IceCure Medical Ltd. (NASDAQ: ICCM) is experiencing significant growth in sales of its ProSense cryoablation system and anticipates a crucial FDA decision regarding its use in early-stage breast cancer treatment in the first quarter of 2025. The company's ProSense system saw a 42% increase in North American sales in 2024, driven by growing acceptance of cryoablation as a minimally invasive alternative to surgical tumor removal.
The FDA's decision on market authorization for ProSense follows a positive vote from the FDA's Medical Device Advisory Committee Panel, which reviewed data from the ICE3 study. This study, the largest controlled multi-center clinical trial for liquid nitrogen-based cryoablation of low-risk, early-stage malignant breast tumors, reported a 96.3% recurrence-free rate at five years, with 100% patient and physician satisfaction. These results, published in the Annals of Surgical Oncology, are comparable to those achieved with lumpectomy, the current standard of care.
ProSense Cryoablation System
The ProSense Cryoablation System utilizes liquid nitrogen to destroy tumors by freezing. This minimally invasive procedure offers several potential benefits, including faster recovery times, reduced pain, and fewer surgical risks and complications. The system is designed for convenient office-based procedures, enhancing accessibility for patients.
ICESECRET Kidney Cancer Study
In addition to its application in breast cancer, ProSense is also being investigated for the treatment of kidney cancer. Interim results from the ICESECRET study revealed an 88.7% recurrence-free rate. These findings are particularly relevant for patients who are not eligible for kidney-preserving surgery, addressing a significant unmet need in the treatment of kidney cancer.
Expansion and Future Objectives
IceCure Medical is actively expanding its market presence and exploring strategic partnerships. The company received regulatory clearance for its next-generation XSense cryoablation system and is pursuing regulatory approval for ProSense in China. With a growing body of clinical evidence and a fortified intellectual property portfolio, IceCure is poised for continued growth and innovation in the field of minimally invasive tumor treatment.
Eyal Shamir, CEO of IceCure Medical, stated, "De-escalation of surgery...is being evaluated in studies and emerging as a growing trend in practice. As a minimally invasive option, cryoablation with ProSense offers an excellent choice for de-escalation of surgery with results that parallel invasive surgery - and doctors and their patients are taking notice."
