IceCure Medical's ProSense Cryoablation System Receives Regulatory Approval In Brazil; $6.6M In Sales Expected In Brazilian Market Over The Next Five Years Per Distribution Agreement Guarantees.
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| Title: | IceCure Medical's ProSense Cryoablation System Receives Regulatory Approval In Brazil; $6.6M In Sales Expected In Brazilian Market Over The Next Five Years Per Distribution Agreement Guarantees. |
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| Authors: | Happy Mohamed |
| Source: | Benzinga. 09/05/2023. |
| Abstract: | CAESAREA, Israel, Sept. 5, 2023 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: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, today announced that its ProSense System has received regulatory approval as a Class III device from the Brazilian Health Regulatory Agency ("ANVISA"). ProSense's disposable cryoprobes and introducers, were previously registered as Class II devices by ANVISA. Applications for both the ProSense System and its disposable cryoprobes and introducers were submitted to ANVISA by IceCure's distributor in Brazil, Ktrfios Importação e Exportação LTDA ("Ktrfios"). ProSense's indications approved by ANVISA are oncology, which includes the ablation of benign and malignant tissues in the breast, prostate, kidney, lung, liver, musculoskeletal, and skin tissue, as well as for palliative intervention and other indications. [ABSTRACT FROM PUBLISHER] |
| Database: | Newspaper Source Plus |
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| Abstract: | CAESAREA, Israel, Sept. 5, 2023 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: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, today announced that its ProSense System has received regulatory approval as a Class III device from the Brazilian Health Regulatory Agency ("ANVISA"). ProSense's disposable cryoprobes and introducers, were previously registered as Class II devices by ANVISA. Applications for both the ProSense System and its disposable cryoprobes and introducers were submitted to ANVISA by IceCure's distributor in Brazil, Ktrfios Importação e Exportação LTDA ("Ktrfios"). ProSense's indications approved by ANVISA are oncology, which includes the ablation of benign and malignant tissues in the breast, prostate, kidney, lung, liver, musculoskeletal, and skin tissue, as well as for palliative intervention and other indications. [ABSTRACT FROM PUBLISHER] |
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