Icecure Medical Ltd. - ICCM STOCK NEWS

IceCure Medical (NASDAQ: ICCM) will announce its financial results for the nine months ending September 30, 2022, on December 5, 2022. The results will be shared via a press release at 7:30 a.m. EST, followed by a conference call at 8:00 a.m. EST featuring Dr. Hania Bednarski, a cryoablation specialist. IceCure's ProSense technology offers a non-invasive alternative for tumor treatment. The system is FDA-cleared and CE-marked in Europe, focusing on breast, kidney, bone, and lung cancers. Forward-looking statements regarding the company’s future performance will be included.

IceCure Medical (NASDAQ: ICCM) achieved a significant milestone with the Centers for Medicare & Medicaid Services (CMS) assigning its ProSense cryoablation procedure for breast cancer to a Medicare Payment Group, effective January 1, 2023. This is the first payment assignment for cryoablation of breast cancer, contingent upon FDA marketing authorization. The procedure, priced at approximately $3,400, aims to provide a cost-effective alternative to traditional surgery, potentially improving patient outcomes and healthcare economics. IceCure's CEO emphasized the importance of this step in advancing treatment options for early-stage breast cancer.

IceCure Medical Ltd (NASDAQ: ICCM) announced its initiatives for Breast Cancer Awareness Month, focusing on the ProSense® cryoablation system, which offers a minimally invasive, effective treatment option for early-stage low-risk breast cancer. The company has filed for FDA marketing authorization and expanded installation of ProSense in multiple countries including the US and Europe. Key activities included physician training webinars and demonstrations at international conferences, emphasizing the system's cosmetic benefits and patient empowerment.

IceCure Medical filed a De Novo Classification Request with the FDA for the ProSense® System, targeting early-stage low-risk breast cancer patients unsuitable for surgery. The initial filing addresses approximately $80 million in annual market potential for 43,000 cases in the U.S., with plans for a broader submission for 65,000 cases post-2024. The interim ICE3 clinical trial showed a low ipsilateral breast tumor recurrence (IBTR) rate of 3.09%. IceCure anticipates benefits over traditional lumpectomy, including reduced complications and costs.

IceCure Medical (Nasdaq: ICCM) has announced that its ProSense Cryoprobes and Introducers have received regulatory approval from Brazil's ANVISA, following an application by KTRFIOS in June 2022. The company anticipates strong demand for its ProSense Cryoablation System, which is still awaiting approval. The distribution agreement guarantees at least $6.6 million in sales over five years upon receiving full regulatory approval. This system offers a minimally invasive alternative to surgical tumor removal for treating various types of tumors.

IceCure Medical Ltd. (NASDAQ: ICCM) has submitted a regulatory filing with Vietnam's Ministry of Health for its ProSense System, designed for treating benign and malignant tumors. This technology presents a non-surgical alternative, targeting various cancers including breast, lung, liver, and kidney. Vietnam's medical device market, valued at $1.4 billion in 2019, is expected to grow at 10% annually through 2024. CEO Eyal Shamir expressed optimism about distributor interest in the fast-growing Vietnamese healthcare market, following recent successes in China and Japan.

IceCure Medical Ltd. (NASDAQ: ICCM) reports a 27% revenue decline to approximately $1.5 million for the six months ended June 30, 2022. Key highlights include an exclusive agreement with Shanghai Medtronic for IceSense3 systems, targeting minimum purchases of $3.5 million over three years. ProSense systems have been installed in multiple global locations, with NMPA approval for IceSense3 expected by year-end 2022. However, the company faced increased R&D and operational expenses, resulting in a net loss of approximately $9.0 million, or $0.24 per share.

IceCure Medical Ltd. (NASDAQ: ICCM) will report its H1 2022 business and financial results on August 15, 2022, at 4:00 p.m. EDT. Following the report, a conference call hosted by management and Dr. Kenneth Tomkovich, the co-primary investigator of the ICE3 trial, is scheduled for 4:30 p.m. EDT. IceCure specializes in minimally-invasive cryoablation technology, notably the ProSense® System, aimed at treating tumors by freezing. The company focuses on various cancers, including breast and kidney cancer, and its technology is FDA-cleared and CE-marked in Europe.

IceCure Medical Ltd (NASDAQ: ICCM) announced its submission of a regulatory filing to Health Canada for the approval of ProSense®, a minimally invasive cryoablation system targeting the treatment of breast tumors and other cancers. With current approvals in 14 countries, including the U.S. and Europe, IceCure aims to expand its market presence. CEO Eyal Shamir noted significant interest from Canadian healthcare providers for its technology, particularly as demand for outpatient solutions has surged post-pandemic. An estimated 28,600 Canadian women will be diagnosed with breast cancer in 2022.