Seeks to expand regulatory approval in
China where IceSense3 has already
been approved
CAESAREA, Israel, Jan. 27,
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 submitted a regulatory filing with China's National Medical Products
Administration ("NMPA") for the approval of its ProSense®
Cryoablation System. IceCure's IceSense3, its predecessor
cryoablation system, already has regulatory approval in
China.
The indicated use for ProSense® in China, per the Company's regulatory filing
application, is as a cryosurgical tool in the fields of general
surgery including breast tissue, dermatology, thoracic surgery
including lung tissue, gynecology, oncology, proctology, and
urology including kidney tissue. The ProSense® application with the
NMPA expands upon the current IceSense3 clearance to include a
total of five different cryoprobes of varying length, diameter, and
ice ball shape, as well as the use of introducers, which provide
increased accessibility to the targeted tissue in certain
indications.
"China is potentially a very
large market for cryoablation and we are moving forward with an
expanded line of available products, as well as securing
reimbursement, so that IceCure can be ideally positioned to serve
this important geography," stated IceCure CEO, Eyal Shamir.
About ProSense®
The ProSense® Cryoablation System is a minimally
invasive cryosurgical tool that provides the 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
procedures for breast tumors.
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 belief that China is
potentially a very large market for cryoablation and that the
Company is moving forward with an expanded product line of
available products, as well as securing reimbursement, so that
IceCure can be ideally positioned to the Chinese market. 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
Logo:
https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/icecure-files-for-regulatory-approval-of-prosense-cryoablation-system-in-china-302360682.html
SOURCE IceCure Medical
