Full Press Release Details
IceCure's ProSense Substantially
Reduces Abdominal Wall Endometriosis Pain with High Procedural Efficacy
Independent study reports pain scores declined
from a median of 8 on a scale of 0-10 to a median of 0 for patients who had ProSense cryoablation procedures
ProSense is FDA cleared and approved
in the European Union for gynecological indications
CAESAREA, Israel, September 4, 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 encouraging findings
from a recently published, independently conducted study evaluating the efficacy and safety of personalized percutaneous single-probe
liquid-nitrogen cryoablation with ProSense in treating symptomatic abdominal wall endometriosis ("AWE").
AWE is a debilitating condition, often occurring in surgical scars
after caesarean sections. It is characterized by cyclic pain and a palpable mass, significantly impacting the quality of life of the individual.
Traditional treatments, including hormonal therapy and surgery, have their limitations, which has prompted interest in minimally invasive
techniques such as cryoablation.
The peer-reviewed study,
published in Journal of Personalized Medicine, titled "Efficacy and Safety of Percutaneous Single-Probe Cryoablation Using Liquid
Nitrogen in the Treatment of Abdominal Wall Endometriosis," was conducted at N mes University Hospital in N mes, France.
The study enrolled 14 patients with a total of 23 AWE lesions, who were treated between September 2022 and April 2025.
"We are very pleased to share the results of this independent
study which concluded that percutaneous cryoablation with ProSense is a safe and effective minimally invasive cryosurgical tool for
abdominal wall endometriosis, offering significant pain relief and excellent cosmetic outcomes," stated IceCure's Chief Executive
Officer, Eyal Shamir. The researchers went on to state it should be considered as part of multidisciplinary care for women with AWE. Evidence
of ProSense 's efficacy in multiple gynecological indications further supports its commercial potential and momentum.
Key Study Highlights include the following:
According to the World
Health Organization, endometriosis affects about 10% of women who are at reproductive age globally, or 190 million people. Endometriosis
is a chronic disease associated with severe, life-impacting symptoms. AWE has a reported
incidence rate of 0.03% - 3.5% of women.
The ProSense Cryoablation System provides a minimally invasive
method 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 Asia.
Forward Looking Statements
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 benefits of percutaneous cryoablation with ProSense ; that ProSense is a safe and effective minimally
invasive cryosurgical tool for abdominal wall endometriosis, offering significant pain relief and excellent cosmetic outcomes; and the
belief that ProSense 's efficacy in multiple gynecological indications supports its commercial potential and momentum. 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 March 27, 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