IceCure Medical's ProSense® Cryoablation Granted FDA Marketing Authorization for Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above: Significant Development in Giving Women with Breast Cancer Minimally Invasive Care
IceCure Medical (Nasdaq: ICCM) announced on October 3, 2025 that the FDA granted marketing authorization for ProSense® cryoablation for local treatment of early-stage, biologically low-risk breast cancer in women aged ≥70 with tumors ≤1.5 cm, when combined with adjuvant endocrine therapy. The authorization cites supporting data including the ICE3 trial (194 patients) showing a 3.1% 5‑year local recurrence rate. The FDA requested a post‑market study of ~400 patients at 30 sites. IceCure will hold a webcast on October 6, 2025 at 8:30 AM ET.
IceCure Medical (Nasdaq: ICCM) ha annunciato il 3 ottobre 2025 che la FDA ha concesso l'autorizzazione alla commercializzazione di ProSense® cryoablation per il trattamento locale del cancro al seno in fase iniziale, biologicamente a basso rischio, nelle donne di età ≥70 anni con tumori ≤1,5 cm, quando combinato con la terapia endocrina adiuvante. L'autorizzazione cita dati di supporto, tra cui lo studio ICE3 (194 pazienti) che mostra un tasso di recidiva locale a 5 anni del 3,1%. La FDA ha richiesto uno studio post-mercato di circa 400 pazienti in 30 siti. IceCure terrà una webcast il 6 ottobre 2025 alle 8:30 AM ET.
IceCure Medical (Nasdaq: ICCM) anunció el 3 de octubre de 2025 que la FDA concedió la autorización de comercialización para ProSense® cryoablation para el tratamiento local del cáncer de mama en etapas tempranas, biológicamente de bajo riesgo, en mujeres ≥70 años con tumores ≤1,5 cm, cuando se combina con la terapia endocrina adyuvante. La autorización cita datos de apoyo, incluido el ensayo ICE3 (194 pacientes) que muestra una tasa de recurrencia local a 5 años de 3,1%. La FDA solicitó un estudio postcomercial de ~400 pacientes en 30 sitios. IceCure realizará una retransmisión por webcast el 6 de octubre de 2025 a las 8:30 AM ET.
IceCure Medical (나스닥: ICCM)은 2025년 10월 3일 FDA가 ProSense® cryoablation을 초기 단계이며 생물학적으로 저위험인 여성의 국소 유방암 치료로 허가했다고 발표했습니다. 연령이 ≥70세인 여성에서 종양이 ≤1.5 cm일 때 보조 내분비 치료와 함께 사용할 때의 허가입니다. 이 허가는 5년간 국소 재발률이 3.1%인 ICE3 연구(194명) 등 지지 데이터를 인용합니다. FDA는 약 400명 정도의 30개 사이트에서의 후속 시장 연구를 요청했습니다. IceCure은 2025년 10월 6일 오전 8:30 ET에 웹캐스트를 진행할 예정입니다.
IceCure Medical (Nasdaq: ICCM) a annoncé le 3 octobre 2025 que la FDA avait accordé l'autorisation de commercialisation de ProSense® cryoablation pour le traitement local du cancer du sein à un stade précoce, biologiquement à faible risque, chez les femmes ≥70 ans avec des tumeurs ≤1,5 cm, lorsque associée à une thérapie endocrinienne adjuvante. L'autorisation cite des données de soutien, notamment l'essai ICE3 (194 patients) montrant un taux de récidive locale à 5 ans de 3,1%. La FDA a demandé une étude post-commercialisation d'environ 400 patients à 30 sites. IceCure organisera une diffusion en direct par webcast le 6 octobre 2025 à 8h30 ET.
