FDA decision on marketing authorization
expected in the first quarter of 2025
CAESAREA, Israel, Nov. 8, 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, announced the
U.S. Food and Drug Administration's ("FDA") Medical Device Advisory
Committee Panel's (the "Advisory Panel") favorable recommendation
with 9 panelists voting in favor and 5 voting against the
benefit-risk profile of IceCure's ProSense®. The majority of
panelists voted that the benefits of IceCure's ProSense® System
outweigh the risks when used according to the proposed indications
for the treatment of patients with early-stage low risk invasive
breast cancer with cryoablation and adjuvant endocrine therapy.
Among those that voted "no", there were three who stated that if
the FDA applied adequate special controls, this would have swayed
their opinion in favor.
"This is a significant milestone on the path towards the
marketing authorization of ProSense® cryoablation in the U.S. for
early-stage low risk breast cancer and I believe a critically
important development for women seeking an alternative to
lumpectomy," stated IceCure's Chief Executive Officer, Eyal Shamir. "We expect the FDA's decision,
based on the Advisory Panel's recommendation, in the first quarter
of 2025. Our U.S. sales and distribution team is ready to support
doctors and patients in the event of a successful marketing
authorization for ProSense® in breast cancer."
The Advisory Panel's favorable vote was based on the
comprehensive body of data available on ProSense® as a treatment
for early-stage low risk breast cancer, including results from the
Company's ICE3 study compared with data from the current standard
of care, lumpectomy, as well as testimonies and input from a broad
range of key stakeholders, including women with breast cancer and
their family members, patient advocacy groups, doctors, nurses and
researchers.
The purpose of the Advisory Panel was for the FDA to obtain
independent non-binding 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 included breast
surgeons, interventional radiologists, breast oncologists, and
representatives from the patient, consumer, and regulatory
communities.
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,
India, Brazil 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: that this is a significant milestone on the path
towards the approval of ProSense® cryoablation
in the U.S. for early-stage low risk breast cancer; the
belief that this approval is critically important development for
women seeking an alternative to lumpectomy; that the Company
expects to receive news of the FDA's decision in the first quarter
of 2025; and that the Company's U.S. sales and distribution team is
ready to support doctors and patients in the event of successful
marketing authorization for ProSense® in breast
cancer. 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