Spectral AI (MDAI) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Technology overview and clinical applications

• DeepView system uses AI and imaging to predict wound healing, classifying wounds as viable or non-viable for burns and diabetic foot ulcers.

• Provides objective, consistent assessments, outperforming generalists and even experts in some cases.

• Technology aims to improve equity of care across diverse clinical settings, including emergency departments and remote locations.

• Miniaturization projects target battlefield and mobile healthcare applications, expanding potential use cases.

Market opportunity and commercialization

• Annual spend is estimated at $3B for burns and $12B for diabetic foot ulcers.

• Target markets include 125 burn centers, 5,000 emergency departments, 1,100 wound care clinics, and 4,000 private practices.

• Commercial deployments underway in the UK, with five sites evaluating the device and first commercial sales expected later this year.

• Expansion plans include Australia (via Special Access Scheme), Europe (pending CE/CA mark), and Gulf countries.

Partnerships, funding, and regulatory progress

• BARDA has provided nearly $250M in funding across three contracts, supporting development, clinical trials, and FDA submission.

• Current BARDA contract base phase runs through Q1 2026, supporting ongoing clinical and regulatory work.

• Device has FDA breakthrough designation, enabling more frequent regulatory interactions.