ISO 13485 Certification Recommended and
Anticipated in Q3 2023
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230615449953/en/
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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