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) announced significant stakeholder engagement ahead of the FDA Medical Device Advisory Committee Panel scheduled for November 7, 2024. The panel will evaluate the marketing authorization of ProSense® cryoablation system for treating early-stage low risk breast cancer. The Advisory Panel will include breast surgeons, interventional radiologists, and industry experts who will provide recommendations on the benefit-risk profile of ProSense®, a minimally-invasive technology that destroys tumors by freezing as an alternative to surgical removal. Public comments from doctors, nurses, researchers, and breast cancer patients are available on the FDA website, with the FDA's final decision expected by early 2025.
IceCure Medical (Nasdaq: ICCM) has received a Notice of Allowance from the U.S. Patent and Trademark Office for its invention titled "Cryogenic System Connector". This is the first global patent issued for this key component of IceCure's next-generation XSense™ cryoablation system, which uses liquid nitrogen. The XSense™ system and its cryoprobes have FDA clearance for all indications already approved for IceCure's flagship ProSense® system.
The innovative connector technology is designed to improve usability and maintain cryogen integrity during cryoablation procedures. XSense™ has the potential to address additional indications in the global tumor ablation market, estimated at $1.67 billion in 2023. IceCure's CEO, Eyal Shamir, emphasized the company's commitment to strengthening its intellectual property assets as its cryoablation systems gain worldwide commercial traction.
IceCure Medical's ProSense® cryoablation technology was featured in six global studies at the 2024 European Society of Breast Imaging (EUSOBI) Conference. Highlights include:
1. The ICE3 trial abstract won the EUSOBI 2024 Abstract Award, showing a 96.3% recurrence-free rate for small, low-risk breast cancers treated with ProSense® and endocrine therapy.
2. The THERMAC Trial, comparing thermal ablation methods, won the EUSOBI Young Physician Scientists Prize. Cryoablation demonstrated the highest complete ablation rate at 94% with no adverse events.
3. IceCure exhibited ProSense® at EUSOBI, conducting demos and Q&A sessions with breast cryoablation experts.
4. Six studies presented at EUSOBI 2024 showcased ProSense®'s efficacy in treating breast cancer and fibroadenomas, supporting IceCure's global commercial activities.
IceCure Medical announced the publication of its ICE3 trial results in the Annals of Surgical Oncology. The study, titled 'Cryoablation Without Excision for Early–Stage Breast Cancer: ICE3 Trial 5–Year Follow–Up on Ipsilateral Breast Tumor Recurrence', presents findings on using ProSense® cryoablation for early-stage, low-risk breast cancer.
Key results include:
- 96.3% recurrence-free rate for women treated with ProSense® and endocrine therapy
- 4.3% ipsilateral breast tumor recurrence rate at 5 years
- 96.7% breast cancer survival rate
- 100% patient and physician satisfaction with cosmetic outcomes
- No serious device-related adverse events reported
The publication precedes IceCure's FDA Advisory Panel Meeting for ProSense® marketing authorization, scheduled for November 7, 2024.
IceCure Medical (Nasdaq: ICCM) announced the publication of an independent study on its ProSense® cryoablation system in the British Journal of Radiology. The study, led by Dr. Franco Orsi at the European Institute of Oncology, demonstrated a 97.7% technical success rate in treating tumors of the lung, bone, and soft tissues. ProSense®, a liquid nitrogen-based system, was found to have favorable safety compared to argon-based systems and to be more cost-effective and easier to manage.
The study assessed 85 patients with 96 lesions, showing only minor complications that resolved without significant intervention. It highlighted cryoablation's growing role in early oncology treatments, particularly for patients with comorbidities or those avoiding surgery. The research also emphasized interventional radiology as the fourth pillar of oncology, alongside clinical oncology, surgical oncology, and radiation therapy.
IceCure Medical (Nasdaq: ICCM) announced that the FDA's Medical Device Advisory Committee Panel will meet on November 7, 2024, to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for early-stage low risk breast cancer. This public forum will review data, including results from the ICE3 study, which showed a 96.3% recurrence-free rate at 5 years for patients treated with ProSense® and adjuvant endocrine therapy. The FDA is expected to make a decision on marketing authorization by early 2025. ProSense® could potentially benefit an estimated 70,000 women diagnosed annually in the U.S. with this condition.
IceCure Medical (Nasdaq: ICCM), developer of minimally-invasive cryoablation technology, announced its participation in two upcoming investor conferences. CEO Eyal Shamir will conduct one-on-one meetings with institutional investors at both the H.C. Wainwright 26th Annual Global Investment Conference (September 9-11, 2024) and the Lake Street Capital Markets 8th Annual Best Ideas Growth Conference (September 12, 2024).
The company's presentation will focus on its ProSense® technology for non-surgical treatment of benign and cancerous tumors, as well as upcoming regulatory and operating catalysts. CFO and COO Ronen Tsimerman will join the H.C. Wainwright meetings virtually. A virtual presentation will be available on-demand starting September 9 at 7:00 AM ET for the H.C. Wainwright conference.
IceCure Medical (Nasdaq: ICCM) has received a Notice of Allowance from the USPTO for a continuation patent on its novel cryogenic pump technology. This patent, effective until 2041, reinforces IceCure's global IP leadership in cryoablation technologies. The innovative pump, submersible in liquid nitrogen, works in a closed circuit and improves cooling rates during procedures. It's designed for multiple or longer duration procedures without liquid nitrogen refills and enables a wider range of cryoprobes and catheters.
The patent broadens the applications of IceCure's cryoablation platform across various technology fields. CEO Eyal Shamir stated that this patent supports the potential for increasing indications, procedures, and applications with their next-generation cryoablation systems. The timing aligns with existing FDA approvals and the anticipated FDA decision on clearance for early-stage breast cancer in Q1 2025.
IceCure Medical (ICCM) reported a 20% growth in ProSense® system and probe sales for the first half of 2024, reflecting continued adoption in the U.S. and other global markets. Key highlights include:
1. FDA Medical Device Advisory Committee expected in Q4 2024 for early-stage, low risk breast cancer treatment.
2. Interim results from ICESECRET kidney cancer trial expected by December 2024.
3. Terumo to file for regulatory approval in Japan in Q1 2025.
4. Total revenue grew to $1,754,000 from $1,647,000 in H1 2023.
5. Net loss narrowed to $6,690,000 ($0.14 per share) from $7,657,000 ($0.17 per share) in H1 2023.
6. Cash and cash equivalents of $10.5 million as of June 30, 2024.
IceCure Medical (Nasdaq: ICCM) announced results from an independent study on its ProSense® cryoablation technology for breast cancer treatment. The study, published in the British Journal of Radiology, showed:
- 100% complete ablation rate for Luminal A and B breast cancer tumors ≤ 25mm after 16 months median follow-up
- 95.6% of patients offered cryoablation accepted it
- Median patient age was 87 (range 60-96)
- No major complications were observed
The study concluded that cryoablation is a safe, effective alternative to surgery for early-stage breast cancer in non-surgical patients, well-tolerated as an outpatient procedure. IceCure CEO Eyal Shamir highlighted the potential increasing demand for ProSense® due to the aging population and higher breast cancer risk with age.
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