- Publication comes ahead of the FDA Advisory Panel Meeting
for Marketing Authorization of ProSense® in Early-Stage
Low Risk Breast Cancer scheduled for November 7, 2024
- 96.3% recurrence free rate for women treated with
ProSense® cryoablation and endocrine therapy; 100% of
patients and treating physicians were satisfied with the cosmetic
outcome.
- Lead study author, Dr. Richard E.
Fine, is an ICE3 investigator and winner of the 2024
American Society of Breast Surgeons' Scientific Impact Award for
his presentation of the ICE3 trial data.
- ProSense® offers women the choice of a quick
minimally invasive in-office procedure under local anesthesia with
minimal pain, minimal scarring and rapid recovery as compared to
lumpectomy which involves full anesthesia and hours of surgery and
recovery, followed by 1-2 weeks of limited movement.
CAESAREA, Israel, Sept. 24,
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 article titled, "Cryoablation
Without Excision for Early–Stage Breast Cancer: ICE3 Trial 5–Year
Follow–Up on Ipsilateral Breast Tumor Recurrence" in the Annals
of Surgical Oncology, the official journal of the Society of
Surgical Oncology. The open access article, which is available
HERE, presents the results of IceCure's ICE3 trial, the largest
controlled multicenter clinical trial ever completed in the U.S.
for liquid nitrogen ("LN2") based cryoablation of small,
low-risk, early-stage malignant breast tumors as an alternative to
surgery. The lead author of the study is Dr. Richard Fine, an ICE3 Investigator, who
co-authored the publication with 24 doctors who
are ProSense® users including co-primary
investigator, Dr. Kenneth
Tomkovich.
"Publication of our final ICE3 results in this prestigious
peer-reviewed surgical oncology journal is a very important
milestone toward ProSense® being widely recognized as a
safe and effective alternative to surgery for low-risk, early-stage
breast cancer, and it is very well timed, as we look ahead to our
U.S. Food and Drug Administration ("FDA") Advisory Panel meeting in
November," stated IceCure's Chief Executive Officer, Eyal Shamir. "We believe the wealth of data
presented in the article will support and accelerate the market
adoption of ProSense®, should the FDA grant marketing
clearance. Our thanks go out to Dr. Fine, his co-authors, and the
entire team of doctors and patients who participated in ICE3, with
the aim of bringing a minimally invasive and patient-friendly
alternative to women with low-risk, early-stage breast cancer."
Dr. Fine commented, "Our analysis of the trial's primary
outcome, ipsilateral breast tumor recurrence (IBTR) at 5 years,
suggests that cryoablation with ProSense® is safe and
effective for patients with early-stage low-risk breast cancer. At
the 5-year follow-up, we observed local control similar to surgical
standard of care. Cryoablation may be considered as an alternative
to lumpectomy in this select population if followed by appropriate
adjuvant treatment. Future study within a clinical trial or
registry is encouraged to confirm cryoablation as a viable
alternative to surgical excision."
Key highlights and findings from the article
include:
- 194 patients meeting eligibility received successful
cryoablation treatment per protocol and were included in the final
results for analysis.
- The mean age was 74.9 years (55–94) with a mean tumor size of
7.4 mm transverse (2.8–14.0 mm) and 8.1 mm sagittal (2.5–14.9
mm).
- With a mean follow-up period of 54.16 months for the total
population of the ICE3 trial, the IBTR rate at 5 years was 4.3% and
breast cancer survival was 96.7%.
- Of the 124 patients who received cryoablation and endocrine
therapy, the IBTR was 3.7%, resulting in a recurrence-free rate of
96.3%.
- No serious device-related adverse events were reported.
- Quality-of-life score demonstrated statistically significant
improvement (p < 0.001) in distress at 6 months as compared with
baseline.
- 100% of patients and treating physicians were satisfied with
the cosmetic outcome.
- ICE3 is a non-randomized trial that was conducted at 19 sites
in the U.S.
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 the
belief that publication of the Company's final ICE3 results in the
Annals of Surgical Oncology is an important milestone toward
ProSense® being widely recognized as a safe and
effective alternative to surgery for low-risk, early-stage breast
cancer, and that it is well timed, in advance of the FDA Advisory
Panel, the belief that the data presented in the article will
support and accelerate the market adoption of ProSense®,
should the FDA grant marketing clearance, and other clinical
considerations in future studies. 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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