- Independent study published in Gland Surgery and
conducted at Kameda Medical Center in Japan by ProSense® users including Dr. Kizuki
Matsumoto and Dr. Eisuke
Fukuma
- Patients who underwent cryoablation compared to
breast-conserving therapy (BCT) reported significantly higher
satisfaction (71.0±18.6 vs. 56.3±16.5) in the primary
outcome with a mean follow-up of 4.2 and 4.0 years,
respectively
- Data support continued move toward de-escalation of
breast cancer treatment from BCT (lumpectomy) to nonsurgical
options including cryoablation
CAESAREA, Israel, March 10,
2025 /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 titled 'Post-treatment patient satisfaction in early-stage
breast cancer: Comparison of cryoablation versus breast
conservation therapy using BREAST-Q' in the peer reviewed journal
Gland Surgery. The study was conducted at the Breast Center,
Kameda Medical Center in Kamogawa, Chiba,
Japan by the co-authors of the article, Dr. Kizuki
Matsumoto, Dr. Yuko Asano, Dr.
Hiroki Matsui, and Dr. Eisuke Fukuma. A leading expert and breast
surgeon, Dr. Eisuke Fukuma has
performed over 600 ProSense® breast cryoablation procedures, has
presented on ProSense® and has trained other doctors at medical
conferences.
In Japan, the de-escalation of
treatment for breast cancer continues, with breast-conserving
therapy ("BCT"), typically defined as standard of care breast
surgery or lumpectomy, representing approximately 60% of all breast
cancer cases, as novel nonsurgical options have emerged.
"In this study we aimed to evaluate and compare patient
satisfaction after BCT and cryoablation. Assessing the patient's
health-related quality of life ("HRQOL") holds significant clinical
importance and studies examining long-term satisfaction following
cryoablation, particularly in Asian patients, are limited," stated
Dr. Kizuki Matsumoto. "Because of improved survival outcomes,
breast cancer is becoming a chronic disease, making the survivor's
quality of life and satisfaction a major focus of treatment. We
were pleased with the outcome of the study and believe the use of
cryoablation in breast cancer will be more widespread in the
future."
IceCure's Chief Executive, Eyal
Shamir commented, "We are grateful to the team at Kameda
Medical Center for initiating this important study which focuses on
women's satisfaction. The data clearly demonstrate that
cryoablation resulted in greater quality of life and patient
satisfaction than standard of care surgery in this early-stage
breast cancer patient population. We believe these results will
support our distribution partner, Terumo Corporation, in its
application for regulatory approval of ProSense® for breast cancer
in Japan."
Highlights from the study:
- A total of 147 Asian female breast cancer patients underwent
cryoablation with ProSense® (n=42) or BCT (n=105). Among the 112
patients with stage 0 or 1 disease, 36 met the exclusion criteria
and were excluded from the analysis. The remaining 76 (35 from the
cryoablation group and 41 from the BCT group) were included in the
analysis.
- The study used the BREAST-Q questionnaire to assess patient
HRQOL and satisfaction.
- Patients who underwent cryoablation compared to BCT reported
significantly higher satisfaction (71.0±18.6 vs. 56.3±16.5) in the
primary outcome, with a mean follow-up of 4.2 and 4.0 years,
respectively. This satisfaction trend was consistent across all the
other measures.
- The authors of the study indicate they believe patient
satisfaction is higher with cryoablation of breast cancer as it
does not involve excision, leaving breast volume and symmetry
unchanged.
About ProSense®
The ProSense® Cryoablation System is a minimally invasive
cryosurgical tool that provides the 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
procedures for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced
liquid-nitrogen-based cryoablation therapy systems for the
destruction 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 belief that assessing HRQOL holds significant clinical
performance; the belief that cryoablation for treating breast
cancer will be more widespread in the future; the belief that the
data from the Kameda Medical Center study demonstrate that
cryoablation resulted in greater quality of life and patient
satisfaction than standard of care surgery in the early-stage
breast cancer patient population; and the belief that the results
from the Kameda Medical Center study will support Terumo
Corporation in its application for regulatory approval of ProSense®
for breast cancer 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
Logo:
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SOURCE IceCure Medical
