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.
About IceCure Medical Ltd. (Nasdaq: ICCM)
IceCure Medical Ltd. is a commercial-stage medical device company revolutionizing the treatment of tumors through its advanced cryoablation technology. Headquartered in Caesarea, Israel, IceCure develops, manufactures, and markets minimally invasive systems that utilize liquid nitrogen to freeze and destroy tumors. The company's flagship product, the ProSense® Cryoablation System, offers a safe, effective, and non-surgical alternative to traditional tumor removal methods, targeting both benign and malignant tumors in areas such as the breast, kidney, lung, liver, bone, and soft tissues.
Core Technology and Value Proposition
IceCure's cryoablation technology employs liquid nitrogen to create large lethal zones, effectively freezing and destroying tumor cells while preserving surrounding healthy tissue. This approach minimizes surgical risks, accelerates recovery times, and reduces pain and complications. The ProSense® system is portable and designed for use in outpatient settings, making it a cost-effective solution for healthcare providers and patients alike.
Market Position and Industry Context
IceCure operates within the rapidly growing minimally invasive surgery market, which is projected to reach $174 billion by 2029. The company's innovative technology aligns with the global trend toward de-escalation of surgery, particularly in oncology. By providing an alternative to surgical procedures like lumpectomy for early-stage breast cancer, IceCure addresses a critical need for less invasive, patient-friendly treatment options. Its systems are cleared for use in major markets, including the U.S., Europe, China, and Japan, and are supported by a robust portfolio of over 50 patents.
Clinical Validation and Applications
IceCure's technology has been validated through extensive clinical trials, including the landmark ICE3 study, which demonstrated a 96.3% recurrence-free rate in early-stage breast cancer patients treated with cryoablation. Additional studies, such as ICESECRET for kidney cancer and THERMAC for breast cancer, further highlight the efficacy and safety of its systems. These trials underline the company's commitment to evidence-based innovation and its ability to meet the stringent requirements of regulatory bodies worldwide.
Global Reach and Strategic Partnerships
IceCure's products are marketed and sold globally, with strategic partnerships in key regions, including a collaboration with Terumo Corporation in Japan. The company continues to expand its footprint through regulatory filings, such as the recent submission to China's National Medical Products Administration for the ProSense® system. Its next-generation XSense™ system, featuring advanced cryogenic technology, has received FDA clearance and is poised to address additional indications.
Competitive Differentiation
IceCure sets itself apart with its proprietary liquid nitrogen-based technology, which offers superior efficacy compared to other thermal ablation methods like microwave and radiofrequency ablation. Its systems are supported by a growing body of peer-reviewed studies and real-world data, establishing IceCure as a leader in the cryoablation space.
Conclusion
With a strong focus on innovation, clinical validation, and global market penetration, IceCure Medical Ltd. is at the forefront of transforming tumor treatment. Its minimally invasive cryoablation technology not only improves patient outcomes but also aligns with the healthcare industry's shift toward cost-effective, outpatient care solutions.
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.
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.
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