Study Using IceCure's ProSense® Treatment Results in 100% Tumor Reduction in Early-Stage Breast Cancer

Rhea-AI Summary

IceCure Medical Ltd. announces groundbreaking results from an independent study on breast cancer treatment using its ProSense® System, reporting a median tumor reduction of 100% at 6 and 12 months post-cryoablation. The study conducted on inoperable women aged 60-92 showcases the effectiveness of cryoablation technology in destroying tumors non-invasively, offering new hope for patients who cannot undergo surgery.

Medical Research Analyst

The recent findings on cryoablation for breast cancer present a significant advancement in non-surgical cancer treatment options. Cryoablation, which involves freezing the tumor to destroy cancer cells, offers a less invasive alternative to traditional surgery, particularly for patients who are unable to undergo surgical procedures due to health issues or personal choice.

The reported 100% median tumor size reduction at 6 and 12 months is a remarkable outcome, especially given the patient demographic of older women with comorbidities. This suggests that cryoablation could be a game-changer for patient groups with limited treatment options. It's important, however, to consider the sample size and the study's single-site nature when evaluating these results. Larger, multi-site studies would be beneficial to confirm efficacy and safety across a broader population.

From a research perspective, the correlation between Contrast Enhanced Mammography (CEM) outcomes and biopsy results is also noteworthy. This could indicate a reliable non-invasive method for post-procedure monitoring, reducing the need for more invasive follow-up procedures.

Healthcare Economist

The potential impact of IceCure's ProSense® System on healthcare economics should not be underestimated. Minimally invasive procedures such as cryoablation can significantly reduce hospital stays, recovery times and overall treatment costs. For healthcare systems burdened by the high costs of cancer treatment, this could represent substantial savings.

Moreover, the ability to treat patients who are otherwise considered inoperable opens up new avenues for patient care. This could lead to increased demand for cryoablation procedures, which in turn may drive growth for IceCure Medical Ltd. and similar companies. However, the broader economic implications will depend on reimbursement policies, market penetration and the technology's adoption by healthcare providers.

Market Research Analyst

As IceCure Medical Ltd. seeks to expand the approval and availability of the ProSense® System globally, these study results could play a pivotal role in influencing regulatory decisions and market acceptance. A 100% median tumor reduction rate is a compelling data point that may enhance the company's value proposition to both clinicians and patients.

The company's stock performance could be positively influenced by this news, as investors often react favorably to positive clinical outcomes. However, investor sentiment will also be shaped by the company's ability to navigate the regulatory landscape, secure approvals and establish reimbursement pathways in various countries. The long-term impact on the stock will also hinge on the technology's adoption rate and the competitive landscape of breast cancer treatments.

Independent study in women deemed inoperable for breast cancer reports median tumor reduction of 100% at 6 and 12 months following cryoablation

CAESAREA, Israel, Feb. 26, 2024 /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 new data from a preliminary, independent breast cancer study conducted by Principal Investigator and ProSense® user, Dr. Federica. di Naro, of Azienda Ospedaliero-Universitaria Careggi, Diagnostic Senology Unit in Florence, Italy. IceCure previously announced interim results from this study on October 5, 2023. ProSense® is approved in Italy for numerous indications, including breast cancer.

In the single-site study conducted between January 2022 and January 2024, ultrasound-guided cryoablation using ProSense® was performed on 39 women aged 60-92, who had biopsy-proven malignant lesions, and were deemed inoperable due to advanced age and comorbidities, or who refused surgery. Patients were monitored at 1, 3, 6 and 12 months post-procedure, at which time the tumor size reduction rate was evaluated by ultrasound. Also at 12 months post-procedure, the effectiveness of the procedure was further evaluated by core needle biopsy on the post-procedural scar (inside the breast at the site of the tumor) and contrast enhanced mammography ("CEM") to determine the presence or absence of residual tumoral cells and effectiveness of cryoablation.

The median breast cancer tumor size reduction rates reported in the study were as follows:

1 month: 27.8%
3 months: 60.9%
6 months: 100.0%
12 months: 100.0%

"These are phenomenal results of 100% median tumor size reduction in as little as 6 months and its effectiveness demonstrated by correlation between CEM outcomes versus biopsy at 12 months after our minimally invasive procedure that takes up to 40 minutes. We are so pleased that women in this study, who were deemed inoperable, benefitted from cryoablation," stated IceCure CEO Eyal Shamir. "We are working hard to get ProSense® approved, available and affordable for as many women as possible in a number of countries around the world. This independent study is further validation of our mission, and we thank Dr. di Naro for her initiative in leading the study and giving patients options that save and prolong lives."

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 statement in this press release when it discusses its endeavors to get ProSense® approved, available and affordable for as many women as possible in a number of countries around the world. 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, 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.

Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462

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SOURCE IceCure Medical

FAQ

What were the median tumor reduction rates at 1, 3, 6, and 12 months post-cryoablation in the study?

The median breast cancer tumor reduction rates reported in the study were: 1 month - 27.8%, 3 months - 60.9%, 6 months - 100.0%, 12 months - 100.0%.

Who conducted the independent breast cancer study on cryoablation using ProSense®?

The study was conducted by Principal Investigator and ProSense® user, Dr. Federica di Naro, at Azienda Ospedaliero-Universitaria Careggi, Diagnostic Senology Unit in Florence, Italy.

What is the purpose of the ProSense® System developed by IceCure Medical Ltd.?

The ProSense® System is a minimally-invasive cryoablation technology that destroys tumors by freezing, providing an alternative to surgical tumor removal.

Where is ProSense® approved for use, including the treatment of breast cancer?

ProSense® is approved in Italy for various indications, including the treatment of breast cancer.

How many women were included in the study on cryoablation for breast cancer treatment?

The study included 39 women aged 60-92 with biopsy-proven malignant lesions who were deemed inoperable due to advanced age and comorbidities or who refused surgery.