Two New Publications from the Independent THERMAC Trial Featuring IceCure's ProSense® in Breast Cancer Finds 95% of Patients Satisfied with Thermal Ablation; ProSense® Cryoablation Achieves Highest Complete Ablation Rate
IceCure Medical (NASDAQ: ICCM) announced two significant publications from the independent THERMAC Trial evaluating its ProSense® cryoablation system in breast cancer treatment. The trial, conducted in the Netherlands, compared different thermal ablation methods for early-stage breast cancer.
The first study, published in the European Journal of Surgical Oncology, revealed that 95% of patients were satisfied with thermal ablation, with 91% preferring it over surgery. The second publication in Radiology demonstrated that ProSense® achieved the highest complete ablation rate among alternatives, with no complications.
Key findings showed that 94% of thermal ablation cases were rated good or excellent compared to 80% for surgery. ProSense® required no oncoplastic surgery, while other methods needed additional interventions. The successful phase II results led investigators to select cryoablation as the preferred technique for a future phase III trial comparing it with surgery.
IceCure Medical (NASDAQ: ICCM) ha pubblicato due studi importanti derivati dal trial indipendente THERMAC, che ha valutato il suo sistema di crioablazione ProSense® nel trattamento del tumore al seno. Lo studio, condotto nei Paesi Bassi, ha confrontato diverse tecniche di ablazione termica per il carcinoma mammario in fase iniziale.
Il primo lavoro, apparso sull'European Journal of Surgical Oncology, ha riportato che il 95% delle pazienti si è detto soddisfatto dell’ablazione termica e il 91% l'ha preferita all'intervento chirurgico. La seconda pubblicazione su Radiology ha mostrato che il ProSense® ha ottenuto il più alto tasso di ablazione completa tra le opzioni testate, senza complicazioni.
I risultati chiave indicano che il 94% dei casi trattati con ablazione termica è stato giudicato buono o eccellente, contro l’80% della chirurgia. ProSense® non ha richiesto interventi oncoplastici, mentre altre tecniche ne hanno necessitati. Gli esiti positivi della fase II hanno portato gli sperimentatori a scegliere la crioablazione come tecnica preferita per un futuro trial di fase III che la confronterà con la chirurgia.
IceCure Medical (NASDAQ: ICCM) anunció dos publicaciones importantes del ensayo independiente THERMAC, que evaluó su sistema de crioablación ProSense® en el tratamiento del cáncer de mama. El ensayo, realizado en los Países Bajos, comparó distintos métodos de ablación térmica para tumores de mama en estadios tempranos.
El primer estudio, publicado en la European Journal of Surgical Oncology, mostró que el 95% de las pacientes estaban satisfechas con la ablación térmica, y el 91% la prefirió frente a la cirugía. La segunda publicación en Radiology demostró que ProSense® alcanzó la mayor tasa de ablación completa entre las alternativas, sin complicaciones.
Los hallazgos clave indicaron que el 94% de los casos de ablación térmica fueron calificados como buenos o excelentes, frente al 80% en cirugía. ProSense® no requirió cirugía oncoplástica, mientras que otros métodos sí necesitaron intervenciones adicionales. Los exitosos resultados de la fase II llevaron a los investigadores a seleccionar la crioablación como técnica preferida para un futuro ensayo de fase III que la comparará con la cirugía.
IceCure Medical (NASDAQ: ICCM)는 독립적인 THERMAC 시험에서 자사 ProSense® 냉동절제 시스템을 유방암 치료에 적용한 두 편의 주요 논문을 발표했습니다. 네덜란드에서 수행된 이 시험은 초기 유방암에 대한 다양한 열적 절제 방법을 비교했습니다.
첫 번째 연구(European Journal of Surgical Oncology 게재)는 환자의 95%가 열적 절제에 만족했고 91%가 수술보다 이를 선호한다고 보고했습니다. Radiology에 실린 두 번째 연구는 ProSense®가 대안들 중에서 가장 높은 완전 절제율을 보였으며 합병증이 없었다고 밝혔습니다.
