Hyperfine Enrolls First Participant In Contrast PMR Trial To Evaluate Contrast-Enhanced Ultra-Low-Field Portable MRI

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced the enrollment of the first patient in the Contrast PMR study, a prospective, multi-center clinical study designed to evaluate the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI. The study is intended to support a future FDA submission to expand the Swoop® system's intended use to include gadolinium-based contrast agents, potentially unlocking new applications across multiple care settings.

The primary objective of the study is to evaluate the visualization of brain lesions, including lesions associated with blood-brain barrier disruption, using contrast agents with ultra-low-field portable MRI. Visualization benefits will be assessed using three endpoints related to lesion appearance. The study will enroll approximately 70 patients across multiple sites in the United States.