- Independent, third-party data published in highly
influential peer-reviewed journal, Cancers,
concluded cryoablation with ProSense® is a safe, local
treatment for breast cancer with low complication rate, high
complete ablation rate and satisfactory overall survival (OS),
progression free survival (PFS) and local tumor
control
- 8.9% recurrence rate in population of 45 patients who had
previously received various therapies before cryoablation including
surgery, radiation therapy, or chemotherapy with tumor sizes of up
to 4 centimeters in diameter. Of those patients, 11 had recurrent
tumors and 21 had metastatic disease
- The higher-risk population in this European study
contrasts with the early-stage breast cancer patient subjects in
the U.S. ICE3 study
CAESAREA, Israel, July 9, 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 evaluating its
flagship cryoablation system ProSense® titled: "CT-Guided
Percutaneous Cryoablation of Breast Cancer: A Single-Center
Experience" in Cancers, a leading peer-reviewed oncology
journal. The study, led by Principal Investigator Professor
Thomas J. Vogl, was conducted at the
Institute of Radiology and Nuclear Medicine, University Hospital
Frankfurt, at Goethe University,
Germany.
Professor Vogl commented, "Liquid Nitrogen-based cryoablation
was found to be a safe local treatment for breast cancer, with a
low complication rate—in fact, none were observed in the study. We
experienced a very high complete ablation rate of 100%. Overall
survival, progression free survival and local tumor control were
all good, especially given the very heterogenous patient
population. The fact that this is a minimally invasive procedure
that can be performed on an outpatient basis with excellent
cosmetic results are clear advantages. We look forward to further
evaluations of cryoablation especially in comparison to other
treatment modalities for early, recurrent, and metastatic breast
cancer."
"While this study's patient population is very different from
our U.S. based ICE3 study and the target indication for which we
have filed for regulatory approval in the U.S., the results of the
study are highly valuable for ProSense® users in Europe where our system is approved for
general breast cancer treatment. This higher risk patient
population included patients with metastatic disease and tumors of
up to 4 centimeters in diameter, as compared to our ICE3 study
population with early-stage disease and tumors smaller than 2
centimeters in diameter, indicating a very different recurrence
rate. Importantly, it further informs and supports the use cases of
ProSense® across a broader range of breast cancer diagnoses, from
newly diagnosed early-stage to metastatic and recurrent disease,"
stated IceCure CEO Eyal Shamir. "We
thank Dr. Vogl, his team, and University Hospital Frankfurt for
their initiative in conducting this study and expanding the body of
knowledge for the cryoablation of breast cancer."
This independent study, which received no financial support from
IceCure, retrospectively evaluated the efficacy and safety of
liquid-nitrogen based CT-guided cryoablation with ProSense®.
Patients were treated in out-patient settings with curative
intention for non-metastatic patients, while patients with
metastases were treated to achieve local tumor control. The patient
population (n=45, with 56 tumors) with a mean age of 55.6 ± 12.5
years (range, 31.3–86.0 years) was very heterogeneous and different
from IceCure's ICE3 study population and included 11 patients with
recurrent tumors and 21 patients with metastatic disease. Patients
were observed at three, six, nine, and 12 months, respectively, and
after the first year were followed up biannually. There were four
cases of local tumor progression, representing a rate of 8.9%.
There were no complications observed in any of the 56 ablations and
initial complete ablation was achieved in 100% of cases.
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:
further evaluations of cryoablation, especially in comparison to
other treatment modalities for early, recurrent and metastatic
breast cancer. 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