#USA #Chicago #IceCure Medical #Cryoablation #ProSense

IceCure Medical's ProSense® Cryoablation Data Overview

At the recent Annual Meeting of the Radiological Society of North America (RSNA) in Chicago, significant findings regarding IceCure Medical's ProSense® cryoablation technology for the treatment of low-risk breast cancer were disclosed. The presentation conducted by Dr. Kenneth Tomkovich, a co-principal investigator of the ICE3 trial, emphasized the potential of this innovative therapy as a viable alternative to traditional surgical methods.

Background of the ICE3 Trial

The ICE3 trial is a pivotal study aimed at evaluating the safety and effectiveness of cryoablation, a minimally invasive procedure which destroys tumors by freezing them. Unlike conventional surgical options, ICE3 targets early-stage breast cancer patients whose tumors are less than 1.5 cm, providing them with a less invasive choice while still achieving favorable clinical outcomes.

Dr. Tomkovich highlighted the importance of the findings stating, "The significance of the ICE3 results in the field of radiology, especially among breast radiologists, cannot be overstated." He continued by mentioning that this was the largest study of its kind, establishing critical data to support a transition towards cryoablation in breast cancer care.

Study Findings and Implications

The results presented revealed an impressive five-year recurrence rate of only 3.7%, with comparable statistics found within the ICE3 trial population. This is noteworthy, as these rates are considerably similar to those achieved through the current standard of care, surgical lumpectomy. The data also indicated significant advantages associated with the cryoablation procedure:

1. Outpatient Convenience: The procedure can be performed in an outpatient setting under local anesthesia, minimizing the strain on healthcare resources and patient recovery time.
2. Minimal Adverse Events: The only reported adverse events were of minor severity, underlining the safety of the procedure.
3. Patient Satisfaction: There was a remarkable 100% satisfaction rate among patients regarding cosmetic outcomes, an essential factor since many patients are concerned about the aesthetic results post-surgery.
4. Potential Elimination of Sentinel Lymph Node Biopsy: The findings suggest that this invasive procedure may not be necessary for patients in the ICE3 cohort, leading to even reduced procedural risks.

These insights are pivotal, projecting a safe and effective primary treatment alternative for small, low-risk breast cancers, which can reshape patient choices in clinical practice.

Endorsement and Market Outlook

These results have garnered increased awareness and attention within various medical specialty forums globally, marking an essential step towards broader acceptance and implementation of cryoablation in breast cancer treatment. IceCure Medical's CEO, Eyal Shamir, noted the significance of these findings as a vital support for gaining market traction leading up to the anticipated decision from the U.S. Food and Drug Administration (FDA) on ProSense®'s marketing authorization in early 2025.

The ProSense® system itself leverages liquid nitrogen technology to create extensive lethal zones for tumor destruction, enhancing recovery time, reducing pain, and lowering the overall surgical risks and complications involved in traditional tumor removal procedures. Its design allows for efficient, office-based operations that could further improve patient accessibility to cutting-edge cancer therapies.

Conclusion

The presentation of ICE3 trial results at the RSNA 2024 Annual Meeting underscores IceCure Medical's commitment to revolutionizing breast cancer treatment with its innovative cryoablation technology. As the industry anticipates an FDA approval, ProSense® stands at the forefront of a promising shift towards less invasive cancer therapies that prioritize both patient outcomes and satisfaction. It's a development that holds the potential to trend positively on how breast cancer is treated and offers hope to patients seeking alternatives to surgery.