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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): September 27, 2023
SPECTRAL
AI, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-40058 |
|
85-3987148 |
(State
or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S.
Employer
Identification No.) |
2515
McKinney Avenue, Suite 1000
Dallas, Texas |
|
75201 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(972)
499-4934
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of
the following provisions:
☐ | Written
communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencements
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbols |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
MDAI |
|
The
Nasdaq Stock Market LLC |
Redeemable
Warrants, each whole warrant exercisable for one share of Common Stock, at an exercise price of $11.50 per share |
|
MDAIW |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 1.01 Entry into a Material Definitive Agreement.
On
September 27, 2023, Spectral AI, Inc. (the “Company”), entered into a contract (the “BARDA Contract”)
with the Biomedical Advanced Research and Development Authority (“BARDA”). BARDA is a division of the U.S. Department
of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. Under the BARDA Contract, the Company
will receive an award to support the advanced development of the DeepView® System, the Company’s AI-driven burn wound imaging
technology, to be used at emergency departments, trauma centers and burn centers, for both routine burn care and as a medical countermeasure
for use in burn mass casualty incidents.
The
BARDA Contract could result in payments to the Company of up to approximately $149 million. The BARDA Contract consists of an initial
base period and option periods that BARDA may exercise, subject to the Company achieving specified milestones and deliverables. Together
with the Company’s previously awarded BARDA contracts, the BARDA Contract brings the total support from BARDA to nearly $251 million.
The
BARDA Contract contains terms and conditions that are customary for government contracts of this nature, including provisions giving
the government the right to terminate the contract at any time for its convenience.
The
foregoing is a brief description of the material terms of the BARDA Contract and does not purport to be a complete description of the
rights and obligations of the parties thereunder. The foregoing description is qualified in its entirety by reference to the BARDA Contract,
which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending September 30, 2023.
Item 7.01. Regulation FD Disclosure.
On
September 28, 2023, the Company issued a press release announcing its entry into the BARDA Contract, a copy of which is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.
The
information in this Item 7.01 to this Current Report on Form 8-K, and in Exhibit 99.1 furnished herewith, shall not be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing
under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such
a filing.
Item 9.01. Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Dated:
September 28, 2023
|
SPECTRAL
AI, INC. |
|
|
|
By: |
/s/
Wensheng Fan |
|
Name:
|
Wensheng
Fan |
|
Title: |
Chief
Executive Officer |
2
Exhibit 99.1
Spectral
MD Awarded BARDA Project BioShield Contract Valued at $149 Million for
AI-Driven
DeepView® Burn Wound Imaging Technology
DALLAS,
Sept. 28, 2023
– Spectral MD, Inc. (“SMD”), a
subsidiary of Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“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
it has been awarded a new contract valued at up to $149 million by the Biomedical Advanced Research and Development Authority (BARDA),
part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S.
Department of Health and Human Services. The contract is for the advanced development of the DeepView® System, the Company’s
AI-driven burn wound imaging technology, to be used at emergency departments, trauma centers and burn centers, for both routine burn
care and as a medical countermeasure for use in burn mass casualty incidents (BMCI).
This
multi-year contract includes an initial award of nearly $55 million to support the clinical validation and FDA clearance of DeepView®
for commercial marketing and distribution purposes, a major milestone that enables the technology to become a key component of the U.S.
government’s BMCI preparedness efforts. The initial
award places up to 30 DeepView® devices at various burn centers and emergency rooms
to support the clinical validation study and will transition to being used in routine care upon FDA clearance. The
contract also includes options with an additional total value of approximately $95 million and can be exercised for additional
product development, procurement, and deployment of
DeepView® at U.S. emergency departments, trauma centers and burn centers in a phased approach. These deployments will enable SMD
to conduct health economic and outcome research to support broader clinical adoption of the DeepView® System.
Previously
in 2013 and 2019, SMD was awarded BARDA contracts totaling $123 million, of which $101 million has been committed to date. Together with
this new contract, it brings the total potential support from BARDA to nearly $251 million. This new contract represents the largest
contract ever awarded to SMD.
“We
appreciate that our DeepView® platform has been selected to address a critical need in preparing our country for possible BMCI events,”
said Wensheng Fan, the Company’s CEO. “This is a significant contract award that enables us to accelerate the late-stage
clinical development and commercialization of our DeepView® System. We are most grateful to BARDA for enabling us to help physicians
and their burn patients who will benefit from the use of DeepView®. For the first time, there will be an accurate and objective solution
in burn wound healing assessment to guide treatment. Spectral MD is committed to the development of impactful medical technologies, and
we will aim to bring DeepView® to market as quickly as possible.”
Jeffrey
Carter, M.D., the Company’s Chief Medical Consultant, added, “The current standard of care for burn wound assessment that
is crucial in determining next-step treatment relies largely on the clinical judgement of physicians. However, diagnostic accuracy can
be as low as 50%. This unmet clinical need is dramatically magnified in the event of a BMCI, where the ability to triage burn patients
rapidly and properly would be crucial in allocating valuable resources and managing the surgical burden. The DeepView® technology
represents a new paradigm in the assessment of burn wounds and can provide meaningful clinical guidance to physicians in their diagnosis
and treatment recommendations.”
This
work supports BARDA’s mission to identify medical countermeasures which help counter the effects of a BMCI and address the current
limitations within the United States’ burn care infrastructure. According to the American Burn Association, 1.1 million Americans
suffer from burn injuries each year, with 500,000 presenting to emergency departments, and 40,000 requiring hospitalization. In contrast
to this demand, only two percent of U.S. hospitals have burn centers, and there are only about 250 burn surgeons in the United States.
To
bridge this gap in care, the Company’s DeepView®
System, which received Breakthrough Device Designation from the FDA in 2017 for its burn indication,
integrates proprietary imaging technology and AI-enabled algorithms to see deep below the surface of the skin to distinguish between
healthy and damaged tissue. By seeing what the human eye cannot, DeepView® delivers
a binary wound healing prediction to assist physicians in determining whether a burn will heal on its own or if surgery is required.
Studies with DeepView® have demonstrated a burn diagnostic accuracy rate of 92% on Day 1, well above the estimated >50% accuracy
of non-specialists and even the estimated 70% accuracy of burn specialist assessments.
This
project is being supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for
Strategic Preparedness and Response; BARDA, under contract number 75A50123C00049.
The findings and conclusions have not been formally disseminated by the Department of Health and Human Services and should not be construed
to represent any agency determination or policy.
About
Spectral MD
Spectral
MD, Inc., is a subsidiary of Spectral AI, Inc., 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 and diabetic foot ulcers. The Company
is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView®
System. DeepView® is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound’s
healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of substantially exceeding
the current standard of care in the future, DeepView® is expected to provide faster and more accurate treatment insight towards value
care by improving patient outcomes and reducing healthcare costs. For more information about DeepView®, 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 SEC, including the 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.
Contacts: |
|
|
|
Investors: |
|
|
|
The Equity Group |
|
Devin Sullivan |
Conor Rodriguez |
Managing Director |
Analyst |
dsullivan@equityny.com |
crodriguez@equityny.com |
|
|
Media: |
|
|
|
Russo Partners |
|
David Schull or Guillermo Ruiz, M.D., Ph.D. |
Guillermo Ruiz, M.D., Ph.D. |
Russo Partners |
Russo Partners |
(858) 717-2310 |
(858) 717-2310 |
david.schull@russopartnersllc.com |
Guillermo.ruiz@russopartnersllc.com |
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