CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM), known for its cryoablation technology that treats tumors by freezing, announced a study published in the American Journal of Roentgenology, which suggests cryoablation is a safe and effective treatment for breast cancer patients who are not candidates for surgery. The independent multi-institutional study, led by Dr. Karim Oueidat and Dr. Robert Ward of the Warren Alpert Medical School of Brown University, involved 112 patients treated at seven U.S. institutions. It found recurrence-free rates of 94.7%, 87.8%, and 81.8% at one, two, and three years respectively.
The research included patients with metastatic disease, large tumors, and comorbidities, who were generally ineligible for clinical trials. IceCure's own ICE3 study had previously focused on early-stage breast cancer patients. The independent study's participants, with a median age of 71, underwent cryoablation using various systems including IceCure's ProSense®. A high technical success rate of 98.2% was observed, with a low incidence of minor adverse events and no moderate or major events reported. The study emphasized the procedure's safety and efficacy, particularly for those who are poor surgical candidates.
IceCure's CEO, Eyal Shamir, commented on the findings, highlighting the potential of ProSense® to provide non-surgical treatment options for a broader range of patients. The company's ProSense® system uses liquid nitrogen for tumor destruction and is marketed globally for approved indications, including in the U.S., Europe, and China.
The study's publication follows IceCure's regulatory submission for U.S. approval of ProSense® for treating early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. The research reflects a significant step in expanding treatment options for patients with limited access to conventional surgical methods. This information is based on a press release statement by IceCure Medical.
In other recent news, IceCure Medical Ltd. has been making significant strides in the medical field. The company reported a 30% increase in Q1 product sales for 2024, reaching $743,000, despite recording a net loss of $3.6 million for the quarter. IceCure maintains a strong cash position with $11 million in reserves. The company has presented promising clinical study results at the 32nd Annual Meeting of the Japanese Breast Cancer Society, indicating a 99.74% recurrence-free rate in a study involving patients treated with ProSense®.
Furthermore, an independent study discussed at the symposium reported zero cases of local breast cancer recurrence or distant metastasis over a five-year period following treatment with ProSense®. These recent developments highlight the potential of IceCure's cryoablation system as a minimally invasive alternative to traditional surgery.
The U.S. Food and Drug Administration (FDA) is set to review IceCure's ProSense® System, a technology for the treatment of early-stage breast cancer, in the fourth quarter of 2024. Lastly, IceCure's partnership with Terumo Corporation is expected to file for regulatory approval of ProSense® for breast cancer treatment in Japan in the first quarter of 2025.
InvestingPro Insights
IceCure Medical Ltd. (NASDAQ:ICCM) is making strides with its innovative cryoablation technology, and the latest study published in the American Journal of Roentgenology adds to the company's credibility in providing effective non-surgical treatment options for breast cancer patients. As IceCure continues to grow and seek further regulatory approvals, the company's financial health and stock performance are key areas of interest for investors.
According to InvestingPro data, IceCure Medical holds a market capitalization of $29.48 million, which reflects its size within the biotechnology and medical device sector. Despite facing challenges, such as a negative P/E ratio of -2.42 and an adjusted P/E ratio for the last twelve months as of Q1 2024 of -2.03, IceCure's revenue has shown growth. The company's revenue growth for the last twelve months as of Q1 2024 stands at 7.02%, with a quarterly increase of 4.65% in Q1 2024. This growth trajectory is supported by analysts who anticipate sales growth in the current year, as per one of the InvestingPro Tips.
However, it's important to note that the company is not currently profitable, with an operating income margin of -468.09% for the last twelve months as of Q1 2024. This aligns with another InvestingPro Tip which indicates that IceCure is quickly burning through cash, a factor that investors should consider. Moreover, the stock has experienced significant volatility, with a 6-month price total return of -55.43% and a 3-month return of -49.17% as of the date provided.
InvestingPro Tips also highlight that IceCure holds more cash than debt on its balance sheet and has liquid assets that exceed short-term obligations, which may provide some financial stability amidst the stock's recent downturns. For investors seeking more in-depth analysis, there are additional InvestingPro Tips available, which can offer further insights into IceCure's financial health and stock performance.
For those interested in exploring these metrics and tips in more detail, InvestingPro offers a comprehensive set of tools and analyses to support investment decisions. Visit the InvestingPro platform for a full list of tips and data on IceCure Medical Ltd. (https://www.investing.com/pro/ICCM).
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