IceCure Receives Regulatory Approval in Israel for its Next-Generation XSense™ Cryoablation System for Breast Cancer and Other Indications
IceCure Medical (NASDAQ: ICCM) has received regulatory approval from Israel's Ministry of Health for its next-generation XSense™ cryoablation system. The system, which uses liquid-nitrogen based technology to destroy tumors by freezing, has been approved for multiple indications including breast cancer, gynecology, oncology, and general surgery.
The XSense™ System and CryoProbes had previously received FDA clearance in mid-2024 for all indications currently approved for the company's ProSense® system. This minimally invasive treatment option aims to reduce cancer care costs, accelerate patient recovery, and provide an alternative to surgical tumor removal.
IceCure Medical (NASDAQ: ICCM) ha ottenuto l’approvazione regolatoria da parte del Ministero della Salute israeliano per il sistema di crioablazione XSense™ di prossima generazione. Il sistema, che impiega una tecnologia a base di azoto liquido per distruggere i tumori congelandoli, è stato autorizzato per molte indicazioni, tra cui cancro al seno, ginecologia, oncologia e chirurgia generale.
Il sistema XSense™ e i CryoProbes avevano già ottenuto l’approvazione FDA a metà del 2024 per tutte le indicazioni attualmente approvate per il sistema ProSense® dell’azienda. Questa opzione di trattamento minimamente invasiva punta a ridurre i costi della cura del cancro, accelerare il recupero dei pazienti e offrire un’alternativa alla rimuzione chirurgica del tumore.
IceCure Medical (NASDAQ: ICCM) ha recibido la aprobación regulatoria del Ministerio de Salud de Israel para su sistema de crioablación XSense™ de nueva generación. El sistema, que utiliza tecnología basada en nitrógeno líquido para destruir tumores congelándolos, ha sido aprobado para múltiples indicaciones, incluyendo cáncer de mama, ginecología, oncología y cirugía general.
El sistema XSense™ y los CryoProbes ya habían obtenido la aprobación de la FDA a mediados de 2024 para todas las indicaciones actualmente aprobadas para el sistema ProSense® de la empresa. Esta opción de tratamiento mínimamente invasiva busca reducir los costos de la atención oncológica, acelerar la recuperación de los pacientes y ofrecer una alternativa a la extirpación quirúrgica del tumor.
IceCure Medical (나스닥: ICCM)이스라엘 보건부로부터 차세대 XSense™ 냉동소작 시스템에 대한 규제 승인을 받았습니다. 액화질소를 이용해 암을 얼려 파괴하는 이 시스템은 유방암, 부인과, 종양학, 일반외과를 포함한 여러 적응증에 대해 승인되었습니다.
XSense™ 시스템과 CryoProbes는 이미 2024년 중반 FDA 승인을 받았으며 현재 ProSense® 시스템에 대해 승인된 모든 적응증에 해당합니다. 이 최소침습적 치료 옵션은 암 치료 비용을 줄이고, 환자의 회복을 가속화하며, 종양 수술적 제거에 대한 대안을 제공하는 것을 목표로 합니다.
IceCure Medical (NASDAQ: ICCM) a reçu l’approbation réglementaire du Ministère de la Santé israélien pour son système XSense™ de cryoablation de nouvelle génération. Le système, qui utilise une technologie à base d’azote liquide pour détruire les tumeurs par congelation, a été approuvé pour plusieurs indications, dont le cancer du sein, la gynécologie, l’oncologie et la chirurgie générale.
Le système XSense™ et les CryoProbes avaient déjà obtenu une approbation FDA à la mi-2024 pour toutes les indications actuellement approuvées pour le système ProSense® de l’entreprise. Cette option de traitement peu invasive vise à réduire les coûts des soins contre le cancer, accélérer le rétablissement des patients et offrir une alternative à l’ablation chirurgicale des tumeurs.
IceCure Medical (NASDAQ: ICCM) hat eine Zulassung von Israels Gesundheitsministerium für das XSense™-Cryoablation-System der nächsten Generation erhalten. Das System, das eine auf flüssigem Stickstoff basierende Technologie zur Tumordestruktion durch Einfrieren verwendet, wurde für mehrere Indikationen zugelassen, darunter Brustkrebs, Gynäkologie, Onkologie und Allgemeinchirurgie.
Das XSense™-System und CryoProbes hatten zuvor eine FDA-Zulassung Mitte 2024 für alle Indikationen erhalten, die derzeit für das ProSense®-System des Unternehmens genehmigt sind. Diese minimalinvasive Behandlungsoption zielt darauf ab, die Kosten in der Krebsbehandlung zu senken, die Genesung der Patienten zu beschleunigen und eine Alternative zur chirurgischen Tumorentfernung zu bieten.
