Positive Data from IceCure's Kidney Cancer Clinical Study Presented at Interventional Radiology Conference: Minimally Invasive Approach Results in Shorter Hospitalization and Minor Impact on Renal Function

• ICESECRET interim results, as previously announced, demonstrated ProSense® to be safe and effective in treating kidney tumors with 89.5% recurrence-free rate
• More data is expected in the fourth quarter of 2024, including data on patients with an average follow up of approximately 3 years 
• $6.92 billion global kidney cancer treatment market in 2024 expected to reach $8.78 billion by 2029—ProSense® is approved for the treatment of benign and malignant kidney tumors in the U.S., Europe, and numerous other countries

CAESAREA, Israel, June 12, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" 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 data from an interim analysis of its ICESECRET kidney cancer trial were presented at the 3^rd Annual Israeli Conference on Interventional Radiology in Tel Aviv, Israel on June 10, 2024. Dr. Avivit Shoham, Deputy Director of the Vascular and Interventional Radiology Unit at Beilinson Rabin Medical Center, presented a session on Cryotherapy of Renal Malignancies in Israel, which included data previously shared in December 2022 at the Urological Association Conference in Eilat, Israel.

Professor Sarel Halachmi, the Principal Investigator of the ICESECRET clinical trial, said, "Cryoablation is a safe and effective, minimally invasive ablative approach for treating renal cell carcinoma presenting with tumors ≤3 centimeters, resulting in shorter hospitalization than nephrectomy and minor side effects on the renal function and on hemoglobin levels. Further studies are needed to confirm cryoablation as a viable option to treat kidney lesions."

IceCure's CEO Eyal Shamir added, "The data were very well received by interventional radiologists attending the conference from around the world and locally here in Israel. We are pleased to advance ProSense®'s applications across numerous indications. Kidney cancer is an indication in which our minimally invasive cryoablation system may offer significant benefits."

About ICESECRET
ProSense® is being evaluated for the indication of kidney cancer in ICESECRET, a prospective, multicenter, single-arm clinical trial performed at Bnai-Zion Medical Center, Haifa, Israel, and Shamir Medical Center, Zerifin, Israel. The trial includes 115 patients (138 lesions) with localized small renal masses of ≤5 centimeters who were treated with ProSense® cryoablation under CT guidance. Full engulfment of the renal lesion, including a safety margin of 0.5 centimeters was achieved in approximately 96% of the procedures where there was no anatomical limitation. Follow-up visits are performed 6 weeks, 6 months, 1 year, and then annually up to 5 years after the procedure. During the follow-up visits, data related to local recurrence, based on CT imaging, is collected. Safety was determined by monitoring procedure-related adverse events throughout the study.

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 prospective future studies and that ProSense® may be able to offer benefits to patients with kidney 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, 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.

IR Contact:

Email: [email protected]
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462

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SOURCE IceCure Medical