Upcoming FDA Advisory Panel for IceCure's ProSense® Marketing Authorization Receives Large Number of Public Comments from Stakeholders

Rhea-AI Summary

IceCure Medical (NASDAQ: ICCM) announced significant stakeholder engagement ahead of the FDA Medical Device Advisory Committee Panel scheduled for November 7, 2024. The panel will evaluate the marketing authorization of ProSense® cryoablation system for treating early-stage low risk breast cancer. The Advisory Panel will include breast surgeons, interventional radiologists, and industry experts who will provide recommendations on the benefit-risk profile of ProSense®, a minimally-invasive technology that destroys tumors by freezing as an alternative to surgical removal. Public comments from doctors, nurses, researchers, and breast cancer patients are available on the FDA website, with the FDA's final decision expected by early 2025.

Positive

• FDA Advisory Panel review indicates progress in regulatory pathway
• Strong stakeholder engagement demonstrated through numerous public comments
• Potential market expansion into early-stage breast cancer treatment

Negative

• Final FDA approval still pending and uncertain
• Marketing authorization depends on Advisory Panel recommendations

• Comments from key stakeholders, including doctors, nurses, researchers, and breast cancer patients, are available on FDA website
• FDA Advisory Panel providing recommendations and vote on information concerning the benefit-risk profile for a De Novo marketing submission of the IceCure ProSense^® Cryoablation System in early-stage low risk breast cancer scheduled for November 7, 2024

CAESAREA, Israel, Oct. 29, 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 that a large number of public comments have been posted from key stakeholders ahead of the U.S. Food and Drug Administration (the 'FDA') Medical Device Advisory Committee Panel (the 'Advisory Panel') for marketing authorization of ProSense^® cryoablation in early-stage low risk breast cancer, which 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 potential granting of marketing authorization of ProSense^® for treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The Advisory Panel will include breast surgeons, interventional radiologists, industry representatives from the regulatory community, and other experts.

The Advisory Panel's Public Docket for ProSense^®, which is publicly available here: https://www.regulations.gov/docket/FDA-2024-N-4057 provides details and comments made by stakeholders including breast cancer patients oncologists, surgeons, radiologists, nurses, researchers, other experts, and those expressing they wished ProSense^® had been available for their loved one. A live webcast of the Advisory Panel meeting is available to the public at the following HYPERLINK: https://www.youtube.com/watch?v=PMS5dJRtLIo

"We are highly encouraged by the large number of comments received for the Advisory Panel's consideration regarding the role of ProSense^® as a minimally-invasive treatment option for early-stage low risk breast cancer patients. Key stakeholders, including breast cancer patients, have shared their first-hand experience with ProSense^®," stated IceCure's CEO, Eyal Shamir. "We look forward to the public forum on November 7, along with the Advisory Panel's vote, which the FDA will consider in making its decision, expected by early 2025."  

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 advanced liquid-nitrogen-based cryoablation therapy systems 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 Company's flagship ProSense^® 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 FDA Advisory Panel and the composition thereof; and the prospective outcome of the Advisory Panel and FDA decision and timing thereof. 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

Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

 

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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 is scheduled for November 7, 2024.

What is the purpose of IceCure's ProSense (ICCM) FDA Advisory Panel meeting?

The Advisory Panel will provide recommendations and vote on the benefit-risk profile for ProSense's De Novo marketing submission for treating early-stage low risk breast cancer.

When is the FDA expected to make a final decision on IceCure's ProSense (ICCM)?

The FDA is expected to make its final decision on ProSense by early 2025.

What type of cancer treatment is IceCure's ProSense (ICCM) designed for?

ProSense is designed for early-stage low risk invasive breast cancer treatment using cryoablation and adjuvant endocrine therapy.