Full Press Release Details
IceCure Submits Filing for Regulatory Approval
of its Next-Generation XSense Cryoablation System in Israel
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, February 24, 2025 - 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.
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