REG - Spectral MD Holdings - DFU Clinical Study Interim Results & Burn Update

Spectral MD HoldingsAnnouncement

18/01/2023 07:00

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RNS Number : 0470N  Spectral MD Holdings, Ltd.  18 January 2023

Spectral MD Holdings, Ltd.

        ("Spectral MD" or the
"Company")

 

Positive Interim Results from DFU Clinical Study

& Burn Clinical Study Update

 DeepView® accuracy increases to 86% in diagnosis of DFU healing potential
on day one

 

LONDON, U.K. AND DALLAS, TX, U.S. - Spectral MD Holdings, Ltd. (AIM: SMD), a
predictive analytics company with proprietary AI algorithms and optical
technology for faster and more accurate treatment decisions in wound care,
announces the interim results for its Diabetic Foot Ulcer ("DFU") Clinical
Study, initiated in June 2022. The DeepView® Wound Imaging System diagnostic
accuracy calculated in the interim analysis, being the prediction of a 50% DFU
size reduction by week four, has improved five-percentage points to 86% on day
one. This increase in diagnostic accuracy will strengthen the Company's
planned 2023 FDA submission for its DeepView® DFU indication.

 

The four-week milestone in DFU reduction in the clinical treatment pathway for
a DFU patient is meaningful to determine if alternative treatment is needed.
The interim analysis was performed with an initial 100 U.S. adult subjects out
of the targeted 200 subjects enrolled, and showed:

 

·    86% diagnostic accuracy, from the previously reported 81%

·    89% sensitivity

·    83% specificity

 

Currently, there are no diagnostic tools available in DFU healing prediction.
The standard of care for DFU relies on physicians using a wait-and-see
approach of up to 30 days to determine if there is a need for advanced
intervention.

 

The DFU study is currently running at five clinical sites in the U.S.  As the
Company's regulatory strategy evolves, it is adding additional clinical sites,
three contracted, to ensure study completion in 1H 2023. The Company plans to
announce additional EU/UK DFU clinical studies in the near future and will
provide updates accordingly. The Company remains on track to complete its FDA
2023 regulatory submission.

 

Niko Pagoulatos, Chief Operating Officer of Spectral MD, said: "We are
encouraged by the interim observations from the DFU Clinical Study, and we
look forward to completing enrollment to finalize DeepView® DFU indication
performance analysis and to submit for regulatory approvals. The results from
the interim analysis further validate how the DeepView® technology could
significantly help transform the lives of people suffering from Diabetic Foot
Ulcers."

 

Dr. Brock Liden, Podiatry Wound Specialist at Wound and Feet Liden and
Principal Investigator in the DFU Clinical Study, commented: "These are
extremely encouraging results that show the incredible potential of DeepView®
to significantly transform how we treat, manage, and assess Diabetic Foot
Ulcers. Diabetic Foot Ulcers are unusually challenging due to the many
comorbidities associated with diabetes, which may interrupt the healing
process. I look forward to the continued collaboration with Spectral MD as we
work to collect meaningful data to further validate this transformative
technology."

 

 

 

 

Burn Indication Update:

 

The Company has been working on the BARDA funding contract for the Burn
indication, and the recent US$ 8.2 million contract expansion with BARDA
continues to support interoperability features and commercial readiness for
the DeepView® Wound Imaging System. The updates for the current DeepView®
Burn AI Training Study are:

 

·    Since year end 31 December 2022, adult enrollment is complete.

·    The study population covers demographic and geographic variability.

·   The study is currently performed at 11 world-renowned research
hospitals, with additional pediatric research sites established.

·    Study is expected to be completed 1H 2023.

 

Spectral MD is in constant communication with BARDA to further develop its
infrastructure readiness for a federal level commercial contract.

 

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.                        investors.spectralmd.com
 Wensheng Fan, Chief Executive Officer             via Walbrook PR
 Nils Windler, Chief Financial Officer

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

 Vadim Alexandre/Rob Rees (Sales & Broking)

 Stifel Nicolaus Europe Limited (Joint Broker)     Tel: +44 (0)20 7710 7600

 Charles Hoare / Ben Maddison / Nick Harland

 Will Palmer-Brown

 Walbrook PR Ltd (Media & Investor Relations)      Tel: +44 (0)20 7933 8780 or spectralMD@walbrookpr.com
 Paul McManus / Louis Ashe-Jepson /                Mob: +44 (0)7980 541 893 / +44 (0)7747 515 393

 Sam Allen                                         +44 (0)7502 558 258

 

About 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 Imaging System.

www.spectralmd.com

info@spectralmd.com

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