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IceCure Medical's ProSense® Cryoablation System Submitted for Regulatory Approval in Brazil
Regulatory filing submitted by KTRFIOS, IceCure's distributor in BrazilFiling includes breast and other cancers, benign tumors, palliative intervention, and
About this update from Icecure Medical Ltd.
[{"type":"text","content":"Regulatory filing submitted by KTRFIOS, IceCure's distributor in BrazilFiling includes breast and other cancers, benign tumors, palliative intervention, and other indicationsCAESAREA, Israel, June 9, 2022 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (\"IceCure\" or the \"Company\"), developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal (\"ProSense\"), today announced that KTRFIOS IMPORTACAO E EXPORTACAO LTDA., IceCure's distributor in Brazil (\"KTRFIOS\"), has submitted a regulatory filing to the Brazilian Health Regulatory Agency (\"ANVISA\") for the approval of ProSense for several indications. KTRFIOS has submitted this regulatory filing as part of an agreement signed with IceCure which includes KTRFIOS' guarantee of at least $6.6 million in total sales for five years following such regulatory approval and a down payment of $344,000 for 50% of the initial order.\nThe indications for use included in the ANVISA application are for oncology, including ablation of benign and malignant tissues in breast, prostate, kidney, lung, liver, musculoskeletal, and skin tissues, as well as for palliative intervention and other indications.\nAccording to the World Health Organization's (WHO) Cancer Tomorrow | IARC project, Brazil had a population of over 200 million with an estimated 592,000 cancer cases in 2020, 88,500 of which were breast cancer. The WHO expects the number of breast cancer cases in Brazil to rise to 99,800 by 2025. Therefore, IceCure believes there is a clear need for minimally-invasive cancer treatments, such as ProSense, in the Brazilian market.\n\"We are very pleased to be working with KTRFIOS in Brazil, a significant healthcare market in Latin America, and to achieve this major milestone. This regulatory application reflects the broad number of indications for which our ProSense system can provide a highly effective, minimally invasive, and safe method of treatment for cancer patients,\" stated IceCure CEO Eyal Shamir. \"Regulatory approvals in Brazil would add to our global regulatory landscape which now encompasses various indications across 14 countries including the U.S. and Europe.\"\nAbout IceCure MedicalFounded in 2006, Israel-based IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) develops and mar...