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 (Nasdaq: ICCM), a developer of minimally-invasive cryoablation technology for tumor destruction, has announced its plans to release financial and operational results for the six months ended June 30, 2024. The company will issue a press release before the Nasdaq Stock Market opens on Tuesday, August 20, 2024. Additionally, IceCure will host a conference call and webcast at 10:00 a.m. EDT on the same day to discuss the results and other corporate developments.
Investors and interested parties can access the conference call using the following details:
- US: 1-888-407-2553
- Israel/International: +972-3-918-0696
- Live webcast: https://Veidan.activetrail.biz/IcecureQ2-2024
IceCure Medical (Nasdaq: ICCM) announced positive data from a large multi-institutional study on cryoablation of primary breast cancer in patients ineligible for clinical trials. The study, published in the American Journal of Roentgenology, included 112 high-risk patients with a median age of 71. Recurrence-free rates were 94.7%, 87.8%, and 81.8% at 1, 2, and 3 years, respectively. The study used various cryoablation systems, including IceCure's ProSense®, across 7 U.S. institutions. Treatment showed a low frequency of adverse events (6.3% minor, no moderate or major) and high technical success (98.2%). Researchers concluded that cryoablation remains a safe alternative to surgery with good outcomes, especially for poor surgical candidates due to comorbidities.
IceCure Medical (Nasdaq: ICCM) reported key findings from three clinical studies of its ProSense® cryoablation system for breast cancer treatment at the 32nd Annual Meeting of the Japanese Breast Cancer Society. Highlights include:
1. An independent study by Prof. Fukuma showed a 99.74% recurrence-free rate in 389 patients treated over 10 years.
2. Another study by Prof. Kawamoto found 0% local recurrence in a five-year follow-up.
3. Terumo , IceCure's distribution partner, plans to submit an application for regulatory clearance in Japan by Q1 2025.
The demand for minimally invasive breast cancer treatments was a major theme at the conference, with ProSense® gaining traction due to its efficacy, favorable cosmetic results, and potential immune system benefits.
IceCure Medical (Nasdaq: ICCM), a developer of minimally-invasive cryoablation technology for tumor destruction, has received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share. The company has been granted a 180-day grace period until January 14, 2025, to regain compliance. During this period, ICCM's shares will continue trading on the Nasdaq Capital Market.
To regain compliance, ICCM's closing bid price must be at least $1.00 for a minimum of ten consecutive business days. If unsuccessful, the company may be eligible for an additional 180-day compliance period, provided it meets other listing requirements. IceCure Medical states that maintaining its Nasdaq listing is a priority and will consider available options to cure the deficiency if necessary.
An independent study published in 'Cancers' supports the efficacy and safety of IceCure's ProSense® cryoablation system for treating metastatic and recurrent breast cancer. Conducted by Prof. Thomas J. Vogl at the University Hospital Frankfurt, the study involved 45 patients, including those with metastatic disease and recurrent tumors up to 4 cm in diameter. Key findings include a 100% complete ablation rate, 8.9% recurrence rate, and no observed complications. This research, featuring a higher-risk patient group than IceCure's U.S. ICE3 study, underscores ProSense®'s viability across a broader spectrum of breast cancer diagnoses. CEO Eyal Shamir emphasized the significance of these results for ProSense® users in Europe, where the system is approved for general breast cancer treatment.
IceCure Medical announced that the FDA has granted regulatory clearance for its next-generation XSense™ Cryoablation System with CryoProbes. The system, which uses extreme cold to destroy tissues, is cleared for the same indications as its predecessor, ProSense®. These include applications in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The technology addresses conditions such as fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions, and warts. CEO Eyal Shamir stated that this clearance validates the safety and efficacy of the platform, potentially enabling the system to address unmet medical needs in the U.S.
IceCure Medical, developer of the ProSense® System for minimally-invasive cryoablation of tumors, announced its participation in the Northland Capital Markets Virtual Growth Conference on June 25, 2024. The company has achieved key milestones, including the completion of the ICE3 trial and FDA submission for the ProSense® System. CEO Eyal Shamir highlighted board members' recent stock purchases as a sign of confidence. The conference will feature presentations from CEO Shamir and CFO Ronen Tsimerman on recent developments and future catalysts. Interested investors can request virtual meetings for more insights.
IceCure Medical (Nasdaq: ICCM) shared positive interim results from its ICESECRET kidney cancer trial at the 3rd Annual Israeli Conference on Interventional Radiology. The trial features the ProSense® System, a cryoablation technology that freezes tumors. Findings show ProSense® is effective, with an 89.5% recurrence-free rate. Further data is expected in Q4 2024, averaging a 3-year follow-up. The global kidney cancer treatment market, valued at $6.92 billion in 2024, is projected to reach $8.78 billion by 2029. ProSense® is approved in the U.S., Europe, and other regions for benign and malignant kidney tumors. The system offers a minimally invasive alternative to surgery, reducing hospitalization and minimally impacting renal function and hemoglobin levels. CEO Eyal Shamir highlighted the favorable reception of data by interventional radiologists and the potential benefits for kidney cancer patients.
IceCure Medical announced the FDA will convene a Medical Device Advisory Committee to review the De Novo Marketing Clearance Request for its ProSense® System, with a decision expected by early 2025. This review acknowledges the potential public health benefits of ProSense® as a minimally invasive treatment for early-stage breast cancer, affecting approximately 65,000 women annually in the U.S.
ProSense® offers cryoablation technology as an alternative to surgical tumor removal and is already approved in several countries. The Advisory Panel will meet in Q4 2024 to discuss the ICE3 study results, showing 96.3% of patients were free from local recurrence at a 5-year follow-up, with 100% patient and physician satisfaction.
IceCure's CEO, Eyal Shamir, emphasized the transparency and public involvement in the process, anticipating that increased awareness could support commercial efforts in the U.S. upon potential regulatory approval.
IceCure Medical reported a strong Q1 2024 performance with a 30% sales growth for its ProSense® cryoablation system, driven by increased adoption in the U.S. and other global markets. The company completed the landmark ICE3 trial for breast cancer, reporting positive final data and submitting it to the FDA for marketing authorization. Financial highlights include a gross profit of $269,000 and net loss reduction to $3.6 million. Operating expenses decreased due to prudent cash management. The company also secured a new patent in Japan and submitted an FDA application for its next-generation XSense™ system.