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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) reported key findings from three clinical studies of its ProSense® cryoablation system for breast cancer treatment at the 32nd Annual Meeting of the Japanese Breast Cancer Society. Highlights include:
1. An independent study by Prof. Fukuma showed a 99.74% recurrence-free rate in 389 patients treated over 10 years.
2. Another study by Prof. Kawamoto found 0% local recurrence in a five-year follow-up.
3. Terumo , IceCure's distribution partner, plans to submit an application for regulatory clearance in Japan by Q1 2025.
The demand for minimally invasive breast cancer treatments was a major theme at the conference, with ProSense® gaining traction due to its efficacy, favorable cosmetic results, and potential immune system benefits.
IceCure Medical (Nasdaq: ICCM), a developer of minimally-invasive cryoablation technology for tumor destruction, has received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share. The company has been granted a 180-day grace period until January 14, 2025, to regain compliance. During this period, ICCM's shares will continue trading on the Nasdaq Capital Market.
To regain compliance, ICCM's closing bid price must be at least $1.00 for a minimum of ten consecutive business days. If unsuccessful, the company may be eligible for an additional 180-day compliance period, provided it meets other listing requirements. IceCure Medical states that maintaining its Nasdaq listing is a priority and will consider available options to cure the deficiency if necessary.
An independent study published in 'Cancers' supports the efficacy and safety of IceCure's ProSense® cryoablation system for treating metastatic and recurrent breast cancer. Conducted by Prof. Thomas J. Vogl at the University Hospital Frankfurt, the study involved 45 patients, including those with metastatic disease and recurrent tumors up to 4 cm in diameter. Key findings include a 100% complete ablation rate, 8.9% recurrence rate, and no observed complications. This research, featuring a higher-risk patient group than IceCure's U.S. ICE3 study, underscores ProSense®'s viability across a broader spectrum of breast cancer diagnoses. CEO Eyal Shamir emphasized the significance of these results for ProSense® users in Europe, where the system is approved for general breast cancer treatment.
IceCure Medical announced that the FDA has granted regulatory clearance for its next-generation XSense™ Cryoablation System with CryoProbes. The system, which uses extreme cold to destroy tissues, is cleared for the same indications as its predecessor, ProSense®. These include applications in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The technology addresses conditions such as fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions, and warts. CEO Eyal Shamir stated that this clearance validates the safety and efficacy of the platform, potentially enabling the system to address unmet medical needs in the U.S.
IceCure Medical, developer of the ProSense® System for minimally-invasive cryoablation of tumors, announced its participation in the Northland Capital Markets Virtual Growth Conference on June 25, 2024. The company has achieved key milestones, including the completion of the ICE3 trial and FDA submission for the ProSense® System. CEO Eyal Shamir highlighted board members' recent stock purchases as a sign of confidence. The conference will feature presentations from CEO Shamir and CFO Ronen Tsimerman on recent developments and future catalysts. Interested investors can request virtual meetings for more insights.
IceCure Medical (Nasdaq: ICCM) shared positive interim results from its ICESECRET kidney cancer trial at the 3rd Annual Israeli Conference on Interventional Radiology. The trial features the ProSense® System, a cryoablation technology that freezes tumors. Findings show ProSense® is effective, with an 89.5% recurrence-free rate. Further data is expected in Q4 2024, averaging a 3-year follow-up. The global kidney cancer treatment market, valued at $6.92 billion in 2024, is projected to reach $8.78 billion by 2029. ProSense® is approved in the U.S., Europe, and other regions for benign and malignant kidney tumors. The system offers a minimally invasive alternative to surgery, reducing hospitalization and minimally impacting renal function and hemoglobin levels. CEO Eyal Shamir highlighted the favorable reception of data by interventional radiologists and the potential benefits for kidney cancer patients.
IceCure Medical announced the FDA will convene a Medical Device Advisory Committee to review the De Novo Marketing Clearance Request for its ProSense® System, with a decision expected by early 2025. This review acknowledges the potential public health benefits of ProSense® as a minimally invasive treatment for early-stage breast cancer, affecting approximately 65,000 women annually in the U.S.
ProSense® offers cryoablation technology as an alternative to surgical tumor removal and is already approved in several countries. The Advisory Panel will meet in Q4 2024 to discuss the ICE3 study results, showing 96.3% of patients were free from local recurrence at a 5-year follow-up, with 100% patient and physician satisfaction.
IceCure's CEO, Eyal Shamir, emphasized the transparency and public involvement in the process, anticipating that increased awareness could support commercial efforts in the U.S. upon potential regulatory approval.
IceCure Medical reported a strong Q1 2024 performance with a 30% sales growth for its ProSense® cryoablation system, driven by increased adoption in the U.S. and other global markets. The company completed the landmark ICE3 trial for breast cancer, reporting positive final data and submitting it to the FDA for marketing authorization. Financial highlights include a gross profit of $269,000 and net loss reduction to $3.6 million. Operating expenses decreased due to prudent cash management. The company also secured a new patent in Japan and submitted an FDA application for its next-generation XSense™ system.
IceCure Medical (Nasdaq: ICCM), based in Caesarea, Israel, will release its financial and operational results for Q1 2024 on May 28, 2024, before the Nasdaq Stock Market opens. The company, which specializes in the ProSense® System, a cryoablation technology for tumor destruction, will hold a conference call at 11:00 a.m. EDT to discuss the results and other corporate updates. Interested parties can join via phone or live webcast.
IceCure Medical, developer of the ProSense® Cryoablation System, announced that CEO Eyal Shamir will present at the A.G.P / Alliance Global Partners' Virtual Healthcare Company Showcase on May 21, 2024. The presentation will cover key achievements, including the completion of the ICE3 breast cancer cryoablation trial, submission of results to the FDA, and a pending De Novo Classification Request for marketing clearance. Additionally, the company will highlight ProSense®'s growing global reach and its efficacy in women's health and interventional oncology. Shamir emphasized the significance of these developments for enhancing shareholder value and accelerating commercial goals in the U.S. market.
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