IceCure Medical (ناسداك: ICCM) قد حصلت على موافقة التنظيمية من وزارة الصحة الإسرائيلية لنظام XSense™ لإزالة الورم بالتجميد من الجيل التالي. النظام، الذي يستخدم تكنولوجيا تعتمد على النيتروجين السائل لتدمير الأورام عن طريق التجمد، تمت الموافقة عليه لعدة استخدامات بما في ذلك سرطان الثدي، والنساء، والأورام، والجراحة العامة.
كان نظام XSense™ وCryoProbes قد حصلا سابقاً على تصريح FDA في منتصف 2024 لكافة الاستخدامات المعتمدة حالياً للنظام ProSense® للشركة. يهدف هذا الخيار العلاجي الأقل توغلاً إلى تقليل تكاليف رعاية السرطان، وتسريع تعافي المرضى، وتوفير بديل لإزالة الورم جراحياً.
IceCure Medical（纳斯达克：ICCM） 已获得以色列卫生部对其 下一代 XSense™ 冷冻消融系统 的监管批准。该系统利用基于液氮的技术通过冷冻来摧毁肿瘤，已获批多项适应症，包括乳腺癌、妇科、肿瘤科和普通外科。
XSense™ 系统和 CryoProbes 先前在 2024 年中获FDA批准，涵盖目前为公司 ProSense® 系统所获批的所有适应症。这种微创治疗选项旨在降低癌症治疗成本、加速患者康复，并为手术切除肿瘤提供替代方案。
- Regulatory approval received in Israel for XSense™ System across multiple medical indications
- Prior FDA clearance obtained in mid-2024 for the XSense™ system
- Technology potentially reduces treatment costs and recovery time
- Broad range of approved applications including breast cancer treatment
- None.
Insights
IceCure gains regulatory approval in Israel for XSense cryoablation system, expanding its minimally-invasive cancer treatment portfolio.
IceCure Medical has secured an important regulatory milestone with Israeli approval for its next-generation XSense™ cryoablation system. This approval covers a broad range of indications including gynecology, oncology, general surgery, and notably breast cancer treatment. The regulatory win follows FDA clearance obtained in mid-2024 for the same indications previously approved for their flagship ProSense® system.
The XSense™ system represents significant advancement in liquid-nitrogen based cryoablation technology that destroys tumors by freezing them as an alternative to surgical removal. This minimally invasive approach potentially offers three key advantages over traditional surgery: de-escalation of cancer care (reducing treatment intensity while maintaining efficacy), reduced costs for healthcare payers, and faster recovery times for patients.
The breast cancer indication is particularly noteworthy as it addresses a major oncology market. CEO Eyal Shamir specifically highlighted this approval, suggesting the company sees significant commercial potential in this application based on a "growing body of evidence" supporting cryoablation as a viable breast cancer treatment option.
This approval strengthens IceCure's position in the minimally invasive tumor treatment market and could accelerate adoption of their technology across multiple medical specialties including dermatology, neurology, thoracic surgery, ENT, proctology, and urology – all areas where their technology now has regulatory clearance in Israel.
Approved for a broad range of indications including in gynecology, oncology and general surgery
As of mid-2024, XSense™ and its cryoprobes have also received regulatory clearance in
"We believe that this latest regulatory approval for our next-generation cryoablation system reaffirms IceCure's leadership position in liquid-nitrogen based cryoablation," stated IceCure's Chief Executive Officer, Eyal Shamir. "The minimally invasive cryoablation option that we offer across a broad range of indications can de-escalate cancer care, reduce treatment costs for payers, and accelerate recovery time for patients."
"We are particularly pleased with the breast cancer indication approval in
XSense™ is now approved in
About IceCure's Cryoablation Systems
IceCure's platform technology, including the ProSense® Cryoablation System and XSense™ Cryoablation System and CryoProbes, provides a minimally invasive treatment option to destroy tumors by freezing them. The systems uniquely harness the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
IceCure's cryoablation systems enhance patient and provider value by accelerating recovery, reducing pain, surgical risks and complications. With easy, transportable design and liquid nitrogen utilization, ProSense® and XSense™ open the door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
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 alternative to hospital 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
Forward Looking Statements
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. For example, IceCure is using forward looking statements in this press release when it discusses: the belief that the AMAR approval reaffirms IceCure's leadership position in liquid-nitrogen based cryoablation; the potential advantage of XSense; and the belief that the growing body of evidence on cryoablation as a minimally invasive option for breast cancer supports accelerated commercial adoption. 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.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
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SOURCE IceCure Medical
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