TIDMSMD
RNS Number : 6074C
Spectral MD Holdings, Ltd.
22 June 2021
THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS
RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN
WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM, THE
UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF
IRELAND, THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION
WHERE IT IS UNLAWFUL TO RELEASE, PUBLISH OR DISTRIBUTE THIS
ANNOUNCEMENT.
THESE SECURITIES WILL BE OFFERED ONLY OUTSIDE OF THE UNITED
STATES TO NON-U.S. PERSONS, PURSUANT TO THE PROVISIONS OF
REGULATION S OF THE U.S. SECURITIES ACT OF 1933, AS AMED. THESE
SECURITIES WILL NOT BE REGISTERED UNDER THE SECURITIES ACT, AND MAY
NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION
OR AN APPLICABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS.
Spectral MD Holdings, Ltd.
("Spectral MD" or the "Company" or the "Group")
Admission to trading on AIM
& First Day of Dealings
LONDON, U.K. AND DALLAS, TX, U.S. Spectral MD Holdings, Ltd., a
predictive analytics group that develops proprietary AI algorithms
and optical technology for faster treatment decisions in wound
care, is pleased to announce the admission of its entire issued
share capital, being 136,077,064 shares of common stock, to trading
on AIM ("Admission") will take place and dealings will commence at
8.00 a.m. today under the ticker 'SMD' and ISIN 'USU8457V1099'.
The Company's Admission Document was published on 16 June 2021
and is available here: https://investors.spectralmd.com
Summary and Highlights:
-- Oversubscribed Placing for gross proceeds of GBP11.3 million (c.US$16 million)
-- The Placing was conducted at a pre-IPO fully diluted valuation of GBP95m
-- Placing price per share of common stock of 59 pence
-- Market capitalisation (at the Placing Price) of approximately GBP80 million on Admission
-- The 19,067,797 shares of New Common Stock being placed
represent c. 14 per cent. of the Enlarged Share Capital
-- SP Angel Corporate Finance LLP acted as Nominated Adviser,
Broker and Bookrunner in relation to the Placing and has been
retained as the Company's Nominated Adviser and Corporate Broker
from Admission
Introduction to the Group
Using its DeepView(R) Wound Imaging Solution, an internally
developed AI technology and multispectral imaging system which has
designated FDA Breakthrough Device, the Group is able to
distinguish between damaged and healthy human tissue invisible to
the naked eye, providing 'Day One' healing assessments for burn
wounds and diabetic foot ulcers ('DFU').
The Group has to date received substantial support from the US
government with contracts from institutions such as Biomedical
Advanced Research and Development Authority (BARDA), National
Science Foundation (NSF), National Institute of Health (NIH) and
Defense Health Agency (DHA) in support of the burns application for
its DeepView(R) system.
The Company has one principal trading subsidiary, Spectral MD,
Inc., and has set up a permanent establishment in the UK from which
it will be growing its business in the UK and EU.
Reasons for Admission to AIM and use of the proceeds of the
Placing
The Directors believe that Admission will be an important step
in the Group's development as it will assist in building the
profile of its business, particularly in Europe where it is looking
to spearhead growth, and will provide access to wider pools of
capital.
The Group believes that Admission will provide further funding
to undertake clinical trials for the DFU application, which is a
larger market than burn wound assessment, in the US, UK and EU and
to develop a UK-based EMEA headquarters to support CE-Mark approval
and commercial expansion.
The net proceeds of the Placing of the New Common Stock of
approximately GBP9.5 million will be used to:
-- provide capital for the development of the DFU product, this
will include investment in clinical studies supporting the
indication along with progressing regulatory filings;
-- build a European presence from which to progress specific
European regulatory approvals and subsequently to implement the
Group's sales strategy to sell the Group's DeepView(R) product into
various targeted European jurisdictions;
-- build U.S distribution; and
-- provide working capital for the Group.
The benefits of Admission, in addition to the proceeds of the
Placing, will include ongoing incentivisation of key employees
through share based incentivisation structures and building the
profile of the Group in its key international markets.
