REG - AOTI, Inc. - TWO2® in NHS supply chain framework agreement

AotiAnnouncement

22/04/2025 07:00

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RNS Number : 6359F  AOTI, Inc.  22 April 2025

22 April 2025

 

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

 

TWO(2)(®) therapy to be included in NHS supply chain framework agreement for
2025

 

Peer-reviewed health economic study shows TWO(2)(®) therapy would
significantly lower overall diabetic foot care costs for NHS in England

 

AOTI, INC. (AIM: AOTI), a medical technology group focused on the durable
healing of wounds and the prevention of amputations, announces its
multi-modality Topical Wound Oxygen (TWO(2)(®)) therapy has been awarded
inclusion by NHS Supply Chain to the framework agreement for Advanced Wound
Care 2025, which becomes effective on 1(st) September 2025.

 

This follows the recent publication of the results from a new health economic
(HE) study in the Journal of Diabetic Complications(1) and authored by a team
of leading UK-based health economists and diabetic foot clinical experts,
demonstrating that adoption of AOTI's unique TWO(2)(®) therapy within the
National Health Service (NHS) in England, UK, would significantly lower
overall diabetic foot care costs.

 

In England, the estimated cost of diabetic foot disease is almost 1% of the
entire annual NHS budget, which is forecast to reach £192 billion in
2025,(2,3) with non-healing ulcers being the major cost driver. Up to one
third of diabetics will suffer from a diabetic foot ulcer (DFU) in their
lifetime, which are the leading cause of morbidity and lower extremity
amputations in the diabetic population. It is estimated that approximately 66%
of DFUs do not heal within a year, and approximately 50% become infected,
which can lead to life-threatening infections, hospitalisations and limb
amputation.(4)

 

Dr. Mike Griffiths, Chief Executive Officer & President of AOTI,
commented: "It is exciting to see acknowledgement of the clinical and health
economic benefits delivered by our unique cyclical-pressure TWO(2)(®) therapy
with its inclusion in the new framework agreement for Advanced Wound Care.
Once implemented patients across England will have easier access to our proven
limb saving outcomes and the NHS can start to realise substantial cost
savings. These benefits are driven by significantly reduced wound recurrence,
hospitalisations and amputations, all of which translate to improved quality
of life for patients living with these non-healing foot ulcers."

 

NHS supply chain framework agreements, which can run for a period of up to 48
months, enable NHS trusts and healthcare organisations to procure goods and
services. They provide a single route to market for suppliers, simplify
procurement, and aim to deliver cost savings and efficiency while maintaining
high clinical standards.

 

HE study supports cost savings and improved outcomes from NHS adoption of
TWO(2) Therapy

The authors of the study developed a comprehensive health economic model to
estimate the cost effectiveness of TWO(2)(®) therapy, using both the durable
healing outcomes demonstrated in the pivotal TWO(2) Randomised Control Trial
(RCT) and UK healthcare cost norms. The model predicts that TWO(2)(®) therapy
would increase Quality Adjusted Life Years (QALYs) and significantly improve
outcomes relative to standard care, while lowering costs by an estimated
£5,038 per patient, or 16%, over the course of two years compared to the
standard care cost of £31,275 per patient over the same period, meeting the
QALY threshold commonly used by the National Institute for Health and Care
Excellence (NICE) to determine whether new technology is considered "good
value for money" and therefore suitable for funding within the NHS.(5) AOTI
has submitted its needs assessment application through NHS Innovation Service
and looks forward to a future NICE technology appraisal (TA) guidance.

 

 

References

1.   https://doi.org/10.1016/j.jdiacomp.2025.109016
(https://doi.org/10.1016/j.jdiacomp.2025.109016)

2.   https://doi.org/10.1111/dme.13973 (https://doi.org/10.1111/dme.13973)

3. https://lowdownnhs.info/social-care/spring-budget-2025-analysis-can-the-efficiency-drives-solve-health-crisis/
(https://lowdownnhs.info/social-care/spring-budget-2025-analysis-can-the-efficiency-drives-solve-health-crisis/)

4.   https://jamanetwork.com/journals/jama/article-abstract/2806655
(https://jamanetwork.com/journals/jama/article-abstract/2806655)

5.
https://www.nice.org.uk/news/blogs/should-nice-s-cost-effectiveness-thresholds-change-
(https://www.nice.org.uk/news/blogs/should-nice-s-cost-effectiveness-thresholds-change-)

 

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, Alex Davis           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 randomised 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 hospitalisations 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. Also see www.aotinc.net
(http://www.aotinc.net)

 

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