IceCure's ProSense® Featured at CIRSE 2025 Annual Meeting: Positive Clinical Results with Cryoablation from 4 Independent Studies Presented
IceCure Medical (NASDAQ:ICCM) showcased its ProSense® cryoablation technology at the CIRSE 2025 Annual Meeting in Barcelona, featuring 4 independent clinical studies demonstrating positive results. The presentations included 3 studies on breast cancer and 1 on endometriosis, highlighting ProSense's effectiveness as a minimally-invasive tumor treatment alternative.
Key findings included successful outcomes in elderly breast cancer patients, with Institut Curie's study showing safety and efficacy in patients aged 75-94 years. Another study demonstrated significant tumor size reduction when combining cryoablation with hormonal therapy. The endometriosis study revealed remarkable pain reduction from a mean score of 8 to 1, with 95% success rate in MRI-confirmed cases.
The conference featured 3 hands-on training sessions and presentations from 5 Key Opinion Leaders, underlining growing interest from interventional radiologists in breast cancer care.
I principali risultati includono esiti positivi in pazienti anziane affette da cancro al seno, con lo studio dell'Institut Curie che mostra sicurezza ed efficacia in pazienti di età tra 75 e 94 anni. Un altro studio ha dimostrato una significativa riduzione delle dimensioni del tumore quando si associa cryoablation a terapia ormonale. Lo studio sull'endometriosi ha rivelato una notevole riduzione del dolore da una media di 8 a 1, con un tasso di successo del 95% nei casi confermati da MRI.
La conferenza ha visto 3 sessioni di formazione pratiche e presentazioni di 5 opinion leader, sottolineando l'interesse crescente degli interventional radiologists nella cura del cancro al seno.
Los hallazgos clave incluyeron resultados exitosos en pacientes mayores con cáncer de mama, con el estudio del Institut Curie que mostró seguridad y eficacia en pacientes de 75 a 94 años. Otro estudio mostró una reducción significativa del tamaño del tumor al combinar crioablation con terapia hormonal. El estudio sobre endometriosis reveló una reducción notable del dolor, de una puntuación media de 8 a 1, con una tasa de éxito del 95% en casos confirmados por MRI.
La conferencia contó con 3 sesiones de formación prácticas y presentaciones de 5 líderes de opinión, subrayando el creciente interés de los radiólogos intervencionistas en el cuidado del cáncer de mama.
주요 발견으로는 고령 유방암 환자에서의 성공적 결과가 포함되었으며, Institut Curie의 연구는 75-94세 환자에서 안전성과 유효성을 보여주었습니다. 또 다른 연구에서는 냉융치료와 호르몬 요법의 결합으로 종양 크기의 유의미한 감소를 보였습니다. 자궁내막증 연구는 평균 점수 8에서 1로 통증이 크게 감소했고 MRI로 확인된 사례에서 95%의 성공률을 보여주었습니다.
회의에는 3개의 실습 교육 세션과 5명의 의견 리더의 발표가 있었고, 세계적 간질배 합의 의사들(interventional radiologists)이 유방암 관리에 점점 더 관심을 보이고 있음을 강조했습니다.
Les résultats clés incluent des résultats réussis chez des patientes âgées atteintes de cancer du sein, l’étude de l’Institut Curie démontrant sécurité et efficacité chez des patientes de 75 à 94 ans. Une autre étude a montré une réduction significative de la taille de la tumeur en associant cryoablation et hormonothérapie. L’étude sur l’endométriose a révélé une réduction marquée de la douleur, passant de 8 à 1 en moyenne, avec un taux de succès de 95% dans les cas confirmés par IRM.
La conférence a compté 3 sessions de formation pratiques et des présentations de 5 leaders d’opinion, soulignant l’intérêt croissant des radiologues interventionnels pour les soins du cancer du sein.
Zu den wichtigsten Erkenntnissen gehörten erfolgreiche Ergebnisse bei älteren Brustkrebspatientinnen, wobei die Studie des Institut Curie Sicherheit und Wirksamkeit bei Patientinnen im Alter von 75-94 Jahren zeigte. Eine weitere Studie zeigte eine signifikante Tumorverkleinerung, wenn Kryoablation mit Hormontherapie kombiniert wird. Die Endometriose-Studie zeigte eine bemerkenswerte Schmerzlinderung von einem Durchschnitt von 8 auf 1, mit einer Erfolgsquote von 95% bei MRI-bestätigten Fällen.
Die Konferenz umfasste 3 praktische Schulungssitzungen und Präsentationen von 5 Key Opinion Leaders, was das wachsende Interesse von interventionellen Radiologen an der Brustkrebsversorgung unterstreicht.
