GLOBAL RESEARCH ARCHIVE
FDA Clearance Expected in 2Q26; Maintain Buy and $3 PT
Research evidence excerpt
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
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