- Study published in the peer reviewed journal Breast
Cancer
- Excellent cosmetic outcomes, high degree of patient
satisfaction, and improved quality of
life post-cryoablation
- Strategic distribution partner of ProSense® in
Japan, Terumo Corporation, expects
to submit an application for regulatory clearance for breast cancer
in the second half of 202
CAESAREA, Israel, May 7, 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, announced
today that positive data from an independent study (the "Study")
performed in Japan was published
in an article titled "Percutaneous ultrasound–guided cryoablation
for early–stage primary breast cancer: a follow–up study in
Japan," in the journal Breast
Cancer on April 27, 2024. The
Study, which focused on the local control of cancer, safety,
patient quality of life, patient satisfaction, and cosmetic
outcomes of cryoablation for patients with early-stage breast
cancer, is the continuation of a prior pilot study that
demonstrated percutaneous cryoablation treated with ProSense® is a
potential standard treatment for early-stage breast cancer
patients, given compliance to pre-defined patient selection
criteria.
The Study was led by Dr. Hisanori
Kawamoto, M.D., Ph.D. from the Department of Breast Surgery,
Breast and Imaging Center at St. Marianna University School of
Medicine in Japan. Eighteen
early-stage breast cancer patients, with a mean age of 59.0 [±9.0
years], with a mean tumor size of 9.8 ±2.3 mm, who underwent
treatment with ProSense® were followed for a mean of 44.3 months.
No patients had local recurrence or distant metastasis in the
5-year follow-up. No serious adverse events were reported. Cosmetic
outcomes were excellent and the overall patient satisfaction level
and patient quality of life improved post-cryoablation.
The article states that minimally invasive non-surgical
techniques, including cryoablation, aim for curative outcomes while
also acknowledging the importance of preserving or enhancing the
quality of life and cosmetic appearance following the procedure.
The authors of the Study refer to recent trials, including
IceCure's ICE3 trial, for evidence that cryoablation results in
local cancer control rates comparable to lumpectomies in
early-stage breast cancer patients.
Dr. Kawamoto commented, "This is a very important study in
Japan, where we are experiencing
an upward trend in breast cancer cases, especially among women in
their late 40s to early 60s. These are women who often are at very
active stages of their life and therefore there is a growing demand
for treatment options that minimize the chance of or avoid
hospitalization, in addition to resulting in favorable clinical and
cosmetic outcomes. We are very pleased with these results and are
hopeful that ProSense® may become a favored option in Japan upon regulatory approval for early-stage
breast cancer."
"We thank Dr. Kawamoto and his colleagues for conducting this
independent study, which adds to the growing body of efficacy and
safety data for ProSense® as a minimally-invasive option for
early-stage breast cancer," stated IceCure CEO, Eyal Shamir. "We anticipate that our in-country
distribution partner, Terumo Corporation, will file for regulatory
clearance of ProSense® for breast cancer in Japan later this year, which may soon lead to
the approval and commercialization for it in a market where there
is high demand for a minimally-invasive option."
Terumo Corporation owns the exclusive distribution rights for
ProSense® in Japan for a 5-year
term following regulatory approval. In exchange for exclusive
distribution rights, IceCure is expected to receive a total of
$13.2 million in proceeds from Terumo
during this initial term, of which it has received $4 million to date, with an additional
$8.2 million expected upon the
completion of orders, as well as $1
million expected for milestone-based payments.
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 statements in this press release when it discusses: that
percutaneous cryoablation treated with ProSense® is a potential
standard treatment for early-stage breast cancer patients, the
growing demand for minimally invasive treatment options, the hope
that ProSense® may become a favored option in Japan upon regulatory approval for early-stage
breast cancer, the expectation that Terumo Corporation will file
for regulatory clearance in the second half of 2024, and the
expected proceeds of IceCure in connection with its exclusive
distribution rights agreement with Terumo. 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 U.S. Securities
and Exchange Commission (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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