Hyperfine, Inc. announced that the first patients have been enrolled in the CARE PMR (Capturing ARIA Risk Equitably with Portable MR) observational study. The study is designed to assess the clinical utility and workflow benefits of Swoop system images acquired at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer's patients receiving amyloid-related imaging anomalies (ARIA) in Alzheimer' patients receiving amyloid-targeting therapy at the times specified in the labeling (before the fifth, seventh, and fourteenth infusions). Alzheimer'sd disease is the most common form of dementia worldwide, affecting more than six million people in the U.S. alone.

Patients with Alzheimer's can now be treated with amyloid-targeted therapy, which reduces the amyloid plaque burden in the brain. Potential side effects for patients using amyloid-targeting Therapy exist, including ARIA, and patients are required to receive multiple MRI brain scans during their first year of treatment as included in the FDA-approved labeling for the medication. The Swoop system is a portable, AI-powered, ultra-low-field MR brain imaging system designed to be available when and where physicians need it, potentially allowing for timelier treatment decisions.

Brain images acquired with the Swoop system can help physicians diagnose a variety of neurological conditions without the delays, costs, and inconvenience of a conventional high-field MRI scan. The Swoop Portable MR Imaging system is U.S. Food and Drug Administration (FDA) cleared and has been approved for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop System also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop system is commercially available in a select number of international markets.