RCS - Spectral MD Holdings - ISO 13485 Certification Audit Completed

Spectral MD HoldingsAnnouncement

20/06/2023 07:00

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RNS Number : 0495D  Spectral MD Holdings, Ltd.  20 June 2023

 

Spectral MD Holdings, Ltd

        ("Spectral MD" or the
"Company")

 

Completion of ISO 13485 Certification Audit

ISO 13485 Certification Recommended and Anticipated in Q3 2023

 

LONDON, U.K. AND DALLAS, TX, U.S -Spectral MD Holdings, Ltd. (AIM: SMD), an
artificial intelligence (AI) company focused on medical diagnostics for faster
and more accurate treatment decisions in wound care, announces it has
completed the quality management ISO 13485 certification audit for the
manufacture and distribution of its DeepView® Wound Imaging System. ISO 13485
certification has now been recommended and is anticipated in Q3 2023. The
completion of the audit validates Spectral MD's commitment to meeting the
highest standards of quality, reliability, and safety in the medical device
industry.

 

ISO 13485 is an internationally recognized quality standard that specifies
requirements for a quality management system used by an organization
demonstrating its ability to provide medical devices and related services that
consistently meet strict customer and regulatory requirements. The
comprehensive audit of the Company's quality management system was undertaken
by an Independent Registrar.

 

Niko Pagoulatos, Chief Operating Officer of Spectral MD, said: "The completion
of the ISO 13485 certification audit is a strong endorsement of the quality
standards we set at Spectral MD. Once received, it will help us achieve our
goal of maintaining compliance with US and global laws and regulations that
govern the medical device industry. This is a vital certification as we
continue our preparations to enter the commercial phase across DeepView®'s
Burn and Diabetic Foot Ulcer indications."

 

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 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 that have a goal of substantially exceeding the
current standard of care in the future, 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 (http://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 with
Rosecliff, including statements regarding anticipated timing of the proposed
Transaction, (ii) redemptions of Rosecliff common stock, (iii) valuation of
the proposed Transaction, (iv) the closing of the proposed Transaction, (v)
the ability 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, (vi) Rosecliff and Spectral MD's
managements' expectations and expected synergies of the proposed Transaction
and the Combined Company, (vii) the use of proceeds from the proposed
Transaction, (viii) potential government contracts, and (ix) expected
beneficial outcomes and synergies of the proposed Transaction, (x) Spectral
MD's U.S. government contracts and future awards, (xi) FDA, CE and UKCA
regulatory submissions and approvals, (xii) target markets of burn wounds and
diabetic foot ulcers, (xiii) possible competitors, (xiv) future clinical
indications and use of BARDA, (xv) potential PIPE transaction and amount
raised, (xvi) future applications of Spectral MD products, (xvii) potential
indications and areas of interest supported by BARDA, (xviii) future and
pending U.S. patent applications and foreign and international patent
applications, (xvix) the AIM delisting and its effects for U.K. Spectral MD
shareholders, (xxx) the development of DeepView® technology and tools; (xxxi)
the effectiveness of the DeepView® platform in assessing burn wounds, (xxxii)
the reliability of any studies performed by Spectral MD, and (xxxiii) the
completion of any certifications. 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.

 

For further information please contact:

 

 Spectral MD Holdings, Ltd.                               IR@Spectralmd.com
 Christine Marks, VP of Marketing and Commercialization

 SP Angel Corporate Finance LLP (NOMAD and Joint Broker for Spectral MD)                        Tel: +44 (0)20 3470 0470
 Stuart Gledhill / Harry Davies-Ball (Corporate Finance)

 Vadim Alexandre / Rob Rees (Sales & Broking)

 The Equity Group Inc. (US Investor Relations)            dsullivan@equityny.com
 Devin Sullivan, Managing Director                        Tel: 212-836-9608

 Walbrook PR Ltd (UK Media & Investor Relations)          spectralmd@walbrookpr.com
 Paul McManus / Louis Ashe-Jepson /Alice Woodings         Tel: +44 (0)20 7933 8780

 

 

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