Hyperfine (HYPR) investor relations material

Financial performance and outlook

• Achieved $4 million in Q1 revenue, marking 83% year-on-year growth and strong gross margin expansion; ended quarter with over $40 million in cash.

• Guidance for 2024 is $20–$22 million in revenue, 50%–55% gross margin, and reduced cash burn to $26–$28 million, with a cash runway through early 2028.

• Raised $20 million in a private offering in October and added debt in Q1, ensuring strong capitalization.

Regulatory and clinical milestones

• Secured FDA clearance for latest software generation and approvals in Europe (CE, UKCA) and India (CDSCO) for the second-generation system.

• Placed first system in India at AIIMS, New Delhi.

• Ongoing clinical study (ContrastPMR) aims to expand indications to contrast brain MRI exams, with FDA submission planned for later this year.

• Clinical data shows 98% concordance with conventional MRI in the NeuroPMR study and strong results in stroke triage.

Technology and product innovation

• Portable brain MRI operates at 64 mT, a fraction of conventional MRI field strength, enabling point-of-care imaging without specialized facilities or staff.

• AI-driven software and sequence development have led to image quality approaching that of conventional MRI, with 11 software generations and two hardware models.

• Over 200 patents and 250,000 images support ongoing AI and product improvements.

• Model 2 system features enhanced patient experience, faster mobility, and improved image quality.