DeepView® AI- Burn Platform is Designed to
Improve Diagnostic Accuracy, Enhance Patient Outcomes, and Reduce
Healthcare Costs
Spectral MD Holdings, Ltd. (AIM: SMD) (or the “Company”),
an artificial intelligence (AI) company focused on medical
diagnostics for faster and more accurate treatment decisions in
wound care, continues to make progress in developing and
commercializing its AI-enabled DeepView® burn imaging
platform. The DeepView® AI-enabled platform addresses
a current deficiency in wound healing assessment protocols,
specifically, a lack of diagnostic tools and a reliance on the
provider’s experience. Instead of looking at a burn wound from the
outside in, DeepView® allows clinicians to view it
from the inside out. By allowing healthcare providers to see what
can’t be seen by the naked eye, the DeepView® platform
provides a quick and accurate assessment of the severity of a wound
and informs next step treatment.
“The application of AI in healthcare, generally, and the
introduction of new technologies such as Spectral MD’s
DeepView® platform, specifically, reflect the next
phase of an ever-expanding and increasingly holistic approach to
patient care,” said Wengshen Fan, Co-Founder and CEO of Spectral
MD. “We see significant potential for AI-enabled diagnostics in
burn wound assessment to augment the training and expertise of
clinicians while promoting expedited treatment decisions, efficient
workflows, and lower healthcare costs.”
“In the United States and the UK there are over 490,000 and
87,000 burn victims, respectively, who receive emergency medical
treatment each year,” said Mr. Fan. “The initial assessment of
these injuries is crucial in determining appropriate treatment,
specifically, will a wound heal on its own or does it require
surgical intervention? Unfortunately, even burn care specialists
only accurately assess on Day 1 the trajectory of a wound’s healing
process an estimated 50% to 70% of the time. This can result in
sub-optimal patient outcomes, including unnecessary surgeries, and
added stresses across the healthcare continuum.”
Spectral MD’s DeepView® imaging platform – which
received Breakthrough Device Designation from the U.S. Food and
Drug Administration (“U.S. FDA”) in 2018 for its burn indication –
integrates optical technology and AI-enabled algorithms using over
263 billion pixels of proprietary data to see deep below the
surface of the burn to distinguish between healthy and damaged
tissue. In less than 60 seconds, the DeepView®
platform 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 conducted by Spectral MD have
demonstrated a burn diagnostic accuracy rate of 92% on Day 1, well
above the estimated 50% to 70% accuracy of burn specialists.
Spectral MD’s DeepView® imaging platform has been
supported by approximately $130 million of U.S. Government funding
since 2013. Clinical trials are underway and Spectral MD is nearing
commercialization for DeepView® with planned
submissions to the U.S. FDA for the burn indication in 2025.
The views expressed in this news release/article are those of
the authors and may not reflect the official policy or position of
the U.S. Government.
About Spectral MD Spectral MD is a predictive AI company
focused on medical diagnostics for faster and more accurate
treatment decisions in wound care for burn, DFU, and future
clinical applications. At Spectral MD, we are a dedicated team of
forward-thinkers striving to revolutionize the management of wound
care by “Seeing the Unknown”® with our DeepView® Wound Diagnostics
System. The Company’s DeepView® platform is the only 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 that have
a goal of substantially exceeding the current standard of care,
Spectral MD’s diagnostic platform is expected to provide faster and
more accurate treatment insight and improve patient care while
reducing healthcare costs. For more information, visit the Company
at: www.spectralmd.com.
As announced on April 11, 2023, Spectral MD Holdings has entered
into a business combination agreement to combine with Rosecliff
Acquisition Corp I (“Rosecliff”, Nasdaq: RCLF), a special purpose
acquisition company listed on Nasdaq.
