• PRECICE study, financed by the Umberto Veronesi Foundation and the Italian Ministry of Health, is led by multidisciplinary collaborators including breast surgeons, interventional radiologists, and breast imaging and pathology specialists
• PRECICE is exclusively using ProSense® to treat all 233 Luminal A and B patients >50 years of age with early-stage breast cancer, a wider population of patients than ICE3  
• Article published in European Journal of Cancer Prevention describes the PRECICE study and presents the role of cryoablation in the move toward de-escalation of surgical treatment

CAESAREA, Israel, Nov. 19, 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 of early breast cancer: the challenge towards de-escalation of surgical treatment" in the European Journal of Cancer Prevention.

The article, authored by breast surgeons and interventional radiologists including Director of Interventional Radiology at the European Institute of Oncology in Milan, Italy, Franco Orsi, MD, presents a review of recent studies and literature on cryoablation of breast cancer, stating:

"The scientific assumption moving researchers is that cryoablation could represent a precise and safe alternative to the surgery itself for a selected subgroup of women."

The article highlights the Percutaneous Cryoablation of Low-risk Early Breast Cancer (PRECICE) study, led by Principal Investigator, Dr. Orsi. PRECICE is an independent prospective observational 233 patient study that has commenced the enrollment of women 50 years of age and older with unifocal, small (up to 15 mm in diameter), clinically node-negative, luminal A and B breast cancer.

The PRECICE study, which will exclusively use ProSense® to conduct all procedures, will evaluate the technical effectiveness of cryoablation with a median follow-up of five years (with early primary and secondary outcomes after three years). The procedure failure rate will be evaluated for possible residual tumor by mammography, ultrasound, and nuclear MRI at two months before radiotherapy and six months after radiotherapy. If relapse is suspected, an image-guided breast biopsy will be performed. Additional endpoints including quality of life, psychological impact, and economic outcomes will also be evaluated.

"Dr. Orsi and his team are leading one of the largest studies of cryoablation in early-stage breast cancer and examining cryoablation's role as an alternative to lumpectomy. Importantly, PRECICE is using ProSense® to examine a wider population of patients than ICE3 did, including women as young as 50 and those diagnosed with luminal B breast cancer," stated IceCure's CEO, Eyal Shamir. "The accelerating move towards the de-escalation of surgical treatment further supports the potential for excellent patient outcomes, improved healthcare economics, and increased market penetration for ProSense®."   

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 potential of cryoablation as a precise and safe alternative to surgery, the details of the PRECICE study, and the belief that the accelerating move towards the de-escalation of surgical treatment further supports the potential for excellent patient outcomes, improved healthcare economics, and increased market penetration for ProSense®. 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.

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