IceCure Medical Requests FDA Marketing Authorization for Breast Cancer Cryoablation Technology
IceCure Medical Ltd. (Nasdaq: ICCM) has submitted final data to the FDA requesting marketing authorization for ProSense® as a treatment for early stage T1 invasive breast cancer with adjuvant hormone therapy. ProSense® is already cleared for use in the US for treating benign tumors of the breast, and tumors in the kidney and liver.
The company’s ICE3 study evaluated the use of IceCure’s minimally invasive 20-to-40-minute outpatient cryoablation procedure for the treatment of low-risk, early-stage malignant breast tumors. The 5-year recurrence-free rates from the study were in line with expectations and show similar outcomes to lumpectomy, the current standard of care for early-stage breast cancer patients.
“We believe ICE3 is a ground-breaking study and are excited to report that the efficacy data of our minimally invasive ProSense® cryoablation procedure show similar outcomes in recurrence compared to more invasive breast surgery, the current standard of care for early-stage breast cancer,” said IceCure CEO, Eyal Shamir.
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them.
IceCure says that initial reimbursement codes are already in place and its US marketing and commercial team expects rapid adoption of the technology. ProSense® was granted Breakthrough Designation by the FDA in 2021.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment 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 system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
