Full Press Release Details
IceCure's ProSense Cryoablation Safe
and Effective in Destruction of Kidney Tumors with 88.7% Recurrence-Free Rate Based on Interim ICESECRET Study Results
CAESAREA, Israel, December 5, 2024 -
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
interim results from the Company's ICESECRET study of cryoablation for patients with small renal masses ("SRM") who cannot
be offered kidney preserving surgery. Data were presented on December 5, 2024 at the Israeli Urological Association Conference in Eilat,
Israel. The presentation titled "Renal Mass Cryoablation - Interim Analysis of ICESECRET Study" was delivered by Dr. Keren Boguslavsky
of Bnai Zion Medical Center.
Results were reported at a mean follow-up period
of 36 months for 111 patients with 117 lesions. A summary of the key results were:
"The ability to offer cryoablation for kidney
cancer is a large unmet need, particularly in patients who are ineligible for kidney preserving surgery. We are very pleased that ICESECRET's
latest interim results present ProSense as a safe and effective option for these patients. These results are particularly
important since ProSense is already approved for the as a cryosurgical tool in the destruction of malignant and benign
tumors of the kidney in key markets including the U.S. and Europe," stated IceCure's Chief Executive Officer, Eyal Shamir.
According to the American Journal of Roentgenology, small renal masses,
which may be malignant or benign tumors in the kidney, have been increasing in incidence over the past two decades. According
to the American Cancer Society, in 2024, in the United States, an estimated 81,610 new cases of kidney cancer will have been diagnosed,
with approximately 14,390 dying from the disease. Globally, there were more than 434,000 new cases of kidney cancer in 2022 and about
156,000 deaths according to World Cancer Research Fund International.
ICESECRET, a prospective, multicenter, single-arm
clinical trial is being performed at Bnai Zion Medical Center in Haifa, Israel and Shamir Medical Center in Zerifin, Israel and is being
led by Principal Investigator Prof. Halahmi Sarel. The trial includes 114 patients (138 lesions) with localized SRM of 5 cm that
were ablated with ProSense cryoablation under CT guidance. Follow-up visits are performed six weeks, six months, one
year, and then annually up to five 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.
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 China.