IceCure Medical (Nasdaq: ICCM) gab am 3. Oktober 2025 bekannt, dass die FDA die Marktzulassung für ProSense® cryoablation zur lokalen Behandlung von Brustkrebs in frühen, biologisch risikoarmen Stadien bei Frauen ab 70 Jahren mit Tumoren ≤1,5 cm erteilt hat, wenn sie mit einer adjuvanten endokrinen Therapie kombiniert wird. Die Zulassung verweist auf unterstützende Daten, darunter die ICE3-Studie (194 Patienten), die eine lokale Rezidivrate nach 5 Jahren von 3,1% zeigt. Die FDA hat eine Nach-Marktforschungsstudie von ca. 400 Patienten an 30 Standorten angefordert. IceCure wird am 6. Oktober 2025 um 8:30 Uhr ET einen Webcast abhalten.
IceCure Medical (بورصة ناسداك: ICCM) أعلنت في 3 أكتوبر 2025 أن إدارة الغذاء والدواء الأمريكية منحت ترخيصاً لتسويق ProSense® cryoablation لعلاج محلي لسرطان الثدي في مراحله المبكرة، منخفض المخاطر بيولوجياً، لدى النساء بعمر ≥70 عاماً مع أورام ≤1.5 سم، عندما يُدمج مع العلاج الهرموني المساعد. تشير الموافقة إلى بيانات داعمة بما في ذلك تجربة ICE3 (194 مريضا) التي تُظهر معدل تكرار محلي عند 5 سنوات قدره 3.1%. طلبت FDA إجراء دراسة ما بعد التسويق لحوالي 400 مريضا في 30 موقعاً. ستعقد IceCure بثاً مباشراً عبر الويب في 6 أكتوبر 2025 الساعة 8:30 صباحاً بتوقيت شرق الولايات المتحدة.
IceCure Medical（纳斯达克：ICCM） 于 2025年10月3日 宣布，美国食品药品监督管理局（FDA）已批准将 ProSense® cryoablation 用于早期、生物学风险较低的乳腺癌局部治疗，适用于年龄≥70岁、肿瘤≤1.5 cm 的女性，联合辅助内分泌治疗使用。该授权引用了包括 ICE3 试验（194 例患者）在内的支持数据，显示5年局部复发率为 3.1%。FDA 要求进行大约 400 例患者、30 个地点的上市后研究。IceCure 将于 2025年10月6日美国东部时间8:30 AM 举行网络直播。
- FDA marketing authorization for ProSense® cryoablation
- Estimated U.S. addressable population of 46,000 women annually
- ICE3 trial: 194 patients with 3.1% 5‑year local recurrence
- Post‑market study planned: ~400 patients at 30 sites
- Authorized only for women aged ≥70 with tumors ≤1.5 cm
- Approval contingent on a requested post‑market study (~400 patients)
- Indication requires concomitant adjuvant endocrine therapy
- Procedure adverse events reported: edema, bruising, hematoma, skin burn
Insights
FDA cleared ProSense® for local treatment of low‑risk breast cancer in women ≥70, a limited but meaningful non‑surgical option.
What it means: ProSense® received FDA marketing authorization on Oct 3, 2025 for women aged ≥70 with biologically low‑risk tumors ≤1.5 cm when combined with adjuvant endocrine therapy; the decision cites the ICE3 trial and supports an outpatient, non‑surgical alternative to lumpectomy.
Why it matters: The press release provides concrete efficacy and safety data from the ICE3 trial (n=194) showing a 3.1% five‑year local recurrence rate in the treated cohort, and the FDA required a post‑market study (~400 patients at 30 sites) to gather additional evidence for this indication.
Practical implication: Authorization is geographically and clinically specific, expanding options for the estimated annual U.S. population of 46,000 eligible women while preserving the standard pathway of lumpectomy for other patients; monitor the planned post‑market study for broader evidence.
