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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 (Nasdaq: ICCM) has announced that its ProSense Cryoprobes and Introducers have received regulatory approval from Brazil's ANVISA, following an application by KTRFIOS in June 2022. The company anticipates strong demand for its ProSense Cryoablation System, which is still awaiting approval. The distribution agreement guarantees at least $6.6 million in sales over five years upon receiving full regulatory approval. This system offers a minimally invasive alternative to surgical tumor removal for treating various types of tumors.
IceCure Medical Ltd. (NASDAQ: ICCM) has submitted a regulatory filing with Vietnam's Ministry of Health for its ProSense System, designed for treating benign and malignant tumors. This technology presents a non-surgical alternative, targeting various cancers including breast, lung, liver, and kidney. Vietnam's medical device market, valued at $1.4 billion in 2019, is expected to grow at 10% annually through 2024. CEO Eyal Shamir expressed optimism about distributor interest in the fast-growing Vietnamese healthcare market, following recent successes in China and Japan.
IceCure Medical Ltd. (NASDAQ: ICCM) reports a 27% revenue decline to approximately $1.5 million for the six months ended June 30, 2022. Key highlights include an exclusive agreement with Shanghai Medtronic for IceSense3 systems, targeting minimum purchases of $3.5 million over three years. ProSense systems have been installed in multiple global locations, with NMPA approval for IceSense3 expected by year-end 2022. However, the company faced increased R&D and operational expenses, resulting in a net loss of approximately $9.0 million, or $0.24 per share.
IceCure Medical Ltd. (NASDAQ: ICCM) will report its H1 2022 business and financial results on August 15, 2022, at 4:00 p.m. EDT. Following the report, a conference call hosted by management and Dr. Kenneth Tomkovich, the co-primary investigator of the ICE3 trial, is scheduled for 4:30 p.m. EDT. IceCure specializes in minimally-invasive cryoablation technology, notably the ProSense® System, aimed at treating tumors by freezing. The company focuses on various cancers, including breast and kidney cancer, and its technology is FDA-cleared and CE-marked in Europe.
IceCure Medical Ltd (NASDAQ: ICCM) announced its submission of a regulatory filing to Health Canada for the approval of ProSense®, a minimally invasive cryoablation system targeting the treatment of breast tumors and other cancers. With current approvals in 14 countries, including the U.S. and Europe, IceCure aims to expand its market presence. CEO Eyal Shamir noted significant interest from Canadian healthcare providers for its technology, particularly as demand for outpatient solutions has surged post-pandemic. An estimated 28,600 Canadian women will be diagnosed with breast cancer in 2022.
IceCure Medical Ltd (NASDAQ: ICCM) has appointed Gilad Glick, former CEO of Itamar Medical, as a strategic advisor. Glick will enhance the commercialization strategy of IceCure's ProSense® System, targeting global markets, especially the U.S. and EU. ProSense®, known for its minimally invasive cryoablation technology, aims to improve treatments for tumors, including early-stage breast cancer. Glick's expertise is expected to significantly impact IceCure's revenue growth and market penetration.
IceCure Medical (NASDAQ: ICCM) announced that its ProSense cryoablation system was featured at the SIR 2022 Annual Scientific Meeting on June 14, 2022. The event showcased the effectiveness of ProSense for breast cancer treatment, drawing interest from U.S. medical clinics and international distributors. Additionally, IceCure secured a distribution agreement with Shanghai Medtronic for the Chinese market. The promising interim data from the ICE3 study indicates ProSense's potential as a safe, minimally invasive alternative for early-stage breast cancers.
IceCure Medical (NASDAQ: ICCM) announced a distribution agreement with Shanghai Medtronic to supply IceSense3 cryoablation systems in mainland China. The contract requires a minimum purchase of $3.5 million over three years, with first deliveries expected in 2022. This partnership aims to enhance market penetration for cryoablation technology, which is currently underutilized in China. The IceSense3 system has already received approval from China's regulatory body, with additional regulatory submissions planned for disposable probes by the end of 2022.
IceCure Medical (NASDAQ: ICCM) announced that its distributor in Brazil, KTRFIOS, has submitted a regulatory filing to the Brazilian Health Regulatory Agency (ANVISA) for the ProSense system. The application targets multiple cancer treatments including breast and prostate cancer, with KTRFIOS guaranteeing at least $6.6 million in sales within five years of approval. Brazil's rising cancer incidence underscores the demand for innovative treatments. CEO Eyal Shamir highlighted this milestone as pivotal for expanding IceCure's global regulatory landscape, which spans 14 countries including the U.S. and Europe.
IceCure Medical Ltd. (NASDAQ: ICCM) reported Q1 2022 revenues of approximately $0.75 million, a 48% decline from $1.4 million in Q1 2021, primarily due to decreased revenue from distribution agreements and lower sales in Asia amidst COVID restrictions. Gross profit was approximately $0.43 million, with a gross margin of 58%. Operating expenses rose to $4.9 million, resulting in a net loss of $4.4 million ($0.12 per share). Despite these challenges, IceCure saw increased commercial activity and plans to further develop its ProSense® System for breast cancer treatment.
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