HYPR News & Events

Reports Q4 revenue $5.29M vs $2.32M last year. "The launch of our second-generation Swoop scanner, our Optive AI software, and the addition of a new market in the neurology office setting in mid-2025 marks a new era in the adoption of portable brain MRI and the future of our company. We hold a highly proprietary and differentiated technology leadership position in the ability to produce diagnostic quality images with an ultra-low-field magnet," said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. "As we move through 2026, we expect to continue to see growth catalysts accelerate the adoption of the Swoop system across multiple sites of care in the hospital, neurology office and international markets."

Hyperfine announced results from the NEURO PMR study, presented at the American Society of Neuroimaging annual meeting in San Juan, Puerto Rico on January 16. NEURO PMR is the first prospective, multi-center, real-world study to evaluate the clinical utility and patient experience of portable MRI compared to standard-of-care MRI in outpatient neurology clinics. Two sites-DENT Neurologic Institute and Texas Neurology-enrolled 125 patients with neurologic conditions commonly seen in the outpatient setting, including headache, dementia, multiple sclerosis follow-up, and tumor surveillance. Patients received brain imaging on both the portable Swoop system and a conventional high-field MRI, enabling direct modality comparisons. Portable MRI demonstrated 92% concordance with standard MRI in identifying the presence or absence of intracranial pathology during a blinded review by independent neuroradiologists. In unblinded paired image reviews incorporating clinical history, concordance increased to 98%, as assessed by a neurologist and neuroimager. Patients reported that they were four times more likely to choose it over standard MRI. Across all experience measures-including comfort, anxiety, claustrophobia, noise, and overall satisfaction-portable MRI was rated superior to standard MRI.

Hyperfine 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. 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.