IceCure: Request for Marketing Authorization of ProSense® for Early-Stage Breast Cancer Reopened

 IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the U.S. Food and Drug Administration ("FDA") has responded affirmatively to the Company's request for supervisory review ("Appeal") under 21 CFR 10.75 regarding the FDA's prior denial of IceCure's De Novo Classification Request for treating patients with early-stage, low risk breast cancer.

The FDA determined there is sufficient basis to reopen the De Novo file and requested IceCure to submit the full 5-year dataset from the Company's ICE3 trial. The final ICE3 study patient is expected to complete her 5-year follow up examination by the end of February 2024. IceCure plans to expedite data monitoring and analysis to submit the final 5-year dataset to the FDA by April 2024, which is several months ahead of the Company's prior submission timeline.

In its initial De Novo classification request in October 2022, IceCure submitted interim results from its ICE3 study, the largest controlled multi-location clinical trial ever performed for liquid-nitrogen (LN2)-based cryoablation of small, low-risk, early-stage malignant breast tumors. The ICE3 study will provide 5-year recurrence outcomes on a patient population which represents approximately 65,000 people in the U.S. alone annually.

Additionally, the FDA requested that IceCure submit an analysis of the ICE3 results compared with data from the LUMINA study. LUMINA, a study sponsored by the Ontario Clinical Oncology Group (Canada) evaluated the risk of recurrence in patients with low-risk Luminal A breast cancer who were treated with lumpectomy surgery with adjuvant hormone therapy. A full peer-reviewed article on LUMINA results was published in August 2023, while FDA review of IceCure's De Novo request was underway.

IceCure was invited by the FDA to submit real-world data from the use of ProSense® globally, including post-market commercial use in territories where ProSense® is approved for breast cancer, as well as data from independent third-party studies.

https://www.prnewswire.com/news-releases/us-fda-grants-icecure-medicals-appeal-reopens-de-novo-classification-request-for-marketing-authorization-of-prosense-for-early-stage-breast-cancer-302047629.html