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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 Ltd. (NASDAQ: ICCM) reported preliminary unaudited revenue of $4.1 million for 2021, up from $3.9 million in 2020, primarily driven by sales from distribution agreements in Europe and the U.S. ProSense® system. Cash and equivalents surged to $25.6 million from $3.5 million in the prior year, aided by $32 million in equity raises. The company plans to enhance its regulatory and commercial strategies in the U.S., China, and Japan and pursue further FDA approvals for breast cancer treatments.
IceCure Medical Ltd. (NASDAQ: ICCM) shared a letter to shareholders reflecting on its achievements in 2021 and outlining objectives for 2022. The company reported positive interim results from the ICE3 clinical trial and noted progress in gaining regulatory approvals in the U.S., China, and Japan. IceCure also successfully raised $32 million in funding and expanded its global distribution network. Looking ahead, the focus will be on commercialization, regulatory clearances, and the development of next-generation cryoablation systems. The company expressed gratitude to its shareholders for their support.
IceCure Medical Ltd. (NASDAQ: ICCM) announced receiving notification from the European Patent Office of an intention to grant a patent for its proprietary cryogenic pump, which will enhance the ProSense® cryoablation system. This pump is designed for long-term procedures without the need for frequent liquid nitrogen refills, improving efficiency and temperature control. The patent will be effective until 2041. CEO Eyal Shamir highlighted its potential to enhance cryoablation procedures and expand treatment applications.
IceCure Medical Ltd. (NASDAQ: ICCM) announced the closing of its underwritten public offering, raising approximately $17 million by selling 3,892,152 shares at $3.45 each, including an over-allotment of 578,325 shares. Additionally, pre-funded warrants for 1,034,000 shares were offered at $3.449 each. The funds will be utilized for product development, business development, working capital, and general corporate purposes.
IceCure Medical Ltd. (NASDAQ: ICCM) announced a public offering of 3,313,827 shares at $3.45 each, aiming to raise approximately $15 million. The offering includes pre-funded warrants to purchase 1,034,000 shares, priced at $3.449 each. Expected to close by December 13, 2021, the funds will support product development, business growth, and general corporate purposes. A.G.P./Alliance Global Partners is the book-running manager for the offering.
IceCure Medical (NASDAQ: ICCM) announced that interim data from its ICE3 Clinical Trial on cryoablation for small, low-risk breast cancer was presented by Dr. Kenneth Tomkovich at the RSNA meeting, which took place from November 29 to December 2, 2021. Dr. Tomkovich's presentation highlighted the growing acceptance of cryoablation as a treatment option. IceCure's CEO, Eyal Shamir, noted that this recognition supports the promising ICE3 data. The ProSense® System offers a minimally-invasive alternative to surgical tumor removal, focusing on effective treatment options for various cancers.
IceCure Medical Ltd (NASDAQ: ICCM) announced the appointment of Merav Nir Dotan as Vice President of Human Resources, enhancing its commitment to growth in human capital. With over 20 years of HR experience, Nir Dotan is set to support IceCure's global expansion of the ProSense® System, which provides a minimally invasive cancer treatment. The company aims to boost its R&D and clinical divisions as it seeks regulatory approvals in key markets, including the United States and China.
IceCure Medical Ltd. (NASDAQ: ICCM) reported an 11% revenue increase to approximately $2.75 million for the nine months ended September 30, 2021. However, the gross profit fell to $1.55 million, leading to a decreased gross margin of 56%. Operating expenses surged to approximately $8.15 million, resulting in a net loss of approximately $6.73 million or $0.25 per share, compared to a loss of $2.95 million in the prior year. Cash reserves improved to $15.4 million due to a $15 million private placement. Strategic developments include regulatory progress in the U.S. and China.
IceCure Medical Ltd. (NASDAQ: ICCM) announced the publication of a peer-reviewed article in the Journal of Cancer Therapy, highlighting the use of its ProSense™ Cryoablation System for treating early-stage breast cancer in Japan. Conducted at St. Marianna University, the study involved eight women with invasive ductal carcinoma, demonstrating that cryoablation could eliminate small tumors without surgery under general anesthesia. The findings suggest that cryoablation presents a viable alternative to lumpectomy, offering safety and positive cosmetic outcomes, with procedures lasting around 40 minutes.
IceCure Medical (Nasdaq: ICCM) has announced an initial distribution agreement with Mobile SCANMED Systems to exclusively sell its ProSense™ Cryoablation System in Poland. This partnership is expected to pave the way for a long-term agreement within a year. The ProSense system, already CE-marked, provides a minimally invasive solution for cancer treatment, particularly for breast cancer, which saw 24,644 diagnoses in Poland in 2020. An initial purchase order of approximately $100,000 will follow the agreement, enhancing IceCure's presence in the EU market.
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