Additional Information and Where to Find It This press
release is provided for informational purposes only and contains
information with respect to a proposed business combination among
Spectral MD, Rosecliff, Ghost Merger Sub I Inc., a wholly-owned
subsidiary of Rosecliff and Ghost Merger Sub II LLC, a wholly-owned
subsidiary of Rosecliff (the “Transaction”). In connection with the
proposed Transaction, Rosecliff filed with the U.S. Securities and
Exchange Commission (the "SEC") a registration statement on Form
S-4, which includes a preliminary proxy statement/prospectus (as
amended from time to time, the “Registration Statement”). A full
description of the proposed Transaction has been included in the
Registration Statement filed by Rosecliff with the SEC. Rosecliff's
stockholders, investors and other interested persons are advised to
read the Registration Statement as well as other documents that
have been filed or will be filed with the SEC, as these documents
will contain important information about Rosecliff, Spectral MD,
and the proposed Transaction. The Registration Statement has not
yet been declared effective by the SEC. If and when the
Registration Statement is declared effective by the SEC, the proxy
statement/prospectus and other relevant documents for the proposed
Transaction will be mailed to stockholders of Rosecliff as of a
record date to be established for voting on the proposed
Transaction. Rosecliff investors and stockholders will also be able
to obtain copies of the proxy statement/prospectus and other
documents filed with the SEC, without charge, once available, at
the SEC's website at www.sec.gov.
Participants in the Solicitation Rosecliff, Spectral MD
and certain of their respective directors, executive officers,
other members of management and employees may, under SEC rules, be
deemed participants in the solicitation of proxies from Rosecliff's
stockholders with respect to the proposed Transaction. Investors
and security holders may obtain more detailed information regarding
the names and interests in the proposed Transaction of Rosecliff's
directors and officers in Rosecliff's filings with the SEC,
including Rosecliff’s definitive proxy statement, the Registration
Statement and other documents filed with the SEC. Such information
with respect to Spectral MD’s directors and executive officers has
also been included in the Registration Statement.
No Offer or Solicitation This press release and the
information contained herein do not constitute (i) (a) a
solicitation of a proxy, consent or authorization with respect to
any securities or in respect of the proposed Transaction or (b) an
offer to sell or the solicitation of an offer to buy any security,
commodity or instrument or related derivative, nor shall there be
any sale of securities in any jurisdiction in which the offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of any such jurisdiction or
(ii) an offer or commitment to lend, syndicate or arrange a
financing, underwrite or purchase or act as an agent or advisor or
in any other capacity with respect to any transaction, or commit
capital, or to participate in any trading strategies. No offer of
securities in the United States or to or for the account or benefit
of U.S. persons (as defined in Regulation S under the U.S.
Securities Act of 1933 (the “Securities Act”)) shall be made except
by means of a prospectus meeting the requirements of Section 10 of
the Securities Act, or an exemption therefrom. Investors should
consult with their counsel as to the applicable requirements for a
purchaser to avail itself of any exemption under the Securities
Act.
Forward Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. This includes, without
limitation, all statements regarding (i) the proposed Transaction;
(ii) the assumed use of AI in healthcare; (iii) the development of
DeepView® technology and tools, and its ability to perform as
stated; and (iv) planned regulatory submissions. Generally,
statements that are not historical facts, including statements
concerning our possible or assumed future actions, business
strategies, events or results of operations, are forward-looking
statements. These statements may be preceded by, followed by or
include the words “believes,” “estimates,” “expects,” “projects,”
“forecasts,” “may,” “will,” “should,” “seeks,” “plans,”
“scheduled,” “anticipates” or “intends” or similar expressions.
Such forward-looking statements involve risks and uncertainties
that may cause actual events, results or performance to differ
materially from those indicated by such statements. These
forward-looking statements are expressed in good faith, and
Spectral MD and Rosecliff believe there is a reasonable basis for
them. However, there can be no assurance that the events, results
or trends identified in these forward-looking statements will occur
or be achieved. Forward-looking statements speak only as of the
date they are made, and neither Spectral MD nor Rosecliff is under
any obligation, and expressly disclaim any obligation, to update,
alter or otherwise revise any forward-looking statement, whether as
a result of new information, future events or otherwise, except as
required by law.
