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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 announces new data on ProSense cryoablation treatment for breast cancer
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IceCure Medical announces data presentation on ProSense at EUSOBI meeting
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IceCure Medical's De Novo Classification request for breast cancer denied by FDA
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ProSense gaining commercial traction in Europe with CE approval for malignant and benign tissue indications. Symposium presenters demonstrate cryoablation's efficacy rate of 92.8% in avoiding secondary surgery. IceCure to participate in CIRCE 2023 Annual Congress and exhibit ProSense. IceCure sponsors 'Supporting Women in IR Grant' for conference participation.
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IceCure Medical's ProSense System receives regulatory approval as a Class III device from the Brazilian Health Regulatory Agency (ANVISA). The approval allows healthcare providers to conduct procedures with ProSense in various oncology indications. IceCure expects this approval to lead to near-term revenues in the Brazilian market, where there is a high demand for minimally invasive cancer treatments.
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IceCure Medical appoints Shad Good as VP of Sales for North America
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IceCure Medical participated in a cryoablation symposium in Thailand, showcasing its ProSense System. Professor Fukuma, who has performed over 600 procedures with ProSense, praised its effectiveness and minimal side effects. The partnership between IceCure and Terumo Thailand is expected to improve sales momentum. The growing data on ProSense's efficacy supports its use in treating breast, lung, and kidney tumors.
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IceCure Medical Ltd. reports financial results for the six months ended June 30, 2023. The company awaits FDA's response to its regulatory filing for early-stage low-risk breast cancer in high-risk surgery patients. ProSense received regulatory approvals in Canada and China. Cryoablation achieved a 92.8% efficacy in avoiding secondary surgery during a study of endometriosis.
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IceCure Medical Ltd (ICCM) will release its financial and operational results for the six months ended June 30, 2023, with a press release on August 14, 2023. The company will host a conference call to discuss the results and corporate developments, featuring Dr. Robert Ward, a ProSense user and Assistant Professor of Diagnostic Imaging at Brown University. IceCure's ProSense® System is a minimally-invasive cryoablation technology that destroys tumors by freezing, providing an alternative to surgical tumor removal.
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IceCure Medical's ProSense System receives approval from Health Canada, expanding its market potential in North America. The ProSense System is a minimally-invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal. IceCure has already received interest from healthcare providers in Canada and plans to expand its activities in the country. With Canada's highly ranked healthcare system and estimated total health spending of $331 billion in 2022, this approval opens up new opportunities for IceCure.
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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 $1.29 as of January 8, 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 70.2M.
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