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

Insights

Medical Device Regulatory Expert

The FDA's decision to schedule an Advisory Panel meeting for IceCure's ProSense® is a significant milestone in the regulatory process. This indicates that the FDA sees potential in the technology but requires additional expert input before making a final decision. The November 7, 2024 date gives IceCure ample time to prepare a robust presentation of their clinical data.

The focus on early-stage low risk breast cancer patients aligns with the growing trend towards less invasive treatments. If approved, ProSense® could potentially address an estimated market of 70,000 patients annually in the U.S. alone. The anticipated FDA decision by early 2025 provides a clear timeline for investors to monitor.

However, it's important to note that Advisory Panel recommendations are non-binding. While positive feedback would be encouraging, it doesn't guarantee FDA approval. Investors should closely watch for the panel's specific concerns and recommendations, as these could impact the final FDA decision and potential market adoption.

Oncology Specialist

The potential approval of ProSense® cryoablation for early-stage low risk breast cancer could represent a paradigm shift in treatment options. The reported 96.3% freedom from local recurrence at 5 years is promising, especially when combined with adjuvant endocrine therapy. This approach could offer a less invasive alternative to lumpectomy, potentially reducing surgical complications and improving cosmetic outcomes.

The 100% patient and physician satisfaction reported is remarkable, suggesting excellent tolerability and acceptance of the procedure. However, it's important to note that long-term data beyond 5 years will be important to fully establish the efficacy and safety profile of cryoablation compared to standard surgical approaches.

If approved, ProSense® could particularly benefit patients who are poor surgical candidates or those seeking to avoid surgery. However, careful patient selection criteria will be essential to ensure optimal outcomes and prevent undertreatment of more aggressive tumors.

Healthcare Market Analyst

The potential market for ProSense® in early-stage low risk breast cancer is substantial, with an estimated 70,000 eligible patients annually in the U.S. This represents a significant opportunity for IceCure Medical to capture market share in the breast cancer treatment space. If approved, ProSense® could disrupt the current standard of care, potentially impacting surgical device manufacturers and hospitals' revenue streams from breast cancer surgeries.

Investor focus should be on the reimbursement landscape for this new technology. Positive Advisory Panel feedback could pave the way for favorable insurance coverage decisions, which is important for widespread adoption. The 100% patient and physician satisfaction reported suggests strong potential for market penetration if approved.

However, investors should also consider the potential competition from other minimally invasive technologies in development. The outcome of this Advisory Panel meeting could set a precedent for similar technologies, potentially opening up or limiting the market for non-surgical breast cancer treatments.

• 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

CAESAREA, Israel, Sept. 12, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") is scheduled to take place on Thursday, November 7, 2024. The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense® for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.

"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, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by adjuvant endocrine therapy, were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported. The Advisory Panel is expected to make its recommendations at the conclusion of the meeting, at which time the FDA will commence its review process.

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 U.S., Europe, and China.

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 the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 3, 2024, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462

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SOURCE IceCure Medical

FAQ

When is the FDA Advisory Panel meeting for IceCure's ProSense® (ICCM) scheduled?

The FDA Advisory Panel meeting for IceCure's ProSense® (ICCM) is scheduled for November 7, 2024.

What is the purpose of IceCure's ProSense® cryoablation system (ICCM)?

ProSense® is designed to treat early-stage low risk invasive breast cancer using cryoablation as a minimally invasive alternative to lumpectomy.

What were the key results from IceCure's ICE3 study for ProSense® (ICCM)?

The ICE3 study showed that 96.3% of patients treated with ProSense® cryoablation and adjuvant endocrine therapy were estimated to be free from local recurrence at the 5-year follow-up, with 100% patient and physician satisfaction reported.

When does IceCure (ICCM) expect the FDA to make a decision on ProSense® marketing authorization?

IceCure expects the FDA to make a decision regarding marketing authorization of ProSense® by early 2025.