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IceCure Medical Ltd. (Nasdaq: ICCM) is a commercial-stage medical device company specializing in advanced cryoablation systems and technologies. Leveraging liquid nitrogen (LN2), the company’s core offering, the ProSense® System, provides a minimally invasive alternative to surgical tumor removal by freezing tumors found in the breast, lungs, kidneys, bones, and other indications. Founded in Israel, IceCure is a pioneer in the medical field, developing solutions that offer safer, quicker, and more cost-effective treatments compared to traditional surgical interventions.
Recent Achievements:
- IceCure announced positive topline results from its ICE3 study, the largest controlled multicenter clinical trial for LN2-based cryoablation of low-risk, early-stage malignant breast tumors. Approximately 96.39% of patients were local recurrence-free after a 5-year follow-up, with no significant device-related adverse events reported.
- In April 2024, the company filed a 510(k) submission with the FDA for its next-generation single probe cryoablation system, the XSense™ System. This filing aims for clearance for all indications already approved for the ProSense® System, enhancing the system's potential to treat a range of conditions beyond breast tumors, including those in the kidney, liver, and neurology.
- Presented significant findings at the ASBrS 25th Annual Meeting, further demonstrating the efficacy of ProSense® in treating early-stage breast cancer. The presentation garnered strong interest and positive feedback from leading breast surgeons.
- Received regulatory approvals in Brazil, Canada, and China, expanding its global footprint. The company has also entered new distribution agreements in Portugal, India, and Brazil, facilitating the first breast cryoablation procedure in India.
Financial Performance:
For the twelve months ended December 31, 2023, IceCure reported a 26% increase in sales compared to the previous year, transitioning from a research and development phase to a commercial phase. The company’s revenues reached $3.2 million, with a significant portion driven by ProSense® system and disposable probe sales. Despite an overall net loss of $14.7 million, IceCure managed to reduce its operating expenses, enhancing its financial stability.
Partnerships and Pipeline:
IceCure is collaborating with several medical institutions and partners globally, focusing on expanding the clinical applications of ProSense®. Numerous third-party studies are underway to explore new indications such as endometriosis and kidney cancer, showcasing ProSense®’s versatility and potential for broader adoption.
As IceCure awaits the FDA’s decision on its De Novo Classification Request for Marketing Authorization, the company continues to innovate, aiming to establish ProSense® as the gold standard in cryoablation technology worldwide.
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IceCure Medical Ltd. (NASDAQ: ICCM) has received approval from the Central Drugs Standard Control Organization in India for its ProSense® System, a minimally-invasive cryoablation technology for destroying tumors. The system is already marketed and sold in India, with the first breast cancer cryoablation procedure conducted in June 2023. IceCure aims to capitalize on the potential for significant market growth in India and maintain regulatory approvals worldwide.
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IceCure Medical Ltd. (Nasdaq: ICCM) announced the latest release of a study demonstrating the safety and efficacy of the ProSense® System in treating malignant small renal masses. The study offers significant advantages in re-treating initially resistant tumors, achieving a subsequent local control rate of 100%. 92.4% of patients were discharged the day after cyroablation, and the technology's ability to preserve renal function post-treatment is paramount for patients' quality of life. The findings serve as a guide for medical professionals in choosing efficient, cost-effective, and patient-friendly treatment options, benefiting society at large by optimizing kidney tumor management. Success across multiple indications supports ProSense®'s commercialization, particularly in facilities that can use one device across multiple specialties.
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IceCure Medical Ltd. (Nasdaq: ICCM) reported an 11% increase in ProSense® systems and disposable probes sales to $1.7 million for the nine months ended September 30, 2023. The company's expanding regulatory footprint, growing body of evidence-based data, and distribution agreements demonstrate an increasing acceptance of minimally invasive alternatives to standard of care cancer treatment. Despite the denial of the De Novo request by the U.S. FDA for regulatory approval of ProSense® for early-stage breast cancer patients, the company filed an appeal with the FDA. The ICE3 trial is expected to be completed in the first quarter of 2024, and the company is generating substantial additional data from 19 ongoing studies.
