Welcome to our dedicated page for IceCure Medical news (Ticker: ICCM), a resource for investors and traders seeking the latest updates and insights on IceCure Medical stock.
IceCure Medical Ltd. develops and markets liquid-nitrogen-based cryoablation systems for minimally invasive tumor destruction. Its flagship ProSense® system is used for benign and cancerous lesions, with company updates centered on breast, kidney, bone and lung cancer indications and on markets where the device is cleared or approved, including the United States, Europe and Asia.
News about ICCM commonly covers ProSense commercialization, FDA-related breast cancer developments, post-market study activity, clinical evidence such as the ICESECRET kidney cancer study, medical-conference presentations, financial and operating results, and governance changes. The company’s updates also address physician training, reimbursement context and shareholder matters tied to its ordinary shares.
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.
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.