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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 announced the publication of its ICE3 trial results in the Annals of Surgical Oncology. The study, titled 'Cryoablation Without Excision for Early–Stage Breast Cancer: ICE3 Trial 5–Year Follow–Up on Ipsilateral Breast Tumor Recurrence', presents findings on using ProSense® cryoablation for early-stage, low-risk breast cancer.
Key results include:
- 96.3% recurrence-free rate for women treated with ProSense® and endocrine therapy
- 4.3% ipsilateral breast tumor recurrence rate at 5 years
- 96.7% breast cancer survival rate
- 100% patient and physician satisfaction with cosmetic outcomes
- No serious device-related adverse events reported
The publication precedes IceCure's FDA Advisory Panel Meeting for ProSense® marketing authorization, scheduled for November 7, 2024.
IceCure Medical (Nasdaq: ICCM) announced the publication of an independent study on its ProSense® cryoablation system in the British Journal of Radiology. The study, led by Dr. Franco Orsi at the European Institute of Oncology, demonstrated a 97.7% technical success rate in treating tumors of the lung, bone, and soft tissues. ProSense®, a liquid nitrogen-based system, was found to have favorable safety compared to argon-based systems and to be more cost-effective and easier to manage.
The study assessed 85 patients with 96 lesions, showing only minor complications that resolved without significant intervention. It highlighted cryoablation's growing role in early oncology treatments, particularly for patients with comorbidities or those avoiding surgery. The research also emphasized interventional radiology as the fourth pillar of oncology, alongside clinical oncology, surgical oncology, and radiation therapy.
IceCure Medical (Nasdaq: ICCM) announced that the FDA's Medical Device Advisory Committee Panel will meet on November 7, 2024, to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for early-stage low risk breast cancer. This public forum will review data, including results from the ICE3 study, which showed a 96.3% recurrence-free rate at 5 years for patients treated with ProSense® and adjuvant endocrine therapy. The FDA is expected to make a decision on marketing authorization by early 2025. ProSense® could potentially benefit an estimated 70,000 women diagnosed annually in the U.S. with this condition.
IceCure Medical (Nasdaq: ICCM), developer of minimally-invasive cryoablation technology, announced its participation in two upcoming investor conferences. CEO Eyal Shamir will conduct one-on-one meetings with institutional investors at both the H.C. Wainwright 26th Annual Global Investment Conference (September 9-11, 2024) and the Lake Street Capital Markets 8th Annual Best Ideas Growth Conference (September 12, 2024).
The company's presentation will focus on its ProSense® technology for non-surgical treatment of benign and cancerous tumors, as well as upcoming regulatory and operating catalysts. CFO and COO Ronen Tsimerman will join the H.C. Wainwright meetings virtually. A virtual presentation will be available on-demand starting September 9 at 7:00 AM ET for the H.C. Wainwright conference.
IceCure Medical (Nasdaq: ICCM) has received a Notice of Allowance from the USPTO for a continuation patent on its novel cryogenic pump technology. This patent, effective until 2041, reinforces IceCure's global IP leadership in cryoablation technologies. The innovative pump, submersible in liquid nitrogen, works in a closed circuit and improves cooling rates during procedures. It's designed for multiple or longer duration procedures without liquid nitrogen refills and enables a wider range of cryoprobes and catheters.
The patent broadens the applications of IceCure's cryoablation platform across various technology fields. CEO Eyal Shamir stated that this patent supports the potential for increasing indications, procedures, and applications with their next-generation cryoablation systems. The timing aligns with existing FDA approvals and the anticipated FDA decision on clearance for early-stage breast cancer in Q1 2025.
IceCure Medical (ICCM) reported a 20% growth in ProSense® system and probe sales for the first half of 2024, reflecting continued adoption in the U.S. and other global markets. Key highlights include:
1. FDA Medical Device Advisory Committee expected in Q4 2024 for early-stage, low risk breast cancer treatment.
2. Interim results from ICESECRET kidney cancer trial expected by December 2024.
3. Terumo to file for regulatory approval in Japan in Q1 2025.
4. Total revenue grew to $1,754,000 from $1,647,000 in H1 2023.
5. Net loss narrowed to $6,690,000 ($0.14 per share) from $7,657,000 ($0.17 per share) in H1 2023.
6. Cash and cash equivalents of $10.5 million as of June 30, 2024.
IceCure Medical (Nasdaq: ICCM) announced results from an independent study on its ProSense® cryoablation technology for breast cancer treatment. The study, published in the British Journal of Radiology, showed:
- 100% complete ablation rate for Luminal A and B breast cancer tumors ≤ 25mm after 16 months median follow-up
- 95.6% of patients offered cryoablation accepted it
- Median patient age was 87 (range 60-96)
- No major complications were observed
The study concluded that cryoablation is a safe, effective alternative to surgery for early-stage breast cancer in non-surgical patients, well-tolerated as an outpatient procedure. IceCure CEO Eyal Shamir highlighted the potential increasing demand for ProSense® due to the aging population and higher breast cancer risk with age.
IceCure Medical (Nasdaq: ICCM), a developer of minimally-invasive cryoablation technology for tumor destruction, has announced its plans to release financial and operational results for the six months ended June 30, 2024. The company will issue a press release before the Nasdaq Stock Market opens on Tuesday, August 20, 2024. Additionally, IceCure will host a conference call and webcast at 10:00 a.m. EDT on the same day to discuss the results and other corporate developments.
Investors and interested parties can access the conference call using the following details:
- US: 1-888-407-2553
- Israel/International: +972-3-918-0696
- Live webcast: https://Veidan.activetrail.biz/IcecureQ2-2024
IceCure Medical (Nasdaq: ICCM) announced positive data from a large multi-institutional study on cryoablation of primary breast cancer in patients ineligible for clinical trials. The study, published in the American Journal of Roentgenology, included 112 high-risk patients with a median age of 71. Recurrence-free rates were 94.7%, 87.8%, and 81.8% at 1, 2, and 3 years, respectively. The study used various cryoablation systems, including IceCure's ProSense®, across 7 U.S. institutions. Treatment showed a low frequency of adverse events (6.3% minor, no moderate or major) and high technical success (98.2%). Researchers concluded that cryoablation remains a safe alternative to surgery with good outcomes, especially for poor surgical candidates due to comorbidities.
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.
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