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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) has submitted a regulatory filing to China's National Medical Products Administration (NMPA) for its ProSense® Cryoablation System. The company, which already has approval for its IceSense3 system in China, is seeking to expand its presence in the Chinese market.
The ProSense® application includes expanded capabilities compared to IceSense3, featuring five different cryoprobes with varying specifications and introducers for better tissue accessibility. The system's indicated uses cover multiple medical fields including general surgery, breast tissue, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology.
IceCure Medical reported preliminary unaudited results for 2024, showing a 42% increase in ProSense® sales in North America. Total revenue grew to $3.29 million from $3.23 million in 2023, with ProSense® system and probe sales reaching $3.19 million. The company ended 2024 with $7.5 million in cash.
Key developments include the FDA Advisory Panel's favorable vote for ProSense®'s benefit-risk profile in early-stage low-risk breast cancer, with a decision expected in Q1 2025. The ICE3 study showed a 96.3% recurrence-free rate and 100% patient satisfaction. The ICESECRET kidney cancer study demonstrated an 88.7% recurrence-free rate.
The company strengthened its intellectual property with four new patents and received FDA clearance for its XSense™ Cryoablation System. For 2025, IceCure plans to expand in the U.S. market pending FDA authorization and pursue regulatory approvals in Japan and China.
IceCure Medical (NASDAQ: ICCM), a developer of minimally-invasive cryoablation technology for tumor treatment, has announced its return to full compliance with Nasdaq's listing requirements. The company received confirmation from Nasdaq that it has successfully met the minimum bid price requirement under Rule 5550(a)(2), having maintained a closing bid price of $1.00 or higher for at least 10 consecutive business days.
This development resolves the previous bid price deficiency matter, and IceCure will continue to be listed and traded on The Nasdaq Capital Market, now being in full compliance with all Nasdaq continued listing requirements.
IceCure Medical (Nasdaq: ICCM) announced receiving an Intention to Grant Notice from the European Patent Office for its 'Cryogenic System Connector' invention, which is already patented in the United States. The technology is part of the company's XSense™ system, designed to improve safety and maintain cryogen integrity during cryoablation procedures.
The XSense™ system and its cryoprobes have FDA clearance for all indications currently approved for IceCure's flagship ProSense® system. The company aims to address additional indications in the global tumor ablation market, which was valued at $1.67 billion in 2023 according to Grand View Research. The company sees Europe as a major market, with multiple distributors selling ProSense® and various independent clinical studies being conducted across different medical indications.
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.
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