IceCure Announces FDA Advisory Panel Meeting Date for Marketing Authorization of ProSense® in Early-Stage Low Risk Breast Cancer Scheduled for November 7, 2024
Rhea-AI Summary
IceCure Medical (Nasdaq: ICCM) announced that the FDA's Medical Device Advisory Committee Panel will meet on November 7, 2024, to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for early-stage low risk breast cancer. This public forum will review data, including results from the ICE3 study, which showed a 96.3% recurrence-free rate at 5 years for patients treated with ProSense® and adjuvant endocrine therapy. The FDA is expected to make a decision on marketing authorization by early 2025. ProSense® could potentially benefit an estimated 70,000 women diagnosed annually in the U.S. with this condition.
Positive
- ProSense® cryoablation shows potential as a minimally invasive alternative to lumpectomy
- ICE3 study results indicate 96.3% of patients were recurrence-free at 5-year follow-up
- 100% patient and physician satisfaction reported in the study
- Potential market of 70,000 women diagnosed annually in the U.S. with early-stage low risk breast cancer
- FDA decision on marketing authorization expected by early 2025
Negative
- FDA approval is still pending and not guaranteed
- Potential competition from existing surgical treatments
News Market Reaction – ICCM
In the trading session that priced this news, ICCM gained 2.09%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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- Public forum to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for an estimated 70,000 women diagnosed in
U.S. annually with early-stage low risk breast cancer - FDA decision regarding marketing authorization of ProSense® expected by early 2025
"This public forum transparency ensures key stakeholders, including women with early-stage low risk breast cancer, their doctors and payors, can exchange views and data regarding the potential benefits of minimally invasive cryoablation with ProSense® as an alternative to surgery," stated IceCure's CEO, Eyal Shamir. "Following the Advisory Panel, we anticipate that the FDA will make a decision regarding marketing clearance of ProSense® by early 2025."
The Advisory Panel will include breast surgeons, interventional radiologists and industry representatives from the regulatory community. The vast body of data available on ProSense® as a treatment for early-stage low risk breast cancer will be reviewed by the Advisory Panel, including results from the Company's ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up evaluation,
The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before the meeting, at which time IceCure intends to share the link with shareholders via a press release.
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: the upcoming Advisory Panel; the benefits of the Advisory Panel to all stakeholders; the expected timeline and procedure of the Advisory Panel and FDA review process; and that the decision regarding marketing clearance of ProSense® is expected by early 2025. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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