IceCure to submit full 5-year dataset from
entire ICE3 study population to the FDA this spring, ahead of
previous expectation
CAESAREA, Israel, Jan. 30,
2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ:
ICCM) ("IceCure" or the "Company"), developer of the
ProSense® System, a 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 ("FDA") has responded affirmatively to the Company's
request for supervisory review ("Appeal") under 21 CFR 10.75
regarding the FDA's prior denial of IceCure's De Novo
Classification Request for treating patients with early-stage, low
risk breast cancer.
The FDA determined there is sufficient basis to reopen
the De Novo file and requested IceCure to submit the full 5-year dataset from the
Company's ICE3 trial. The final ICE3 study patient is expected to
complete her 5-year follow up examination by the end of
February 2024. IceCure plans to
expedite data monitoring and analysis to submit the final 5-year
dataset to the FDA by April 2024,
which is several months ahead of the Company's prior submission
timeline.
In its initial De Novo classification request in October 2022, IceCure submitted interim results
from its ICE3 study, the largest controlled multi-location clinical
trial ever performed for liquid-nitrogen (LN2)-based cryoablation
of small, low-risk, early-stage malignant breast tumors. The ICE3
study will provide 5-year recurrence outcomes on a patient
population which represents approximately 65,000 people in the U.S.
alone annually.
Additionally, the FDA requested that IceCure submit an analysis
of the ICE3 results compared with data from the LUMINA study.
LUMINA, a study sponsored by the Ontario Clinical Oncology Group
(Canada) evaluated the risk of
recurrence in patients with low-risk Luminal A breast cancer who
were treated with lumpectomy surgery with adjuvant hormone therapy.
A full peer-reviewed article on LUMINA results was published in
August 2023, while FDA review of
IceCure's De Novo request was underway.
IceCure was invited by the FDA to submit real-world data from
the use of ProSense® globally, including post-market
commercial use in territories where ProSense® is approved for
breast cancer, as well as data from independent third-party
studies.
"The FDA has set a very clear path to clearance for
ProSense® in early-stage breast cancer, which may lead to
women having a new, minimally invasive, safe, and effective
treatment option," stated IceCure CEO Eyal
Shamir. "We remain hopeful that final ICE3 data will be in
line with our interim results and are confident that we can deliver
the dataset, comparable analysis, and real-world data to the FDA in
the next few months."
About ProSense®
The ProSense® Cyroablation 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 statement in this press release when it discusses:
expediting data monitoring and analysis to submit the final ICE3
dataset and other real-world data to the FDA by April 2024; that the reopening of the Company's
De Novo Classification Request may lead to women having a new,
minimally invasive, safe and effective treatment option; and that
the Company is hopeful that the final ICE3 data will be in line
with interim results. 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, 2022 filed with the SEC
on March 29, 2023, 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