- Independent, non-sponsored studies by doctors
using ProSense® to treat cancers of the breast, lung, kidney,
and musculoskeletal system, as well as endometriosis and
fibroadenomas
- Growing body of scientific data, including 13 breast
cancer studies, is expected to drive adoption
- ProSense® is approved for various indications in 15
countries including the U.S., Canada, Europe, Brazil, and China
CAESAREA, Israel, Nov. 6, 2023
/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 that in parallel with the growing adoption of ProSense®,
the number of independent, non-sponsored studies of its
cryoablation system has significantly increased. In addition to the
12 studies already published in peer reviewed journals and
presented in scientific conferences, two IceCure studies, ICE3 and
ICESECRET, and 17 independent, non-sponsored studies are ongoing.
There are 13 published and ongoing studies for breast cancer. The
remaining studies are focused on fibroadenomas, endometriosis, and
malignant or benign tumors of the lung, kidney, and musculoskeletal
system.
The ICE3 study, which is expected to be finalized in the first
quarter of 2024, is the largest U.S.-controlled multicenter
clinical trial ever performed for liquid nitrogen-based
cryoablation of early-stage breast cancer. Interim results show a
96.91% recurrence free rate, 100% safety, and 100% doctor and
patient satisfaction with cosmetic results.
A recently published independent study conducted using ProSense®
in Europe to treat early-stage
breast cancer produced very similar results, reporting a 96.8%
success rate in women with early-stage breast cancer who declined
surgery. Another independent study in Europe demonstrated a 93.4% to 96.8% tumor
reduction rate in women diagnosed with molecular subtype Luminal-A
and Luminal-B tumors who were deemed inoperable for breast
cancer.
"The number of practitioners who are currently using ProSense®
and choosing to conduct and publish studies independently is
astonishing, and we believe the high proportion of breast cancer
studies demonstrates a desire to provide women a safe and effective
alternative to the standard of care lumpectomy," stated IceCure's
CEO, Eyal Shamir. "Through our own
market feedback, we understand that doctors and patients favor
minimally invasive procedures that produce results similar to or
superior than open surgery. Cryoablation also reduces costs for
payers and minimizes or eliminates cosmetic scarring. We believe
that all of these studies, collectively, are an indication that we
are at a tipping point in the global commercial adoption of
ProSense® and we hope that the resulting data will lead to changes
in the standard of care for many of these indications."
About IceCure Medical Ltd.
IceCure Medical Ltd. (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 and
Israeli 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: that
studies are anticipated to commence across critical growth markets;
the expected conclusion of its ICE3 study in the first quarter of
2024; and the belief that there is demand for alternative treatment
to the standard of care lumpectomy. 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. Because such
statements deal with future events and are based on IceCure's
current expectations, they are subject to various risks and
uncertainties and actual results, performance, or achievements of
IceCure could differ materially from those described in or implied
by the statements in this press release. The forward-looking
statements contained or implied in this press release are subject
to other risks and uncertainties, some of which are beyond the
control of the Company. Important factors that could cause actual
results, developments and business decisions to differ materially
from those anticipated in these forward-looking statements include,
among other things: our planned level of revenues and capital
expenditures; our available cash and our ability to obtain
additional funding; our ability to market and sell our products;
legal and regulatory developments in the
United States and other countries; our ability to maintain
our relationships with suppliers, distributors and other partners;
our ability to maintain or protect the validity of our patents and
other intellectual property; our ability to expose and educate
medical professionals about our products; political, economic and
military instability in the Middle
East, specifically in Israel; as well as those 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.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
Logo:
https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/substantial-evidence-based-data-currently-being-generated-by-19-ongoing-studies-using-icecure-medicals-prosense-cryoablation-system-301978309.html
SOURCE IceCure Medical