REG - AOTI, Inc. - NICE fast track recommendation for Topical Oxygen

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RNS Number : 7352X  AOTI, Inc.  03 September 2025

3 September 2025

 

AOTI, INC. (the "Company" or "Group" or "AOTI")

 

NICE announces fast track treatment recommendation for Topical Oxygen Therapy

 

TWO(2)(®) therapy is now active on NHS Supply Chains' Advanced Wound Care
Framework

 

Enables accelerated marketing in the UK

 

AOTI, INC. (AIM: AOTI), a medical technology group focused on the durable
healing of wounds and the prevention of amputations, today announces that
topical oxygen therapy is included in the National Institute for Health and
Care Excellence (NICE)'s updated Diabetic Foot Problems: Prevention and
Management guideline, and the Company's Topical Wound Oxygen (TWO(2)(®))
therapy is now active on the Advanced Wound Care framework, awarded by NHS
Supply Chain.

 

The updated NICE guidelines include topical oxygen therapy as an adjunct to
standard care for diabetic foot ulcers that are not responding to
treatment(1), reflecting increasing recognition from national health
authorities of the clinical value and potential of TWO(2)(®) therapy to
improve outcomes in difficult-to-heal wounds. This follows completion of
NICE's exceptional surveillance(2) review of its diabetic foot problems:
prevention and management (NG19) guideline and marks a positive step forward
in the UK market, earlier than previously expected.

 

TWO(2)(®) therapy is now active on NHS Supply Chain's Advanced Wound Care
Framework, which provides NHS organisations and public bodies with a
pre-approved, compliant route to procure a wide range of advanced wound care
products and services. This allows AOTI to accelerate marketing TWO(2)(®)
therapy to Trusts, Integrated Care Boards (ICBs), and community care
organisations and provides streamlined access to its clinically proven,
cost-effective benefits.

 

Professor Michael Edmonds, MD, FRCP, Consultant Physician and Professor of
Diabetic Foot Medicine at Kings College London and King's College Hospital,
where he established the world's first multidisciplinary diabetic foot clinic,
with patients now being treated with TWO(2)(®) therapy, commented: "I am
delighted that clinicians across the NHS and, most importantly, our patients,
now have easier access to this innovative limb-saving therapy. The diabetic
foot epidemic shows no sign of abating and is forecast to consume 1% of the
entire £192bn NHS budget this year. TWO(2)(®) therapy is an evidence-proven
adjunctive treatment which has been demonstrated to more durably heal chronic
wounds and that patients can apply in their home, helping to improve access to
care while reducing resource utilisation and healthcare spending."

 

Dr Mike Griffiths, Chief Executive Officer & President of AOTI, said:
"With TWO(2)(®) therapy now on the NHS framework and with its inclusion in
the NICE treatment guidelines, patients in England have access to its
sustained healing benefits, helping to reduce the burden on strained national
healthcare resources while delivering substantial quality of life benefits for
patients at home. In addition to these meaningful clinical improvements,
recently published health economic research has demonstrated that broad
adoption of TWO(2)(®) therapy within the NHS would significantly lower
overall diabetic foot care costs.(3) This recognition by another of Europe's
leading healthcare bodies is consistent with the recent G-BA recommendation in
Germany and is ahead of our expectations. Such continued positive decisions
only further validates our clinical and value proposition supporting a
positive coverage determination by CMS in the United States"

 

The impact of the NICE fast-track treatment recommendation is not expected to
materially change the financial outlook for this year.

 

1.
https://www.nice.org.uk/guidance/ng19/evidence/july-2025-exceptional-surveillance-of-diabetic-foot-problems-prevention-and-management-nice-15373951597
(https://www.nice.org.uk/guidance/ng19/evidence/july-2025-exceptional-surveillance-of-diabetic-foot-problems-prevention-and-management-nice-15373951597)

2.   Exceptional Surveillance is the NICE process of an accelerated, focused
review of a guideline when significant new evidence, a change in clinical
practice, or a new policy objective makes it necessary to update a guideline
outside of its normal surveillance cycle. The process involves considering new
evidence and feedback from stakeholders to determine if the guideline
recommendations need to be updated.
https://www.nice.org.uk/process/pmg20/chapter/ensuring-that-published-guidelines-are-current-and-accurate
(https://www.nice.org.uk/process/pmg20/chapter/ensuring-that-published-guidelines-are-current-and-accurate)
.

3.     Marion Kerr, Daisy Wild, Michael Edmonds, Andrew J.M. Boulton, Cost
effectiveness of topical wound oxygen therapy for chronic diabetic foot
ulcers, Journal of Diabetes and its Complications, Volume 39, Issue 5, 2025,
10901. https://doi.org/10.1016/j.jdiacomp.2025.109016
(https://doi.org/10.1016/j.jdiacomp.2025.109016) .

 

ENDS

 

 AOTI, INC.

 Dr. Mike Griffiths, Chief Executive Officer   +44 (0)20 3727 1000

 Jayesh Pankhania, Chief Financial Officer     ir@aotinc.net (mailto:ir@aotinc.net)

 Peel Hunt LLP (Nominated Adviser and Broker)

 Dr. Christopher Golden, James Steel           +44 (0)20 7418 8900

 FTI Consulting (Financial PR & IR)

 Ben Atwell, Simon Conway,                     +44 (0)20 3727 1000

 Natalie Garland-Collins                       AOTI@fticonsulting.com (mailto:AOTI@fticonsulting.com)

 

ABOUT AOTI, INC.

 

AOTI, INC. was founded in 2006 and is based in Oceanside, California, US and
Galway, Ireland, providing innovative solutions to resolve severe and chronic
wounds worldwide. Its products reduce healthcare costs and improve the quality
of life for patients with these debilitating conditions. The Company's
patented non-invasive Topical Wound Oxygen (TWO(2)(®)) therapy has
demonstrated in differentiating, robust, double-blinded randomized controlled
trials (RCT) and real-world evidence (RWE) studies to more-durably reduce the
recurrence of Diabetic Foot Ulcers (DFUs), resulting in an unprecedented 88
per cent reduction in hospitalizations and 71 per cent reduction in
amputations over 12 months. TWO(2)(®) therapy can be administered by the
patient at home, improving access to care and enhancing treatment compliance.
TWO(2)(®) therapy has received regulatory clearance from the US (FDA), Europe
(CE Mark), UK (MHRA), Health Canada, the Chinese National Medical Products
Administration, Australia (TGA) and in Saudi Arabia. TWO(2)(®) therapy has
also recently received positive recommendation from the Federal Joint
Committee of Gemeinsamer Bundesausschuss (G-BA) in Germany and National
Institute for Health and Care Excellence (NICE) in the United Kingdom. Also
see www.aotinc.net (http://www.aotinc.net)

 

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