Hyperfine (HYPR) investor relations material

Key product and technology highlights

• Developed the first FDA-cleared portable brain MRI, offering a strong proprietary position and AI-enabled image quality with over 200 patents.

• The Swoop® system, powered by Optive AI™, delivers near-conventional MRI image quality at ultra-low field strength (64 milli-Tesla), enabling use in diverse care settings without specialized infrastructure.

• AI integration supports artifact removal and image reconstruction, with 10 generations of software upgrades and multiple FDA AI clearances.

• The platform is currently focused on brain imaging but has potential for expansion to other anatomies and clinical use cases.

• Clinical evidence supports use in critical care, neurology offices, and for conditions like stroke and Alzheimer's, with ongoing and completed studies.

Market opportunity and commercialization

• U.S. market opportunity exceeds $6 billion, with potential to grow north of $16 billion as deployment expands to community and primary care settings.

• Early commercialization targets critical care, emergency departments, ORs, clinics, and neurology offices, both inside and outside hospitals.

• International expansion includes partnerships (e.g., King's College London, Gates Foundation) and anticipated entry into the India market.

• The system is reimbursed under the same CPT code as conventional MRI, supporting adoption in both hospital and office settings.

• The first sale of the latest generation scanner was completed within 31 days of FDA clearance, indicating strong commercial momentum.

Financial and operational outlook

• The Swoop® system is priced at $550,000 in the U.S. for hospitals, with contracts typically spanning two to five years and recurring revenue streams.

• Achieving just 1.5% U.S. device penetration could yield $100 million in revenue, with significant operating leverage and gross margin expansion expected.

• ROI for hospitals is estimated at one to one and a half years, much shorter than typical capital equipment.

• Office-based neurologists represent a fast-growing segment due to shorter sales cycles and streamlined accreditation and reimbursement processes.

• The company is positioned for transformative top-line growth in the second half of the year, supported by a strong technical and strategic team.