- 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
Logo:
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SOURCE IceCure Medical