Hyperfine (HYPR) Piper Sandler 37th Annual Healthcare Conference summary

Market opportunity and business fundamentals

• First FDA-cleared portable brain MRI enables access in critical care, ER, and OR settings, with a $6B current addressable market and potential to exceed $15B as technology expands to prevention and primary care.

• Attractive growth rates, gross margins, and disciplined spending support strong fundamentals and operating leverage.

• Over 190 global installations, 250,000+ images collected, and 200+ patents issued, providing a significant competitive advantage.

Technology and innovation

• Next-generation Swoop scanner with Optive AI software delivers best-ever image quality at 64 millitesla, enabling portability and intuitive operation via iPad.

• AI is used for denoising and reconstructing images, ensuring high-quality scans even in artifact-prone environments.

• System integrates seamlessly into clinical workflows and is reimbursed under conventional MRI codes.

• Recognized by FDA for leadership in AI-enabled medical technologies.

Commercial strategy and expansion

• Business structured into hospital, office, and international verticals, with commercial expansion across all three.

• Recent FDA clearance and Q3 launch of next-gen Swoop system led to placements in neurology offices, critical care, and ERs.

• International growth through distributors, with launches in Europe and anticipated regulatory approval in India for 2026.

• CapEx business model with $550,000 MSRP, annual software/service fees, and strong contract manufacturing partnerships.