Wensheng Fan, CEO of Spectral MD Holdings, Ltd., said: "We are
delighted with the support shown by institutional investors in our
AIM IPO, which is a key milestone in our commercial development.
Our technology enables clinicians to make 'Day One' decisions on
burn injuries which can significantly reduce patient recovery time
and improve the outcome of the healing process. These funds will
support further development of our DFU application, build a greater
UK and European presence and help the Company gain the necessary
regulatory approvals to bring the DeepView(R) technology into these
markets.
"We are now well funded to develop our DFU technology through to
commercial launch, which positions us well in a significant and
continually growing market worldwide. Diabetes affects over 30
million people in the US and more than 415 million globally.
"Spectral MD has the opportunity to support patient recovery
from life-changing injuries worldwide and revolutionise the
management of wound care. We look forward to keeping our
shareholders updated as we deliver on that mission."
For further information please contact:
Spectral MD Holdings, Ltd. www.spectralmd.com
Wensheng Fan, Chief Executive Officer via Walbrook PR
Wan Lung Eng, Chief Financial Officer
SP Angel Corporate Finance LLP (NOMAD Tel: +44 (0)20 3470 0470
& BROKER)
Stuart Gledhill/Caroline Rowe (Corporate
Finance)
Vadim Alexandre/Rob Rees (Sales & Broking)
Walbrook PR Ltd (Media & Investor Tel: +44 (0)20 7933 8780 or spectralMD@walbrookpr.com
Relations)
Paul McManus/Sam Allen Mob: +44 (0)7980 541 893 / +44 (0)7502
Alice Woodings 558 258
+44 (0)7407 804 654
About Spectral MD Holdings, Ltd. ( www.spectralmd.com)
Background and history
Spectral MD Holdings, Ltd. was established through the
technology transfer department of the University of Texas
Southwestern with its operating subsidiary being incorporated in
the US State of Delaware in 2009. The Group's initial focus was to
provide clinicians with the ability to understand and predict
pressure ulcers for bed-ridden patients. NSF grants supported these
endeavours until the Group's focus shifted to providing healing
assessments for burn wounds.
In 2018, the US Food & Drug Administration ('FDA')
designated the DeepView(R) technology as a Breakthrough Device for
its burn indication. It is not common for a medical technology to
have gained such prestigious acknowledgement and therefore this
status not only emphasises the FDA's recognition of DeepView(R)'s
scientific and technological value, but also provides the Group
with an expedited regulatory framework for the burn application and
expectation of Medicare reimbursement for a period of four years
post FDA approval.
From 2013 to 2019, the Group engaged in and completed a BARDA
contract, referred to as BARDA Burn I, to investigate the use of
its technology as a surgical-triage tool for burn victims in a mass
casualty event.
Stemming from the completion of BARDA Burn I, the Group focused
its technology on the integration of multi-spectral imaging and AI
algorithms and began exploring other clinical applications, such as
DFUs and level of amputation selection. In July 2019, the Group
entered into a second contract with BARDA, referred to as BARDA
Burn II, to further develop the DeepView(R) technology as a medical
countermeasure for mass casualty events. The performance period for
this contract is four and a half years and is valued at up to US$89
million across all of its phases.
DeepView(R)
DeepView(R) is a predictive analytics platform that combines AI
algorithms and medical imaging for wound prediction. 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(R) imaging, data extraction, AI model
building and AI wound healing prediction.
-- The DeepView(R) 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.
-- DeepView(R)'s proprietary optics are able to extract millions
of data points or AI model features 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 53 billion pixels with ever-growing
clinically-validated data points.
-- The AI algorithm then produces a wound healing prediction 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(R) 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 physician 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 follow-up or
risking patient noncompliance with standard wound therapy. The
current clinical accuracy of DeepView(R) is 83 per cent. for DFUs.
For burn wounds, the clinician can make an immediate and objective
determination for appropriate candidates for surgery as well as
determining what specific areas of the burn wound will require skin
grafting. DeepView(R)'s current accuracy for burn wounds is 91 per
cent., compared with current physician accuracy of 50 per cent. to
70 per cent. DeepView(R) demonstrates a much higher diagnostic
accuracy for burn wounds and DFUs.
