CAESAREA, Israel, July 2, 2019 - IceCure Medical Ltd. (ICCM.TA), developer of the next generation liquid-nitrogen-based cryoablation technology to treat malignant and benign tumors by freezing, announced today that its application for a new CPT code, describing the use of cryoablation for treating cancerous breast tumors, has been approved by the American Medical Association (AMA).
Category III CPT Codes are typically issued for emerging innovative technologies and procedures, to support better tracking in the use of these procedures. These codes also enable providers to apply for reimbursement for procedures using cryoablation therapy for ablating malignant breast tumors. Category III CPT Codes are generally limited to a number of years, until the requirements for a Category I CPT code are met.
IceCure expects that the new reimbursement code will provide important support for further adoption of cryoablation therapy for breast cancer.
"The new CPT code is another significant milestone for IceCure in establishing cryotherapy, a minimally-invasive intervention available for women diagnosed with breast cancer, as an important treatment option," said Eyal Shamir, CEO of IceCure Medical. "Obtaining this code was supported by five American-based medical societies, including the American Society of Breast Surgeons (ASBrS), the American College of Surgeons (ACS), and the two leading interventional radiology associations – Radiological Society of North America (RSNA) and Society of Interventional Radiology (SIR)."
The growing recognition of the role of cryoablation in managing breast cancer is further evidenced by the presentation, in May 2018, of the interim results from the landmark ICE3 clinical study. ICE3 is the largest controlled multicenter clinical trial ever performed for nitrogen-based cryoablation of small, low-risk, early stage malignant breast tumors without subsequently removing them.
The company is currently in discussions with the Food and Drug Administration (FDA) to expand the use of its flagship cryoablation system, ProSense™, to enable minimally-invasive cryoablation treatment of cancerous breast tumors. ProSense™ is already cleared by the FDA for use as a non-surgical solution to treat non-cancerous breast tumors (Fibroadenoma) in outpatient and office settings.
"The most effective interventions currently available for breast cancer patients are invasive, and at times, deforming surgeries," commented Dr. Richard Fine, past President of the American Society of Breast Surgeons and the Principal Investigator of the ICE3 study. "Cryoablation is a very safe, virtually painless and effective treatment that can be performed in outpatient settings using local anesthesia. The new CPT code is an important step in recognizing the role of cryotherapy by the US healthcare system."