MDAI Spectral Ai, Inc. - 8-K

EX-99.1
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ea029296201ex99-1.htm
PRESS RELEASE ISSUED BY SPECTRAL AI, INC. ON JUNE 1, 2026

Exhibit
99.1

Spectral
AI Announces Voting Results of Annual Meeting of Stockholders

Provides
Update and Outlook Following Receipt of FDA De Novo Clearance for

DeepView®
System for Burn Indication

DALLAS,
TX - June 1, 2026 - Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”) , an artificial
intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced
results from its 2026 Annual Meeting of Stockholders, held on May 29, 2026.

The
Company also provided an overview of its accomplishments to date and targeted milestones for 2026 following the receipt of De Novo Classification
for its DeepView® System from the U.S. Food and Drug Administration (“FDA”).

2026
Annual Meeting of Stockholders

A
total of 17,267,570 shares representing 54.3% of the Company’s total shares outstanding were represented at the meeting, either
in person or by proxy. All three of the proposals set forth by the Company were approved by its stockholders.

The
voting results are detailed below. Five directors were elected to serve on the Company’s Board of Directors until the next Annual
Meeting of Stockholders:

●

Dr.
J. Michael DiMaio, MD, a founder of the Company and Chairman of the Board of Directors

●

Richard
Cotton, Chairman of the Company’s Audit Committee and Lead Independent Director

●

Martin
Mellish, Chairman of Aspen Advisory Services Ltd.

●

Deepak
Sadagopan, Business Lead, Value Based Platform at Risant Health

●

Marion
Snyder, Zone Vice President, Strategic Accounts, at Shockwave Medical

The
Company’s stockholders also ratified the appointment of Forvis Mazars, LLP as the Company’s independent registered public
accounting firm for the 2026 fiscal year and authorized the reservation and issuance of shares of common stock pursuant to a Securities
Purchase Agreement dated October 24, 2025.

A
New Chapter for Spectral AI

“The
receipt of FDA clearance for our DeepView System for Burn Indication is the culmination of years of hard work by our dedicated team and
a defining moment in Spectral AI’s history,” said Vincent Capone, Chief Executive Officer. “Spectral AI is now poised
to evolve from a late stage, pre-clearance medical device company to a scaling, commercially focused enterprise. We are moving forward
with renewed momentum and a clear vision for the future.”

Key
2026 Operational and Business Achievements

●

Received
FDA clearance for the DeepView System for Burn Indication; with this classification, Spectral
AI is now authorized to commence commercial distribution activities in the United States.

●

Awarded
$31.7 million of advanced funding from the Biomedical Advanced Research and Development Authority
(“BARDA”) to accelerate and support additional feature aspects for the DeepView
System.

●

Expanded
leadership team in advance of commercial activities, including the recent appointment of
David McGuire as Chief Financial Officer.

●

Delivered
a fully functioning prototype of our Deep View System handheld device under our Department
of Defense contract through the contracting consortium called MTEC.

●

Finalized
the development of the Outcome Study, which will focus on the benefits derived from the use
of the DeepView System across clinician workflows and patients’ journeys with an intended
scope of approximately 286 patients spread across 12 clinical sites.

●

Showcased
the DeepView System at this year’s Annual Meeting of the American Burn Association
(“ABA”), which included an overview of the technology to attendees at the ABA
Innovation Theater.

●

Received
the “Small Business Innovator Award” at the inaugural Texas Innovation Conference,
which was held in April 22-23, 2026 at the campus of Texas Christian University.

Anticipated
Operational and Commercial Milestones

●

Generate
first-ever commercial sales of the DeepView System by year end 2026:

○

United States : Phase
II of our contract with BARDA includes funding for the procurement of up to 30 DeepView System devices in burn centers and level
one trauma centers and emergency departments across the United States.

○

International :
We anticipate initial sales in the UK, Australia or the Gulf Cooperation Council nations by the fourth quarter of 2026 following
an update to our UKCA authorization (initially obtained in 2024) to reflect the characteristics of the DeepView System as cleared
by the FDA.

●

Continue
to strengthen executive and sales team by filling key positions to support the commercial roll out of the DeepView System.

●

Initiate
Outcome Study in the fourth quarter of 2026. The Study is designed to demonstrate the surgical precision that results from a wound
assessment made by the DeepView System and how improved time to treatment decisions will beneficially impact a patient’s overall
care journey.

About
the DeepView System

Spectral
AI’s DeepView System is a non-invasive, predictive medical device which combines multispectral imaging with a proprietary AI algorithm
to assess the healing potential of areas within the burn wounds. The DeepView System provides clinicians with an immediate, data-driven
assessment of whether areas within burn wounds are unlikely to heal within 21 days and may require significant medical intervention,
enabling earlier and more informed treatment decisions. The image acquisition takes 0.2 seconds, and all image processing
and AI model classification takes approximately 20 to 25 seconds. The DeepView System is trained and tested against a proprietary and
clinically validated database of over 340 billion pixels of burn wound image data.

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About
Spectral AI

Spectral
AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound
care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by
“Seeing the Unknown®” with its DeepView System. The DeepView System is being developed as a predictive diagnostic device
to offer clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical
intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView System is
expected to provide fast and accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs.
Spectral AI has been named to TIME’s list of World’s Top HealthTech companies 2025. For more information about the DeepView
System, visit www.spectral-ai.com.

Forward-Looking
Statements

Certain
statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions
of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans,
objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,”
“expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,”
“seeks,” “may,” “will,” “should,” “future,” “propose” and variations
of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking
statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of
known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that
could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers
are cautioned not to place undue reliance on any forward-looking statements.

Investors
should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections
of the Company’s filings with the US Securities and Exchange Commission, including the Company’s Registration Statement and
the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause
actual events and results to differ materially from those contained in the forward-looking statements.

Investors:

The
Equity Group

Devin Sullivan

Conor Rodriguez

Managing Director

Associate

[email protected]

[email protected]

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