IceCure Announces Positive Data from the Largest Multi-Institutional Study of its Kind: "Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials"

Rhea-AI Summary

IceCure Medical (Nasdaq: ICCM) announced positive data from a large multi-institutional study on cryoablation of primary breast cancer in patients ineligible for clinical trials. The study, published in the American Journal of Roentgenology, included 112 high-risk patients with a median age of 71. Recurrence-free rates were 94.7%, 87.8%, and 81.8% at 1, 2, and 3 years, respectively. The study used various cryoablation systems, including IceCure's ProSense®, across 7 U.S. institutions. Treatment showed a low frequency of adverse events (6.3% minor, no moderate or major) and high technical success (98.2%). Researchers concluded that cryoablation remains a safe alternative to surgery with good outcomes, especially for poor surgical candidates due to comorbidities.

Positive

• High recurrence-free rates of 94.7%, 87.8%, and 81.8% at 1, 2, and 3 years respectively
• Low frequency of adverse events (6.3% minor, no moderate or major)
• High technical success rate of 98.2% for cryoablation procedures
• Study supports cryoablation as a safe alternative to surgery for high-risk patients

Negative

• Study included various cryoablation systems, not exclusively IceCure's ProSense®

Medical Research Analyst

This study represents a significant advancement in breast cancer treatment options, particularly for high-risk patients. The 94.7%, 87.8% and 81.8% recurrence-free rates at 1, 2 and 3 years respectively are promising, especially considering the study population included patients with metastatic disease and large tumors. The 98.2% technical success rate and low 6.3% minor adverse event rate further underscore the procedure's efficacy and safety.

However, it's important to note that this study's population differs from IceCure's ICE3 study, which focused on early-stage breast cancer. The broader applicability demonstrated here could potentially expand the market for cryoablation technologies like ProSense®, pending further research and regulatory approvals.

Financial Analyst

This independent study could significantly impact IceCure's market position. While the company's ICE3 study targets early-stage breast cancer, this research opens doors to a broader patient base, potentially including those with more advanced disease or comorbidities. This expansion could substantially increase the addressable market for ProSense®.

However, investors should note that the study used multiple cryoablation systems, not just ProSense®. The positive results don't exclusively benefit IceCure but could boost the entire cryoablation market. The company's success will depend on its ability to leverage these findings in regulatory approvals and market penetration strategies. The ongoing FDA approval process for early-stage breast cancer remains important for near-term prospects.

Oncology Doctor

This study is a game-changer in breast cancer treatment, especially for high-risk patients often excluded from clinical trials. The recurrence-free rates are impressive given the challenging patient population. The low adverse event rate (6.3% minor, no moderate or major) is particularly noteworthy, suggesting cryoablation could be a safer alternative to surgery for certain patients.

However, we must interpret these results cautiously. The median patient age of 71 and the inclusion of patients with comorbidities may limit generalizability. Long-term follow-up and comparison with standard surgical outcomes in similar populations are needed. Still, this study opens exciting possibilities for personalized treatment approaches in breast cancer management.

• Investigator initiated independent study included higher risk patients such as those with metastatic disease, large tumors, and comorbidities, as compared to IceCure's ICE3 study which treated early-stage breast cancer patients
• Recurrence-free rates were 94.7%, 87.8%, and 81.8%, at 1, 2, and 3 years, respectively
• Study published in American Journal of Roentgenology was conducted at 7 U.S. institutions and led by Principal Investigators Dr. Karim Oueidat and Dr. Robert Ward, both of the Warren Alpert Medical School of Brown University

CAESAREA, Israel, Aug. 7, 2024 /PRNewswire/ -- 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 titled "Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials: A Multi-institutional Study" in a leading radiology journal, the American Journal of Roentgenology (AJR).

This multi-institutional study is the largest study of breast cancer cryoablation in women ineligible for prospective clinical trials due to particular patient or tumor characteristics. IceCure's ICE3 study, which evaluated the Company's ProSense® cryoablation system, enrolled early-stage breast cancer patients only. Based on the ICE3 results, IceCure has filed for regulatory approval of ProSense® in the U.S. for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.

As reported in the AJR, the independent study evaluated 112 patients with a median age of 71. ProSense® was one of four different cryoablation systems used for procedures performed at 7 U.S. institutions by 7 different radiologists, including 4 breast radiologists, 2 breast and interventional radiologists, and 1 interventional radiologist. The recurrence-free rates were 94.7%, 87.8%, and 81.8%, at 1, 2, and 3 years, respectively, when accounting for death, including from comorbidities, as a competing risk. Treatment with cryoablation had a low frequency of adverse events (AEs), with 6.3% of patients having minor AEs and no moderate or major AEs having occurred. A high frequency of procedures, 98.2%, were technically successful. The researchers concluded that in certain individuals with unfavorable patient or tumor characteristics, cryoablation remains a safe alternative to surgery that has overall good outcomes, especially in patients who are poor surgical candidates due to comorbidities. Patients in the independent study generally underwent cryoablation based on their preference for cryoablation.

"This study underscores the opportunity for cryoablation with ProSense® to offer a much-needed non-surgical alternative for women who may not be eligible for surgery," stated IceCure CEO Eyal Shamir. "It is important to note that the researchers found cryoablation to be a safe procedure with good outcomes, even in this higher risk population, which included patients with metastatic disease, large tumors, and more than half of the study participants having comorbidities. We thank the researchers and institutions for their initiative and participation in this independent 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 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 the conclusion from the study that cryoablation remains a safe alternative to surgery that has overall good outcomes, especially in patients who are poor surgical candidates due to comorbidities, and that the study underscores the opportunity for cryoablation with ProSense® to offer a much-needed non-surgical alternative for women who may not be eligible for surgery. 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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SOURCE IceCure Medical

FAQ

What were the recurrence-free rates in the IceCure ICCM breast cancer cryoablation study?

The study reported recurrence-free rates of 94.7%, 87.8%, and 81.8% at 1, 2, and 3 years, respectively, for breast cancer patients treated with cryoablation.

How many patients were included in the IceCure ICCM breast cancer cryoablation study?

The study included 112 patients with a median age of 71 who were ineligible for clinical trials due to particular patient or tumor characteristics.

What was the technical success rate of cryoablation in the IceCure ICCM study?

The study reported a high technical success rate of 98.2% for cryoablation procedures performed across 7 U.S. institutions.

What were the adverse event rates in the IceCure ICCM breast cancer cryoablation study?

The study showed a low frequency of adverse events, with 6.3% of patients experiencing minor adverse events and no moderate or major adverse events reported.