تشمل النتائج الرئيسية نتائج ناجحة لدى مرضى كبار السن المصابات بسرطان الثدي، حيث أظهر دراسة معهد كوري نتائج السلامة والفعالية لدى المرضى الذين تتراوح أعمارهم بين 75 و94 عامًا. أظهرت دراسة أخرى انخفاضًا كبيرًا في حجم الورم عند الجمع بين التجميد العلاجي والعلاج الهرموني. كشفت دراسة الانتباذ البطاني الرحمي عن انخفاض ملحوظ في الألم من متوسط 8 إلى 1، مع معدل نجاح 95% في الحالات الموثقة بالتصوير بالرنين المغناطيسي.
تضمنت المؤتمر ثلاث جلسات تدريب عملية وعروض من 5 قادة آراء، مما يؤكد الاهتمام المتزايد لدى أخصائيي الأشعة التدخلية برعاية سرطان الثدي.
主要发现包括在老年乳腺癌患者中的成功结果，Institut Curie 的研究显示在 75-94 岁患者中的安全性和有效性。另一项研究显示在联合激素治疗时，肿瘤大小显著缩小。关于子宫内膜异位症的研究显示疼痛从平均评分 8 降至 1，MRI 确诊病例的成功率为 95%。
会议还设有 3 场动手培训课程 和来自 5 位意见领袖 的演讲，凸显介入放射科医生在乳腺癌护理方面日益增长的兴趣。
- Multiple independent studies validated ProSense® effectiveness across different applications
- Strong clinical results in breast cancer treatment, especially for elderly patients unable to undergo surgery
- Significant pain reduction (from 8/10 to 1/10) demonstrated in endometriosis treatment
- 95% success rate shown in endometriosis cases confirmed by MRI
- Growing adoption potential indicated by well-attended training sessions
- Studies primarily focused on limited patient populations (elderly, surgery-ineligible)
- Current breast cancer applications mainly restricted to specific tumor types (HR+/HER2-)
Insights
Multiple independent studies validate IceCure's ProSense® cryoablation effectiveness for breast cancer and endometriosis, strengthening clinical credibility and market potential.
IceCure's ProSense® cryoablation system is gaining significant clinical validation through multiple independent studies presented at CIRSE 2025. The technology, which uses liquid nitrogen to freeze and destroy tumors as an alternative to surgery, was featured in four separate clinical presentations with compelling results.
The most noteworthy findings came from three breast cancer studies that demonstrated ProSense®'s effectiveness in specific patient populations. In elderly patients deemed ineligible for surgery (mean age 83.4 years), the combination of cryoablation with hormonal therapy significantly reduced tumor size compared to hormonal therapy alone. At Institut Curie, a study of 55 elderly patients (median age 86) with HR+/HER2- breast cancers showed ProSense® to be a safe and effective alternative to surgery. A third study confirmed cryoablation's efficacy specifically in small, low-grade hormone receptor-positive tumors.
Particularly interesting was the endometriosis application presented by Prof. Frandon, where pain scores dramatically decreased from a mean of 8 to 1 (on a scale of 1-10), with 95% of cases showing necrotic changes and resolution of hemorrhagic signals on MRI. This suggests potential market expansion beyond oncology.
The PRECICE trial deserves special attention as it's sponsored by the Italian Ministry of Health and exclusively using ProSense® to treat 234 Luminal A and B patients over 50 years with early-stage breast cancer—a broader population than IceCure's own ICE3 study.
What makes these findings particularly valuable is that they come from investigator-initiated studies rather than company-sponsored research, providing independent validation of ProSense®'s clinical utility. The fact that three hands-on training sessions were "very well attended" indicates growing physician interest, especially among interventional radiologists looking to expand their practice to breast cancer care, representing a potential new customer segment for IceCure.
Presentations from 5 Key Opinion Leaders on ProSense® cryoablation including 3 independent studies on breast cancer and 1 on endometriosis
3 hands-on training sessions for doctors interested in using ProSense® were very well attended
Dedicated CIRSE focus session on the breast shows the growing interest from interventional radiologists to expand their practice to include care for breast cancer patients
"We had a very successful participation at CIRSE this year, as ProSense® offers what we believe is the most advanced clinically proven LN2 cryoablation system to the growing number of interventional radiologists looking to grow their practice in breast care," stated IceCure's Chief Executive Officer, Eyal Shamir. "As always, we truly appreciate the medical doctors who have conducted their own investigator-initiated studies of ProSense® and who continue to actively share their findings and positive experiences with their colleagues at these important medical conferences."
