CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM), a company specializing in cryoablation technology for tumor treatment, announced findings from an independent study published in the peer-reviewed journal Cancers. The study, conducted at University Hospital Frankfurt, Germany, evaluated the safety and efficacy of IceCure's ProSense® system, a liquid nitrogen-based cryoablation treatment for breast cancer.
The research, led by Professor Thomas J. Vogl, involved 45 patients with breast cancer, including cases with recurrent and metastatic disease. The study reported a 100% initial complete ablation rate and no complications across 56 tumor ablations. Moreover, the study noted a low local tumor progression rate of 8.9%.
Cryoablation with ProSense® is a minimally invasive procedure that freezes and destroys tumors, offering benefits such as outpatient treatment, accelerated recovery, and reduced surgical risks. The system is currently approved in Europe for general breast cancer treatment and is marketed globally for various benign and cancerous lesions.
The patient demographic in the European study differed from that of IceCure's U.S.-based ICE3 study, which focused on early-stage breast cancer patients with smaller tumors. Despite the higher risk profile of the European study's patient population, which included individuals with metastatic disease and larger tumors, the results highlighted the potential of cryoablation as a treatment across a broader range of breast cancer diagnoses.
IceCure CEO Eyal Shamir expressed gratitude to Professor Vogl and his team for their work and emphasized the value of the study's findings for ProSense® users, particularly in Europe. The study received no financial support from IceCure, ensuring its independence.
IceCure Medical develops and markets cryoablation therapy systems that serve as an alternative to traditional surgical tumor removal. The company's flagship product, ProSense®, is part of a growing field of treatments aimed at improving patient outcomes and reducing healthcare costs.
The information is based on a press release statement from IceCure Medical.
In other recent news, IceCure Medical has been making significant strides in the healthcare sector. The U.S. Food and Drug Administration (FDA) is preparing to convene a Medical Device Advisory Committee panel to review IceCure's ProSense® System, a minimally invasive cryoablation technology for early-stage breast cancer treatment. This panel discussion is anticipated to occur in the fourth quarter of 2024, with the FDA's decision on marketing clearance expected by early 2025.
Parallel to this, IceCure reported a 30% increase in product sales in the first quarter of 2024, reaching $743,000. Despite this, the company recorded a net loss of $3.6 million for the quarter, but it maintains a strong cash position with $11 million in reserves. Analysts are closely watching these developments and the company's ongoing discussions with the FDA regarding the data submission.
IceCure's ICE3 study data, which will be presented to the panel, has shown promising results, demonstrating a 96.3% estimated 5-year local recurrence-free rate for patients treated with ProSense® followed by hormone therapy.
The ProSense® system, which uses liquid nitrogen to freeze and destroy tumors, is already approved in various countries and is awaiting FDA approval in the U.S. These recent developments highlight IceCure's commitment to advancing minimally invasive treatment options for cancer patients.
InvestingPro Insights
As IceCure Medical Ltd. (NASDAQ:ICCM) makes strides in the medical field with its ProSense® cryoablation technology, investors are closely monitoring the company's financial health and market performance. According to the latest data from InvestingPro, IceCure Medical holds a market capitalization of 35.86M USD, which reflects the current market value of its outstanding shares.
Despite the promising results of the independent study and the potential of ProSense® in treating a broad range of breast cancer diagnoses, InvestingPro Tips indicate that analysts are cautious about the company's profitability in the short term. They do not anticipate IceCure will be profitable this year, and the company has been quickly burning through cash. This is a critical consideration for investors, as sustained cash burn could impact the company's ability to fund ongoing operations and growth initiatives.
In terms of financial metrics, IceCure's price-to-earnings (P/E) ratio stands at -2.44, with an adjusted P/E ratio for the last twelve months as of Q1 2024 at -2.47. This negative P/E ratio is indicative of the company not generating net income currently. Moreover, the company's revenue growth for the last twelve months as of Q1 2024 was reported at 7.02%, showing a moderate increase in sales.
For those interested in a deeper analysis, there are an additional 10 InvestingPro Tips available for IceCure Medical, which can be accessed by visiting https://www.investing.com/pro/ICCM. These tips provide a comprehensive view of the company's financial status, stock performance, and market outlook. 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 at InvestingPro.
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