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U.S. Food and Drug Administration Grants Regulatory Clearance to IceCure for Next-Gen XSense™ Cryoablation System with CryoProbes
CAESAREA, Israel, July 1, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of
About this update from Icecure Medical Ltd.
[{"type":"text","content":"CAESAREA, Israel, July 1, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (\"IceCure\", \"IceCure Medical\" or the \"Company\"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has received marketing authorization from the United States Food and Drug Administration (the \"FDA\") for its next-generation single probe cryoablation system, the XSense™ Cryoablation System with CryoProbes.\n\n\"This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology,\" commented Eyal Shamir, IceCure's Chief Executive Officer. \"The next-generation XSense™ system is cleared for the same indications as our flagship ProSense® system and we believe it has future potential to address other indications in the U.S. for significant indications with unmet needs. Through our innovation, IceCure is a global leader in liquid nitrogen-based cryoablation systems that offer a new minimally invasive treatment with benefits for patients, doctors and payors alike.\"\nXSense™ and its cryoprobes are cleared for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. The system is designed to destroy tissue by the application of extreme cold temperatures, including fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts.\nAbout IceCure's Cryoablation Systems\nIceCure's platform technology, including the ProSense® Cryoablation System and XSense™ Cryoablation System and CryoProbes, provides a minimally invasive treatment option to destroy tumors by freezing them. The systems uniquely harness the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.\nIceCure's cryoablation systems enhance patient and provider value by accelerating recovery, reducing pain, surgical risks and complications. With easy, transportable design and liquid nitrogen utilization, ProSense® and XSense™ open the door to fast and convenient office-based proc...