CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM) announced significant clinical trial results for its ProSense® cryoablation treatment for early-stage low-risk breast cancer. The findings, published in the Annals of Surgical Oncology, indicate a 96.3% recurrence-free rate when combined with endocrine therapy.
The ICE3 trial, deemed the largest U.S. controlled multicenter study for liquid nitrogen-based cryoablation, involved 194 eligible patients who underwent the minimally invasive procedure. The average patient age was 74.9, with tumor sizes ranging from 2.8 to 14.9 mm. After an average follow-up of 54.16 months, the ipsilateral breast tumor recurrence (IBTR) rate stood at 4.3%, with a breast cancer survival rate of 96.7%.
Dr. Richard E. Fine, the lead study author and an ICE3 investigator, highlighted the trial's five-year outcomes, suggesting cryoablation with ProSense® as a safe and effective patient-friendly alternative to lumpectomy, especially when followed by appropriate adjuvant treatment.
Patients and treating physicians reported a 100% satisfaction rate with the cosmetic outcomes, and no serious device-related adverse events were noted. Additionally, a significant improvement in quality-of-life scores was observed six months post-treatment.
IceCure CEO Eyal Shamir expressed optimism for the ProSense® system's potential market adoption pending FDA approval, with the FDA Advisory Panel meeting scheduled for November 7, 2024. Shamir emphasized the role of the ICE3 trial results in supporting the safety and efficacy of ProSense® as an alternative to surgical tumor removal.
The company's cryoablation technology offers a quick, office-based procedure under local anesthesia, boasting minimal pain, scarring, and rapid recovery compared to traditional surgery.
The information is based on a press release statement from IceCure Medical, which develops and markets cryoablation therapy systems for treating benign and cancerous tumors, primarily focusing on breast, kidney, bone, and lung cancers.
In other recent news, IceCure Medical Ltd. has been the focus of several noteworthy developments. The company has reported an 8% year-over-year increase in total revenue for the second quarter of fiscal year 2024, exceeding expectations with earnings of $1.0 million. This growth was primarily driven by a 20% increase in sales of IceCure's ProSense systems and disposable probes, particularly in Europe, the U.S., and Japan.
Furthermore, the U.S. Patent and Trademark Office has granted a Notice of Allowance to IceCure for a continuation application related to its "Cryogen Pump" technology, extending the protection of its technology until 2041. H.C. Wainwright has also adjusted its stock price target for IceCure, reducing it to $2.50 from the previous $3.00, but maintaining a Buy rating.
The company is anticipating a U.S. FDA medical device advisory committee panel meeting to discuss ProSense for the treatment of early-stage low-risk invasive breast cancer. A positive recommendation from the panel could lead to FDA marketing clearance for ProSense as early as 2025. IceCure's partner in Japan, Terumo, also plans to seek regulatory approval for ProSense in Japan for the same indication in the first quarter of 2025. These are the recent developments in IceCure Medical's journey.
InvestingPro Insights
As IceCure Medical Ltd. (NASDAQ:ICCM) continues to make strides in the medical field with its ProSense® cryoablation treatment, the company's financial health and market performance provide additional context for investors. With a market capitalization of $31.59 million and a revenue growth of 3.6% over the last twelve months as of Q2 2024, IceCure shows a modest increase in sales. However, the company's operating income margin during the same period was notably negative at -432.13%, reflecting significant operating costs relative to its revenue.
InvestingPro Tips suggest that while analysts expect sales to grow in the current year, they do not anticipate IceCure will be profitable within the year. This aligns with the company's current price-to-earnings (P/E) ratio of -2.36, which indicates that the company is not generating net income at present. Additionally, IceCure's stock price has experienced volatility, with a 6-month price total return of -46.39%, emphasizing the stock's fluctuating nature in recent times.
Despite the challenges, IceCure holds more cash than debt on its balance sheet, which could offer some financial flexibility as they pursue FDA approval for ProSense®. For detailed analysis and further insights, investors can explore additional InvestingPro Tips available at https://www.investing.com/pro/ICCM, where they will find comprehensive financial metrics and expert commentary.
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