Welcome to our dedicated page for Icecure Medical Ltd. news (Ticker: ICCM), a resource for investors and traders seeking the latest updates and insights on Icecure Medical Ltd. stock.
IceCure Medical Ltd. (Nasdaq: ICCM) is a commercial-stage medical device company that develops liquid-nitrogen-based cryoablation systems for minimally invasive destruction of benign and cancerous tumors. News about IceCure often centers on its flagship ProSense® Cryoablation System and its role as an option to surgical tumor removal, particularly in breast cancer and other oncology indications.
Investors and clinicians following ICCM news can expect updates on regulatory milestones, commercial expansion, and clinical data. Recent company communications highlight U.S. Food and Drug Administration (FDA) marketing authorization for ProSense® for the local treatment of low-risk breast cancer with adjuvant endocrine therapy in women aged 70 and above, including those not suitable for surgery. News items also cover regulatory approvals in markets such as Switzerland and Israel, as well as patent developments for next-generation systems like XSense™ and cryogen flow control technologies.
IceCure’s news flow frequently includes coverage of independent clinical studies and conference presentations. ProSense® has been featured in abstracts and talks at major meetings such as the Radiological Society of North America (RSNA) Annual Meeting, the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) Annual Meeting, and the European Society of Breast Imaging (EUSOBI) Congress. These reports describe clinical experience in breast cancer, lung cancer, musculoskeletal tumors, kidney lesions, and abdominal wall endometriosis.
Company updates may also address financial and operational results, commercial traction in regions including North America and Europe, and interactions with Nasdaq listing requirements. For users tracking ICCM, this news page provides a centralized view of press releases, clinical milestones, regulatory developments, and commercialization updates related to IceCure’s cryoablation platforms.
IceCure Medical Ltd. (Nasdaq: ICCM) announced interim results from the ICESECRET study, presented at the Urological Association Conference in Eilat, Israel. The ProSense system effectively treats renal lesions under 5 cm in patients unfit for kidney-preserving surgery. Out of 115 enrolled patients, an 89.5% recurrence-free rate was observed for lesions ≤3 cm. The study reported 5 serious adverse events, with the majority being mild and resolved quickly. ProSense is approved in the U.S. and Europe for treating both benign and malignant kidney tumors.
IceCure Medical Ltd. (Nasdaq: ICCM) announced the promotion of Galit Bar Malik to VP of Operations and Service and the appointment of Vincent Chun Hung Chan as an independent director. Chan, a seasoned private equity executive with over 30 years of experience, brings a strong background in managing investment projects and corporate governance. This strategic addition aims to bolster operations in light of anticipated sales growth for the ProSense® system, which treats tumors through cryoablation technology. The company is focusing on launching ProSense in key markets, including Asia.
IceCure Medical (Nasdaq: ICCM) reported a 22% revenue decline to $2.1 million for the nine months ending September 30, 2022, but noted a positive sales increase of 65% in the U.S. and 37% in Europe. Key developments include the FDA filing for ProSense cryoablation for breast cancer and achieving Medicare coverage with a CPT Category III code effective January 1, 2023. Operating expenses rose to $13.8 million, leading to a net loss of $13 million. The company has $14.2 million in cash as of September 30, 2022. A conference call discussing these results is scheduled for December 5, 2022.
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IceCure Medical Ltd (NASDAQ: ICCM) will announce its financial results for the nine months ending September 30, 2022, on December 5, 2022, at 7:00 a.m. EST. A conference call will follow at 8:00 a.m. EST, featuring Dr. Hania Bednarski, an expert in minimally-invasive cryoablation technology. The ProSense® System, developed by IceCure, is a cryoablation treatment for tumors, providing a non-surgical alternative. Dr. Bednarski has been actively training surgeons in this technology.
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.
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