Full Press Release Details
IceCure Submits FDA Regulatory Filing for New
Cryoablation System with Cryoprobes
Continuous innovation as a global leader
in minimally invasive liquid-nitrogen based cryoablation systems
CAESAREA, Israel, April 2, 2024 -
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."
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
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.