IceCure Medical’s ProSense Cryoablation Treatment Gains FDA Approval

IceCure Medical has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its ProSense cryoablation treatment designed for women aged 70 and over with early-stage, low-risk breast cancer. This approval marks ProSense as the first medical device to obtain FDA clearance for the local treatment of breast cancer, according to the company.

The ProSense procedure involves a minimally invasive approach where local anesthesia is administered, and a doctor employs ultrasound imaging to guide a thin hollow needle, known as a cryoprobe, into the breast tumor. Once in position, the cryoprobe uses liquid nitrogen to create extremely cold temperatures, which effectively destroys the tumor by forming an ice ball around the targeted tissue.

The FDA’s decision to authorize ProSense was influenced by data from a multi-centre clinical trial involving 194 patients. Results indicated that only 3.1% of patients with hormone receptor-positive and HER2-positive breast cancer experienced local recurrence within five years following treatment with cryoablation combined with endocrine therapy.

While the FDA has granted approval, it has mandated that IceCure conduct a post-market surveillance study to collect further data on the treatment’s long-term efficacy and safety. This additional study is expected to include approximately 400 patients.

IceCure highlights several advantages of ProSense, including the preservation of breast shape, a short outpatient procedure, and reduced recovery time. Most adverse events reported during studies were mild, with common issues including swelling, bruising, hematoma, skin burns, and postoperative pain.

Following the announcement, shares of IceCure Medical (ICCM) saw a brief surge, reaching a high of $1.4 before settling back down. Retail sentiment surrounding ICCM stock shifted dramatically, moving from ‘bearish’ to ‘extremely bullish’ within a day, leading to a notable increase in message volume on social media platforms. Despite a 4% decline this year, ICCM stock has risen approximately 74% over the past 12 months.

The approval of ProSense represents a significant advancement in treatment options for older women diagnosed with low-risk breast cancer, aiming to provide a less invasive alternative while ensuring effective outcomes.