Forward-looking statements are inherently subject to risks,
uncertainties and assumptions. In addition to risk factors
previously disclosed in Rosecliff’s reports filed with the SEC and
those identified elsewhere in this press release, the following
factors, among others, could cause actual results to differ
materially from forward-looking statements or historical
performance: (i) risks associated with product development and
regulatory review, including the time, expense and uncertainty of
obtaining clearance, approval or De Novo classification for
Spectral MD’s DeepView technology, (ii) Spectral MD’s ability to
obtain additional funding when needed and its dependence on
government funding, (iii) expectations regarding Spectral MD’s
strategies and future financial performance, including its future
business plans or objectives, prospective performance and
opportunities and competitors, revenues, products and services,
pricing, operating expenses, market trends, liquidity, cash flows
and uses of cash, capital expenditures, and Spectral MD’s ability
to invest in growth initiatives and pursue acquisition
opportunities; (iv) the risk that the proposed Transaction may not
be completed in a timely manner at all, which may adversely affect
the price of Rosecliff’s securities; (v) the failure to satisfy the
conditions to the consummation of the proposed Transaction,
including the adoption of the business combination agreement by the
stockholders of Rosecliff and the stockholders of Spectral MD, and
the receipt of certain governmental and regulatory approvals; (vi)
the lack of third party valuation in determining whether or not to
pursue the proposed Transaction; (vii) the ability of Rosecliff to
regain compliance with Nasdaq Capital Market listing requirements
and to maintain listing, or for the Combined Company to be listed,
on the Nasdaq Capital Market; (viii) the occurrence of any event,
change or other circumstances that could give rise to the
termination of the business combination agreement; (ix) the outcome
of any legal proceedings that may be instituted against Rosecliff
or Spectral MD following announcement of the proposed Transaction;
(x) the risk that the proposed Transaction may not be completed by
Rosecliff’s business combination deadline and the potential failure
to obtain an extension of the business combination deadline; (xi)
the effect of the announcement or pendency of the proposed
Transaction on Spectral MD’s business relationships, operating
results, and business generally; (xii) volatility in the price of
Rosecliff’s securities due to a variety of factors, including
changes in the competitive and regulated industries in which
Rosecliff plans to operate or Spectral MD operates, variations in
operating performance across competitors, changes in laws and
regulations affecting Rosecliff's or Spectral MD’s business,
Spectral MD’s inability to implement its business plan or meet or
exceed its financial projections and changes in the combined
capital structure; (xiii) Rosecliff’s ability to raise capital as
needed; (ixv) the ability to implement business plans, forecasts,
and other expectations after the completion of the proposed
Transaction and identify and realize additional opportunities; (xv)
the risk that the announcement and consummation of the proposed
Transaction disrupts Spectral MD’s current operations and future
plans; (xvi) the ability to recognize the anticipated benefits of
the proposed Transaction; (xvii) unexpected costs related to the
proposed Transaction; (xviii) the amount of any redemptions by
existing holders of the Rosecliff common stock being greater than
expected; (xix) limited liquidity and trading of Rosecliff’s
securities; (xx) geopolitical risk and changes in applicable laws
or regulations; (xxi) the possibility that Rosecliff and/or
Spectral MD may be adversely affected by other economic, business,
and/or competitive factors; (xxii) operational risk; and (xxiii)
changes in general economic conditions, including as a result of
the COVID-19 pandemic. The foregoing list of factors is not
exhaustive. You should carefully consider the foregoing factors and
the other risks and uncertainties described in the “Risk Factors”
sections of the Rosecliff’s Annual Report on Form 10-K, Quarterly
Reports on Form 10-Q, the Registration Statement and the other
documents filed by Rosecliff from time to time with the SEC. 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.
Readers are cautioned not to put undue reliance on
forward-looking statements, and neither Spectral MD nor Rosecliff
assumes any obligation and do not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise, except as required by securities and
other applicable laws. Neither Spectral MD nor Rosecliff gives any
assurance that it will achieve its expectations.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230508005585/en/
For further information please contact: Spectral MD
Holdings, Ltd. Christine Marks VP of Marketing and
Commercialization IR@Spectralmd.com
SP Angel Corporate Finance LLP (NOMAD and Joint Broker for
Spectral MD) Stuart Gledhill / Harry Davies-Ball (Corporate
Finance) Vadim Alexandre / Rob Rees (Sales & Broking) Tel: +44
(0)20 3470 0470
The Equity Group Inc. (US Investor Relations) Devin
Sullivan, Managing Director dsullivan@equityny.com Tel:
212-836-9608
Walbrook PR Ltd (UK Media & Investor Relations) Paul
McManus / Louis Ashe-Jepson /Alice Woodings
spectralMD@walbrookpr.com Tel: +44 (0)20 7933 8780
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