Full Press Release Details
IceCure Announces Positive FDA Development:
Understanding on Path Forward for Marketing Authorization of ProSense Cryoablation in Women 70+ with Early-Stage Breast Cancer
CAESAREA, Israel, April 30th, 2025 - 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 it concluded a productive
meeting with the leadership of the U.S. Food and Drug Administration's ("FDA") Center for Devices and Radiological Health
("CDRH") regarding the Company's De Novo marketing authorization request for ProSense in the treatment of early-stage
low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over which represents approximately 46,000
patients annually in the U.S.
During the meeting, the FDA requested that IceCure conduct a study
after marketing authorization has been granted ("the post-market study"), with the aim of producing additional data in this
indication. IceCure will present its post-market study plan, which is expected to include a minimum of 400 patients at 25 sites, to the
FDA, and upon the CDRH's approval of such plan, the FDA's final marketing authorization decision is expected.
IceCure is now working diligently on the plan of the post-market study
which IceCure plans to submit in approximately a few weeks. The Company is in the process of recruiting clinical sites and doctors across
the U.S., including at the American Society of Breast Surgeons (ASBrS) Annual Meeting which takes place April 30 - May 4, 2025.
The Company believes this post-market study will support accelerated market adoption of ProSense in early-stage breast cancer.
"This is a very positive development, and we are pleased to have
had such a positive discussion with the FDA's CDRH leadership so that women aged 70 and over across America can have access to a
minimally invasive option for early-stage breast cancer with ProSense ," stated Eyal Shamir, IceCure's Chief Executive Officer.
"We are laser focused on the plan of our post-market study and look forward to finalizing it following deep engagement with the
leading breast surgeons and radiologists in the U.S., including at ASBrS this week. As such, the meeting with the FDA is very well timed.
We look forward to the FDA's approval of our post-market study plan and final marketing authorization decision for ProSense
in this indication. Our U.S. sales team is ready for commercialization."
Post-market study procedures will have access to reimbursement under
the CPT III code, which covers $3,800 of facility costs. IceCure expects additional reimbursement coverage in the future pending the FDA's
marketing authorization and other factors, including the post-market activity and recommendations from professional medical associations,
including the ASBrS.
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 Asia.
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 prospective post-market study plan, the Company's intention to submit such plan in
approximately a few weeks and the presentation of the post-market study plan; the expectation of the FDA's final marketing authorization
decision for ProSense upon the CDRH's approval of the post-market study plan; the Company's belief that the post-market
study will support accelerated market adoption of ProSense in early-stage breast cancer; the Company's prospective engagement
with leading breast surgeons and radiologists in the U.S. to finalize the post-market study; and the belief that the Company's U.S.
sales team is ready for commercialization. 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, 2024 filed with the SEC on March 27, 2025, 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.