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Overview of IceCure Medical Ltd.
IceCure Medical Ltd (ICCM) is a commercial-stage medical device company specializing in liquid nitrogen-based cryoablation systems. The company develops and markets minimally invasive technologies designed to destroy tumors through cryoablation, offering a viable alternative to traditional surgical tumor removal. By harnessing the power of liquid nitrogen, IceCure's systems create large lethal zones within tumors, providing a safe and efficient method for treating a variety of conditions including breast, kidney, bone, and lung cancers. This technology is proving essential in the shift toward less invasive medical treatments, marking significant advancements in the field of oncology.
Core Business and Technology
The primary focus of IceCure is on research, development, and commercialization of cryoablation therapy systems. Their flagship product leverages advanced cryogenic engineering to deliver precise ablation of both benign and malignant tumors. Using state-of-the-art cryoprobes and proprietary liquid nitrogen systems, IceCure offers a minimally invasive alternative that reduces surgical risks, shortens recovery times, and minimizes patient discomfort compared to conventional surgical methods. This robust technological foundation is supported by a significant portfolio of patents and continued innovation, underscoring the company’s commitment to remaining at the forefront of cryosurgical treatments.
Market Position and Industry Significance
Within the medical device market, IceCure occupies a unique niche by focusing exclusively on cryoablation. The company’s solutions are positioned as important tools for solid tumor treatments in multiple clinical settings, including hospitals and office-based procedures. With a strong emphasis on clinical research, IceCure’s technologies have been validated through extensive studies and trials, further enhancing their credibility among medical professionals. The company’s achievements, such as receiving key regulatory approvals and positive evaluations from expert panels, also contribute to its recognized position within the competitive landscape of minimally invasive surgery technologies.
Clinical Evidence and Research
IceCure’s commitment to rigorous clinical validation is evident in its comprehensive body of research. Multiple studies and clinical trials have demonstrated that cryoablation using IceCure’s systems achieves outcomes comparable to standard surgical interventions but with significantly lower rates of complications and shorter recovery periods. The company’s approach has garnered attention at major medical conferences, and independent studies consistently highlight the efficacy and safety of their methodology. This research-based approach not only drives clinical adoption but also reinforces the trustworthiness and expertise of IceCure’s technology in the field of oncologic treatment.
Innovation and Regulatory Milestones
Innovation is a core driver for IceCure, which continually refines its technology and expands its intellectual property portfolio. With multiple patents already granted and more under review, the company remains dedicated to advancing its cryoablation systems to meet an expanding range of clinical needs. Strategic regulatory approvals across key global markets such as the U.S., Europe, China, and others attest to the quality and reliability of its products. These achievements reflect IceCure’s commitment to improving patient outcomes and strengthening its market presence in the competitive field of medical devices.
Application and Patient Benefits
IceCure’s cryoablation systems are distinguished by their ability to provide effective tumor destruction with minimal patient discomfort. The technology not only reduces the pain and risks associated with conventional surgery but also facilitates faster recovery times, allowing patients to resume their normal lives more quickly. By offering an office-based, easy-to-perform procedure, IceCure is expanding access to advanced treatment options and paving the way for broader acceptance of minimally invasive therapies in oncologic care.
Conclusion
IceCure Medical Ltd stands as a notable innovator in the field of cryoablation therapy. With a deep commitment to clinical research, technological innovation, and regulatory excellence, the company provides a compelling alternative to traditional surgery for tumor management. Its focused approach and comprehensive product portfolio underscore its significance in the broader context of minimally invasive medical treatments, cementing its role as a trusted entity among healthcare professionals and stakeholders worldwide.
IceCure Medical (Nasdaq: ICCM) announced that its ProSense® System was featured in a study conducted at Tenon Hospital in Paris, highlighting the efficacy of cryoablation in treating symptomatic extraperitoneal endometriosis. The published study showed a pain-free survival rate of 93.75% at 6 months and 82.72% at 36 months post-procedure. The study involved 42 patients and reported an efficacy rate of 92.8% in avoiding secondary surgery. Additionally, pain reduction was significant, decreasing from a median of 8/10 to 0/10 at follow-up. The independent study, presented by Dr. Francois H. Cornelis, is critical, considering that 190 million women globally suffer from endometriosis with limited effective treatments. IceCure's ProSense System holds regulatory approvals in various countries, including FDA clearance.
On April 19, 2023, IceCure Medical (Nasdaq: ICCM) announced its decision to voluntarily delist its ordinary shares from the Tel Aviv Stock Exchange (TASE). The last trading day on the TASE will be July 20, 2023, with the official delisting occurring on July 24, 2023. Post-delisting, shares will continue to trade exclusively on the Nasdaq, where the company aims to focus its efforts. The Chairman emphasized that this move will reduce redundant listing costs and is intended to enhance shareholder value, particularly in the U.S. healthcare market, where their ProSense cryoablation technology shows significant potential. Despite the delisting, the company will maintain compliance with SEC regulations and continue filing public reports.
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.