The Market - Unmet clinical need
To the Group's knowledge, there are no diagnostic imaging
products that provide clinicians with an objective and immediate
assessment of a wound's healing potential and which benefit from
the application of AI. Currently, healthcare professionals rely on
their experience and subjective assessments to determine if wounds,
such as burn injuries and DFU, will respond to therapeutic
treatment.
Burns
In the US and UK, respectively, there are approximately 490,000
and 87,000 burn victims who receive emergency medical treatment
each year. Burn victims have varying degrees of tissue damage upon
initial admission to the emergency room and burn surgeons must
evaluate tissue viability as either healing or non-healing to
determine what areas of the burn wound must be surgically excised
for grafting. Management has identified that clinicians have a 50
to 70 per cent. accuracy in assessing the viability of burned
tissue. Physicians typically admit the patient for a period of up
to 21 days to wait for the viable tissue to present itself as
healing or non-healing before taking the patient to surgery.
Unfortunately, this "wait and see" period comes at an above average
cost for the facility and duress for the burn victim. Currently,
the average hospital stay is 8.1 days with an average cost of
approximately US$24,000. DeepView(R) provides the physician with a
'Day One' healing assessment and enables the physician to triage
the patient to the appropriate setting sooner. In addition, the
technology assists the physician in accurately determining which
areas of the burn wound are appropriate for excision and
grafting.
DFU
Diabetes (type 1 and type 2) affects over 30 million people in
the US alone and more than 415 million people worldwide. DFU is a
severe chronic diabetic complication that consists of lesions in
the deep tissues associated with neurological disorders and
peripheral vascular disease in the lower limbs. It is the most
frequently recognised, complex and costly symptom of diabetes and
can lead to limb amputation if left undiagnosed, misdiagnosed or
untreated.
There is a large and growing number of diabetic patients who
suffer from DFU, with over 4 million, 0.2 million and 1 million
receiving treatment in the U.S., UK and EU respectively every year.
However, there is currently no effective diagnostic pathway for DFU
patients in the U.S., the UK or EU. In the U.S., patients must
undergo standard wound care therapy for 30 days prior to receiving
advanced wound care therapy (negative pressure wound therapy,
synthetic skin substitute grafts, and hyperbaric oxygen
therapy).
Many of these chronic wounds will not respond to standard wound
care therapy and would have benefited from advanced wound care
therapy on 'Day One'. Further complicating this clinical issue,
management has identified that clinicians' wound healing
predictions have a 50 per cent. accuracy rate. DeepView(R)'s
primary objective is to provide physicians with a healing
prediction that enables them to therapeutically intervene earlier
in the patient's care pathway. Unfortunately, diagnostic tools to
assess the healing potential of DFUs, such as trans-cutaneous
oxygen measurement (TCOM), ankle-brachial index (ABI), and doppler
ultrasounds do not provide a wound healing prediction. These
systems are often inaccurate and only provide a range of values
that indirectly correlate to wound healing. All current systems
claiming to be effective in determining DFU healing potential
measure only one physiologic parameter, however, the Company
believes that a single parameter cannot effectively discriminate
healing from non-healing DFUs. The American Heart Association
stated in a 2019 scientific summary that "No single vascular test
has been identified as the most important predictor of wound
healing or major amputation for the threatened limb". In the US,
DFU patients have an annual cost of up to US$63,100 per patient and
see an outpatient provider, on average, 15.5 times per year.
Non-healing DFUs in the UK are reported as being four times more
expensive than DFUs that heal. DeepView(R) aims to reduce waiting
times, minimise patient costs and lower the probability of
infections by offering advanced wound care therapy on 'Day
One'.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCFBMATMTITBLB
(END) Dow Jones Newswires
June 22, 2021 02:00 ET (06:00 GMT)
Spectral Md (LSE:SMD)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Spectral Md (LSE:SMD)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024
