IceCure Expands ProSense® ChoICE Study for Low-Risk Breast Cancer adding Legacy Health in Portland, OR as U.S. Clinical Site

What was announced

IceCure Medical announced the addition of Legacy Health’s Legacy Medical Group–Surgical Oncology at Good Samaritan Medical Center in Portland, Oregon as a new U.S. clinical site in the ChoICE post-market study evaluating ProSense® cryoablation for low-risk breast cancer. The company named Nathalie Johnson, M.D., FACS to provide clinical leadership for the Legacy Good Samaritan site, and identified local physicians Marco Aru and Jennifer Garreau as co-investigators. The release frames this as an expansion of the U.S. clinical network supporting the study.

Sources: S1

Study scope and regulatory status

According to the company release, the ChoICE Study is an FDA-approved post-market study designed to generate additional real-world clinical data on ProSense® in the treatment of low-risk breast cancer. IceCure states the study is expected to enroll approximately 400 patients across up to 30 clinical sites in the United States and is being conducted under a standardized protocol.

Sources: S1

Clinical leadership and site support

The announcement identifies Nathalie Johnson, M.D., FACS as co-primary investigator for the ChoICE Study and says she will provide clinical leadership for the Legacy Good Samaritan site's participation. The Legacy Health Oncology Clinical Research team is cited as supporting enrollments at the site.

Sources: S1

Company and product background

The release restates IceCure's business focus on minimally-invasive, liquid-nitrogen-based cryoablation systems and notes that ProSense® has been cleared by the FDA for a specified local breast cancer indication described in the release.

Sources: S1

Why this may matter (inference)

If the study enrolls and completes per the standardized protocol described by the company, additional post-market clinical data on ProSense® could broaden evidence available about its use as a minimally invasive alternative to surgery for eligible patients with low-risk breast cancer. The addition of a recognized regional health system and named clinical leadership may affect local enrollment capacity and operational execution of the study.

Sources: S1

What remains uncertain

• All study size, enrollment timing and outcomes described in the press release are forward-looking statements from the company and are not independently verified by the issuer; enrollment expectations are not guarantees.
• The press release is issuer-provided information and does not constitute independent clinical validation of safety or effectiveness beyond the statements and regulatory clearances reported by the company.
• The release describes FDA clearance and a post-market study but does not provide trial data, endpoints, enrollment timeline, or interim results in the text provided.