{"id":911629,"date":"2025-11-19T09:09:54","date_gmt":"2025-11-19T14:09:54","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-reports-financial-operational-results-for-the-nine-months-ended-september-30-2025\/"},"modified":"2025-11-19T09:09:54","modified_gmt":"2025-11-19T14:09:54","slug":"icecure-reports-financial-operational-results-for-the-nine-months-ended-september-30-2025","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-reports-financial-operational-results-for-the-nine-months-ended-september-30-2025\/","title":{"rendered":"IceCure Reports Financial & Operational Results for the Nine Months Ended September 30, 2025"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Momentum building in the U.S. and rising interest globally following landmark FDA marketing<\/i>
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\n authorization for local cryoablation treatment of low-risk breast cancer<\/i>\n <\/p>\n

\n Demand for ProSense\u00ae systems expected to accelerate in 2026<\/i>\n <\/p>\n

\n Total U.S. population of approximately 200,000 patients, includes women aged 70+, those<\/i>
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\n not suitable for surgery and benign breast tumors\u00a0<\/i>\n <\/p>\n

\n Conference call to be held today, November 19, 2025<\/span> at 10:00 am Eastern Time<\/span><\/i>\n <\/p>\n

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\n CAESAREA, Israel<\/span>
\n <\/span>, Nov. 19, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0IceCure Medical Ltd.<\/a> (NASDAQ: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today reported financial results as of and for the nine months ended September 30, 2025<\/span>.<\/p>\n

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\n \"IceCure_Medical_Logo\"\n <\/div>\n

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In October 2025<\/span>, the U.S. Food and Drug Administration (“FDA”) granted marketing authorization to\u00a0IceCure’s De Novo application for the ProSense\u00ae cryoablation system for the local treatment of breast cancer in patients \u226570 years of age with biologically low-risk tumors \u22641.5 cm in size and treated with adjuvant endocrine therapy.<\/p>\n

“This was a landmark quarter for IceCure and the patients we aim to serve,” said Eyal Shamir<\/span>, Chief Executive Officer of IceCure Medical. “The FDA’s marketing authorization for ProSense\u00ae in low-risk breast cancer in women aged 70 and over marks a historic milestone and validates years of rigorous clinical research, positioning IceCure at the forefront of minimally invasive breast cancer care. In addition to the 46,000 patients that are 70+, we believe there are an additional 88,000 patients not suitable for or willing to go through surgery and approximately 63,000 patients with benign breast tumors who can also benefit from cryoablation.”<\/p>\n

“The immediate response to the FDA’s decision has been overwhelming and we are getting interest in the U.S. and globally from new potential users including breast surgeons, interventional and breast radiologists who are asking for demonstrations and installations,” added Mr. Shamir. “Over the past few months, we’ve seen an uptick in probe sales to our installed base of existing ProSense\u00ae users in the U.S. and internationally. Further expanding ProSense\u00ae’s availability, we recently received regulatory approval in Switzerland<\/span> for indications including breast cancer.”<\/p>\n

“Our U.S. sales team is hard at work. We expect ProSense\u00ae installations and procedure volume to increase and are very optimistic about our commercial traction,” Shamir concluded.<\/p>\n

\n Upcoming Catalysts<\/b>\n <\/p>\n