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.
About IceCure Medical Ltd. (Nasdaq: ICCM)
IceCure Medical Ltd. is a commercial-stage medical device company revolutionizing the treatment of tumors through its advanced cryoablation technology. Headquartered in Caesarea, Israel, IceCure develops, manufactures, and markets minimally invasive systems that utilize liquid nitrogen to freeze and destroy tumors. The company's flagship product, the ProSense® Cryoablation System, offers a safe, effective, and non-surgical alternative to traditional tumor removal methods, targeting both benign and malignant tumors in areas such as the breast, kidney, lung, liver, bone, and soft tissues.
Core Technology and Value Proposition
IceCure's cryoablation technology employs liquid nitrogen to create large lethal zones, effectively freezing and destroying tumor cells while preserving surrounding healthy tissue. This approach minimizes surgical risks, accelerates recovery times, and reduces pain and complications. The ProSense® system is portable and designed for use in outpatient settings, making it a cost-effective solution for healthcare providers and patients alike.
Market Position and Industry Context
IceCure operates within the rapidly growing minimally invasive surgery market, which is projected to reach $174 billion by 2029. The company's innovative technology aligns with the global trend toward de-escalation of surgery, particularly in oncology. By providing an alternative to surgical procedures like lumpectomy for early-stage breast cancer, IceCure addresses a critical need for less invasive, patient-friendly treatment options. Its systems are cleared for use in major markets, including the U.S., Europe, China, and Japan, and are supported by a robust portfolio of over 50 patents.
Clinical Validation and Applications
IceCure's technology has been validated through extensive clinical trials, including the landmark ICE3 study, which demonstrated a 96.3% recurrence-free rate in early-stage breast cancer patients treated with cryoablation. Additional studies, such as ICESECRET for kidney cancer and THERMAC for breast cancer, further highlight the efficacy and safety of its systems. These trials underline the company's commitment to evidence-based innovation and its ability to meet the stringent requirements of regulatory bodies worldwide.
Global Reach and Strategic Partnerships
IceCure's products are marketed and sold globally, with strategic partnerships in key regions, including a collaboration with Terumo Corporation in Japan. The company continues to expand its footprint through regulatory filings, such as the recent submission to China's National Medical Products Administration for the ProSense® system. Its next-generation XSense™ system, featuring advanced cryogenic technology, has received FDA clearance and is poised to address additional indications.
Competitive Differentiation
IceCure sets itself apart with its proprietary liquid nitrogen-based technology, which offers superior efficacy compared to other thermal ablation methods like microwave and radiofrequency ablation. Its systems are supported by a growing body of peer-reviewed studies and real-world data, establishing IceCure as a leader in the cryoablation space.
Conclusion
With a strong focus on innovation, clinical validation, and global market penetration, IceCure Medical Ltd. is at the forefront of transforming tumor treatment. Its minimally invasive cryoablation technology not only improves patient outcomes but also aligns with the healthcare industry's shift toward cost-effective, outpatient care solutions.
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.
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.
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