Icecure Medical Ltd. Stock Price, News & Analysis

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.