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 reported preliminary unaudited results for 2024, showing a 42% increase in ProSense® sales in North America. Total revenue grew to $3.29 million from $3.23 million in 2023, with ProSense® system and probe sales reaching $3.19 million. The company ended 2024 with $7.5 million in cash.
Key developments include the FDA Advisory Panel's favorable vote for ProSense®'s benefit-risk profile in early-stage low-risk breast cancer, with a decision expected in Q1 2025. The ICE3 study showed a 96.3% recurrence-free rate and 100% patient satisfaction. The ICESECRET kidney cancer study demonstrated an 88.7% recurrence-free rate.
The company strengthened its intellectual property with four new patents and received FDA clearance for its XSense™ Cryoablation System. For 2025, IceCure plans to expand in the U.S. market pending FDA authorization and pursue regulatory approvals in Japan and China.
IceCure Medical (NASDAQ: ICCM), a developer of minimally-invasive cryoablation technology for tumor treatment, has announced its return to full compliance with Nasdaq's listing requirements. The company received confirmation from Nasdaq that it has successfully met the minimum bid price requirement under Rule 5550(a)(2), having maintained a closing bid price of $1.00 or higher for at least 10 consecutive business days.
This development resolves the previous bid price deficiency matter, and IceCure will continue to be listed and traded on The Nasdaq Capital Market, now being in full compliance with all Nasdaq continued listing requirements.
IceCure Medical (Nasdaq: ICCM) announced receiving an Intention to Grant Notice from the European Patent Office for its 'Cryogenic System Connector' invention, which is already patented in the United States. The technology is part of the company's XSense™ system, designed to improve safety and maintain cryogen integrity during cryoablation procedures.
The XSense™ system and its cryoprobes have FDA clearance for all indications currently approved for IceCure's flagship ProSense® system. The company aims to address additional indications in the global tumor ablation market, which was valued at $1.67 billion in 2023 according to Grand View Research. The company sees Europe as a major market, with multiple distributors selling ProSense® and various independent clinical studies being conducted across different medical indications.
IceCure Medical (NASDAQ: ICCM) presented data from its ICE3 trial of ProSense® cryoablation technology at the Radiological Society of North America's 2024 Annual Meeting. The study, presented by ICE3 Co-Principal Investigator Dr. Kenneth Tomkovich, demonstrated promising results for treating early-stage low-risk breast cancer.
Key findings include a five-year recurrence rate of 3.7% with adjuvant endocrine therapy and 4.3% in the eligible trial population, comparable to surgical lumpectomy outcomes. The procedure offers significant advantages over surgery, including outpatient treatment with local anesthesia, minor adverse events, and 100% patient satisfaction with cosmetic outcomes.
Following a favorable FDA Advisory Panel vote in November 2024, the FDA's marketing authorization decision is expected in Q1 2025. The ICE3 trial, being the largest of its kind, supports the transition towards less invasive breast cancer treatment options.
IceCure Medical (NASDAQ: ICCM) announced promising interim results from their ICESECRET study evaluating ProSense® cryoablation for small renal masses. The study, involving 111 patients with 117 lesions over a mean follow-up of 36 months, showed:
- 82% of patients remained tumor-free
- 88.7% success rate in patients with single tumors 3 cm without prior kidney cancer
- Short procedure time of approximately 25 minutes
The technology is currently approved for benign and malignant kidney tumors in the U.S., Europe, and other countries, addressing a significant market with an estimated 81,610 new kidney cancer cases expected in the U.S. in 2024.
IceCure Medical reported strong financial results for the first nine months of 2024, with 36% growth in ProSense® system and probe sales to $2.3M. Gross profits increased 41%, with non-GAAP gross profits up 104%. Gross margins improved to 43% from 37% year-over-year. The FDA Advisory Panel voted favorably for ProSense®'s benefit-risk profile in early-stage low risk breast cancer, with a final FDA marketing authorization decision expected in Q1 2025. The company maintained $10.7M in cash as of September 30, 2024, and raised $8.1M through share offerings. Research and development expenses decreased 15%, while sales and marketing expenses increased to support growth.
IceCure Medical (NASDAQ: ICCM) has received a Notice of Allowance from Japan's Patent Office for its 'Cryogenic System with Multiple Submerged Pumps' invention. This technology enables a next-generation MSense™ multiprobe cryoablation system that can independently control multiple cryoprobes for treating larger tumors. The patent strengthens IceCure's position in Japan, where their partner Terumo plans to file for ProSense® regulatory approval for breast cancer treatment in 2025.
IceCure Medical (Nasdaq: ICCM), a developer of minimally-invasive cryoablation technology for tumor treatment, will release its Q3 2024 financial and operational results before Nasdaq market opening on November 26, 2024. The company will host a conference call and webcast at 10:00 AM EST the same day to discuss the results and corporate developments. The call will be accessible via US toll-free and international dial-in numbers, with a live webcast available through the company's website.
IceCure Medical's ProSense® has been selected for the PRECICE study, a major breast cryoablation research initiative led by the European Institute of Oncology. The study, sponsored by the Umberto Veronesi Foundation and Italian Ministry of Health, will exclusively use ProSense® to treat 233 patients aged 50+ with early-stage breast cancer (Luminal A and B).
The study details were published in the European Journal of Cancer Prevention, highlighting cryoablation as a potential alternative to surgical treatment. The research will evaluate technical effectiveness with a five-year median follow-up, examining procedure failure rates through various imaging methods and additional endpoints including quality of life and economic outcomes.
IceCure Medical (Nasdaq: ICCM) received a favorable recommendation from the FDA Advisory Panel for its ProSense® cryoablation system with a 9-5 vote supporting its benefit-risk profile for treating early-stage low risk breast cancer. The panel's decision was based on comprehensive data from the ICE3 study and stakeholder testimonies. Three of the dissenting voters indicated they would have voted in favor with adequate FDA special controls. The FDA's final marketing authorization decision is expected in Q1 2025. ProSense® offers a minimally-invasive alternative to lumpectomy by destroying tumors through freezing.