Another Success: IceCure Receives Israeli AMAR Approval for Use of its Freezing Technology in Specific Indications, Following an Earlier General Approval
The AMAR approval allows for freezing of benign and malignant tumors including breast, lungs, bones, liver, lymphatic tissue, lymph nodes and endocrine glands
CAESAREA, Israel, Aug. 5, 2019 /PRNewswire/ -- IceCure Medical Ltd. (TASE: ICCM), an Israeli medical device company that has developed a minimally-invasive cryoablation technology to treat malignant and benign tumors by freezing without the need for surgery, has received Israeli AMAR authorization for use of its freezing technology in specific indications. The new approval will enable the company to market its product in procedures for freezing of benign and malignant tumors, including and among others, breast, lungs, bones, liver, lymphatic tissue, lymph nodes and endocrine glands. This achievement comes hot on the back of the company receiving a Class 3 CPT code from the American Medical Association that enables providers to apply for reimbursement for procedures using cryoablation therapy for ablating malignant breast tumors.
The AMAR specific approval supports a previous granted general approval that enabled IceCure to market its products in procedures for freezing of benign and malignant tumors for general indications, including for the field of oncology, urology, dermatology and general surgery. The new approval, as opposed to the general approval, will allow doctors in Israel to use the company's product to freeze tumors in specific medical indications, in which the company already operates in various worldwide territories, including for breast and lung cancer.
Eyal Shamir, CEO of IceCure: "This specific approval in Israel is an important achievement that will support IceCure to expand our technology use. Doctors can now more easily destroy benign and malignant tumors for a wide range of indications that will help save and improve the lives of many patients. The approval in Israel follows the recent approval of the American Medical Association (AMA) application for CPT Code Category 3 for ablating malignant breast tumors. We are confident these combined regulatory approvals will help further enhance clinical acceptance of our technology and advance our business development efforts to help make patient care more affordable and accessible worldwide."
About IceCure Medical
Founded in 2006, IceCure Medical Ltd. (TASE: ICCM), is a medical device company that develops and markets a minimally-invasive cryoablation technology to treat malignant and benign tumors by freezing without the need for surgery. 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. With IceCure's primary focus areas being breast, kidney and lung cancer, ProSense™ is currently offered in a number of countries worldwide, including the United States on a limited basis. To learn more, please visit: www.icecure-medical.com
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SOURCE IceCure Medical
Released August 5, 2019