- Demand for minimally invasive breast cancer treatment was
overarching theme of the conference
- In one independent study led by Professor Fukuma, 389
patients treated for up to 10 years had 99.74% recurrence free
rate
- Another independent study led by Professor Kawamoto found
0% breast cancer local recurrence in five-year follow
up
- ProSense® expected to gain further traction in
Japan, as distribution partner
Terumo Corporation plans to submit application to the
Pharmaceuticals and Medical Devices Agency ("PMDA") for regulatory
clearance for breast cancer in the first quarter of
2025
CAESAREA, Israel, July 22,
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 that key findings from three clinical studies of
ProSense® in the treatment of breast cancer were presented at the
32nd Annual Meeting of the Japanese Breast Cancer Society on
July 12, 2024 in Miyagi, Japan.
During a symposium titled, "New techniques and strategies in
breast surgery", chaired by Professor Takayuki Kinoshita, Division of Breast Surgery,
NHO Tokyo Medical Center, data on breast cancer cryoablation with
ProSense® were presented by Prof. Eisuke
Fukuma, Breast Center, Kameda Medical Center, and Prof.
Hisanori Kawamoto, Department of
Breast Surgery, Breast and Imaging Center at St. Marianna
University School of Medicine.
Demand for minimally invasive breast cancer treatment was an
overarching theme of the Japanese Breast Cancer Society Annual
Meeting and of high interest to the over 3,500 meeting attendees.
The data on cryoablation was well received at the symposium.
Symposium Chair Professor Kinoshita commented, "cryoablation
for treating breast cancer has the potential to become an
alternative to open surgery and other minimally invasive solutions
in Japan. The data presented
suggests excellent cosmetic results. As this procedure moves toward
being incorporated into routine clinical practice after PMDA
approval, we are pleased to have more data presented at this
important annual meeting to leading breast cancer physicians in
Japan."
Professor Fukuma, who has performed over 600 breast cryoablation
procedures with ProSense®, presented a summary of IceCure's ICE3
study data as well the latest data from his ongoing research of
ProSense® to treat breast cancer at Kameda Medical Center. From
April 2014 through August 2020, 389 breast cancer patients with
tumor lesions of less than 15 millimeters in diameter were treated
with ProSense®. The ipsilateral breast tumor recurrence rate (IBTR)
was 0.26%, resulting in a 99.74% recurrence free rate.
"The results with ProSense® continue to be excellent, and this
is why cryoablation is becoming a common procedure here," Professor
Fukuma stated. "Patients are becoming more interested. They are
coming in and asking to learn more about it. In addition to great
efficacy on treating tumors and favorable cosmetic results, there
is evidence that cryoablation has potentially favorable impacts on
the immune system, further improving longer term outcomes."
Professor Kawamoto presented data from an independent study he
led which demonstrated zero (0%) breast cancer local recurrence or
distant metastasis five years following treatment with ProSense®.
These findings, which were published in the peer reviewed journal
Breast Cancer, were previously announced by IceCure on
May 7, 2024. 18 early-stage breast
cancer patients 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 serious adverse events were reported. Cosmetic outcomes were
excellent and the overall patient satisfaction level and patient
quality of life improved post-cryoablation.
"Japan is a very important
market for ProSense® since we are partnered with Terumo
Corporation, the largest medical device company in the country, and
a growing number of doctors who are using ProSense® as part of
their clinical studies are publishing compelling results," stated
IceCure CEO Eyal Shamir. "We expect
Terumo Corporation will file for regulatory approval of ProSense®
for breast cancer in Japan in the
first quarter of 2025, with the aim of making our cryoablation
system more commercially available to doctors and patients alike in
Japan."
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 that
cryoablation for treating breast cancer has the potential to become
an alternative to open surgery and other minimally invasive
solutions in Japan, the potential
of the impending Pharmaceuticals and Medical Devices Agency
approval of the procedure and its potential to become routine
practice, that cryoablation has potentially favorable impacts on
the immune system, further improving longer term outcomes, and the
expectation that Terumo Corporation will file for regulatory
approval of ProSense® for breast cancer in Japan in the first quarter of 2025, with the
aim of making IceCure's cryoablation system more commercially
available to doctors and patients in Japan. 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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