IceCure Medical Reports Independent Study Published in PLOS One Demonstrating ProSense® Cryoablation Safe and Effective in Treatment of Breast Fibroadenomas
MWN-AI** Summary
IceCure Medical Ltd. recently announced the publication of a significant independent study in the peer-reviewed journal PLOS One, detailing the efficacy and safety of its ProSense® cryoablation system for treating benign breast tumors known as fibroadenomas. With cryoablation being a non-invasive alternative to surgical excision, this study reinforces the potential for ProSense® as a preferred treatment method.
Conducted at the Premier Med Healthcare Institute in Hungary and led by Dr. Teodora Filipov and Dr. Pál Ákos Deák, the research revealed that ProSense® achieved an impressive median volume reduction of 80.6% at approximately six months and 92.9% at one year following treatment. The study uniquely focused on larger fibroadenomas, utilizing multiple cryoprobe relocations to ensure comprehensive tumor treatment. This represents a shift from previous studies, which predominantly assessed smaller lesions.
IceCure estimates that cryoablation could efficiently address around 63,000 cases of fibroadenoma excision annually in the U.S., making this innovation highly relevant. The findings may prompt updates in treatment guidelines issued by medical societies such as the American Society of Breast Surgeons, potentially impacting clinical practices for benign breast tumors.
Eyal Shamir, CEO of IceCure, emphasized the importance of these findings in demonstrating the safety and efficacy of ProSense® cryoablation, particularly for women seeking a minimally invasive treatment option with reduced recovery times and minimal scarring.
The ProSense® system, which utilizes liquid nitrogen for creating effective treatment areas, has FDA clearance for low-risk breast cancer treatment in specific patient demographics, further enhancing its clinical adoption as a viable alternative to surgical interventions for various tumors.
MWN-AI** Analysis
IceCure Medical Ltd. (Nasdaq: ICCM) has recently announced the publication of an independent study validating the efficacy of its ProSense® Cryoablation system in treating breast fibroadenomas. The demonstration of a remarkable 92.9% reduction in tumor volume one year post-treatment highlights a significant advancement in minimally invasive treatment options for benign breast tumors, a market that IceCure estimates could address approximately 63,000 cases in the U.S. annually.
For investors, this study underscores a pivotal opportunity for both market penetration and potential shifts in treatment protocols within medical societies. The independence and peer-review of the study add credibility, potentially influencing guidelines issued by influential groups such as the American Society of Breast Surgeons.
Moreover, given the overwhelming evidence supporting ProSense®'s safety and effectiveness, the device is poised for increased adoption in clinical settings. With an aging global population and a growing demand for less invasive procedures, IceCure’s technology aligns well with current healthcare trends favoring rapid recovery and minimal scarring.
From a financial perspective, IceCure's growth trajectory looks promising, especially as healthcare providers seek alternatives to surgical excision, which is still the standard care for fibroadenomas. This could translate to an increase in revenues and broaden the company's market share in cryoablation therapy.
As the company navigates potential regulatory and market hurdles, investors should remain cautious yet optimistic. The results of this latest study could lead to increased healthcare provider engagement, patient awareness, and ultimately, an uptick in stock performance. As we move forward, monitoring follow-up studies, regulatory decisions, and partnership developments will be critical in evaluating IceCure Medical’s long-term value in the rapidly evolving oncology landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
Treatment with ProSense® resulted in 92.9% volume reduction of fibroadenoma one-year post-cryoablation
Findings may impact treatment guidelines issued by medical societies for large non-cancerous breast tumors; study is believed to be the first to evaluate larger lesions and use multiple cryoprobe relocations
ProSense® Cryoablation has FDA-clearance for fibroadenomas
CAESAREA, Israel, March 2, 2026 /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 option to surgical tumor removal, today announced the publication of an independent, investigator-initiated study evaluating ProSense® for the treatment of non-cancerous breast tumors, or fibroadenomas. The study, titled "Cryoablation for fibroadenoma with liquid nitrogen-based system: A retrospective analysis of prospectively collected data," was published in the peer-reviewed journal PLOS One.
Fibroadenoma is the most common benign breast lesion identified through core needle biopsy. Up to 10% of women will have a fibroadenoma at some point in their lives, according to the Cleveland Clinic. Surgical excision is currently the standard of care for many fibroadenomas, particularly for larger lesions or those causing discomfort. IceCure estimates that cryoablation could address approximately 63,000 cases of fibroadenoma excision in the U.S. annually.
"We believe this publication is very significant because it reinforces the safety and effectiveness of ProSense® cryoablation for fibroadenomas and may contribute to updates in treatment guidelines for non-cancerous breast tumors issued by medical societies in key markets where ProSense® is used, including the American Society of Breast Surgeons," said Eyal Shamir, IceCure's Chief Executive Officer. "Previous studies supporting cryoablation for fibroadenomas were often limited to lesions 4 centimeters or smaller, and many were published more than a decade ago. This study is unique in that it includes a large patient cohort and evaluates larger lesions using multiple cryoprobe relocations. We are grateful to the study's investigators for their pursuit of improved outcomes for patients and their use of ProSense® for their study."
The study was conducted at the Premier Med Healthcare, Training, and Research Institute in Hungary and led by Dr. Teodora Filipov and Dr. Pál Ákos Deák. The investigators concluded that cryoablation with a liquid nitrogen system, specifically ProSense®, proved safe and effective, demonstrating a median volume reduction of 80.6% at approximately six months and 92.9% at one-year post-treatment. The study further found that sequential cryoprobe relocations preserve safety and efficacy. ProSense® cryoprobes can be relocated up to three times per patient, per procedure enabling physicians to fully treat large or multifocal lesions through complete ablation coverage.
IceCure believes these findings further support the growing clinical adoption of minimally invasive cryoablation as an alternative to surgical excision for benign breast tumors, particularly for women seeking minimal scarring and short procedure times.
About ProSense®
The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.
ProSense® 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 in the 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 the 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 option to 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 United States, Europe and Asia.
Forward Looking Statement
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 potential number of cases of fibroadenoma excision that cryoablation could address in the U.S. annually; the potential impact of the study's findings on future treatment guidelines for non-cancerous breast tumors; the possibility that the results may contribute to updates by medical societies such as the American Society of Breast Surgeons; and the expectation that these findings will further support the growing clinical adoption of ProSense as an alternative to surgical excision for benign breast tumors. 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, 2024 filed with the U.S. Securities and Exchange Commission ("SEC") on March 27, 2025, 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
Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
SOURCE IceCure Medical
FAQ**
How does the independent study published in PLOS One regarding IceCure Medical Ltd. ICCM provide evidence for the increased adoption of ProSense® Cryoablation in clinical practice for treating larger fibroadenomas compared to previous studies?
What are the implications of the reported 92.9% volume reduction in fibroadenomas one year post-treatment with ProSense® Cryoablation by IceCure Medical Ltd. ICCM on current treatment guidelines issued by medical societies?
Considering the study's findings, how might IceCure Medical Ltd. ICCM address potential concerns from healthcare professionals regarding the safety and effectiveness of cryoablation for non-cancerous breast tumors?
How can IceCure Medical Ltd. ICCM leverage the results of the PLOS One study to enhance its marketing strategy for ProSense® Cryoablation in both domestic and international markets?
**MWN-AI FAQ is based on asking OpenAI questions about IceCure Medical Ltd. (NASDAQ: ICCM).
NASDAQ: ICCM
ICCM Trading
-3.98% G/L:
$0.6415 Last:
64,866 Volume:
$0.668 Open:
