Welcome to our dedicated page for IceCure Medical Ltd. Ordinary Shares news (Ticker: ICCM), a resource for investors and traders seeking the latest updates and insights on IceCure Medical Ltd. Ordinary Shares stock.
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) has priced its public offering of 8,787,880 ordinary shares at $1.65 each, aiming to raise approximately $14.5 million before expenses. The funds will be utilized for developing next-generation systems, clinical data collection, regulatory approvals, marketing, and general corporate purposes. The offering is expected to close on December 23, 2022, pending customary conditions. A.G.P./Alliance Global Partners serves as the lead placement agent.
IceCure Medical Ltd. (Nasdaq: ICCM) announced a public offering of its ordinary shares, with all securities offered by the Company. The offering's completion is subject to market conditions, and details regarding size and terms are uncertain. Proceeds will fund the development of next-gen systems, clinical data collection, and regulatory approvals, among other uses. A.G.P./Alliance Global Partners is the lead placement agent. This offering is made under an effective shelf registration statement filed with the SEC.
IceCure Medical Ltd. (Nasdaq: ICCM) announced interim results from the ICESECRET study, presented at the Urological Association Conference in Eilat, Israel. The ProSense system effectively treats renal lesions under 5 cm in patients unfit for kidney-preserving surgery. Out of 115 enrolled patients, an 89.5% recurrence-free rate was observed for lesions ≤3 cm. The study reported 5 serious adverse events, with the majority being mild and resolved quickly. ProSense is approved in the U.S. and Europe for treating both benign and malignant kidney tumors.
IceCure Medical Ltd. (Nasdaq: ICCM) announced the promotion of Galit Bar Malik to VP of Operations and Service and the appointment of Vincent Chun Hung Chan as an independent director. Chan, a seasoned private equity executive with over 30 years of experience, brings a strong background in managing investment projects and corporate governance. This strategic addition aims to bolster operations in light of anticipated sales growth for the ProSense® system, which treats tumors through cryoablation technology. The company is focusing on launching ProSense in key markets, including Asia.
IceCure Medical (Nasdaq: ICCM) reported a 22% revenue decline to $2.1 million for the nine months ending September 30, 2022, but noted a positive sales increase of 65% in the U.S. and 37% in Europe. Key developments include the FDA filing for ProSense cryoablation for breast cancer and achieving Medicare coverage with a CPT Category III code effective January 1, 2023. Operating expenses rose to $13.8 million, leading to a net loss of $13 million. The company has $14.2 million in cash as of September 30, 2022. A conference call discussing these results is scheduled for December 5, 2022.
IceCure Medical Ltd (NASDAQ: ICCM) will announce its financial results for the nine months ending September 30, 2022, on December 5, 2022, at 7:00 a.m. EST. A conference call will follow at 8:00 a.m. EST, featuring Dr. Hania Bednarski, an expert in minimally-invasive cryoablation technology. The ProSense® System, developed by IceCure, is a cryoablation treatment for tumors, providing a non-surgical alternative. Dr. Bednarski has been actively training surgeons in this technology.
IceCure Medical (NASDAQ: ICCM) will announce its financial results for the nine months ending September 30, 2022, on December 5, 2022. The results will be shared via a press release at 7:30 a.m. EST, followed by a conference call at 8:00 a.m. EST featuring Dr. Hania Bednarski, a cryoablation specialist. IceCure's ProSense technology offers a non-invasive alternative for tumor treatment. The system is FDA-cleared and CE-marked in Europe, focusing on breast, kidney, bone, and lung cancers. Forward-looking statements regarding the company’s future performance will be included.
IceCure Medical (NASDAQ: ICCM) achieved a significant milestone with the Centers for Medicare & Medicaid Services (CMS) assigning its ProSense cryoablation procedure for breast cancer to a Medicare Payment Group, effective January 1, 2023. This is the first payment assignment for cryoablation of breast cancer, contingent upon FDA marketing authorization. The procedure, priced at approximately $3,400, aims to provide a cost-effective alternative to traditional surgery, potentially improving patient outcomes and healthcare economics. IceCure's CEO emphasized the importance of this step in advancing treatment options for early-stage breast cancer.
IceCure Medical Ltd (NASDAQ: ICCM) announced its initiatives for Breast Cancer Awareness Month, focusing on the ProSense® cryoablation system, which offers a minimally invasive, effective treatment option for early-stage low-risk breast cancer. The company has filed for FDA marketing authorization and expanded installation of ProSense in multiple countries including the US and Europe. Key activities included physician training webinars and demonstrations at international conferences, emphasizing the system's cosmetic benefits and patient empowerment.
FAQ
What is the current stock price of IceCure Medical Ltd. Ordinary Shares (ICCM)?
What is the market cap of IceCure Medical Ltd. Ordinary Shares (ICCM)?
What is IceCure Medical Ltd. known for?
What is the ProSense® System?
What recent achievements has IceCure Medical made?
How has IceCure Medical's financial performance been recently?
What are some key financial highlights for IceCure Medical?
What partnerships does IceCure Medical have?
What is the significance of the ICE3 study?
What are IceCure Medical's future plans?
What new products is IceCure Medical developing?
How is IceCure Medical expanding its global reach?
