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.
Overview of IceCure Medical Ltd.
IceCure Medical Ltd (ICCM) is a commercial-stage medical device company specializing in liquid nitrogen-based cryoablation systems. The company develops and markets minimally invasive technologies designed to destroy tumors through cryoablation, offering a viable alternative to traditional surgical tumor removal. By harnessing the power of liquid nitrogen, IceCure's systems create large lethal zones within tumors, providing a safe and efficient method for treating a variety of conditions including breast, kidney, bone, and lung cancers. This technology is proving essential in the shift toward less invasive medical treatments, marking significant advancements in the field of oncology.
Core Business and Technology
The primary focus of IceCure is on research, development, and commercialization of cryoablation therapy systems. Their flagship product leverages advanced cryogenic engineering to deliver precise ablation of both benign and malignant tumors. Using state-of-the-art cryoprobes and proprietary liquid nitrogen systems, IceCure offers a minimally invasive alternative that reduces surgical risks, shortens recovery times, and minimizes patient discomfort compared to conventional surgical methods. This robust technological foundation is supported by a significant portfolio of patents and continued innovation, underscoring the company’s commitment to remaining at the forefront of cryosurgical treatments.
Market Position and Industry Significance
Within the medical device market, IceCure occupies a unique niche by focusing exclusively on cryoablation. The company’s solutions are positioned as important tools for solid tumor treatments in multiple clinical settings, including hospitals and office-based procedures. With a strong emphasis on clinical research, IceCure’s technologies have been validated through extensive studies and trials, further enhancing their credibility among medical professionals. The company’s achievements, such as receiving key regulatory approvals and positive evaluations from expert panels, also contribute to its recognized position within the competitive landscape of minimally invasive surgery technologies.
Clinical Evidence and Research
IceCure’s commitment to rigorous clinical validation is evident in its comprehensive body of research. Multiple studies and clinical trials have demonstrated that cryoablation using IceCure’s systems achieves outcomes comparable to standard surgical interventions but with significantly lower rates of complications and shorter recovery periods. The company’s approach has garnered attention at major medical conferences, and independent studies consistently highlight the efficacy and safety of their methodology. This research-based approach not only drives clinical adoption but also reinforces the trustworthiness and expertise of IceCure’s technology in the field of oncologic treatment.
Innovation and Regulatory Milestones
Innovation is a core driver for IceCure, which continually refines its technology and expands its intellectual property portfolio. With multiple patents already granted and more under review, the company remains dedicated to advancing its cryoablation systems to meet an expanding range of clinical needs. Strategic regulatory approvals across key global markets such as the U.S., Europe, China, and others attest to the quality and reliability of its products. These achievements reflect IceCure’s commitment to improving patient outcomes and strengthening its market presence in the competitive field of medical devices.
Application and Patient Benefits
IceCure’s cryoablation systems are distinguished by their ability to provide effective tumor destruction with minimal patient discomfort. The technology not only reduces the pain and risks associated with conventional surgery but also facilitates faster recovery times, allowing patients to resume their normal lives more quickly. By offering an office-based, easy-to-perform procedure, IceCure is expanding access to advanced treatment options and paving the way for broader acceptance of minimally invasive therapies in oncologic care.
Conclusion
IceCure Medical Ltd stands as a notable innovator in the field of cryoablation therapy. With a deep commitment to clinical research, technological innovation, and regulatory excellence, the company provides a compelling alternative to traditional surgery for tumor management. Its focused approach and comprehensive product portfolio underscore its significance in the broader context of minimally invasive medical treatments, cementing its role as a trusted entity among healthcare professionals and stakeholders worldwide.
IceCure Medical (Nasdaq: ICCM) provided an update on its FDA marketing authorization timeline for ProSense® cryoablation system in early-stage breast cancer treatment. The company now expects the FDA's decision after Q1 2025, extending beyond the initial timeline.
The FDA process has involved extensive stakeholder engagement due to the product's novelty and breast cancer's public health significance. In November 2024, an FDA Medical Device Advisory Committee Panel, comprising breast surgeons, interventional radiologists, oncologists, and patient representatives, voted favorably on ProSense®'s benefit-risk profile for treating early-stage low-risk breast cancer with endocrine therapy.
ProSense® uses minimally-invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal. The company continues to work closely with the FDA towards a De Novo marketing authorization decision.
