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 tumours
Image: The new approval allows doctors in Israel to freeze tumours in specific medical indications. Photo: Courtesy of David Mark from Pixabay.
IceCure Medical, 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.”
Source: Company Press Release.