IceCure Medical Receives FDA Response to De Novo Classification Request for Breast Cancer
- ProSense system continues to have FDA clearance for other indications in the U.S.
- ProSense cryoablation procedure available to women sooner for low-risk breast cancer
- ProSense system received Breakthrough Device Designation in March 2021
- No significant device-related adverse events reported
- De Novo Classification request denial affects breast cancer indication
- FDA requires additional scientific literature for lumpectomy comparison
- Company working with FDA to address comments
"The positive expected five-year results based on the interim analysis of the ICE3 trial, which demonstrated a survival-based estimate for the 5-year ipsilateral breast tumor recurrence (IBTR) of
The Company's ProSense system was given a Breakthrough Device Designation by the FDA in March 2021, and previously received clearance in the
ICE3 is the largest controlled multi-location clinical trial ever performed for liquid nitrogen (LN2)–based cryoablation of small, low-risk, early-stage malignant breast tumors without subsequently removing them. The trial began in 2014 and has 194 eligible patients) in 19 hospitals and medical centers across the
*Based on the last interim results release on October 19, 2022, there have been 6 cases of ipsilateral breast tumor recurrence ("IBTR") out of 194 patients, or
About ProSense
ProSense cryoablation is a minimally invasive, non-surgical, outpatient 40-minute procedure that only requires a local
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
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 and Israeli 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: the expected plan and progress towards completion of the follow-up on the ICE3 clinical study in February 2024; evaluating all strategies to efficiently and effectively address the FDA's comments; and the expected 5-year results passed on the interim analysis of the ICE3 trial. Historic 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. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those 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.
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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