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European Study Provides More Evidence Supporting IceCure's ProSense is Safe & Effective Cryoablation Treatment for Metastatic and Recurrent Breast Cancer Independent, third-party data published in highly influential peer

Key Takeaway: A recent independent study published in the journal Cancers has validated the safety and effectiveness of IceCure's ProSense cryoablation treatment for metastatic and recurrent breast cancer. Conducted at the University Hospital Frankfurt, the study reported a 100% complete ablation rate with no complications observed in a heterogeneous patient population. Furthermore, the findings suggest that ProSense is a viable outpatient procedure, offering promising outcomes in terms of survival and local tumor control. These results enhance the clinical significance of ProSense across a wider spectrum of breast cancer cases in Europe.

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POSITIVE FACTORS

  • ProSense demonstrates a 100% complete ablation rate.
  • Low complication rate observed in the study with no complications reported.
  • The treatment can be performed on an outpatient basis with good cosmetic results.
  • The study supports ProSense's broader applicability for various breast cancer diagnoses.

Full Press Release Details

European Study Provides More Evidence Supporting
IceCure's ProSense is Safe & Effective Cryoablation Treatment for Metastatic and Recurrent Breast Cancer
Independent, third-party data published in highly influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense is a safe, local treatment for breast cancer with low complication rate, high complete ablation rate and satisfactory overall survival (OS), progression free survival (PFS) and local tumor control
8.9% recurrence rate in population of 45 patients who had previously received various therapies before cryoablation including surgery, radiation therapy, or chemotherapy with tumor sizes of up to 4 centimeters in diameter. Of those patients, 11 had recurrent tumors and 21 had metastatic disease
The higher-risk population in this European study contrasts with the early-stage breast cancer patient subjects in the U.S. ICE3 study
CAESAREA, Israel, July 9, 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
the publication of an independent study evaluating its flagship cryoablation system ProSense titled: "CT-Guided Percutaneous
Cryoablation of Breast Cancer: A Single-Center Experience" in Cancers, a leading peer-reviewed oncology journal. The study,
led by Principal Investigator Professor Thomas J. Vogl, was conducted at the Institute of Radiology and Nuclear Medicine, University
Hospital Frankfurt, at Goethe University, Germany.
Professor Vogl commented, "Liquid Nitrogen-based
cryoablation was found to be a safe local treatment for breast cancer, with a low complication rate-in fact, none were observed
in the study. We experienced a very high complete ablation rate of 100%. Overall survival, progression free survival and local tumor control
were all good, especially given the very heterogenous patient population. The fact that this is a minimally invasive procedure that can
be performed on an outpatient basis with excellent cosmetic results are clear advantages. We look forward to further evaluations of cryoablation
especially in comparison to other treatment modalities for early, recurrent, and metastatic breast cancer."
"While this study's patient population
is very different from our U.S. based ICE3 study and the target indication for which we have filed for regulatory approval in the U.S.,
the results of the study are highly valuable for ProSense users in Europe where our system is approved for general breast cancer
treatment. This higher risk patient population included patients with metastatic disease and tumors of up to 4 centimeters in diameter,
as compared to our ICE3 study population with early-stage disease and tumors smaller than 2 centimeters in diameter, indicating a very
different recurrence rate. Importantly, it further informs and supports the use cases of ProSense across a broader range of breast
cancer diagnoses, from newly diagnosed early-stage to metastatic and recurrent disease," stated IceCure CEO Eyal Shamir. "We
thank Dr. Vogl, his team, and University Hospital Frankfurt for their initiative in conducting this study and expanding the body of knowledge
for the cryoablation of breast cancer."
This independent study, which received no financial
support from IceCure, retrospectively evaluated the efficacy and safety of liquid-nitrogen based CT-guided cryoablation with ProSense .
Patients were treated in out-patient settings with curative intention for non-metastatic patients, while patients with metastases were
treated to achieve local tumor control. The patient population (n=45, with 56 tumors) with a mean age of 55.6 12.5 years (range,
31.3-86.0 years) was very heterogeneous and different from IceCure's ICE3 study population and included 11 patients with recurrent
tumors and 21 patients with metastatic disease. Patients were observed at three, six, nine, and 12 months, respectively, and after the
first year were followed up biannually. There were four cases of local tumor progression, representing a rate of 8.9%. There were no complications
observed in any of the 56 ablations and initial complete ablation was achieved in 100% of cases.
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
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
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: further evaluations of cryoablation,
especially in comparison to other treatment modalities for early, recurrent and metastatic breast 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.

Frequently Asked Questions

What does the ProSense system treat?

The ProSense system treats tumors, both benign and cancerous, by freezing them.

How effective is cryoablation with ProSense?

Cryoablation with ProSense achieved a complete ablation rate of 100% in the study.

What was the recurrence rate in the study population?

The study reported an 8.9% recurrence rate among the 45 patients evaluated.

Is ProSense safe for patients?

Yes, the study found no complications, indicating ProSense is a safe treatment.

Who conducted the independent cryoablation study?

The study was led by Professor Thomas J. Vogl at University Hospital Frankfurt.

Last updated: Jul 9, 2024