- Demonstrates public health importance of
assessing ProSense®'s potential to offer optimal treatment
that benefits women with early-stage breast cancer
- Patients, patient advocacy groups, doctors, and the
general public will be welcome to participate and comment in the
open public hearing
- IceCure welcomes a transparent public forum to share ICE3
study results and show how ProSense® cryoablation could potentially
offer a minimally invasive alternative treatment to women diagnosed
with early-stage breast cancer estimated at 65,000 in the U.S.
annually
- ProSense® is already approved for the treatment of
early-stage breast cancer in numerous European countries, as well
as Brazil, India, and China
CAESAREA, Israel, June 4, 2024
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM)
("IceCure", "IceCure Medical" 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") will convene a Medical Device Advisory Committee for a
panel meeting (the "Advisory Panel") to obtain independent expert
advice on scientific, technical, and policy matters related to
ProSense® to help the FDA make a sound decision.
"We believe the opportunity to have a public, transparent, and
open forum about this important women's health issue, led by
outside, independent experts including physicians and researchers,
will be highly beneficial to all stakeholders," stated IceCure's
CEO, Eyal Shamir. "We applaud the
FDA's decision to convene the Advisory Panel and for acknowledging
the public health importance of being able to offer a minimally
invasive alternative to lumpectomy. The ICE3 data for ProSense®,
which has been consistently positive throughout IceCure's ICE3
study, will be shared with the Advisory Panel, highlighting its
clinical and economic benefits and why women who have undergone a
ProSense® cryoablation procedure have reported a 100% satisfaction
rate. As we continue to engage with the FDA leading up to the
Advisory Panel, we believe increased awareness of ProSense® as a
result of the Advisory Panel may enable our U.S. commercial team to
further support our commercial efforts upon potential regulatory
approval in the U.S."
The Advisory Panel is expected to convene in the fourth quarter
of 2024, with an FDA decision on whether to approve ProSense®
expected by early 2025. The FDA is expected to provide the exact
date for the Advisory Panel in the coming weeks, which the Company
will also make known to its shareholders. The FDA generally makes
Advisory Panel meeting materials and the live webcast link
available to the public no later than two business days before any
meeting. The Advisory Panel will review the vast body of data
available on ProSense® as a treatment for early-stage breast
cancer, including results from the 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 hormone therapy, were estimated to be free from local
recurrence. 100% patient and physician satisfaction was
reported.
As part of its De Novo Classification Request for Marketing
Authorization, IceCure submitted data, including its final ICE3
study results, to the FDA, as part of its request for clearance for
ProSense® for the indication of treating patients with early stage
T1 invasive breast cancer with cryoablation and adjuvant hormone
therapy.
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 (Sullivan)
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 impending submission of materials and data for
and expected timeline and procedure of the Advisory Panel that is
expected to take place in the last quarter of 2024, the belief that
increased awareness of ProSense® as a result of the Advisory Panel
will further the Company's commercial efforts upon potential
regulatory approval, and that the decision on whether to approve
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
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