CESAREA, Israel – IceCure Medical Ltd. Known for developing cryoablation technology, NASDAQ:ICCM presented promising clinical trial results at the 32nd Annual Meeting of the Japan Breast Cancer Society on July 12, 2024. The trials highlighted the effectiveness of the company’s ProSense® system in breast treatment. cancer with minimally invasive procedures.
The symposium, which focused on new techniques in breast surgery, showed a 99.74 percent recurrence-free rate in a study of 389 patients treated with ProSense® from April 2014 to August 2020. These patients had breast tumors up to 15 millimeters in diameter. Professor Eisuke Fukuma, who has performed more than 600 breast cryoablation treatments, presented the findings and highlighted the effectiveness of the procedure and its potential benefits for the immune system.
Additionally, Professor Hisanori Kawamoto discussed an independent study that found no locally recurrent breast cancer or metastases over five years after ProSense® treatment. This study involved 18 early-stage breast cancer patients and reported no serious side effects, and improved patient satisfaction and quality of life after treatment.
The conference highlighted the growing interest in minimally invasive breast cancer treatments among the 3,500 attendees. Symposium chairman Professor Takayuki Kinoshita stated that cryoablation could become an alternative to open surgery in Japan pending approval by the Medicines and Medical Devices Agency (PMDA).
IceCure CEO Eyal Shamir expressed optimism about the Japanese market and highlighted the partnership with Terumo Corporation, Japan’s largest medical device manufacturer. Terumo is expected to seek regulatory approval for ProSense® for the treatment of breast cancer in Japan in the first quarter of 2025, with the goal of making the cryoablation system more widely available to healthcare providers and patients.
The ProSense® Cryoablation System freezes tumors using liquid nitrogen and provides a non-surgical option for destroying benign and cancerous lesions in various organs, including the breast, kidney, lung and liver. IceCure Medical markets the ProSense® System worldwide and has approvals for approved indications in the United States, Europe and China.
In other recent news, IceCure Medical has made significant advances in the medical field. The US Food and Drug Administration (FDA) plans to convene a Medical Devices Advisory Committee meeting to review IceCure’s ProSense® System, a minimally invasive technology for the treatment of early-stage breast cancer. The panel’s review is expected to take place in the last quarter of 2024, and the FDA is expected to make a decision on marketing authorization in early 2025.
Financially, IceCure reported a 30 percent increase in 2024 product revenue in the first quarter to $743,000. Despite this growth, the company’s net loss was $3.6 million in the quarter. However, IceCure maintains a strong cash position with $11 million in reserves.
In addition, IceCure has submitted the final results of the ICE3 study to the FDA as part of its marketing authorization application for De Novo classification. Data from the ICE3 trial showed high patient satisfaction and an estimated local recurrence-free rate of 96.3% with ProSense® followed by hormone therapy. These are some of the recent achievements of IceCure, a company specializing in cryoablation treatments for benign and cancerous tumors.
Insights from InvestingPro
Although IceCure Medical Ltd. (NASDAQ:ICCM) is gaining attention for its innovative cryoablation technology, so it’s important to look at the company’s financial health and market performance. According to InvestingPro, IceCure Medical has a market capitalization of $35.78 million, reflecting the market’s current valuation. Despite the promising clinical results, analysts have noted that the company is not expected to be profitable this year, with a reported operating profit margin of -468.09% for the trailing twelve months to Q1 2024. This indicates significant operating costs compared to the company’s income.
InvestingPro Tips suggests that while IceCure Medical’s revenue will grow by 7.02% over the trailing 12 months from Q1 2024, the company is also burning cash quickly. This financial metric is crucial for investors, especially when assessing the company’s long-term sustainability and possible need for additional capital. Additionally, the share price has experienced significant volatility, down 38.82% over the past three months, which may be of interest to investors looking for potential income points or considering the risks of such fluctuations.
For those interested in a deeper analysis, InvestingPro offers additional tips on IceCure Medical, available at https://www.investing.com/pro/ICCM. You can enhance your investment research experience by using a coupon code NEWS 24 Apply to get up to 10% off a Pro annual subscription and a Pro+ annual or semi-annual subscription. A total of 11 other InvestingPro tips are available for IceCure Medical, which provide a comprehensive picture of the company’s financial situation and market development.
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