Independent study in women deemed inoperable for breast
cancer reports median tumor reduction of 100% at 6 and 12 months
following cryoablation
CAESAREA, Israel, Feb. 26,
2024 /PRNewswire/ -- 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 new data from a preliminary, independent
breast cancer study conducted by Principal Investigator and
ProSense® user, Dr. Federica. di Naro, of Azienda
Ospedaliero-Universitaria Careggi, Diagnostic Senology Unit in
Florence, Italy. IceCure
previously announced interim results from this study on
October 5, 2023. ProSense® is
approved in Italy for numerous
indications, including breast cancer.
In the single-site study conducted between January 2022 and January
2024, ultrasound-guided cryoablation using ProSense® was
performed on 39 women aged 60-92, who had biopsy-proven malignant
lesions, and were deemed inoperable due to advanced age and
comorbidities, or who refused surgery. Patients were monitored at
1, 3, 6 and 12 months post-procedure, at which time the tumor size
reduction rate was evaluated by ultrasound. Also at 12 months
post-procedure, the effectiveness of the procedure was further
evaluated by core needle biopsy on the post-procedural scar (inside
the breast at the site of the tumor) and contrast enhanced
mammography ("CEM") to determine the presence or absence of
residual tumoral cells and effectiveness of cryoablation.
The median breast cancer tumor size reduction rates reported in
the study were as follows:
1 month: 27.8%
3 months: 60.9%
6 months: 100.0%
12 months: 100.0%
"These are phenomenal results of 100% median tumor size
reduction in as little as 6 months and its effectiveness
demonstrated by correlation between CEM outcomes versus biopsy
at 12 months after our minimally invasive procedure that takes up
to 40 minutes. We are so pleased that women in this study, who were
deemed inoperable, benefitted from cryoablation," stated IceCure
CEO Eyal Shamir. "We are working
hard to get ProSense® approved, available and affordable for as
many women as possible in a number of countries around the world.
This independent study is further validation of our mission, and we
thank Dr. di Naro for her initiative in leading the study and
giving patients options that save and prolong lives."
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 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 its
endeavors to get ProSense® approved, available and affordable for
as many women as possible in a number of countries around the
world. 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.
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IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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SOURCE IceCure Medical