CAESAREA, Israel, July 1, 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 it has received marketing authorization from the United
States Food and Drug Administration (the "FDA") for its
next-generation single probe cryoablation system, the XSense™
Cryoablation System with CryoProbes.
"This latest FDA regulatory clearance further validates the
safety and efficacy of our platform cryoablation technology,"
commented Eyal Shamir, IceCure's
Chief Executive Officer. "The next-generation XSense™ system is
cleared for the same indications as our flagship ProSense® system
and we believe it has future potential to address other indications
in the U.S. for significant indications with unmet needs. Through
our innovation, IceCure is a global leader in liquid nitrogen-based
cryoablation systems that offer a new minimally invasive treatment
with benefits for patients, doctors and payors alike."
XSense™ and its cryoprobes are cleared for all of the
indications for which ProSense® has already received the requisite
FDA clearance, including general minimally invasive cryoablation in
the fields of general surgery, dermatology, neurology (including
cryoanalgesia), thoracic surgery, ENT, gynecology, oncology,
proctology and urology. The system is designed to destroy tissue by
the application of extreme cold temperatures, including
fibroadenomas, kidney tissue, liver metastases, tumors, skin
lesions and warts.
About IceCure's Cryoablation Systems
IceCure's platform technology, including the ProSense®
Cryoablation System and XSense™ Cryoablation System and CryoProbes,
provides a minimally invasive treatment option to destroy tumors by
freezing them. The systems uniquely harness 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.
IceCure's cryoablation systems enhance patient and provider
value by accelerating recovery, reducing pain, surgical risks and
complications. With easy, transportable design and liquid nitrogen
utilization, ProSense® and XSense™ open the 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 belief that
XSense™ has future potential to address other indications in the
U.S. for significant indications with unmet needs. 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