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IceCure Medical Reports First Half 2023 Financial & Operational Results: Global Adoption of Cryoablation Technology Gaining Momentum
Company awaits FDA's response to its regulatory filing for early-stage low risk breast cancer in patients who are at high risk for surgeryRenowned physician,
About this update from Icecure Medical Ltd.
[{"type":"text","content":"Company awaits FDA's response to its regulatory filing for early-stage low risk breast cancer in patients who are at high risk for surgeryRenowned physician, Dr. Robert Ward, to participate on the Company's conference call scheduled for today at 10am EDTCAESAREA, Israel, Aug. 14, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (\"IceCure\" or the \"Company\"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported financial results as of and for the six months ended June 30, 2023, as well as operational and recent corporate developments.\nSecond Quarter Highlights and Recent Achievements\nSuccessful transition from clinical stage to commercial stage continues as ProSense received regulatory approvals in Canada and ChinaAccelerated adoption with new distribution agreement in Portugal Cryoablation achieved a 92.8% efficacy in avoiding secondary surgery during a physician-sponsored cryoablation study of endometriosis, which affects about 10% of women who are at reproductive age globally, or 190 million people according to the World Health Organization (WHO)\"Our goal this year is to successfully transition from a development/clinical stage to a commercial stage company. I believe the regulatory clearances for ProSense in Canada and China demonstrate that we are well on our way to achieving our objective,\" stated IceCure Chief Executive Officer, Eyal Shamir. \"We remain highly committed to this strategy and believe it will be significantly enhanced upon U.S. Food and Drug Administration (FDA) approval. The FDA review is continuing to progress and is consistent with the standard de novo review process. We remain highly engaged with the FDA and we look forward to its pending response. We are also implementing our go-to market strategy through greater market awareness and are working to increase reimbursement for ProSense procedures in order to make it accessible to those seeking a non-invasive alternative to a lumpectomy, today's standard of care.\"\nSecond Quarter of 2023 and Recent Operating Highlights\nProSense Used in American Society of Breast Surgeons (ASBrS) Annual Meeting's 1st Ever Course on Cryoablation: At the ASBrS 24th Annual Meeting, the Society's first-ever continuing medical education (\"CME\"...