Israeli cancer treatment company IceCure Medical Ltd. (TASE:ICCM), which has developed liquid-nitrogen-based cryoablation technology to treat malignant and benign tumors by freezing, has announced 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). The new Category III CPT code is expected to support further adoption of minimally invasive cryoablation treatments for breast cancer.
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 Medical CEO Eyal Shamir said, “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. 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 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.
IceCure is in discussions with the US 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”.
Founded in 2006, IceCure Medical develops and markets minimally-invasive cryoablation therapies for women’s health and the interventional oncology market, with the primary focus areas being breast, kidney and lung cancer. The Company’s proprietary, flagship ProSense liquid-nitrogen based system, has received US FDA 510k and CE Mark approvals and is safe, innovative with clinical and economic benefits compared to the current standard of care.
Published by Globes, Israel business news - en.globes.co.il - on July 3, 2019
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