Full Press Release Details
ICE3 5-Year Trial Results Published in the Peer Reviewed Annals of Surgical Oncology Journal: ProSense Cryoablation Without Excision
for Early-Stage, Low-Risk Breast Cancer Demonstrates 96.3% Recurrence Free Rate
CAESAREA, Israel, Sept. 24, 2024 (GLOBE NEWSWIRE)
-- 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
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."
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."
highlights and findings from the article include:
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.
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.