IceCure Medical's ProSense® cryoablation system is demonstrating significant promise as a non-surgical alternative for early-stage breast cancer treatment, according to multiple studies presented at recent European oncology conferences.
The liquid nitrogen-based technology, which destroys tumors by freezing them, was featured prominently at both the European Conference on Interventional Oncology (ECIO) 2025 in Rotterdam and the St. Gallen International Breast Cancer Conference in Vienna.
Clinical Evidence Supports Efficacy and Safety
At ECIO 2025, Dr. Sophie Wooldrik presented results from the THERMAC trial, which compared three thermal ablation techniques for breast cancer. ProSense® cryoablation achieved a 94% efficacy rate with zero complications, significantly outperforming radiofrequency and microwave ablation alternatives. Notably, patient satisfaction was exceptionally high, with 95% of participants stating they would choose thermal ablation over breast-conserving surgery.
"Only cryoablation met the requirement to proceed to a phase 3 study," Dr. Wooldrik reported during her presentation. The THERMAC trial enrolled 41 women with early-stage breast cancer.
In a separate study presented by Professor Thomas Vogl of Germany, CT-guided cryoablation demonstrated safety and efficacy in treating primary breast cancer. The study of 45 patients with 56 tumors showed a mean progression-free survival of 2.9 years.
Long-Term Data Supporting Clinical Adoption
The ICE3 trial, a landmark study of ProSense® in early-stage breast cancer, continues to produce encouraging long-term data. Dr. Richard Fine presented the 5-year results at the St. Gallen conference, showing an overall ipsilateral breast tumor recurrence (IBTR) rate of just 3.61% among 194 patients.
"The ICE3 trial suggests that cryoablation with ProSense®, complemented by adjuvant therapy, is a viable alternative to surgical excision for selected patients with early-stage, low-risk breast cancer with recurrence rates comparable to those following lumpectomy," Dr. Fine concluded.
The study specifically enrolled patients aged ≥60 with unifocal, hormone receptor-positive, HER2-negative invasive ductal carcinomas measuring ≤1.5 cm. Patients who received only endocrine therapy with cryoablation had a 5-year IBTR rate of 3.22%.
Expanding Patient Populations
Researchers are now exploring the potential to expand cryoablation to additional patient populations. Dr. Ava Kwong from Hong Kong presented data evaluating the use of ProSense® in broader patient groups than those included in the ICE3 trial.
"This study evaluated expanding ICE3's inclusion criteria to T1 breast cancer of all IHC subtypes, including triple negative breast cancer, and younger age range," Dr. Kwong explained. Her team found that cryoablation could completely ablate T1 breast cancers across these expanded criteria.
Benefits for Non-Surgical Candidates
For patients who cannot undergo surgery, cryoablation may offer a particularly valuable alternative. Dr. Lucía Graña López from Spain presented findings on 54 patients (median age 87) who were either inoperable or declined surgery. The study achieved complete tumoral necrosis in 81.7% of the 60 treated tumors, with 100% success in luminal cancers up to 2.5 cm.
"The procedure was well tolerated, with no major complications observed," Dr. López reported, suggesting that cryoablation could serve as an effective alternative for elderly or high-risk patients.
Commercial Implications
Eyal Shamir, IceCure's Chief Executive Officer, noted the growing commercial potential for ProSense® in Europe and other global markets.
"As minimally invasive technologies like ProSense® have advanced the science of cancer care, interventional oncology is becoming an increasingly viable and preferred pathway for the treatment of breast cancer in Europe, next to current standard of care surgical, medical, and radiological methods," Shamir stated.
The company believes ProSense® is the leading cryoablation system for early-stage breast cancer tumors on the market today, a position reinforced by the significant presence at these prestigious conferences.
Technology and Procedure
The ProSense® system utilizes liquid nitrogen to create large lethal zones for tumor destruction. The procedure is performed on an outpatient basis under local anesthesia, eliminating the need for hospital stays associated with traditional surgery.
This minimally invasive approach offers several potential advantages, including faster recovery, reduced pain, and fewer surgical risks and complications. The system's portable design also enables convenient office-based procedures.
Future Directions
Several ongoing studies continue to evaluate ProSense® in various settings. The European Institute of Oncology in Italy has launched the PRECICE study (Percutaneous Cryoablation of Low-risk Early Breast Cancer), which aims to enroll 233 patients over age 50 with small, luminal A and B breast cancers.
Additionally, researchers from the Netherlands are planning a Phase III trial of cryoablation based on the promising results from the THERMAC study.
As the body of evidence continues to grow, cryoablation with ProSense® appears positioned to potentially transform the treatment landscape for select breast cancer patients, offering a non-surgical alternative that maintains oncological efficacy while improving quality of life.
