Substantial Evidence-Based Data Currently Being Generated by 19 Ongoing Studies Using IceCure Medical's ProSense® Cryoablation System

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Nov 06, 2023, 08:00 ET

Independent, non-sponsored studies by doctors using ProSense® to treat cancers of the breast, lung, kidney, and musculoskeletal system, as well as endometriosis and fibroadenomas
Growing body of scientific data, including 13 breast cancer studies, is expected to drive adoption
ProSense® is approved for various indications in 15 countries including the U.S., Canada, Europe, Brazil, and China

CAESAREA, Israel, Nov. 6, 2023 /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 that in parallel with the growing adoption of ProSense®, the number of independent, non-sponsored studies of its cryoablation system has significantly increased. In addition to the 12 studies already published in peer reviewed journals and presented in scientific conferences, two IceCure studies, ICE3 and ICESECRET, and 17 independent, non-sponsored studies are ongoing. There are 13 published and ongoing studies for breast cancer. The remaining studies are focused on fibroadenomas, endometriosis, and malignant or benign tumors of the lung, kidney, and musculoskeletal system.

The ICE3 study, which is expected to be finalized in the first quarter of 2024, is the largest U.S.-controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage breast cancer. Interim results show a 96.91% recurrence free rate, 100% safety, and 100% doctor and patient satisfaction with cosmetic results.

A recently published independent study conducted using ProSense® in Europe to treat early-stage breast cancer produced very similar results, reporting a 96.8% success rate in women with early-stage breast cancer who declined surgery. Another independent study in Europe demonstrated a 93.4% to 96.8% tumor reduction rate in women diagnosed with molecular subtype Luminal-A and Luminal-B tumors who were deemed inoperable for breast cancer.

"The number of practitioners who are currently using ProSense® and choosing to conduct and publish studies independently is astonishing, and we believe the high proportion of breast cancer studies demonstrates a desire to provide women a safe and effective alternative to the standard of care lumpectomy," stated IceCure's CEO, Eyal Shamir. "Through our own market feedback, we understand that doctors and patients favor minimally invasive procedures that produce results similar to or superior than open surgery. Cryoablation also reduces costs for payers and minimizes or eliminates cosmetic scarring. We believe that all of these studies, collectively, are an indication that we are at a tipping point in the global commercial adoption of ProSense® and we hope that the resulting data will lead to changes in the standard of care for many of these indications."

About IceCure Medical Ltd.

IceCure Medical Ltd. (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 and Israeli 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 statement in this press release when it discusses: that studies are anticipated to commence across critical growth markets; the expected conclusion of its ICE3 study in the first quarter of 2024; and the belief that there is demand for alternative treatment to the standard of care lumpectomy. 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. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, some of which are beyond the control of the Company. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things: our planned level of revenues and capital expenditures; our available cash and our ability to obtain additional funding; our ability to market and sell our products; legal and regulatory developments in the United States and other countries; our ability to maintain our relationships with suppliers, distributors and other partners; our ability to maintain or protect the validity of our patents and other intellectual property; our ability to expose and educate medical professionals about our products; political, economic and military instability in the Middle East, specifically in Israel; as well as those 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 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.

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Todd Kehrli
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SOURCE IceCure Medical