On September 20, 2023 IceCure Medical Ltd. (Nasdaq: ICCM), developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported that the U.S. Food and Drug Administration ("FDA") has at this time denied the Company’s De Novo Classification request for breast cancer which was submitted based on interim analysis from its ICE3 study (Press release, IceCure Medical, SEP 20, 2023, View Source [SID1234635296]). The FDA’s position on the De Novo Classification request for breast cancer has no effect on ProSense’s FDA cleared authorization for other indications in the U.S. and patients in the U.S. continue to have access to ProSense for those treatments. The Company is pursuing all avenues to address the FDA’s response as global adoption of ProSense outside of the United States continues to build. IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients who are at high risk to surgery (not suitable for surgical alternatives). IceCure continues its ICE3 clinical study, the largest clinical trial of its kind, which is expected to complete during the first quarter of 2024.
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"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 4.3%*, allowed us a rare and unique opportunity to submit a De Novo Classification request and make our minimally-invasive ProSense cryoablation procedure available to women sooner for this important and underserved indication," commented Eyal Shamir, Chief Executive Officer. "We, along with our regulatory consultants, believe the FDA’s response to the De Novo Classification request is largely due to the FDA’s need for additional scientific literature as a comparator rate of recurrence in patients treated with lumpectomy. We are committed to working with the FDA to address its comments by using the broadly available published scientific literature on recurrence outcomes in patients treated with lumpectomy. ProSense remains available in the U.S. under prior FDA clearances and we will continue to execute our plan and progress towards achieving our primary objective of completing the 5-year follow ups with our last patients in the ICE3 study by the first quarter of 2024, while we simultaneously evaluate all strategies to efficiently and effectively address the FDA’s comments."
The Company’s ProSense system was given a Breakthrough Device Designation by the FDA in March 2021, and previously received clearance in the U.S. for general minimally invasive cryoablation applications, including kidney, liver and benign breast tumors. ProSense is approved for the treatment of malignant breast tumors in other jurisdictions, including Europe, China, and Brazil.
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 U.S., including Columbia University Medical Center and Mount Sinai Beth Israel. The expected survival-based estimate for the 5-year IBTR was 4.3%* for patients who received ProSense system cryoablation treatment are free of recurrence, with one-third of patients reaching 5 years post treatment. Additionally, to date, there have been no significant device-related adverse events reported with no scarring or change in shape and size of the breasts, while 100% of doctors and 100% of patients reported satisfaction with the cosmetic results.
*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 3.09%. The survival-based estimate for the 5-year IBTR is 4.3% with a one-sided 95% confidence level, upper bound of 8.4% for the entire study.
About ProSense
ProSense cryoablation is a minimally invasive, non-surgical, outpatient 40-minute procedure that only requires a local 1% lidocaine injection (similar to its use by dentists when performing certain dental procedures) enabling the patient to remain alert during the procedure and then walk out of the doctor’s office to resume their day. Cryoablation costs less than the current standard of care breast cancer surgery of lumpectomy or partial mastectomy which requires general anesthesia and has cosmetic consequences.