ProSense® was featured in the following:
- 3 Hands-on device trainings for cold ablation featuring ProSense® were conducted
- Honorary lecture "Breaking barriers in breast cancer - cryoablation as the ultimate expression of IO's de-escalation philosophy," delivered by Dr. Franco Orsi, Chief of Interventional Radiology, European Institute of Oncology,
- Dr. Orsi highlighted the PRECICE trial and ProSense® cryoablation system as the study's chosen technology to treat breast cancer patients
- PRECICE, an independent study led by Dr. Orsi and the European Institute of Oncology, with sponsorship from the Italian Ministry of Health, is exclusively using ProSense® to treat 234 Luminal A and B patients >50 years of age with early-stage breast cancer, a wider population of patients than IceCure's ICE3 study
- 3 presentations on breast cancer were delivered during the Focused Therapies for Challenging Tumors session
- Abstract Title: Comparative assessment of non-surgical treatment strategies for breast cancer: evaluating the effectiveness of cryoablation with hormonal therapy versus cryoablation alone and hormonal therapy alone in patients deemed ineligible for surgery;
- Presenter: Dr. Sofia Baldi Giorgi, Radiology Resident, Careggi University Hospital,
- Study's Focus: To evaluate the most effective non-surgical treatment for breast cancer in patients ineligible for surgery by comparing ultrasound-guided cryoablation combined with hormonal therapy ("HT") versus cryoablation alone and HT alone; mean age 83.4 years
- Key Findings: Cryoablation combined with HT significantly reduced mean tumor size and residual disease compared to HT alone, supporting its potential as a promising treatment for surgery-ineligible patients
- Abstract Title: Cryoablation for Small HR+ Breast Cancers in Elderly Patients: A Prospective Study of the First 55 Patients Treated at Institut Curie
- Presenter: Dr. Toulsie Ramthohul, Interventional Radiologist, Institut Curie Hospital,
- Study's Focus: Prospective study that evaluated the clinical and radiological outcomes of the first 55 patients treated at Institute Curie with cryoablation as an alternative to surgery for cT1 hormone receptor-positive (HR+) human epidermal growth factor receptor 2- negative (HER2-) breast cancers in elderly patients; median age was 86 years; age range 75-94 years
- Key Findings: Cryoablation using ProSense® is a safe and effective alternative to surgery for elderly patients with small HR+/Her2- breast cancers, even in high-risk populations
- Abstract Title: Differential efficacy of cryoablation in breast tumor subtypes: ultrasound-guided scar biopsy evaluation one-year post-treatment
- Presenter: Dr. Francesca Pugliese, Radiology Resident, EdiR, Breast Imaging, Careggi University Hospital,
- Study's Focus: To assess the effectiveness of cryoablation in different subtypes of breast tumors, a cohort of 39 inoperable biopsy-proven B5 (malignant) lesions underwent ultrasound-guided scar biopsy evaluations one year post-treatment
- Key Findings: Cryoablation was found to be a safe and effective option for patients with small, low-grade hormone receptor-positive (HR+), unifocal invasive ductal carcinoma (IDC) (the patient cohort evaluated in the study), offering a potential alternative to breast-conserving surgery.
- Presentation of a study by Dr. Ghizlane Touimi Benjelloun, Chu De Nîmes, Nîmes,
France on ProSense® in the treatment of abdominal wall endometriosis by
- Presenter: Prof. Julien Frandon, Director of the Interventional Radiology Department, Nîmes University Hospital
- Abstract Title: Efficacy and safety of percutaneous single probe cryoablation using liquid nitrogen in treatment of abdominal wall endometriosis
- Study's Focus: To evaluate the effectiveness and safety of percutaneous image-guided single probe cryoablation in treating symptomatic abdominal wall endometriosis ("AWE") lesions, with a focus on pain relief and treatment outcomes
- Key Findings: Pain scores significantly decreased from a mean of 8 on a scale of 1 to 10 to a mean of 1 on a scale of 1 to 10. MRI showed necrotic changes and resolution of hemorrhagic signals in
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment 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 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 ProSense® offers the most advanced clinically proven LN2 cryoablation system. 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
Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/icecures-prosense-featured-at-cirse-2025-annual-meeting-positive-clinical-results-with-cryoablation-from-4-independent-studies-presented-302562830.html
SOURCE IceCure Medical
FAQ
What were the key findings of ProSense® cryoablation studies presented at CIRSE 2025?
How effective is IceCure's ProSense® for breast cancer treatment in elderly patients?
What results did ProSense® show in treating endometriosis at CIRSE 2025?
Which patient populations were studied for IceCure's ProSense® cryoablation system?
How is ICCM's ProSense® different from traditional breast cancer treatments?
