Full Press Release Details
IceCure Announces Positive Data from the Largest
Institutional Study of its Kind: "Cryoablation of Primary Breast
Cancer in Patients Ineligible for Clinical Trials"
CAESAREA, Israel, August 7, 2024 -
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
the publication of an independent study titled "Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials:
A Multi-institutional Study" in a leading radiology journal, the American Journal of Roentgenology (AJR).
This multi-institutional study is the largest
study of breast cancer cryoablation in women ineligible for prospective clinical trials due to particular patient or tumor characteristics.
IceCure's ICE3 study, which evaluated the Company's ProSense cryoablation system, enrolled early-stage breast cancer
patients only. Based on the ICE3 results, IceCure has filed for regulatory approval of ProSense in the U.S. for the indication of
treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.
As reported in the AJR, the independent study
evaluated 112 patients with a median age of 71. ProSense was one of four different cryoablation systems used for procedures performed
at 7 U.S. institutions by 7 different radiologists, including 4 breast radiologists, 2 breast and interventional radiologists, and 1 interventional
radiologist. The recurrence-free rates were 94.7%, 87.8%, and 81.8%, at 1, 2, and 3 years, respectively, when accounting for death, including
from comorbidities, as a competing risk. Treatment with cryoablation had a low frequency of adverse events (AEs), with 6.3% of patients
having minor AEs and no moderate or major AEs having occurred. A high frequency of procedures, 98.2%, were technically successful. The
researchers concluded that in certain individuals with unfavorable patient or tumor characteristics, cryoablation remains a safe alternative
to surgery that has overall good outcomes, especially in patients who are poor surgical candidates due to comorbidities. Patients in the
independent study generally underwent cryoablation based on their preference for cryoablation.
"This study underscores the opportunity
for cryoablation with ProSense to offer a much-needed non-surgical alternative for women who may not be eligible for surgery,"
stated IceCure CEO Eyal Shamir. "It is important to note that the researchers found cryoablation to be a safe procedure with good
outcomes, even in this higher risk population, which included patients with metastatic disease, large tumors, and more than half of the
study participants having comorbidities. We thank the researchers and institutions for their initiative and participation in this independent
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
advanced liquid-nitrogen-based cryoablation therapy systems 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 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 conclusion from the study
that cryoablation remains a safe alternative to surgery that has overall good outcomes, especially in patients who are poor surgical candidates
due to comorbidities, and that the study underscores the opportunity for cryoablation with ProSense to offer a much-needed non-surgical
alternative for women who may not be eligible for surgery. 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.