REG - Spectral MD Holdings - Trading Update and Notice of Results

Spectral MD HoldingsAnnouncement

01/02/2022 07:00

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RNS Number : 2320A  Spectral MD Holdings, Ltd.  01 February 2022

 

1 February 2022

Spectral MD Holdings, Ltd

("Spectral MD" or the "Company" or the "Group")

 

Full Year Trading update and Notice of Results

 

Unaudited cash and loss for the year ahead of expectations

Burn and Diabetic Foot Ulcer clinical studies and regulatory pathway on track

 

LONDON, U.K AND DALLAS, TX, U.S. - Spectral MD Holdings, Ltd. (AIM: SMD), a
predictive analytics company that develops proprietary AI algorithms and
optical technology for faster and more accurate treatment decisions in wound
care, provides a trading update for the year ended 31 December 2021.

 

The Company can confirm that both its unaudited loss for the year and negative
EBITDA are expected to be materially ahead of current market expectations with
the 31 December 2021 unaudited cash position also marginally ahead of
expectations. This has been primarily driven by lower costs per subject
associated with the Diabetic Foot Ulcer ("DFU") clinical training study.
Additionally, unaudited grant revenue, deriving from the Company's BARDA
funding contract for the Burn indication, is expected to be broadly in line
with market expectations.

 

Notice of Results

 

The Company intends to publish its audited preliminary results for the year
ended 31 December 2021 by the end of March.

 

Wensheng Fan, CEO of Spectral MD Holdings, Ltd, said: "Spectral continues to
make good progress on its clinical and regulatory pathway and the Company is
on track to deliver on its expected milestones notwithstanding the continued
challenges of the Covid pandemic. Cash and loss for the year are both expected
to have exceeded expectations, with BARDA grant revenue broadly in line with
expectations. I look forward to providing further updates at the time of the
preliminary results."

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulations
(EU) No. 596/2014 as it forms part of UK domestic law by virtue of the
European Union (Withdrawal) Act 2018 ('MAR'). Upon the publication of this
announcement via Regulatory Information Service ('RIS'), this inside
information is now considered to be in the public domain.

For further information, please contact:

 Spectral MD Holdings, Ltd.                                                            https://investors.spectralmd.com/ (https://investors.spectralmd.com/)
 Wensheng Fan, Chief Executive Officer                                                 via Walbrook PR

 Nils Windler, Chief Financial Officer

 SP Angel Corporate Finance LLP (Nominated Adviser and Joint Broker)                   +44 (0) 20 3470 0470
 Stuart Gledhill / Caroline Rowe (Corporate Finance)

 Vadim Alexandre / Rob Rees (Sales and Corporate Broking)

 Stifel Nicolaus Europe Limited (Joint Broker)                                         +44 (0) 20 7710 7600
 Charles Hoare / Ben Maddison / Will Palmer-Brown

 Walbrook PR Ltd (Media & Investor Relations)      +44 (0)20 7933 8780 or spectralMD@walbrookpr.com
 Paul McManus / Sam Allen                                                              +44 (0)79 8054 1893/ +44 (0)75 0255 8258

 Louis Ashe-Jepson                                                                     +44 (0) 7747 515393

 

About Spectral MD:
 

 

Using its DeepView® Wound Imaging Solution, an internally developed AI
technology and multispectral imaging solution that has received FDA
Breakthrough Designation for the burn indication, Spectral MD is able to
distinguish between non-healing and healing human tissue invisible to the
naked eye. Spectral MD currently is able to provide 'Day One' healing
assessments for burn wounds and diabetic foot ulcers with other applications
being explored.

 

Spectral MD has to date received substantial support from the U.S. government
with contracts from institutions such as Biomedical Advanced Research and
Development Authority, National Science Foundation, National Institute of
Health and Defense Health Agency in support of the burn application for its
DeepView® solution, with total grant funding received to date from all of
these organisations of over $93 million, including $40.5 million received in
2021. This grant funding is non-dilutive to our shareholders and the Company
believes it validates the important nature of our mission and technology. The
Company leverages this funding to support R&D efforts that are applicable
to burn, DFU and potentially other indications where DeepView® can play an
important role in Day 1 wound healing assessment.

 

The Company has two principal trading subsidiaries, Spectral MD, Inc. and
Spectral MD UK Limited.

 

DeepView®

DeepView® is a predictive analytics platform that integrates proprietary AI
algorithms and advanced optical technology for wound healing predictions. It
is non-invasive, non-radiation, non-laser and does not require the use of
injectable dye. This integration can be characterised into four distinct
components: DeepView® imaging, data extraction, AI model building and AI
wound healing prediction.

 

·    The DeepView® imaging technology consists of patented,
proprietary, multi-spectral optics and sensors that can classify wound tissue
physiology and capture the viability of various biomarkers within the skin.
The imaging technology extracts appropriate clinical data, processes the
image, and displays a comparison of the original image next to an image with a
colour overlay of the non-healing portions of the wound. The image acquisition
takes 0.2 seconds, and the output takes approximately 20 to 25 seconds.

 

·    The DeepView® data extraction consists of proprietary optics that
are able to collect millions of data points from each raw image. This
information is then used to build and continually improve the AI model, which
is trained and tested against a proprietary database of more than 66.7 billion
pixels with an ever-growing input of clinically validated data points.

 

·    The AI algorithm then produces a predictive wound healing assessment
in the form of an objective, accurate, and immediate binary wound healing
prediction. This prediction is graphically represented to the clinician
through a coloured overlay of the original image that annotates the
non-healing portion of the wound.

 

DeepView® is designed to allow clinicians to make a more accurate, timely
and informed decision regarding the treatment of the patient's wound. In the
case of DFUs, a non-healing assessment would provide the clinician with the
appropriate justification to use an advanced wound care therapy on 'Day One'
as opposed to waiting 30 days and potentially losing the patient to lack of
patient follow-up or risking patient noncompliance with standard wound
therapy. For burn wounds, the clinician can make an immediate and objective
determination to identify appropriate candidates for surgery as well as
determining what specific areas of the burn wound will require skin
grafting. DeepView®'s current accuracy for determining the healing potential
of burn wounds is 92 percent in adults and 88 percent in children, compared
with current physician accuracy of 50 to 70 percent. The current clinical
accuracy of DeepView® is 83 percent for DFUs.  Both of these accuracy
percentages are expected to increase with additional R&D efforts,
including clinical studies.

 

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