CAESAREA, Israel - The U.S. Food and Drug Administration (FDA) is set to convene a Medical Device Advisory Committee panel meeting to review IceCure Medical Ltd.'s ProSense® System, a minimally invasive cryoablation technology designed for the treatment of early-stage breast cancer. The panel, consisting of independent experts, will assess the scientific and technical merits of ProSense® and provide guidance to the FDA.
IceCure's CEO, Eyal Shamir, expressed approval of the FDA's decision, emphasizing the public health significance of offering a less invasive treatment option compared to traditional surgery.
The ICE3 study data, which will be presented to the panel, has shown promising results, including a high patient satisfaction rate and a 96.3% estimated 5-year local recurrence-free rate for patients treated with ProSense® followed by hormone therapy.
The Advisory Panel is anticipated to take place in the fourth quarter of 2024, with the FDA's decision on ProSense®'s marketing clearance expected by early 2025. The exact date for the panel will be announced in the coming weeks.
ProSense® utilizes liquid nitrogen to freeze and destroy tumors and is already approved in various European countries, Brazil, India, and China. IceCure has submitted the final ICE3 study results to the FDA as part of its De Novo Classification Request for Marketing Authorization for the indication of treating early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.
IceCure Medical, listed on Nasdaq (NASDAQ: ICCM), specializes in cryoablation therapy for benign and cancerous tumors, with a focus on breast, kidney, bone, and lung cancers. The ProSense® system offers a shorter procedure time and may reduce recovery periods, pain, surgical risks, and complications.
This news is based on a press release statement from IceCure Medical. The company's forward-looking statements are subject to various factors that could cause actual results to differ materially, including regulatory developments, market conditions, and the ability to maintain key relationships and intellectual property. IceCure does not undertake any obligation to update these statements following the date of the press release.
InvestingPro Insights
As IceCure Medical Ltd. (NASDAQ: ICCM) prepares for the FDA panel review of its ProSense® System, investors and stakeholders may find it valuable to consider the company's financial health and market performance. With a market capitalization of 48.02 million USD and a price-to-book ratio over the last twelve months as of Q1 2024 standing at 4.13, IceCure presents an interesting profile in the medical device sector.
InvestingPro Tips for ICCM highlight that the company holds more cash than debt on its balance sheet and has liquid assets that exceed short-term obligations, which may provide financial flexibility as it navigates the regulatory process. Additionally, analysts anticipate sales growth in the current year, which could be a positive sign for the company's future revenue streams.
On the other hand, it is important to note that IceCure is not expected to be profitable this year and has not been profitable over the last twelve months. The company is also quickly burning through cash, which could be a point of concern for potential investors. Despite these challenges, IceCure has demonstrated a strong return over the last five and ten years, which may interest long-term investors.
Investors looking for a deeper analysis can find additional InvestingPro Tips on IceCure Medical, with a total of 9 tips available at https://www.investing.com/pro/ICCM. To gain access to these insights, users can utilize the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.