- Investigator initiated independent study included higher
risk patients such as those with metastatic disease, large tumors,
and comorbidities, as compared to IceCure's ICE3 study which
treated early-stage breast cancer patients
- Recurrence-free rates were 94.7%, 87.8%, and 81.8%, at 1,
2, and 3 years, respectively
- Study published in American Journal of Roentgenology was
conducted at 7 U.S. institutions and led by Principal Investigators
Dr. Karim Oueidat and Dr.
Robert Ward, both of the Warren
Alpert Medical School of Brown
University
CAESAREA, Israel, Aug. 7, 2024
/PRNewswire/ -- 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 study."
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 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.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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