IceCure Medical’s Treatment For Low-Risk Breast Cancer In Women Aged 70 And Over Receives FDA Approval

Shares of IceCure Medical (ICCM) went as high as $1.4 on Friday afternoon before paring back gains after the U.S. Food and Drug Administration granted marketing authorization for ProSense, a minimally invasive cryoablation treatment.

ProSense is for patients aged 70 and over with early-stage low-risk breast cancer and treated with adjuvant endocrine therapy. It is the first and only medical device to receive FDA marketing authorization for the local treatment of breast cancer, the company stated.

During the ProSense cryoablation procedure, a doctor injects local anesthesia and uses ultrasound imaging to guide a small cryoprobe, a thin hollow needle, into the breast tumor. Once the cryoprobe is placed, liquid nitrogen creates extremely cold temperatures, which destroy the breast tumor by creating an ice ball around the targeted tissue.

The approval of the treatment was based on data, including a multi-centre clinical trial with 194 patients. Only 3.1% of patients with hormone receptor-positive and HER2-breast cancer treated locally with cryoablation and endocrine therapy experienced local recurrence of breast cancer within five years after treatment in the study, IceCure said.

The company, however, stated that the FDA has requested it conduct a post-market surveillance study to generate additional data. The post-market study is expected to include approximately 400 patients, IceCure said.

IceCure lists several benefits to its treatment, including maintenance of breast shape, a short, outpatient procedure, and reduced recovery time. The majority of adverse events identified in studies were swelling, bruising, hematoma, skin burn, and postoperative pain, which were mild in severity, it added.

On Stocktwits, retail sentiment around ICCM stock soared from ‘bearish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘extremely high’ levels.

ICCM stock is down 4% this year but up by about 74% over the past 12 months. 

Read also: Rocket Pharma Stock Gets A Price Target Cut After Withdrawing FDA Application For Rare Bone Marrow Disorder Gene Therapy

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