CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM), an Israel-based medical device company specializing in cryoablation technology, has been granted a Notice of Allowance by the U.S. Patent and Trademark Office for a continuation application related to its "Cryogen Pump" technology. This development, announced on Wednesday, enhances IceCure's intellectual property (IP) estate, with its patents now spanning multiple global jurisdictions including Europe and Japan.
The continuation patent, which extends the protection of IceCure's technology until 2041, is part of the company's strategy to expand the range of medical procedures that can be performed using its platform. IceCure's cryoablation systems, including the ProSense® system, are designed to freeze and destroy tumors as an alternative to traditional surgical removal. The technology is currently used for treating various types of cancer, such as those found in the breast, kidney, bone, and lung.
IceCure's latest cryogenic pump is notable for its submersible design in liquid nitrogen and its ability to operate in a closed circuit, enhancing the cooling rate during cryoablation procedures. It also facilitates the use of diverse cryoprobes and catheters, allowing for multiple or extended-duration procedures without the need to replenish liquid nitrogen. This pump is integrated into IceCure's XSense™ cryoablation system.
CEO Eyal Shamir commented on the potential of the new patent to increase the number of indications and applications for IceCure's cryoablation systems. Additionally, the company is awaiting a decision from the U.S. Food and Drug Administration on clearance for treating early-stage breast cancer, expected in early 2025.
The press release also contained forward-looking statements regarding the company's leadership in cryoablation technologies and its potential market expansion. However, it noted that past scientific research and clinical trials do not guarantee future results.
This latest patent allowance is a significant step for IceCure as it continues to solidify its position in the cryoablation market. The company's technology offers a minimally invasive option for tumor treatment, which is marketed and sold globally in approved regions, including the U.S., Europe, and China.
The information on this development is based on a press release statement from IceCure Medical.
In other recent news, IceCure Medical has reported notable growth in its second quarter financial results for fiscal year 2024, with a total revenue of $1.0 million, an 8% increase year-over-year, surpassing the projected $0.9 million. This growth was largely driven by a 20% increase in sales of its ProSense systems and disposable probes, especially in Europe, the U.S., and Japan. Despite a net loss of $3.1 million, this figure was less than the anticipated loss of $3.6 million.
H.C. Wainwright has adjusted its stock price target for the company, reducing it to $2.50 from the previous $3.00, but retained a Buy rating. In addition, IceCure Medical raised $5.035 million in gross proceeds from the sale of ordinary shares in the first half of 2024.
Looking ahead, the company's management is anticipating an FDA medical device advisory committee panel meeting in the fourth quarter of 2024 to discuss ProSense for the treatment of early-stage T1 invasive breast cancer. The FDA's final decision on the De Novo marketing clearance application for ProSense is expected in early 2025.
Moreover, IceCure Medical is preparing to present interim data from its ICESECRET study, which investigates the use of ProSense in treating kidney cancer, by December 2024. Terumo, IceCure's partner in Japan, also plans to seek regulatory approval for ProSense for the treatment of early-stage low-risk breast cancer with endocrine therapy in Japan in the first quarter of 2025. These are among the recent developments that investors may find noteworthy.
InvestingPro Insights
As IceCure Medical Ltd. (NASDAQ:ICCM) fortifies its intellectual property with the recent patent allowance for its cryogen pump technology, the company's financial metrics and stock performance provide additional context for investors considering the potential of this medical device innovator. According to InvestingPro, IceCure holds a market capitalization of $34.17 million, reflecting its position in the market relative to peers.
Despite the optimism surrounding its technology, IceCure's financial health shows signs of challenge. The company is not profitable over the last twelve months, with an adjusted operating income of -$14.42 million and a negative return on assets of -71.93%. This may raise concerns about the company's financial stability and its ability to sustain operations without additional funding. Nonetheless, IceCure's gross profit margin stands at 40.32%, indicating a solid performance in generating profit from sales before overhead costs are considered.
InvestingPro Tips highlight that IceCure has more liquid assets than short-term obligations, suggesting the company is well-positioned to cover immediate liabilities. Additionally, analysts anticipate sales growth in the current year, which could signal improving prospects for the company's financial performance. However, with a P/E ratio of -2.36 and an adjusted P/E ratio for the last twelve months as of Q2 2024 at -2.5, investors may exercise caution due to the company's current lack of profitability.
For those interested in a deeper analysis, InvestingPro offers additional InvestingPro Tips, providing a comprehensive picture of IceCure Medical's market potential and investment outlook.
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