Data on IceCure's ProSense® Cryoablation for Low-Risk Breast Cancer Presented at Radiological Society of North America's 2024 Annual Meeting

Rhea-AI Summary

IceCure Medical (NASDAQ: ICCM) presented data from its ICE3 trial of ProSense® cryoablation technology at the Radiological Society of North America's 2024 Annual Meeting. The study, presented by ICE3 Co-Principal Investigator Dr. Kenneth Tomkovich, demonstrated promising results for treating early-stage low-risk breast cancer.

Key findings include a five-year recurrence rate of 3.7% with adjuvant endocrine therapy and 4.3% in the eligible trial population, comparable to surgical lumpectomy outcomes. The procedure offers significant advantages over surgery, including outpatient treatment with local anesthesia, minor adverse events, and 100% patient satisfaction with cosmetic outcomes.

Following a favorable FDA Advisory Panel vote in November 2024, the FDA's marketing authorization decision is expected in Q1 2025. The ICE3 trial, being the largest of its kind, supports the transition towards less invasive breast cancer treatment options.

• ICE3 trial results presented by ICE3 Co-Principal Investigator Dr. Kenneth Tomkovich
• FDA Advisory Panel voted in favor of IceCure's ProSense® cryoablation benefit-risk profile in early-stage low risk breast cancer in Nov. 2025
• FDA's marketing authorization decision expected in Q1, 2025 

CAESAREA, Israel, Dec. 16, 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 that data from its ICE3 trial of ProSense's® in early-stage breast cancer were presented at the Radiological Society of North America's 2024 Annual Meeting on December 5, 2024 in Chicago, IL. The abstract titled "Cryoablation as a primary treatment for low-risk breast cancer less than 1.5 cm without surgical excision final results of the ICE3 Trial" was presented by Dr. Kenneth Tomkovich, co-principal investigator of the ICE3 trial.

Dr. Tomkovich commented, "The significance of the ICE3 results in the field of radiology, especially among breast radiologists, cannot be overstated. As the largest study of its kind, ICE3 provides crucial data that can support the shift towards the de-escalation of breast cancer care with cryoablation as a less invasive procedure, enabling the cohort of patients included in ICE3 to have a safe and effective option to surgical lumpectomy."

"ProSense®'s ICE3 results are gaining increasing prominence across a range of medical specialty conferences globally, as well as through prominent peer reviewed journals. This is critical support for market adoption leading up to the expected decision of the U.S. Food and Drug Administration ("FDA") regarding marketing authorization of ProSense® for early-stage breast cancer in the U.S.," stated IceCure CEO Eyal Shamir.

The presentation's findings included the following:

• The overall five-year recurrence rate of 3.7% in combination with adjuvant endocrine therapy and 4.3% in the eligible ICE3 trial population is similar to reported recurrence rates for the current standard of care, surgical lumpectomy.
• Substantial benefits, as compared to surgery, include performance in an outpatient setting using local anesthesia, the only reported adverse events being minor in severity, and 100% patient satisfaction with cosmetic outcomes.
• Results of the ICE3 trial suggest that cryoablation for small low-risk breast cancers is a safe and effective primary treatment option alternative to surgical lumpectomy.
• Sentinel lymph node biopsy is likely not required in this cohort of patients

About ProSense®
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.

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 belief that the significance of the ICE3 results in the field of radiology, especially among breast radiologists, cannot be overstated, the belief that ICE3 provides crucial data that can support the shift towards the de-escalation of breast cancer care with cryoablation as a less invasive procedure, enabling the cohort of patients included in ICE3 to have a safe and effective option to surgical lumpectomy, and that ProSense®'s ICE3 results gaining increasing prominence is critical support for market adoption leading up to the expected decision of the FDA regarding marketing authorization of ProSense® for early-stage breast cancer in the U.S. 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 are the key results of IceCure's ICE3 trial for breast cancer treatment?

The ICE3 trial showed a 3.7% five-year recurrence rate with adjuvant endocrine therapy and 4.3% in the eligible population, comparable to surgical lumpectomy. The trial demonstrated 100% patient satisfaction with cosmetic outcomes and only minor adverse events.

When is the FDA expected to make a decision on ProSense's marketing authorization?

The FDA's marketing authorization decision for ProSense® is expected in Q1 2025, following a favorable Advisory Panel vote in November 2024.

What advantages does ProSense cryoablation offer over traditional surgery for breast cancer?

ProSense cryoablation offers several advantages: it can be performed in an outpatient setting using local anesthesia, has only minor reported adverse events, and achieves 100% patient satisfaction with cosmetic outcomes.

What size breast tumors were treated in the ICCM ICE3 trial?

The ICE3 trial focused on low-risk breast cancers less than 1.5 cm in size.

Where was IceCure's ICE3 trial data presented in December 2024?

The ICE3 trial data was presented at the Radiological Society of North America's 2024 Annual Meeting in Chicago, IL on December 5, 2024.