Welcome to our dedicated page for Icecure Medical Ltd. news (Ticker: ICCM), a resource for investors and traders seeking the latest updates and insights on Icecure Medical Ltd. stock.
About IceCure Medical Ltd. (Nasdaq: ICCM)
IceCure Medical Ltd. is a commercial-stage medical device company revolutionizing the treatment of tumors through its advanced cryoablation technology. Headquartered in Caesarea, Israel, IceCure develops, manufactures, and markets minimally invasive systems that utilize liquid nitrogen to freeze and destroy tumors. The company's flagship product, the ProSense® Cryoablation System, offers a safe, effective, and non-surgical alternative to traditional tumor removal methods, targeting both benign and malignant tumors in areas such as the breast, kidney, lung, liver, bone, and soft tissues.
Core Technology and Value Proposition
IceCure's cryoablation technology employs liquid nitrogen to create large lethal zones, effectively freezing and destroying tumor cells while preserving surrounding healthy tissue. This approach minimizes surgical risks, accelerates recovery times, and reduces pain and complications. The ProSense® system is portable and designed for use in outpatient settings, making it a cost-effective solution for healthcare providers and patients alike.
Market Position and Industry Context
IceCure operates within the rapidly growing minimally invasive surgery market, which is projected to reach $174 billion by 2029. The company's innovative technology aligns with the global trend toward de-escalation of surgery, particularly in oncology. By providing an alternative to surgical procedures like lumpectomy for early-stage breast cancer, IceCure addresses a critical need for less invasive, patient-friendly treatment options. Its systems are cleared for use in major markets, including the U.S., Europe, China, and Japan, and are supported by a robust portfolio of over 50 patents.
Clinical Validation and Applications
IceCure's technology has been validated through extensive clinical trials, including the landmark ICE3 study, which demonstrated a 96.3% recurrence-free rate in early-stage breast cancer patients treated with cryoablation. Additional studies, such as ICESECRET for kidney cancer and THERMAC for breast cancer, further highlight the efficacy and safety of its systems. These trials underline the company's commitment to evidence-based innovation and its ability to meet the stringent requirements of regulatory bodies worldwide.
Global Reach and Strategic Partnerships
IceCure's products are marketed and sold globally, with strategic partnerships in key regions, including a collaboration with Terumo Corporation in Japan. The company continues to expand its footprint through regulatory filings, such as the recent submission to China's National Medical Products Administration for the ProSense® system. Its next-generation XSense™ system, featuring advanced cryogenic technology, has received FDA clearance and is poised to address additional indications.
Competitive Differentiation
IceCure sets itself apart with its proprietary liquid nitrogen-based technology, which offers superior efficacy compared to other thermal ablation methods like microwave and radiofrequency ablation. Its systems are supported by a growing body of peer-reviewed studies and real-world data, establishing IceCure as a leader in the cryoablation space.
Conclusion
With a strong focus on innovation, clinical validation, and global market penetration, IceCure Medical Ltd. is at the forefront of transforming tumor treatment. Its minimally invasive cryoablation technology not only improves patient outcomes but also aligns with the healthcare industry's shift toward cost-effective, outpatient care solutions.
IceCure Medical Ltd. (Nasdaq: ICCM) has announced its educational support for a pioneering continuing medical education (CME) course on cryotherapy at the American Society of Breast Surgeons' 24th Annual Meeting in Boston, scheduled for April 26-30, 2023. This course will feature hands-on training with ProSense®, IceCure's minimally-invasive cryoablation technology aimed at treating early-stage breast cancer. The ICE3 trial interim results, indicating a cancer recurrence rate of only 3.09%, will be highlighted during the course, emphasizing the potential of cryoablation as a non-invasive alternative to surgery. The FDA is currently reviewing IceCure's regulatory submission for marketing authorization of ProSense. Company leadership expresses optimism about the growing interest in cryoablation among breast surgeons, which could facilitate quicker adoption of this innovative treatment.
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.
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