IceCure Medical (NASDAQ: ICCM) showcased its ProSense® cryoablation technology at the 19th Annual St. Gallen Breast Cancer Conference, with six peer-reviewed studies presented and to be published in The Breast journal. The studies demonstrate ProSense®'s efficacy in treating breast cancer through tumor freezing.
Key findings include the ICE3 trial showing a 3.61% recurrence rate at 5 years (7/194 patients), with patients receiving endocrine therapy showing a 3.22% recurrence rate. An independent study in Hong Kong successfully expanded treatment to include triple negative breast cancer and younger patients.
The THERMAC trial compared different ablation methods, with ProSense® achieving 94% complete ablation rate and 0% adverse events, outperforming other techniques. Additional studies demonstrated success in treating inoperable patients, with 81.7% complete tumoral necrosis in 60 treated tumors, and showed particular effectiveness in luminal cancers up to 2.5cm.
IceCure Medical (Nasdaq: ICCM) has received a Notice of Allowance from China for its novel 'Cryogenic System Connector' invention, completing patent protection in major global markets including the U.S., Europe, and Japan. The company, which develops minimally-invasive cryoablation technology for tumor destruction, has created an innovative cryogenic pump with several key features:
- Submersible in liquid nitrogen (LN2)
- Operates in a closed circuit
- Enables cryoprobe temperature control
- Improves cooling rate during procedures
- Designed for multiple or longer procedures without LN2 refills
This technological advancement allows IceCure to develop a new generation of compact cryoablation systems and expand their product portfolio to include thinner cryoprobes and catheters. The company currently holds over 50 granted patents for cryoablation systems and cryoprobes.
IceCure Medical (NASDAQ: ICCM) announced significant findings from an independent study published in Gland Surgery, comparing patient satisfaction between their ProSense® cryoablation technology and traditional breast-conserving therapy (BCT) for breast cancer treatment.
The study, conducted at Kameda Medical Center in Japan, revealed that patients who underwent cryoablation reported significantly higher satisfaction scores (71.0±18.6) compared to BCT patients (56.3±16.5), with mean follow-up periods of 4.2 and 4.0 years respectively. The research included 147 Asian female breast cancer patients, with 76 meeting the final analysis criteria (35 cryoablation, 41 BCT).
The study utilized the BREAST-Q questionnaire to assess health-related quality of life and satisfaction. Researchers attributed the higher satisfaction in cryoablation patients to the preservation of breast volume and symmetry, as the procedure doesn't require tissue excision. This data supports the ongoing trend toward de-escalation of breast cancer treatment from surgical to nonsurgical options in Japan.
IceCure Medical (Nasdaq: ICCM) has submitted a regulatory approval filing to Israel's Ministry of Health for its next-generation XSense™ System and CryoProbes. The application covers multiple indications already approved for ProSense®, including general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology.
The company has already secured FDA marketing authorization for the XSense™ System. The filing aligns with growing trends in surgical de-escalation and increasing adoption of minimally invasive cryoablation procedures. The global minimally invasive surgery market is projected to grow at a 17% CAGR between 2022-2029, reaching $174 billion by 2029.
IceCure Medical (NASDAQ: ICCM) showcased its ProSense® cryoablation technology at the 2025 Society of Interventional Oncology Annual Meeting in Las Vegas. Two independent studies demonstrated ProSense®'s safety and efficacy in breast cancer, with one study from the Netherlands winning the 'Highest Scoring Abstract' award. This study concluded that cryoablation was the only thermal ablative technique warranting a Phase 3 trial versus surgery.
The company sponsored a Breast Cryoablation Mini Master Class, featuring leading experts in the field. The FDA's decision on ProSense® market authorization for early-stage breast cancer is expected in Q1 2025. The Dutch study showed 94% complete ablation rate for cryoablation with 0% adverse events, while a Romanian study reported 100% technical success for tumors ≤35 mm with high physician and patient satisfaction.
IceCure Medical (Nasdaq: ICCM) has submitted a regulatory filing to China's National Medical Products Administration (NMPA) for its ProSense® Cryoablation System. The company, which already has approval for its IceSense3 system in China, is seeking to expand its presence in the Chinese market.
The ProSense® application includes expanded capabilities compared to IceSense3, featuring five different cryoprobes with varying specifications and introducers for better tissue accessibility. The system's indicated uses cover multiple medical fields including general surgery, breast tissue, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology.
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.
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