On July 25, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System ( "ProSense") that destroys tumors by freezing as an alternative to surgical tumor removal, reported the submission of a regulatory filing with the Canadian governmental agency, Health Canada, for approval of IceCure’s ProSense System and its cryoprobes for the treatment of numerous indications including (Press release, IceCure Medical, JUL 25, 2022, View Source [SID1234616917]):
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Oncology – ablation of benign and malignant breast tumors as well as benign and malignant tumors of the lung, liver, and musculoskeletal system, and for palliative intervention;
Urology – ablation of renal cell carcinoma;
Thoracic surgery – ablation of cancerous lesions in the lung tissue; and
Other indications and for general surgery.
The ProSense System currently has regulatory approval for various indications in 14 countries, including in the U.S. and Europe.
According to statistics from the Canadian Cancer Society, an estimated 28,600 women will be diagnosed with breast cancer in Canada in 2022, while an estimated 30,000 people will be diagnosed with lung cancer. Furthermore, breast cancer is the most common cancer among Canadian women. About 1 in 8 women will be diagnosed with the disease in their lifetime.
"We have been contacted by multiple Canadian healthcare providers, including hospitals, with requests to purchase and implement ProSense for treating a range of indications, with malignant breast tumors being the most pressing need," stated IceCure CEO, Eyal Shamir. "We believe demand is being driven by a combination of ProSense’s rising prominence in the global market and health care providers discovering, over the past two years during the pandemic, that they needed minimally invasive solutions that can be administered in an outpatient setting outside of an operating room. The benefits of minimally invasive procedures have become clearer than ever, driving demand in a post-pandemic environment. We hope to receive Health Canada’s approval, further expanding ProSense’s global regulatory and commercial footprint."