IceCure Receives High Level of Interest from Breast Surgeons at ASBrS 2025 Annual Meeting Following Recent Positive FDA Development on ProSense® Cryoablation
Rhea-AI Summary
IceCure Medical (NASDAQ: ICCM) reported strong interest from breast surgeons at the ASBrS 2025 Annual Meeting following recent positive FDA developments for their ProSense® cryoablation system. The company's ICE3 study was recognized as one of the "Best Papers of 2024" and received favorable mention during the ASBrS Presidential Address.
The FDA has requested a post-market study for ProSense® in treating early-stage low-risk breast cancer in women aged 70+ when combined with adjuvant endocrine therapy. The planned study will include 400 patients across 25 sites. The company's participation at ASBrS included system demonstrations, ultrasound course training, and an expert booth meeting featuring former ASBrS President Dr. Nathalie Johnson.
Positive
- Recent positive FDA development regarding marketing authorization pathway for ProSense®
- ICE3 study recognized as one of the 'Best Papers of 2024'
- High interest from breast surgeons in participating in post-market study
- Favorable mention of cryoablation technology in ASBrS Presidential Address
Negative
- FDA requires additional post-market study before final marketing authorization
- Marketing authorization still pending FDA approval
- Limited initial market to women aged 70 and over with early-stage low-risk breast cancer
News Market Reaction – ICCM
In the trading session that priced this news, ICCM gained 0.95%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Breast surgeons expressed strong interest in participating in IceCure's planned post-market study for ProSense® in the treatment of early-stage breast cancer
- ICE3 study named as one of the "Best Papers of 2024"
- Cryoablation was mentioned favorably during the ASBrS Presidential Address
"We couldn't be more pleased with the high level of interest in ProSense® at the ASBrS 2025 Annual Meeting and the reaction of breast surgeons to the recent positive
The Company's participation included:
- Exhibiting its ProSense® cryoablation system at its booth and providing hands-on demonstrations;
- Sponsoring and participating in the pre-conference ultrasound course where hands-on ProSense® training was provided; and
- Hosting an Expert Booth meeting titled "The Future of Cryoablation in Breast Cancer: A Focus on the Patient Journey" with featured speaker Dr. Nathalie Johnson, former ASBrS President, and guest speaker Dr. Richard Fine, ICE3 Investigator
During the ASBrS Presidential Address, cryoablation was positively mentioned and the importance of breast surgeons needing to have the skills to provide all therapeutic procedures for their patients was underscored—including minimally invasive and percutaneous procedures, such as cryoablation. The address specifically mentioned the ICE3 study and stated that the ASBrS awaits a final decision from the FDA for breast cancer cryoablation.
Additionally, the ICE3 study was included in the Best Papers of 2024 review where a summary of the data was presented, and it was noted that cryoablation is a technique that should be "in the hands of" breast surgeons.
On April 30, 2025, IceCure announced it concluded a meeting with the FDA's Center for Devices and Radiological Health regarding the Company's De Novo marketing authorization request for ProSense® in the treatment of early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over. During the meeting, the FDA requested that IceCure conduct a study after marketing authorization has been granted, with the aim of producing additional data in this indication. IceCure will present its post-market study plan, which is expected to include a minimum of 400 patients at 25 sites, to the FDA, and upon the approval of such plan, the FDA's final marketing authorization decision is expected.
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
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 prospective participation of doctors in the planned post-market study; the Company's belief that its technology can offer greater choice to women with early-stage breast cancer; the prospective final decision from the FDA for marketing authorization for ProSense in the treatment of early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over; and the Company's prospective post-market study plan presentation. 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 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
Todd Kehrli
Phone: 310-625-4462
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