Full Press Release Details
IceCure Reports 70% Growth in Active U.S. Commercial
Base for Breast Cancer Cryoablation Following FDA Clearance
Increase driven by FDA clearance, clinical guideline
support, and increased physician demand. Significant rise in number of leads for ProSense systems generated at U.S. medical society
conferences compared to last year
ProSense breast cancer cryoablation procedures
have been performed in major cities across the U.S.
CAESAREA, Israel, June 17, 2026 -
IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), today reported
a 70% increase in its U.S. active commercial install base of ProSense for breast cancer cryoablation following U.S. Food and Drug
Administration (FDA) marketing authorization in October 2025, reflecting accelerating commercial adoption, expanding physician demand
and continued growth in the Company's U.S. footprint.
IceCure develops and commercializes its minimally
invasive cryoablation technology that destroys tumors by freezing, offering an option to surgical tumor removal for the local treatment
of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgery.
IceCure has continued to add new ProSense
systems to its installment base at clinics and hospitals across the U.S. As adoption expands, ProSense breast cancer cryoablation
procedures have been performed in major metropolitan areas throughout the country, including Los Angeles, New York, Atlanta, Dallas, Detroit,
Philadelphia, Phoenix, Memphis and many other communities.
The Company had strong engagement at two of the
leading breast health conferences held this earlier year, the Society of Breast Imaging ("SBI") Annual Symposium and the American
Society of Breast Surgeons ("ASBrS") Annual Meeting, where IceCure generated significantly more sales leads for ProSense
systems compared to the same events in 2025, prior to FDA authorization, reflecting significantly increased interest from physicians and
healthcare providers.
"With growing physician interest, expanding
clinical acceptance, and increased patient awareness, we believe we remain in the early stages of a significant commercial opportunity
for breast cancer cryoablation in the U.S.," said IceCure's Chief Executive Officer, Eyal Shamir. "We are focused on continuing
to expand our installed base, supporting physicians with training and education and increasing access to ProSense for eligible patients."
In addition to regulatory approval, other factors
Growing Clinical Acceptance - ASBrS recently
updated its Resource Guide to recommend cryoablation as a local treatment option for low-risk breast cancer patients, marking an important
milestone in the clinical adoption of minimally invasive breast cancer therapies. IceCure believes the updated guidance reflects growing
recognition among breast surgeons and healthcare professionals of cryoablation's potential role in treating appropriately selected patients.
Increasing Patient Awareness - Patient
awareness of breast cancer cryoablation continues to grow as ProSense receives broader media attention. Recent coverage by Reuters
and local television news segments aired across approximately 190 CBS and CW-affiliated stations nationwide (including Boston, Philadelphia,
and Chicago) have highlighted cryoablation as a minimally invasive alternative to surgery for eligible breast cancer patients. IceCure
believes this increased visibility is helping educate patients and physicians about available treatment options.
The ProSense Cryoablation System is the first
and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine
therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A
full list of benefits and risks can be found on the Company's website.
ProSense 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 in the breast, kidney, lung, and
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 the 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 option to 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.
Forward Looking Statement
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:
accelerating commercial momentum in the U.S. market and growth in the Company's U.S. footprint; growing physician interest in and
demand for ProSense; expanding clinical acceptance and increased patient awareness of ProSense; the believe that the Company is in the
early stages of a significant commercial opportunity for breast cancer cryoablation in the U.S.; the Company's focus on continuing
to expand its installed base, supporting physicians with training and education, and increasing access to ProSense for eligible patients;
and the Company's belief that increased visibility regarding cryoablation is helping educate patients and physicians about available treatment
options. 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, 2025 filed with the
United States Securities and Exchange Commission ("SEC") on March 17, 2026, 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.
Phone: +972-54-227-8916