- ProSense® cryoablation offers the choice of a minimally invasive outpatient procedure that destroys tumors by freezing without surgical removal of breast tissue
- First new innovation in the local treatment of early-stage, low-risk breast cancer in decades and only medical device to be granted FDA marketing authorization for breast cancer treatment
- Offers efficacy and safety similar to standard of care lumpectomy, with excellent cosmetic results and patient satisfaction
- Company conference call to be held at Monday, October 6 at 8:30 AM Eastern Time
"We are excited to add a minimally invasive choice around breast cancer treatments and to offer patients an effective, outpatient procedure," said Eyal Shamir, Chief Executive Officer, IceCure. "With the ProSense® Cryoablation System, we are giving women with low-risk, early-stage breast cancer the choice to freeze their cancer, not their lives, through an effective treatment that minimizes recovery time, and minimal cosmetic changes to the breast."
ProSense® is the first and only medical device to be granted FDA marketing authorization for the local treatment of breast cancer.
ProSense® is authorized by the FDA for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy. Biologically low-risk breast cancer is defined as unifocal tumor, size ≤1.5cm, ER+, PR+, HER2-, Ki-67<
In granting marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study with the aim of producing additional data in this indication. The post-market study is expected to include approximately 400 patients at 30 sites.
Breast cancer cryoablation with ProSense®, is a simple, quick, out-patient procedure that can have a notably positive impact on the patient experience and can be beneficial for patients seeking more choices.
"You don't need any kind of cosmetic follow-up, you don't have a scar, and you don't have the feeling of having lost part of your breast, because it's all still there," said breast cancer patient and ICE3 trial participant, Pam Dixon, when describing her experience with the ProSense® cryoablation procedure. "There was no pain. It was one of the easiest things I've ever done. I don't remember any limitations on my activity."
During the ProSense® cryoablation procedure, a doctor injects local anesthesia and uses ultrasound imaging to guide a small cryoprobe, a thin hollow needle, into the breast tumor. Once the cryoprobe is placed, liquid nitrogen creates extremely cold temperatures (-170C°) which destroys the breast tumor by creating an ice ball around the targeted tissue. Key advantages of ProSense® cryoablation procedure include:
Maintain breast shape: No tissue is removed and there is minimal scarring from the insertion of the cryoprobe. No breast reconstruction is needed.
Short, out-patient procedure with local anesthesia: Average cryoablation procedure time is approximately 30 - 45 minutes with no hospital waiting or overnight stay. Numbing agents (local anesthesia) are injected only into the area being treated and the ice formed during the procedure has a numbing effect.
Reduced recovery time: Patients typically return to normal activity within 24-hours. Median recovery time is one day with a range of 0 – 8 days.
The procedure is monitored in real-time by ultrasound to ensure the ice ball is growing sufficiently around the tumor, and to avoid damage to the skin or muscle. The doctor may use hydro-dissection to protect the skin or muscle during a procedure depending on the location of the tumor. The tissue destroyed by the ice ball is naturally reabsorbed by the body over time and adjacent tissue is left unharmed.
The FDA's marketing authorization was based on an abundance of data including IceCure's ICE3 trial which was published in the Annals of Surgical Oncology. With 194 patients, ICE3 is the largest multi-center clinical trial ever completed for liquid-nitrogen (LN2) based cryoablation for patients aged ≥60 with low-risk, early-stage breast cancer without surgically removing the breast tumor. Only
The majority of the cryoablation procedure-related adverse events besides breast cancer recurrence were edema (swelling), bruising, hematoma (bleeding into tissues), skin burn, and postoperative pain. These were mild in severity and all of these events resolved without any permanent effect.
ICE3 study lead author, Richard Fine, MD, FACS, of the West Cancer Center & Research Institute in
Conference webcast info:
Monday, October 6, 2025 at 8:30 AM
A live webcast will be available at: https://www.veidan-conferencing.com/icecure-investors
A recording of the webcast will be available at: ir.icecure-medical.com
About ProSense®
The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of early-stage, 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 our website.
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 breast, kidney, lung, and liver.
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 that door to fast and convenient office-based procedures 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 option 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 details of the post-market study, including the number of expected patients and sites; and that further data coming out of the post-market study should continue to support that cryoablation with ProSense® is a successful option in the de-escalation of breast cancer care in appropriately selected patients. 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
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FAQ
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