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) 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.
IceCure Medical Ltd (NASDAQ: ICCM) has appointed Gilad Glick, former CEO of Itamar Medical, as a strategic advisor. Glick will enhance the commercialization strategy of IceCure's ProSense® System, targeting global markets, especially the U.S. and EU. ProSense®, known for its minimally invasive cryoablation technology, aims to improve treatments for tumors, including early-stage breast cancer. Glick's expertise is expected to significantly impact IceCure's revenue growth and market penetration.
IceCure Medical (NASDAQ: ICCM) announced that its ProSense cryoablation system was featured at the SIR 2022 Annual Scientific Meeting on June 14, 2022. The event showcased the effectiveness of ProSense for breast cancer treatment, drawing interest from U.S. medical clinics and international distributors. Additionally, IceCure secured a distribution agreement with Shanghai Medtronic for the Chinese market. The promising interim data from the ICE3 study indicates ProSense's potential as a safe, minimally invasive alternative for early-stage breast cancers.
IceCure Medical (NASDAQ: ICCM) announced a distribution agreement with Shanghai Medtronic to supply IceSense3 cryoablation systems in mainland China. The contract requires a minimum purchase of $3.5 million over three years, with first deliveries expected in 2022. This partnership aims to enhance market penetration for cryoablation technology, which is currently underutilized in China. The IceSense3 system has already received approval from China's regulatory body, with additional regulatory submissions planned for disposable probes by the end of 2022.
IceCure Medical (NASDAQ: ICCM) announced that its distributor in Brazil, KTRFIOS, has submitted a regulatory filing to the Brazilian Health Regulatory Agency (ANVISA) for the ProSense system. The application targets multiple cancer treatments including breast and prostate cancer, with KTRFIOS guaranteeing at least $6.6 million in sales within five years of approval. Brazil's rising cancer incidence underscores the demand for innovative treatments. CEO Eyal Shamir highlighted this milestone as pivotal for expanding IceCure's global regulatory landscape, which spans 14 countries including the U.S. and Europe.
IceCure Medical Ltd. (NASDAQ: ICCM) reported Q1 2022 revenues of approximately $0.75 million, a 48% decline from $1.4 million in Q1 2021, primarily due to decreased revenue from distribution agreements and lower sales in Asia amidst COVID restrictions. Gross profit was approximately $0.43 million, with a gross margin of 58%. Operating expenses rose to $4.9 million, resulting in a net loss of $4.4 million ($0.12 per share). Despite these challenges, IceCure saw increased commercial activity and plans to further develop its ProSense® System for breast cancer treatment.
IceCure Medical (NASDAQ: ICCM) is set to release its financial results for Q1 2022 on May 18, 2022, at 7:00 am ET. The announcement will be followed by a conference call at 8:30 am ET, featuring Dr. Richard Fine, discussing the ProSense® System, a cryoablation technology for treating tumors. IceCure specializes in minimally invasive treatments for various cancers, including breast, kidney, and lung cancers. The conference call can be accessed via US and international lines provided in the announcement.
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