- 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:
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SOURCE IceCure Medical