Full Press Release Details
IceCure Receives FDA Marketing Authorization
for ProSense Cryoablation for the Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above
CAESAREA, Israel, October 3, 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 option to surgical tumor removal, today announced that the U.S. Food and
Drug Administration ("FDA") has granted marketing authorization to IceCure's De Novo application for the ProSense
cryoablation system for the local treatment of breast cancer in patients 70 years of age with biologically low-risk tumors 1.5
cm in size and treated with adjuvant endocrine therapy, representing approximately 46,000 women annually in the U.S. The authorized indication
includes patients that are not suitable for surgery for breast cancer treatment.
Potentially Setting a New Standard of Care for the Defined Indication
"ProSense offers the first new innovation in the treatment
of women aged 70 and above with low-risk early-stage breast cancer in decades. We are proud to deliver a significant advancement and enhancement
to women's cancer care and quality of life," stated IceCure's Chief Executive Officer, Eyal Shamir.
"We expect that the FDA's marketing authorization, the
very enthusiastic response from physicians who have had clinical experience with ProSense , and the existing reimbursement code, will
all combine to drive strong demand for our cryoablation procedure in breast cancer. American women aged 70 and above diagnosed with low-risk,
early-stage breast cancer now have access to a minimally invasive procedure that offers safe and effective treatment similar to standard
of care lumpectomy, with excellent cosmetic results and patient satisfaction," Shamir added.
Post-Market Study to Support Commercial Roll Out
In granting marketing authorization, the FDA requested that IceCure
conduct a post-market surveillance study with the aim of producing additional data in this indication. The post-market study is expected
to include approximately 400 patients at 30 sites, and the established reimbursement code may be used to support claims and reimbursement
for the study procedures. These sites, while treating study participants, will also be active commercial sites where any appropriate patient
seeking treatment with ProSense cryoablation may be treated.
The FDA's marketing authorization also establishes that any other
company wishing to file for 510(k) marketing authorization for a different cryoablation system to treat breast cancer will be required
to submit 5 years of follow-up data. To IceCure's knowledge, no other company is currently conducting a breast cryoablation clinical
"Our U.S. team has been diligently preparing for the FDA authorization,
and we are ready to seize the opportunity to expand our U.S. customer base," stated VP of Sales North America, Mr. Shad Good. "While
we expect the post-market study will support our product roll out through the initial 30 clinical sites, we are authorized to immediately
commence ProSense sales and procedures, independent of the post-market study."
The FDA's marketing authorization was based on an abundance of
data including IceCure's ICE3 trial, the largest multi-center clinical trial ever completed for liquid-nitrogen (LN2) based cryoablation
for patients with low-risk, early-stage breast cancer without surgically removing the breast tumor.
ICE3 Investigator Richard Fine, MD, FACS, stated, "As proven
in the ICE3 study, cryoablation with ProSense is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy
patients who took endocrine therapy, with the benefit of being an office-based, non-surgical treatment. data coming out of the post-market study should continue to support and confirm that cryoablation with ProSense is a successful alternative
to surgical excision in appropriately selected patients."
Reimbursement Code Established, ProSense Minimizes Cost of
Treatment for Payors
ProSense enhances patient, provider, and payor value by accelerating
recovery, minimizing pain, surgical risks, and complications, all while minimizing the cost of treatment relative to standard of care
lumpectomy. With its easy, transportable design and LN2 utilization, ProSense opens the door to fast and convenient out-patient procedures
ProSense has access to reimbursement under the CPT III code which
covers $3,800 of facility costs. IceCure expects additional reimbursement coverage in the future based on the FDA's marketing authorization
and other factors including the post market activity and recommendations from professional medical associations.
Full Indication for ProSense in the Treatment of Breast Cancer
ProSense is authorized by the FDA for the local treatment of breast
cancer in patients 70 years of age with biologically low-risk tumors 1.5 cm in size and treated with adjuvant endocrine therapy.
Biologically low-risk breast cancer is defined as unifocal tumor, size 1.5cm, ER+, PR+, HER2-, Ki-67<15% and/or genomic testing
indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or
evidence of lymphovascular invasion), and clinically negative lymph node (N0). The authorized indication includes patients that are not
suitable for surgery for breast cancer treatment. For a complete discussion of the benefits and risks of ProSense Cryoablation System
for the local treatment of breast cancer, please visit our website.
Company Webcast Information:
October 6, 2025 at 8:30 AM EDT
A live webcast will be available at: https://www.veidan-conferencing.com/icecure-investors
A recording of the webcast will be available at: https://www.ir.icecure-medical.com
The ProSense Cryoablation System is the first and only medical
device to receive FDA marketing authorization for the local treatment of early-stage, low-risk breast cancer with adjuvant endocrine therapy
for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list
of benefits and risks can be found on our website.
ProSense 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 in the 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
the 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 option to 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 Asia.
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: that the FDA's approval of ProSense sets a new paradigm in breast cancer care and
potentially sets a new standard of care; that the FDA's marketing authorization, the very enthusiastic response from physicians
who have had clinical experience with ProSense , and the existing reimbursement code, will all combine to drive strong demand for
the Company' cryoablation procedure in breast cancer; that additional reimbursement coverage is expected; the details regarding
the post-market study, including the number of expected patients and sites; that the post-market study sites will also be active commercial
sites where any appropriate patient seeking treatment with ProSense cryoablation may be treated; the expectation that the post-market
study will support the Company's product roll out through the initial clinical sites; and that further data coming out of the post-market
study should continue to support and confirm that cryoablation with ProSense is a successful alternative to surgical excision in
appropriately selected patients. 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, 2024 filed with the SEC on April 3, 2025, 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. Information on, or accessible through, the websites
mentioned above does not form part of this press release.