CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM), a medical device company specializing in cryoablation technology, has announced the submission of a 510(k) application to the U.S. Food and Drug Administration (FDA) for its new XSense™ System and cryoprobes.
The technology aims to provide minimally invasive treatment options for tumor destruction, leveraging the company's existing FDA-cleared ProSense® System indications, which include applications for the kidney, liver, fibroadenomas, and neurology.
The XSense™ System represents IceCure's latest innovation in single probe cryoablation, a process that destroys tumors by freezing them with liquid nitrogen. This method is considered an alternative to traditional surgical tumor removal. According to IceCure CEO Eyal Shamir, the company is building on the global market traction of its ProSense® system by continuing to develop both single and multi-probe cryoablation technologies.
The ProSense® Cryoablation System is currently marketed and sold in various regions, including the U.S., Europe, and China, for the treatment of benign and cancerous lesions. It is designed to offer a safe and effective alternative to more invasive surgical procedures, with the added benefits of reducing recovery time, pain, and surgical risks.
This latest submission is processed separately from the company's De Novo application for breast cancer indications. IceCure's press release also includes forward-looking statements regarding its position as a leader in the field of liquid nitrogen-based cryoablation technologies and its continued technological development.
The company's statements in the press release are forward-looking and involve known and unknown risks, which could cause actual results to differ materially from those anticipated. These risks and uncertainties are detailed in the company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission.
The information in this article is based on a press release statement from IceCure Medical.
InvestingPro Insights
IceCure Medical Ltd. (NASDAQ:ICCM), in its pursuit of advancing cryoablation technologies, has shown a significant price uptick over the last six months, with a 50.86% total return. This positive momentum is further underscored by a recent 9.32% return over the last week, reflecting investor confidence in the company's strategic moves, including the recent 510(k) application submission to the FDA for its XSense™ System.
Despite a challenging revenue landscape in the last twelve months as of Q3 2023, where the company experienced a revenue decline of 17.48%, analysts are optimistic about sales growth in the current year.
This outlook may be buoyed by the market's reception of IceCure's existing ProSense® System and the potential of its new XSense™ technology. The company's market capitalization stands at 58.99M USD, with a notable gross profit margin of 40.92%, suggesting a strong ability to convert sales into profit.
InvestingPro Tips highlight that IceCure holds more cash than debt, which is a positive sign for financial stability. Additionally, the company's liquid assets exceed its short-term obligations, providing a cushion for operational flexibility. However, it is important to note that IceCure is not currently profitable and analysts do not anticipate profitability this year.
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