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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 a 2022 revenue decline to $3.1 million, down from $4.1 million in 2021. However, the company saw 28% year-over-year sales growth in the U.S., driven by rising utilization of the ProSense system, with disposable sales growing from 29% to 43% of total revenue. Notable developments include FDA submission for ProSense marketing authorization in breast cancer and regulatory approval of IceSense3 cryoprobes in China. A partnership with Shanghai Medtronic promises minimum purchase targets of $3.5 million over three years. Despite increased R&D and operating expenses, the balance sheet remains robust with $23.7 million in cash.
IceCure Medical has received approval from China's National Medical Products Administration for its IceSense3 disposable cryoprobes. These will be used with the previously approved IceSense3 console, marking a significant milestone for the company.
Distribution will occur through partnerships with Shanghai Medtronic Zhikang Medical Devices and Beijing Turing Medical Technology. The technology aims to treat malignant and benign tumors in various organs, with a focus on enhancing patient outcomes. CEO Eyal Shamir highlighted the substantial market opportunity in China, especially with around 430,000 new breast cancer cases reported in 2022.
IceCure Medical Ltd. (NASDAQ: ICCM) will announce its 2022 full year financial and operational results on March 29, 2023, prior to market opening. The company focuses on minimally-invasive cryoablation technology through its ProSense® System, designed to freeze and destroy tumors as an alternative to surgery. A conference call to discuss the results and corporate developments will occur at 10:00 a.m. ET on the same day, accessible via US and international dial-in numbers. IceCure's system targets various cancers, including breast and kidney, and is marketed globally with FDA and CE Mark approvals.
IceCure Medical (Nasdaq: ICCM) announced preliminary unaudited results for 2022, revealing revenue of $3.1 million, down from $4.1 million in 2021, mainly due to a 25% decrease in sales across most territories. The company experienced a 28% increase in U.S. sales. As of December 31, 2022, IceCure's cash and cash equivalents stood at $23.6 million, down from $25.6 million in the previous year. IceCure secured a $3,400 CPT Category III code for breast cancer cryoablation, and interim clinical results showed effectiveness in treating kidney tumors.
IceCure Medical Ltd. (NASDAQ: ICCM) participated in the Society of Interventional Oncology's Annual Scientific Meeting in Washington, D.C., from January 19-23, 2023. The company highlighted its ProSense cryoablation system, which was demonstrated live at their booth. Notable discussions included a panel featuring Dr. Kenneth Tomkovich and Dr. Robert Ward, focusing on cryoablation as a treatment option and the interim results of the ICE3 trial for treating early-stage malignant breast tumors. Dr. Tomkovich emphasized growing interest from radiologists in utilizing ProSense, driven by encouraging trial results and the desire for less invasive treatment options.
IceCure Medical Ltd. (Nasdaq: ICCM) announced its participation in the American Society of Breast Surgeons' Breast Fellows Ultrasound Course on January 13-14, 2023. The event, held in Cincinnati, Ohio, featured hands-on training on the ProSense® System, a minimally invasive cryoablation technology for treating tumors. Dr. Richard Fine led a session on cryoablation, emphasizing the importance of ultrasound training for breast surgeons. CEO Eyal Shamir highlighted the course's success in raising awareness and preparing clinicians for future use of ProSense. The company anticipates a response from the FDA regarding its recent marketing authorization filing for ProSense, aimed at enhancing breast cancer treatment.
IceCure Medical (NASDAQ: ICCM) has announced a Notice of Allowance from the U.S. Patent and Trademark Office for its Cryogen Pump patent, valid until February 2040. This patent, also granted in the European Union and allowed in Japan, supports the development of the next generation of cryoablation systems by enhancing the ProSense® System used in minimally invasive tumor treatments. The novel pump expands capabilities by facilitating a faster cooling rate and operational efficiency, essential for more clinical applications. IceCure's technology aims to provide effective alternatives to traditional surgical methods.
IceCure Medical Ltd. (NASDAQ: ICCM) announced a Notice of Allowance from the Japan Patent Office for its Cryogen Pump patent, effective until 2041. This innovative pump allows longer, multiple cryoablation procedures without needing to refill liquid nitrogen, enhancing clinical applications. The pump improves cooling rates and temperature control for cryoprobes. This patent supports IceCure's distribution agreement with Terumo in Japan, strengthening its market presence. IceCure focuses on advanced cryoablation therapy for treating tumors, including breast and kidney cancers, positioning itself as a leader in minimally invasive treatments.
IceCure Medical Ltd. (Nasdaq: ICCM) issued a letter to shareholders outlining its progress and objectives for 2023. Major achievements in 2022 include raising $14.5 million through equity financing, submitting regulatory requests in the U.S., Canada, and Vietnam, and gaining reimbursement approval for cryoablation procedures. The company aims to enhance its market presence, particularly in breast cancer treatment, and is focused on increasing commercialization efforts globally. CEO Eyal Shamir emphasized confidence in growth and the company's financial stability.
IceCure Medical (Nasdaq: ICCM) has successfully closed its public offering of 8,787,880 ordinary shares at a price of $1.65 per share, generating approximately $14.5 million in gross proceeds. The funds will be used for developing next-generation systems, collecting clinical data, regulatory approvals, and general corporate purposes. A.G.P./Alliance Global Partners served as the lead placement agent for the offering.
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