沟通，并富有成效地合作，共同为营销授权的决策而努力。”

Due to the public health importance of breast cancer, the FDA convened a Medical Device Advisory Committee Panel ('Advisory Panel') in

由于乳腺癌在公共卫生方面的重要性，FDA召集了医疗器械咨询委员会小组（“咨询小组”）在

November 2024

2024年11月

to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense® for treating patients with early-stage low risk breast cancer with endocrine therapy. The Advisory Panel, which included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities, voted in favor of ProSense®'s benefit-risk profile in early-stage low risk breast cancer..

为了就与授予ProSense®用于治疗早期低风险乳腺癌患者的内分泌治疗相关的科学、技术和政策事项获取独立的、无约束力的专家建议。咨询小组包括乳腺外科医生、介入放射科医生、乳腺肿瘤科医生以及来自患者、消费者和监管机构代表，投票支持ProSense®在早期低风险乳腺癌中的收益-风险概况。

About IceCure Medical

关于IceCure医疗

IceCure Medical (Nasdaq:

冰疗医疗（纳斯达克：

ICCM

国际计算与认知会议

) 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 alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure.

）开发和销售基于液氮的先进冷冻消融治疗系统，通过冷冻摧毁良性及恶性肿瘤，重点关注的领域包括乳腺癌、肾癌、骨癌和肺癌。其微创技术是一种安全有效的替代医院手术切除肿瘤的方法，可以在相对较短的手术过程中轻松完成。

The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., .

公司的旗舰产品ProSense®系统在全球范围内销售和推广，包括在美国，适用于迄今为止已获批准和许可的适应症。

Europe

欧洲

and

和

Asia

亚洲

。

Forward Looking Statements

前瞻性声明

This press release 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.

本新闻稿包含1995年《私人证券诉讼改革法案》和其他联邦证券法中“安全港”条款所指的前瞻性陈述。诸如“预期”、“预计”、“打算”、“计划”、“相信”、“寻求”、“估计”以及类似表述或这些词语的变化旨在识别前瞻性陈述。

For example, IceCure is using forward looking statements in this press release when it discusses the expected timing of the FDA's marketing authorization decision. 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.

例如，IceCure 在本新闻稿中使用前瞻性声明来讨论 FDA 市场授权决定的预期时间。科学研发以及临床和临床前试验的历史结果并不能保证未来研究或试验的结论会暗示相同甚至相似的结论。

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, 2023 filed with the SEC on April 3, 2024, and other documents.

可能导致实际结果、发展和业务决策与这些前瞻性陈述中预期的内容存在重大差异的重要因素包括但不限于：公司的计划收入水平和资本支出；公司可获得的现金及其获取额外资金的能力；公司推广和销售其产品的能力；美国和其他国家的法律和监管发展；公司维持与供应商、分销商及其他合作伙伴关系的能力；公司维护或保护其专利和其他知识产权有效性能力；公司向医疗专业人士宣传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；以及公司在截至2023年12月31日年度的Form 20-F年报中“风险因素”部分所列的因素，该年报于2024年4月3日提交给美国证券交易委员会（SEC），以及其他文件中提及的因素。

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.

本公司不承担更新这些声明的义务，除非法律要求，在本发布日期之后进行修订或更改。

IR Contact:

投资者关系联系人:

Email:

电子邮件：

investors@icecure-medical.com

投资者@icecure-medical.com

Michael Polyviou

迈克尔·波利维乌

Phone: 732-232-6914