CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM), an Israel-based medical device company, announced today that it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its XSense Cryoablation System with CryoProbes. The system, which is a next-generation single probe cryoablation technology, is designed to destroy tumors by freezing without the need for surgical removal.
The XSense system has been cleared for the same medical uses as IceCure's existing ProSense system, which includes a range of minimally invasive procedures across various specialties such as general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The technology is particularly applied to the treatment of fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions, and warts.
Eyal Shamir, CEO of IceCure, remarked on the FDA's clearance, stating that it validates the safety and efficacy of the company's platform technology. IceCure's cryoablation systems, which use liquid nitrogen, offer a minimally invasive treatment alternative that can benefit patients, healthcare providers, and payors by reducing recovery time, pain, and surgical risks.
The ProSense and XSense systems are marketed by IceCure as providing a convenient and transportable option for office-based procedures, especially for breast tumors. The company's technology focuses on the treatment of benign and cancerous tumors, with a primary emphasis on breast, kidney, bone, and lung cancers.
IceCure's press release also contained forward-looking statements about the potential of the XSense system to address other significant indications with unmet needs in the U.S. However, it is important to note that such statements are speculative and based on the company's expectations.
The FDA's marketing authorization is a regulatory milestone for IceCure, allowing the company to expand its product offerings in the U.S. market. The information reported is based on a press release statement from IceCure Medical.
In other recent news, IceCure Medical's ProSense® System, a minimally invasive cryoablation technology for early-stage breast cancer treatment, is set for review by a Medical Device Advisory Committee panel convened by the U.S. Food and Drug Administration (FDA).
The panel, comprised of independent experts, will assess the scientific and technical merits of ProSense®. The ICE3 study data, demonstrating a 96.3% estimated 5-year local recurrence-free rate for patients treated with ProSense® followed by hormone therapy, will be presented.
Furthermore, IceCure has reported a 30% increase in product sales for the first quarter of 2024, totaling $743,000, despite a net loss of $3.6 million. The company, however, maintains a robust cash position with $11 million in reserves.
These developments come as the company awaits the FDA's decision on ProSense®'s marketing clearance, anticipated by early 2025. ProSense®, already approved in various countries, utilizes liquid nitrogen to freeze and destroy tumors. The company has submitted the final ICE3 study results to the FDA for marketing authorization for treating early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.
InvestingPro Insights
Following the recent FDA marketing authorization for IceCure Medical Ltd.'s (NASDAQ:ICCM) XSense Cryoablation System, the company's financial health and market performance provide additional context for investors considering the stock.
IceCure's market capitalization currently stands at a modest $35.48 million, reflecting its position as a smaller player in the medical device sector. Notably, the company's revenue has seen a growth of 7.02% over the last twelve months as of Q1 2024, indicating a positive trajectory in sales.
Despite this, IceCure has faced challenges, as evidenced by its negative price-to-earnings (P/E) ratio of -2.44, suggesting that the company is not currently profitable. The adjusted P/E ratio for the same period remains consistent at -2.45. Moreover, the stock has experienced significant volatility, with a 30.84% decline in its price total return over the last month and a 42.64% drop over the last three months.
InvestingPro Tips highlight a few key points for potential investors. IceCure holds more cash than debt, which is generally a positive sign of financial stability. Moreover, analysts anticipate sales growth in the current year, aligning with the noted revenue growth. Still, the company is quickly burning through cash and has not been profitable over the last twelve months, which may raise concerns about its long-term financial sustainability.
For those looking to delve deeper into IceCure's financials and market performance, InvestingPro offers a comprehensive analysis with additional InvestingPro Tips. There are currently 11 more tips available on IceCure's profile at InvestingPro, providing a more detailed investment outlook. Interested readers can use coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription, offering a valuable resource for informed investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.