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IceCure Medical Ltd. (Nasdaq: ICCM) has filed an appeal with the U.S. FDA regarding the denial of its De Novo Classification Request for treating early-stage, low-risk breast cancer patients with its ProSense® System. The appeal aims to address the FDA's choice of comparator group and finalize the classification of ProSense®. The ICE3 study, estimating a 95.7% recurrence-free rate and 100% satisfaction with cosmetic results, is expected to be completed in Q1 2024.
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IceCure Medical Ltd. (Nasdaq: ICCM) announced the release of its financial and operational results for the nine months ended September 30, 2023. The company will discuss these results and other corporate developments on a conference call on November 15, 2023, at 10:00 a.m. EST. IceCure is the developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal.
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IceCure Medical announced a significant increase in independent studies of its ProSense cryoablation system, which is used to treat various cancers and conditions. The studies have shown high success rates and safety, with a growing body of scientific data supporting the adoption of ProSense. The company believes these studies indicate a tipping point in the global commercial adoption of the technology.
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IceCure Medical Ltd. receives a notice from Nasdaq indicating non-compliance with the minimum bid price requirement. The company has 180 days to regain compliance by maintaining a minimum bid price of $1.00 per share. If compliance is not regained, the company may be eligible for an additional 180-day compliance period.
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IceCure Medical announced its participation in the 10th Annual Conference of the Breast Imaging Society of India (BISICON 2023) with its distributor Novomed. The ProSense® System, a cryoablation technology for tumor removal, received high interest from doctors and hospitals. The ICE3 study of ProSense® showed a 96.91% recurrence-free rate, 100% safety, and positive cosmetic results. The trial is expected to be finalized in Q1 2024.
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IceCure Medical announces publication of scientific paper highlighting the safety and efficacy of cryoablation in early-stage breast cancer
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IceCure Medical announces positive findings from independent breast cancer study using ProSense cryoablation system
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FAQ
What is the current stock price of IceCure Medical Ltd. Ordinary Shares (ICCM)?
The current stock price of IceCure Medical Ltd. Ordinary Shares (ICCM) is $1.36 as of January 7, 2025.
What is the market cap of IceCure Medical Ltd. Ordinary Shares (ICCM)?
The market cap of IceCure Medical Ltd. Ordinary Shares (ICCM) is approximately 74.4M.
What is IceCure Medical Ltd. known for?
IceCure Medical Ltd. is known for its advanced cryoablation systems and technologies that offer a minimally invasive alternative to surgical tumor removal by freezing tumors with liquid nitrogen.
What is the ProSense® System?
The ProSense® System is IceCure Medical's cryoablation technology that destroys tumors by freezing them. It is a minimally invasive, safe, and effective alternative to traditional surgical tumor removal.
What recent achievements has IceCure Medical made?
Recent achievements include positive topline results from the ICE3 study, a 510(k) submission with the FDA for the XSense™ System, significant presentations at the ASBrS Annual Meeting, and regulatory approvals in Brazil, Canada, and China.
How has IceCure Medical's financial performance been recently?
For the twelve months ended December 31, 2023, IceCure reported a 26% increase in sales compared to the previous year, transitioning from a research and development phase to a commercial phase with revenues reaching $3.2 million.
What are some key financial highlights for IceCure Medical?
Key financial highlights include a 26% increase in ProSense® system and disposable probe sales and a net loss reduction to $14.7 million, showing enhanced financial stability.
What partnerships does IceCure Medical have?
IceCure collaborates with medical institutions and partners globally to expand the clinical applications of ProSense®, including studies on conditions such as endometriosis and kidney cancer.
What is the significance of the ICE3 study?
The ICE3 study is the largest controlled multicenter clinical trial for LN2-based cryoablation of low-risk, early-stage malignant breast tumors. It showed that 96.39% of patients were local recurrence-free after a 5-year follow-up.
What are IceCure Medical's future plans?
Future plans include awaiting the FDA’s decision on the De Novo Classification Request for Marketing Authorization for ProSense® and continuing to innovate and expand the clinical applications of their cryoablation technology.
What new products is IceCure Medical developing?
IceCure is developing the next-generation single probe cryoablation system, the XSense™ System, which has been submitted for FDA clearance for multiple indications.
How is IceCure Medical expanding its global reach?
The company has received regulatory approvals in Brazil, Canada, and China and has entered new distribution agreements in Portugal, India, and Brazil, enhancing its global footprint.
IceCure Medical Ltd. Ordinary Shares