Application covering a wide range of
indications is in line with trends in de-escalation of surgery and
growth in minimally invasive cryoablation procedures, pointing to
strong potential for increasing demand
CAESAREA, Israel, Feb. 24,
2025 /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 filed for regulatory approval with the Medical
Device Division ("AMAR") of Israel's Ministry of Health for its
next-generation single cryoprobe cryoablation system, the XSense™
System and CryoProbes.
The filing contains a request for approval of all indications
for which ProSense® has already received approval in Israel, including general surgery,
dermatology, neurology, including cryoanalgesia, thoracic surgery,
ENT (ear, nose, throat), gynecology, oncology (including benign and
malignant breast tumors), proctology and urology. The Company has
already received marketing authorization from the United States
Food and Drug Administration (the "FDA") for the XSense™ System and
its cryoprobes.
"As a leader in liquid-nitrogen based cryoablation technologies,
we continue to innovate and bring to market healthcare advancements
that support the global move toward de-escalation of surgery and
the substantial increase in minimally invasive surgery procedures,"
stated IceCure's Chief Executive Officer, Eyal Shamir. "While de-escalation of surgery is
a trend specific to the treatment of breast cancer, we see growing
opportunities for our cryoablation systems to offer minimally
invasive solutions in a wide range and expanding number of
indications. We are optimistic about receiving regulatory clearance
for XSense™ in Israel in the
coming months."
The global minimally invasive surgery market is forecast to grow
by a CAGR of 17% between 2022 and 2029 to reach $174 billion by 2029.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM)
develops and markets advanced liquid-nitrogen-based cryoablation
therapy systems for the destruction 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 Company's
view that opportunities for its cryoablation systems are growing in
a wide range and expanding number of indications; the impending
decision on regulatory clearance for XSense™ in Israel by AMAR; and the growth forecast of the
global minimally invasive surgery market, pointing to strong
potential for increasing demand. 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
