CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM), known for its development of cryoablation technology, has presented promising clinical study results at the 32nd Annual Meeting of the Japanese Breast Cancer Society held on July 12, 2024. The studies highlighted the effectiveness of the company's ProSense® system in treating breast cancer with minimally invasive procedures.
The symposium, focusing on new techniques in breast surgery, showcased data indicating a 99.74% recurrence-free rate in a study involving 389 patients treated with ProSense® from April 2014 to August 2020. These patients had breast tumors no larger than 15 millimeters in diameter. Professor Eisuke Fukuma, who has conducted over 600 breast cryoablation procedures, presented the findings, noting the procedure's efficacy and potential benefits to the immune system.
Additionally, Professor Hisanori Kawamoto discussed an independent study with zero cases of local breast cancer recurrence or distant metastasis over a five-year period, following treatment with ProSense®. This study included 18 early-stage breast cancer patients and reported no serious adverse events, with patients experiencing improved satisfaction and quality of life post-treatment.
The conference underscored the growing interest in minimally invasive breast cancer treatments among the 3,500 attendees. Symposium Chair Professor Takayuki Kinoshita remarked on the potential of cryoablation to become an alternative to open surgery in Japan, pending approval from the Pharmaceuticals and Medical Devices Agency (PMDA).
IceCure CEO Eyal Shamir expressed optimism about the Japanese market, highlighting the partnership with Terumo Corporation, Japan's largest medical device company. Terumo is expected to file for regulatory approval of ProSense® for breast cancer treatment in Japan in the first quarter of 2025, aiming to make the cryoablation system more widely available to healthcare providers and patients.
ProSense® Cryoablation System operates by freezing tumors using liquid nitrogen, providing 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 globally, with approvals in the U.S., Europe, and China for cleared indications.
In other recent news, IceCure Medical has been making significant strides in the medical field. The U.S. Food and Drug Administration (FDA) is set to convene a Medical Device Advisory Committee panel meeting to review IceCure's ProSense® System, a minimally invasive technology for the treatment of early-stage breast cancer. The panel review is expected to occur in the fourth quarter of 2024, with an FDA decision on marketing clearance anticipated by early 2025.
In financial developments, IceCure reported a 30% increase in Q1 product sales for 2024, reaching $743,000. Despite this increase, the company recorded a net loss of $3.6 million for the quarter. However, IceCure maintains a strong cash position with $11 million in reserves.
Further, IceCure has submitted the final ICE3 study results to the FDA as part of its De Novo Classification Request for Marketing Authorization. The ICE3 study data demonstrated a high patient satisfaction rate and a 96.3% estimated 5-year local recurrence-free rate for patients treated with ProSense® followed by hormone therapy. These are among the recent developments for IceCure, a company specializing in cryoablation treatments for benign and cancerous tumors.
InvestingPro Insights
As IceCure Medical Ltd. (NASDAQ:ICCM) gains attention for its innovative cryoablation technology, it is essential to consider the company's financial health and market performance. According to InvestingPro, IceCure Medical holds a market capitalization of $35.78 million USD, reflecting its current valuation in the market. Despite the promising clinical results, analysts have noted that the company is not expected to be profitable this year, which aligns with the reported operating income margin of -468.09% for the last twelve months as of Q1 2024. This indicates significant operational costs relative to the company's revenue.
InvestingPro Tips suggest that while IceCure Medical is experiencing revenue growth, with a 7.02% increase over the last twelve months as of Q1 2024, it is also quickly burning through cash. This financial metric is critical for investors to consider, especially when evaluating the company's long-term sustainability and potential need for additional capital. Moreover, the stock price has seen considerable volatility, with a 38.82% decline over the past three months, which may be of interest to investors looking for potential entry points or considering the risks associated with such fluctuations.
For those interested in a deeper analysis, InvestingPro offers additional tips on IceCure Medical, which can be accessed at https://www.investing.com/pro/ICCM. To enhance your investment research experience, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. In total, there are 11 additional InvestingPro Tips available for IceCure Medical, providing a comprehensive view of the company's financials and market performance.
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