주요 결과로는 열적 절제 사례의 94%가 우수 또는 매우 우수로 평가된 반면 수술은 80%였다는 점이 있습니다. ProSense®는 종양성형수술(oncoplastic surgery)이 필요 없었고, 다른 방법들은 추가 시술을 필요로 했습니다. 2상 결과의 성공으로 연구진은 향후 수술과 비교하는 3상 시험에서 냉동절제를 선호 방법으로 선택했습니다.
IceCure Medical (NASDAQ: ICCM) a annoncé deux publications importantes issues de l'essai indépendant THERMAC évaluant son système de cryoablation ProSense® dans le traitement du cancer du sein. L'essai, mené aux Pays-Bas, a comparé différentes méthodes d'ablation thermique pour les cancers du sein à un stade précoce.
La première étude, publiée dans l'European Journal of Surgical Oncology, a révélé que 95% des patientes étaient satisfaites de l'ablation thermique, 91% la préférant à la chirurgie. La seconde publication dans Radiology a démontré que ProSense® obtenait le taux d'ablation complète le plus élevé parmi les alternatives, sans complications.
Les résultats clés montrent que 94% des cas d'ablation thermique ont été jugés bons ou excellents, contre 80% pour la chirurgie. ProSense® n'a nécessité aucune chirurgie oncoplastique, tandis que d'autres méthodes ont exigé des interventions additionnelles. Les résultats positifs de la phase II ont conduit les investigateurs à choisir la cryoablation comme technique privilégiée pour un futur essai de phase III la comparant à la chirurgie.
IceCure Medical (NASDAQ: ICCM) gab zwei bedeutende Publikationen aus der unabhängigen THERMAC-Studie bekannt, die sein ProSense® Kryoablationssystem in der Brustkrebsbehandlung untersuchte. Die Studie in den Niederlanden verglich verschiedene thermische Ablationsmethoden bei frühzeitigem Brustkrebs.
Die erste Studie, veröffentlicht im European Journal of Surgical Oncology, zeigte, dass 95% der Patientinnen mit der thermischen Ablation zufrieden waren und 91% sie der Operation vorzogen. Die zweite Veröffentlichung in Radiology belegte, dass ProSense® die höchste vollständige Ablationsrate unter den Alternativen erzielte, ohne Komplikationen.
Wesentliche Ergebnisse zeigten, dass 94% der Fälle mit thermischer Ablation als gut oder ausgezeichnet bewertet wurden, gegenüber 80% bei der Operation. Für ProSense® war keine onkoplastische Operation erforderlich, während andere Verfahren zusätzliche Eingriffe nötig machten. Die erfolgreichen Phase-II-Ergebnisse veranlassten die Forscher, Kryoablationen als bevorzugte Technik für eine zukünftige Phase-III-Studie zu wählen, die sie mit der Operation vergleichen wird.
- ProSense® achieved highest complete ablation rate with zero complications
- 95% patient satisfaction rate with thermal ablation treatment
- 94% of cases rated good/excellent for cosmetic outcomes vs 80% for surgery
- Zero cases requiring oncoplastic surgery with ProSense® vs up to 40% with alternatives
- Selected as preferred technique for phase III trial
- ProSense® currently only has regulatory approval for breast cancer in EU
- Study limited to 41 patients in phase II trial
Insights
ProSense cryoablation demonstrates superior efficacy and patient satisfaction in THERMAC trial, validating IceCure's minimally-invasive cancer treatment technology.
The newly published THERMAC trial results represent a significant clinical validation for IceCure Medical's ProSense® cryoablation system. The independent phase II trial, which compared three thermal ablation techniques for early-stage breast cancer, found that ProSense® achieved the highest complete ablation rate among competing technologies while reporting zero complications – a critical safety differentiator in the interventional oncology space.
What's particularly compelling is the patient-reported outcomes data. The
The investigators' decision to select cryoablation as the preferred technique for comparison with surgery in a future phase III trial is perhaps the most strategically valuable outcome for IceCure. This positions ProSense® at the forefront of the minimally-invasive tumor treatment paradigm shift and provides a clear pathway toward potential standard-of-care status. While ProSense® already has EU approval for breast cancer, these results strengthen its competitive positioning against both alternative ablation techniques and traditional surgical approaches.
