CAESAREA, Israel – IceCure Medical Ltd. (NASDAQ:ICCM), specializing in cryoablation treatments, has submitted final data to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for its ProSense® System for early stage T1 invasive breast cancer treatment in combination with adjuvant hormone therapy.
The ProSense® System, which has been granted FDA's Breakthrough Designation, is currently approved in the U.S. for various indications, including benign breast tumors and certain kidney and liver tumors.
The company's submission includes a comprehensive data set from the ICE3 5-year follow-up study, which demonstrated a 96.3% recurrence-free rate in patients treated with ProSense® cryoablation followed by hormone therapy. These results were comparable to the standard lumpectomy followed by hormone therapy, which had a 97.7% recurrence-free rate in the LUMINA study and a 97.19% rate reported by an updated PRISMA meta-analysis.
The ICE3 study, considered the largest controlled multicenter clinical trial for cryoablation of low-risk, early-stage malignant breast tumors, evaluated a minimally invasive outpatient procedure lasting between 20 to 40 minutes. According to the final analysis, the procedure had no significant device-related adverse events, and both patients and physicians reported high satisfaction levels.
At the American Society of Breast Surgeons (ASBrS) 25th Annual Meeting, the data presentation by Dr. Richard Fine won the Scientific Impact Award. Dr. Michael Berry, President-Elect of ASBrS, supported the technology's readiness for broader clinical use.
IceCure's CEO, Eyal Shamir, expressed confidence in the study's groundbreaking nature and its potential for widespread adoption, especially in light of existing reimbursement codes for facility expenses. The company anticipates rapid uptake of the procedure upon FDA approval.
Cryoablation is touted as a cost-effective alternative to traditional surgery due to its minimally invasive nature, eliminating the need for general anesthesia and reducing the risk of re-excision. IceCure has already secured Medicare coverage approval for the cryoablation procedure for breast cancer, with a facility fee reimbursement of approximately $3,400.
The ProSense® Cryoablation System utilizes liquid nitrogen to destroy tumors and is marketed globally for cleared indications. This press release is based on a press release statement.
InvestingPro Insights
As IceCure Medical Ltd. (NASDAQ:ICCM) seeks to expand the indications for its ProSense® System, the financial health and market performance of the company are essential factors for investors to consider. With a market capitalization of $57.16 million, IceCure is a relatively small player in the medical device sector, which could mean higher potential for growth but also increased volatility and risk.
InvestingPro data indicates that IceCure has experienced a significant price uptick of 45.35% over the last six months, showcasing investor optimism which may be influenced by the promising results of the ICE3 study and the subsequent FDA submission. However, with a negative P/E ratio of -3.9, the company is not currently profitable, a common scenario for growth-stage medical technology companies investing heavily in research and development.
According to InvestingPro Tips, analysts expect sales growth in the current year, which could be buoyed by the potential FDA approval and adoption of the ProSense® System for early-stage breast cancer treatment. Despite this anticipated growth, the company is quickly burning through cash and is not expected to be profitable this year, highlighting the importance of efficient capital management for its continued operations.
For investors interested in further insights, there are additional InvestingPro Tips available, which could provide deeper analysis and projections for IceCure Medical Ltd. By using the coupon code PRONEWS24, investors can obtain an additional 10% off a yearly or biyearly Pro and Pro+ subscription, gaining access to a comprehensive suite of tools and data to inform their investment decisions.
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