- 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
3rd 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: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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