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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.
Rhea-AI Summary
IceCure Medical Ltd. (Nasdaq: ICCM) announces the successful feature of ProSense® at the BRIIT conference in India, highlighting its innovative cryoablation technology for breast tumors. Dr. Rupa Renganathan and Dr. Hania Bednarski shared their expertise in cryoablation procedures, showcasing ProSense®'s efficacy and regulatory approval in India.
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IceCure Medical Ltd. announces groundbreaking results from an independent study on breast cancer treatment using its ProSense® System, reporting a median tumor reduction of 100% at 6 and 12 months post-cryoablation. The study conducted on inoperable women aged 60-92 showcases the effectiveness of cryoablation technology in destroying tumors non-invasively, offering new hope for patients who cannot undergo surgery.
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IceCure Medical Ltd. (Nasdaq: ICCM) announces educational events featuring ProSense® cryoablation technology at upcoming medical conferences in Japan. Dr. Fukuma to lead sessions focusing on nonsurgical tumor ablation with clinical data and pathology analysis.
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IceCure Medical Ltd. (NASDAQ: ICCM) announced that the FDA has responded affirmatively to the company's request for supervisory review regarding the FDA's prior denial of IceCure's De Novo Classification Request for treating patients with early-stage, low-risk breast cancer. IceCure plans to expedite data monitoring and analysis to submit the final 5-year dataset to the FDA by April 2024, several months ahead of the Company's prior submission timeline. The ICE3 study will provide 5-year recurrence outcomes on a patient population which represents approximately 65,000 people in the U.S. alone annually. IceCure was invited by the FDA to submit real-world data from the use of ProSense® globally, including post-market commercial use in territories where ProSense® is approved for breast cancer, as well as data from independent third-party studies.
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IceCure Medical Ltd. (NASDAQ: ICCM) showcased its ProSense® System at the SIO 2024 Annual Meeting in California, receiving positive feedback from interventional oncologists. ICE3 trial data was central to the Breast Cryoablation Master Class, demonstrating a 96.91% recurrence-free rate. The Company's CEO, Eyal Shamir, expressed optimism about the adoption of cryoablation as a desirable option for early-stage breast cancer.
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ProSense® Users Presenting Groundbreaking Research at Industry Conference
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IceCure Medical Ltd. (Nasdaq: ICCM) has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Stock Market LLC. The company's ProSense® System, a cryoablation technology, has been successful in maintaining a minimum bid price of $1.00 per share for 10 consecutive business days, resolving the prior bid price deficiency matter.
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IceCure Medical Ltd. (Nasdaq: ICCM) experienced a 25% increase in U.S. sales of the ProSense® system and disposable probe in 2023 compared to the previous year. The ICE3 study is nearing completion, with final data readout expected soon. The company saw significant growth in the global rollout of ProSense®, with regulatory clearances in large markets like Brazil, Canada, and China. The trend towards cryoablation procedures is on the rise, especially among breast surgeons and radiologists, with growing support from peer-reviewed journals. IceCure remains optimistic about its global expansion and distribution footprint.
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IceCure Medical Ltd. (Nasdaq: ICCM) announced the publication of a study demonstrating the potential anti-cancer benefits of its ProSense® System, a minimally-invasive cryoablation technology. The study conducted at Case Western Reserve University School of Medicine shows that cryoablation using ProSense® can activate the body's natural immune response by enhancing CD8+ T cells, potentially leading to a more robust immune response against abnormal cells. This development opens up possibilities for increased therapeutic benefits of cryoablation against solid tumors beyond tumor destruction.
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IceCure Medical Ltd. (Nasdaq: ICCM) announced the publication of an independent study in the Annals of Surgical Oncology, stating that cryoablation is an oncologically safe and feasible minimally invasive procedure option for patients with early-stage, low-risk breast cancer. The study suggests that cryoablation is a superior alternative to surgical resection in terms of financial implications. The study was conducted at the Breast Center of Excellence and the Department of Surgery, School of Medicine at Texas Tech University Health Sciences Center.
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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