Hyperfine (HYPR) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Technology and innovation

• Developed the first FDA-cleared, portable, ultra-low field brain MRI system with over 150 patents, enabling deployment across diverse care settings and neurological conditions.

• System is easy to use, operates via tablet, and does not require specialized MR technicians, allowing broader clinical adoption.

• AI-powered software receives regular upgrades, with the ninth generation recently FDA-cleared, maintaining a cadence of two updates per year.

• Platform supports diagnostic imaging from newborns to elderly, with no age restrictions and broad indications for use.

• Partnerships with organizations like the Gates Foundation and King's College London have expanded global reach, especially in remote and low-resource settings.

Market expansion and clinical strategy

• Growth focuses on expanding MRI access to sites lacking conventional MRI, targeting critical care, pediatrics, emergency rooms, clinics, and neurology offices.

• Market opportunity is estimated at $1.5B for current hospital settings, $6B+ for stroke and Alzheimer's, and $16B+ for broader brain health screening.

• Ongoing market adoption studies in stroke (ACTION PMR) and Alzheimer's (CARE PMR) aim to validate workflow and clinical benefits, with workflow phases and broader access expected in the second half of next year.

• Accreditation process for neurology office settings underway, with pilot studies planned to expand into this segment by late next year.

• International expansion includes new distributors in Europe and Asia Pacific, with India market entry expected in the second half of 2025.

Clinical evidence and impact

• Studies show value in critical care, pediatrics, stroke, and Alzheimer's, with 15 publications in current business, 19 in Alzheimer's and stroke, and 10 in brain health.

• CARE PMR study supports monitoring of ARIA complications in Alzheimer's patients on new amyloid therapies, addressing increased MRI demand.

• ACTION PMR study in stroke has completed detection phase and is moving to workflow phase to demonstrate clinical and economic benefits.

• Participation in major conferences has increased clinician and researcher engagement, highlighting the need for accessible MRI.

• User groups and reference centers established to guide further adoption and innovation.