- Expects to submit full dataset to the FDA in April for
marketing authorization of ProSense® for minimally invasive
treatment of early-stage breast cancer
- Study represents largest cryoablation study of its kind
in the U.S. for early-stage low-risk malignant breast
tumors
CAESAREA, Israel, March 19,
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,
today announced positive topline results from the Company's ICE3
study, the largest controlled multicenter clinical trial ever
performed for liquid nitrogen (LN2) based cryoablation of low-risk,
early-stage malignant breast tumors, following the 5-year follow-up
evaluation of the ICE3 study's last patient. In the ICE3 study,
96.39% of patients (187 out of 194 patients) were local
recurrence-free with no significant device-related adverse events
or complications reported.
Based on the strength of the topline results,
ProSense has the potential to be a safe and effective alternative
to lumpectomy for early-stage breast cancer. The Company plans to
complete the analysis and evaluation of the full data set and
expects to submit the results to the U.S. Food and Drug
Administration (the "FDA") in April
2024, as previously requested by the FDA with respect to
IceCure's De Novo Classification Request for Marketing
Authorization of ProSense® for the treatment of early-stage
low-risk breast cancer.
"We are very pleased with this topline outcome
and believe these results demonstrate a highly favorable safety and
efficacy profile that positions ProSense® as a desirable
alternative to lumpectomy for early-stage breast cancer. Having
completed the study on schedule, we are now compiling the full data
set which we plan to submit to the FDA next month for marketing
clearance," stated Eyal Shamir,
Chief Executive Officer of IceCure. "While the FDA evaluates the
data, we are optimistic their upcoming decision will give women in
the U.S. the same access as those who are already benefitting from
ProSense® in other countries."
"On behalf of the entire IceCure team, I thank
the patients, their families, the sites and the clinicians for
taking part in this landmark study. This has been a rigorous and
thoroughly performed, ten-year long trial with positive data at
each interval that is validated by recent independent studies
performed globally by leading physicians ."
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 the Company anticipates that it will submit the results of the
ICE3 study in April 2024; that the
Company believes ProSense®'s potential to offer a safe and
effective alternative to lumpectomy for early-stage breast cancer;
that the ICE3 topline outcome positions ProSense® as a desirable
alternative to lumpectomy for early-stage breast cancer; and that
the Company is optimistic regarding the upcoming decision by the
FDA regarding the Company's De Novo Classification Request for
Marketing Authorization of ProSense® for the treatment of
early-stage breast cancer. 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,
2022 filed with the U.S. Securities and Exchange Commission
(the "SEC") on March 29, 2023, 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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