CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM), a company specializing in minimally invasive cryoablation technology, announced that the FDA's Medical Device Advisory Committee Panel is set to convene on November 7, 2024. The panel will review IceCure's ProSense® system for potential authorization as a treatment for early-stage low-risk invasive breast cancer.
The Advisory Panel, composed of breast surgeons, interventional radiologists, and regulatory community representatives, will assess data from IceCure's ICE3 clinical trial. The trial results showed that 96.3% of patients treated with ProSense® cryoablation and adjuvant endocrine therapy were free from local recurrence at the 5-year follow-up. Additionally, the trial reported complete patient and physician satisfaction with the treatment.
ProSense® aims to offer a minimally invasive alternative to traditional surgery by destroying tumors through freezing, which could benefit approximately 70,000 U.S. women diagnosed annually with this cancer type. The technology is designed to reduce recovery time, pain, and surgical risks, and it is already marketed for certain cleared indications in the U.S., Europe, and China.
The company expects the FDA to provide a decision on the marketing clearance of ProSense® by early 2025. IceCure plans to share the live webcast link of the Advisory Panel meeting with its shareholders once it is made available by the FDA.
This press release includes forward-looking statements regarding the benefits of the Advisory Panel, the review process, and the anticipated timeline for FDA clearance. IceCure's ability to achieve these outcomes may be influenced by various factors, including regulatory developments, market acceptance, and intellectual property protection.
The information in this article is based on a press release statement from IceCure Medical.
In other recent news, IceCure Medical Ltd. has experienced a series of significant developments. The company reported an 8% year-over-year increase in total revenue for the second quarter of fiscal year 2024, surpassing projections with earnings of $1.0 million. This growth was largely driven by a 20% increase in sales of IceCure's ProSense systems and disposable probes, particularly in Europe, the U.S., and Japan.
IceCure also announced an expansion of its patent portfolio, with the U.S. Patent and Trademark Office granting a Notice of Allowance for a continuation application related to its "Cryogen Pump" technology. This development enhances IceCure's intellectual property estate and extends the protection of its technology until 2041.
In terms of analyst notes, H.C. Wainwright adjusted its stock price target for IceCure, reducing it to $2.50 from the previous $3.00, but retained a Buy rating. The company also raised $5.035 million in gross proceeds from the sale of ordinary shares in the first half of 2024.
Looking ahead, IceCure expects significant regulatory events, including a U.S. Food and Drug Administration panel meeting in the fourth quarter of 2024 to discuss ProSense for the treatment of early-stage T1 invasive breast cancer. A final decision on the De Novo marketing clearance application for ProSense is anticipated in early 2025. These developments highlight the ongoing progress and potential of IceCure Medical.
InvestingPro Insights
As IceCure Medical Ltd. (NASDAQ:ICCM) prepares for an important FDA Advisory Panel review of its ProSense® system, investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro data, IceCure currently holds a market capitalization of $30.56 million, reflecting the investor sentiment surrounding its innovative cryoablation technology. Despite the challenges, the company has maintained a revenue growth of 3.6% over the last twelve months as of Q2 2024, showcasing its potential in the medical device sector.
InvestingPro Tips reveal that IceCure holds more cash than debt on its balance sheet, which could provide financial flexibility as it seeks FDA clearance for ProSense®. Additionally, analysts anticipate sales growth in the current year, which may be bolstered by positive outcomes from the upcoming FDA panel review and potential market expansion. On the other hand, IceCure has been quickly burning through cash, which underscores the importance of efficient capital management moving forward.
Investors should note that while the stock price has been quite volatile, with a significant hit over the last six months, IceCure has still managed a strong return over the last five years. The company does not pay a dividend to shareholders, which is typical for growth-focused medical technology firms reinvesting earnings into research and development. With more InvestingPro Tips available, those interested can explore additional insights on IceCure's financial metrics and market prospects at https://www.investing.com/pro/ICCM.
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