PRECICE study, financed by the Umberto Veronesi Foundation
and the Italian Ministry of Health, is led by multidisciplinary
collaborators including breast surgeons, interventional
radiologists, and breast imaging and pathology
specialists
PRECICE is exclusively using ProSense® to treat all 233
Luminal A and B patients >50 years of age with early-stage
breast cancer, a wider population of patients than ICE3
Article published in European Journal of Cancer Prevention
describes the PRECICE study and presents the role of cryoablation
in the move toward de-escalation of surgical treatment
CAESAREA, Israel, Nov. 19,
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 article titled "Cryoablation
of early breast cancer: the challenge towards de-escalation of
surgical treatment" in the European Journal of Cancer
Prevention.
The article, authored by breast surgeons and interventional
radiologists including Director of Interventional Radiology at the
European Institute of Oncology in Milan,
Italy, Franco Orsi, MD,
presents a review of recent studies and literature on cryoablation
of breast cancer, stating:
"The scientific assumption moving researchers
is that cryoablation could represent a precise and safe alternative
to the surgery itself for a selected subgroup of women."
The article highlights the Percutaneous Cryoablation of Low-risk
Early Breast Cancer (PRECICE) study, led by Principal Investigator,
Dr. Orsi. PRECICE is an independent prospective observational 233
patient study that has commenced the enrollment of women 50 years
of age and older with unifocal, small (up to 15 mm in diameter),
clinically node-negative, luminal A and B breast cancer.
The PRECICE study, which will exclusively use ProSense® to
conduct all procedures, will evaluate the technical effectiveness
of cryoablation with a median follow-up of five years (with early
primary and secondary outcomes after three years). The procedure
failure rate will be evaluated for possible residual tumor by
mammography, ultrasound, and nuclear MRI at two months before
radiotherapy and six months after radiotherapy. If relapse is
suspected, an image-guided breast biopsy will be performed.
Additional endpoints including quality of life, psychological
impact, and economic outcomes will also be evaluated.
"Dr. Orsi and his team are leading one of the largest studies of
cryoablation in early-stage breast cancer and examining
cryoablation's role as an alternative to lumpectomy. Importantly,
PRECICE is using ProSense® to examine a wider population of
patients than ICE3 did, including women as young as 50 and those
diagnosed with luminal B breast cancer," stated IceCure's CEO,
Eyal Shamir. "The accelerating move
towards the de-escalation of surgical treatment further supports
the potential for excellent patient outcomes, improved healthcare
economics, and increased market penetration for ProSense®."
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
potential of cryoablation as a precise and safe alternative to
surgery, the details of the PRECICE study, and the belief that the
accelerating move towards the de-escalation of surgical treatment
further supports the potential for excellent patient outcomes,
improved healthcare economics, and increased market penetration for
ProSense®. 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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SOURCE IceCure Medical
