Iryna Drozd/iStock via Getty Images IceCure Medical (NASDAQ:ICCM) said the FDA has agreed to review the agency's denial of De Novo classification for the company’s ProSense cryoablation system in the treatment of early stage, low-risk breast cancer. The Israeli medtech company said it plans to submit the full five-year dataset from its ICE3 study for the product as part of the review.

Iryna Drozd/iStock通过Getty Images IceCure Medical（纳斯达克：ICCM）表示，FDA已同意审查该机构拒绝对该公司ProSense冷冻消融系统进行从头分类，以治疗早期低风险乳腺癌。这家以色列医学技术公司表示，计划提交其ICE3研究中关于该产品的完整五年数据集，作为审查的一部分。

It expects the study's final patient to complete their five-year follow-up exam by the end of February, with submission of the study’s full dataset expected in April. The agency has also requested an analysis of the ICE3 results compared with data from the LUMINA study. The company is also invited to submit real-world data on the product.

它预计该研究的最后一名患者将在2月底完成为期五年的随访检查，并预计在4月提交该研究的完整数据集。该机构还要求对ICE3结果与LUMINA研究数据进行比较分析。该公司还被邀请提交有关该产品的真实数据。

More on IceCure Medical IceCure Medical Ltd (ICCM) Q3 2023 Earnings Call Transcript IceCure shares rally 53% on ProSense kidney cancer study IceCure stock climbs 10% amid FDA appeal, earnings report Seeking Alpha’s Quant Rating on IceCure Medical Historical earnings data for IceCure Medical .

有关IceCure Medical Ltd（ICCM）的更多信息IceCure Medical Ltd（ICCM）2023年第三季度收益通话记录IceCure股价上涨53%，ProSense肾癌研究IceCure股价上涨10%，FDA呼吁，收益报告寻求Alpha对IceCure Medical历史收益数据的量化评级。