Continuous innovation as a global leader in minimally
invasive liquid-nitrogen based cryoablation systems
CAESAREA, Israel, April 2,
2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq:
ICCM) ("IceCure" 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 it has filed a 510(k) submission with the United
States Food and Drug Administration ("FDA") for clearance of its
next-generation single probe cryoablation system, the XSense™
System and cryoprobes. The filing contains a request for clearance
for all of the indications for which ProSense® has already received
the requisite FDA clearance, including general minimally invasive
cryoablation applications for the kidney, liver, fibroadenomas and
neurology.
This new application for IceCure's next-generation single probe
XSense™ with cryoprobes is based on the current clearance of the
ProSense® System, and is being processed separately from the
Company's De Novo application for the breast cancer indication.
"As our ProSense® single probe cryoablation system builds market
traction globally, we continue to develop our technology pipeline
with innovative single and multi-probe systems," stated IceCure CEO
Eyal Shamir. "We believe IceCure is
the technological, clinical and market leader in liquid
nitrogen-based cryoablation technologies that can have a
significant beneficial impact on global healthcare systems by
offering safe, effective, patient-friendly and cost-efficient
alternatives to more invasive surgical procedures."
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
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 statement in this press release when it discusses: the
Company's continual development of its technology pipeline and the
belief that the Company is a leader in liquid nitrogen-based
cryoablation technology. 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, 2022 filed with the SEC
on March 29, 2023, 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-submits-fda-regulatory-filing-for-new-xsense-cryoablation-system-with-cryoprobes-302105533.html
SOURCE IceCure Medical