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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) 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.
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