The methodological strength of having results published in two respected peer-reviewed journals (European Journal of Surgical Oncology and Radiology) adds considerable credibility to these findings. The recognition at multiple medical conferences further suggests growing awareness and acceptance among key opinion leaders in oncology and interventional radiology – critical factors for clinical adoption of novel medical technologies.
From a clinical perspective, the THERMAC trial results offer compelling evidence supporting cryoablation's role in early-stage breast cancer treatment. The superior complete ablation rate achieved by ProSense® compared to radiofrequency ablation (RFA) and microwave ablation (MWA) is particularly noteworthy, especially considering RFA was halted early due to protocol-defined issues.
The patient-reported outcomes demonstrate important advantages beyond technical efficacy. The cosmetic results—rated good or excellent in
Two specific findings deserve attention: First, ProSense® cryoablation was associated with zero cases requiring oncoplastic surgery, compared to
While these phase II results are promising, clinicians will await the phase III trial comparing cryoablation directly to surgery with longer follow-up periods and larger patient populations. The key question remains whether ablation techniques can provide equivalent long-term cancer control to surgical resection. If the upcoming phase III trial confirms these early findings with robust oncological outcomes, it could potentially shift treatment paradigms for select early-stage breast cancer patients toward less invasive approaches.
Article published in European Journal of Surgical Oncology focused on cosmetic outcomes and patient satisfaction reports
Article published in Radiology demonstrated that cryoablation with ProSense® achieved the highest complete ablation rate compared to alternatives with no adverse events
"These peer-reviewed publications further advance ProSense®'s clinical validation," stated IceCure's Chief Executive Officer, Eyal Shamir. "In the THERMAC Trial, ProSense® cryoablation outperformed alternative thermal ablation techniques and delivered cosmetic outcomes superior to surgery, showcasing its safety and efficacy in early-stage breast cancer. We are grateful to Dr. Sophie Wooldrik and her team in
Both published papers, based on the THERMAC Trial, were led by Dr. Sophie Wooldrik, Department of Surgery, Franciscus Gasthuis & Vlietland, in
THERMAC Trial was a phase II study which compared radiofrequency ablation (RFA), microwave ablation (MWA), and cryoablation with ProSense® for early-stage breast cancer. Forty-one (41) patients were included in the study. Based on the phase II results, the study's investigators concluded that cryoablation is the preferred technique for comparison with surgery in a future phase III trial.
The article published in European Journal of Surgical Oncology (EJSO) titled "Cosmetic outcome and patient satisfaction following percutaneous thermal ablation of early-stage breast cancer; results of an open label randomized phase 2 trial" assessed patient-reported cosmetic outcome and satisfaction following percutaneous thermal ablation with ProSense® and breast-conserving surgery.
The findings included the following:
- Overall median cosmetic outcome was good after thermal ablation, and intermediate after surgery (1.6 vs 1.8; P = 0.07)
- Most domains of BREAST-Q (a widely used patient-reported outcome instrument measuring health-related quality-of-life and patient satisfaction in breast surgery) were scored higher after thermal ablation as compared to breast conserving surgery
95% of patients were very satisfied or satisfied with thermal ablation91% would prefer thermal ablation over surgery
- On BCCT core (a method for the objective evaluation of breast cancer conservative treatment)
94% of cases were rated as good or excellent after thermal ablation, compared to80% after surgery
An article related to the same study was published in Radiology, titled "Percutaneous Thermal Ablation for Early-Stage Breast Cancer: An Open-Label, Randomized, Phase II Trial to Select the Preferred Technique for Evaluating Thermal Ablation as a Surgical Alternative."
The findings included the following:
- Cryoablation with ProSense® achieved the highest complete ablation rate with no complications, supporting its selection for a phase 3 trial
- Cryoablation with ProSense® was associated with zero cases requiring oncoplastic surgery, compared to 2 (
40% ) in the RFA group, and 2 (11% ) in the MWA group - RFA was halted early due to protocol-defined issues
- MWA delivered moderate efficacy
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 that cryoablation is the preferred technique for comparison with surgery in a future phase III trial. 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.
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FAQ
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