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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.
IceCure Medical (NASDAQ: ICCM) presented data from its ICE3 trial of ProSense® cryoablation technology at the Radiological Society of North America's 2024 Annual Meeting. The study, presented by ICE3 Co-Principal Investigator Dr. Kenneth Tomkovich, demonstrated promising results for treating early-stage low-risk breast cancer.
Key findings include a five-year recurrence rate of 3.7% with adjuvant endocrine therapy and 4.3% in the eligible trial population, comparable to surgical lumpectomy outcomes. The procedure offers significant advantages over surgery, including outpatient treatment with local anesthesia, minor adverse events, and 100% patient satisfaction with cosmetic outcomes.
Following a favorable FDA Advisory Panel vote in November 2024, the FDA's marketing authorization decision is expected in Q1 2025. The ICE3 trial, being the largest of its kind, supports the transition towards less invasive breast cancer treatment options.
IceCure Medical (NASDAQ: ICCM) announced promising interim results from their ICESECRET study evaluating ProSense® cryoablation for small renal masses. The study, involving 111 patients with 117 lesions over a mean follow-up of 36 months, showed:
- 82% of patients remained tumor-free
- 88.7% success rate in patients with single tumors <3 cm without prior kidney cancer
- 95.6% successful freezing achievement including safety margins
- Preserved renal function across patient cohort
- Short procedure time of approximately 25 minutes
The technology is currently approved for benign and malignant kidney tumors in the U.S., Europe, and other countries, addressing a significant market with an estimated 81,610 new kidney cancer cases expected in the U.S. in 2024.
IceCure Medical reported strong financial results for the first nine months of 2024, with 36% growth in ProSense® system and probe sales to $2.3M. Gross profits increased 41%, with non-GAAP gross profits up 104%. Gross margins improved to 43% from 37% year-over-year. The FDA Advisory Panel voted favorably for ProSense®'s benefit-risk profile in early-stage low risk breast cancer, with a final FDA marketing authorization decision expected in Q1 2025. The company maintained $10.7M in cash as of September 30, 2024, and raised $8.1M through share offerings. Research and development expenses decreased 15%, while sales and marketing expenses increased to support growth.
IceCure Medical (NASDAQ: ICCM) has received a Notice of Allowance from Japan's Patent Office for its 'Cryogenic System with Multiple Submerged Pumps' invention. This technology enables a next-generation MSense™ multiprobe cryoablation system that can independently control multiple cryoprobes for treating larger tumors. The patent strengthens IceCure's position in Japan, where their partner Terumo plans to file for ProSense® regulatory approval for breast cancer treatment in 2025.
IceCure Medical (Nasdaq: ICCM), a developer of minimally-invasive cryoablation technology for tumor treatment, will release its Q3 2024 financial and operational results before Nasdaq market opening on November 26, 2024. The company will host a conference call and webcast at 10:00 AM EST the same day to discuss the results and corporate developments. The call will be accessible via US toll-free and international dial-in numbers, with a live webcast available through the company's website.
IceCure Medical's ProSense® has been selected for the PRECICE study, a major breast cryoablation research initiative led by the European Institute of Oncology. The study, sponsored by the Umberto Veronesi Foundation and Italian Ministry of Health, will exclusively use ProSense® to treat 233 patients aged 50+ with early-stage breast cancer (Luminal A and B).
The study details were published in the European Journal of Cancer Prevention, highlighting cryoablation as a potential alternative to surgical treatment. The research will evaluate technical effectiveness with a five-year median follow-up, examining procedure failure rates through various imaging methods and additional endpoints including quality of life and economic outcomes.
IceCure Medical (Nasdaq: ICCM) received a favorable recommendation from the FDA Advisory Panel for its ProSense® cryoablation system with a 9-5 vote supporting its benefit-risk profile for treating early-stage low risk breast cancer. The panel's decision was based on comprehensive data from the ICE3 study and stakeholder testimonies. Three of the dissenting voters indicated they would have voted in favor with adequate FDA special controls. The FDA's final marketing authorization decision is expected in Q1 2025. ProSense® offers a minimally-invasive alternative to lumpectomy by destroying tumors through freezing.
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.
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