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
Rhea-AI Summary
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.
Positive
- 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
Negative
- ProSense® currently only has regulatory approval for breast cancer in EU
- Study limited to 41 patients in phase II trial
News Market Reaction
On the day this news was published, ICCM gained 1.94%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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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Email: investors@icecure-medical.com
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FAQ
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