IceCure Medical's ProSense® Cryoablation System Submitted for Regulatory Approval in Brazil & More News Here

• Regulatory submitting submitted by KTRFIOS, IceCure’s distributor in Brazil
• Filing consists of breast and different cancers, benign tumors, palliative intervention, and different indications

CAESAREA, Israel, June 9, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” or the “Company”), developer of minimally-invasive cryoablation know-how, the ProSense^® System, that destroys tumors by freezing as a substitute for surgical tumor elimination (“ProSense”), right now introduced that KTRFIOS IMPORTACAO E EXPORTACAO LTDA., IceCure’s distributor in Brazil (“KTRFIOS”), has submitted a regulatory submitting to the Brazilian Health Regulatory Agency (“ANVISA”) for the approval of ProSense for a number of indications. KTRFIOS has submitted this regulatory submitting as a part of an settlement signed with IceCure which incorporates KTRFIOS’ assure of a minimum of $6.6 million in whole gross sales for 5 years following such regulatory approval and a down fee of $344,000 for 50% of the preliminary order.

The indications for use included in the ANVISA utility are for oncology, together with ablation of benign and malignant tissues in breast, prostate, kidney, lung, liver, musculoskeletal, and pores and skin tissues, in addition to for palliative intervention and different indications.

According to the World Health Organization’s (WHO) Cancer Tomorrow | IARC venture, Brazil had a inhabitants of over 200 million with an estimated 592,000 most cancers circumstances in 2020, 88,500 of which had been breast most cancers. The WHO expects the variety of breast most cancers circumstances in Brazil to rise to 99,800 by 2025. Therefore, IceCure believes there’s a clear want for minimally-invasive most cancers remedies, resembling ProSense, in the Brazilian market.

“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,” said 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.”

About IceCure Medical
Founded in 2006, Israel-based IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) develops and markets ProSense®, a sophisticated liquid-nitrogen-based cryoablation remedy for the remedy of tumors (benign and cancerous) by freezing, with the first focus areas being breast, kidney, bone and lung most cancers. Its minimally invasive know-how is a secure and efficient different to hospital surgical tumor elimination that’s simply carried out in a comparatively brief process. The system is marketed and offered worldwide for the indications cleared to-date by the U.S. Food and Drug Administration and accredited in Europe with the CE Mark.

Forward Looking Statements
This press launch accommodates forward-looking statements inside the that means of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and different Federal securities legal guidelines. Words resembling “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and comparable expressions or variations of such phrases are meant to establish forward-looking statements. For instance, IceCure is utilizing ahead trying assertion in this press launch when it discusses regulatory utility submission and path in direction of approvals of its ProSense system and the indications included this utility in Brazil and the potential penetration of the Company’s product in the Brazilian market. Because such statements take care of future occasions and are based mostly on IceCure’s present expectations, they’re topic to varied dangers and uncertainties and precise outcomes, efficiency, or achievements of IceCure might differ materially from these described in or implied by the statements in this press launch. The forward-looking statements contained or implied in this press launch are topic to different dangers and uncertainties, a lot of that are past the management of the Company, together with these set forth in the Risk Factors part of the Company’s Annual Report on Form 20-F for the 12 months ended December 31, 2021 filed with the SEC on April 1, 2022, which is offered on the SEC’s web site, www.sec.gov. The Company undertakes no obligation to replace these statements for revisions or adjustments after the date of this launch, besides as required by regulation.

IR Contact:
Ronen Tsimerman
electronic mail: [email protected]

SOURCE IceCure Medical

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