FDA Clearance Expected in 2Q26; Maintain Buy and $3 PT

研报英文原文证据摘录

FDA Clearance Expected in 2Q26; Maintain Buy and $3 PT

Price Target S&P 500 (rebased)

Our base case assumes that Spectral AI will recognize revenue in line with its FY26 Source: FactSet

guidance of $18.5M from its existing BARDA contract. In addition to this, Spectral AI

will achieve its regulatory and clinical milestones over the next few years to bring a Company DescriptionEQUITY commercial technology to market by 1H26. Spectral AI is a company focused on

predictive medical diagnostics utilizing

artificial intelligence. Founded in 2013,

Upside Scenario Spectral AI's DeepView System uses

Upside to our estimates would be faster clinical and regulatory developments yielding multi-spectral imaging and AI to assess

higher BARDA-related revenue in FY26. More rapid development and commercial wound healing, allowing healthcareRESEARCH approval of the DeepView and DeepView M systems. New indications in other providers to determine next-step

market opportunities. Additional non-dilutive financing sources for OUS commercial treatment protocols. With the DeepView

opportunities or government related development contracts. If MDAI recognizes any Systems, clinicians can make a more

commercial sales in the UK or Australia, this would be upside as well. accurate, timely and informed decision

regarding the treatment of the patient’s

wounds on "Day One." Downside Scenario

Downside to our estimates would come from longer clinical and regulatory

development timelines yielding lower BARDA-related revenue. Setbacks in regulatory

or commercial approvals requiring more analysis, filings, or even clinical data. Lower

uptake of the DeepView system in a commercial setting.

BTIG, LLC Ryan Zimmerman (212) 527-3586 www.btig.com