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) 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.