Aoti, Inc. Regulatory News (AOTI)

3 September 2025

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

NICE announces fast track treatment recommendation for Topical Oxygen Therapy

TWO2® 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 (TWO2®) 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 treatment1, reflecting increasing recognition from national health authorities of the clinical value and potential of TWO2® therapy to improve outcomes in difficult-to-heal wounds. This follows completion of NICE's exceptional surveillance2 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.

TWO2® 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 TWO2® 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 TWO2® 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. TWO2® 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 TWO2® 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 TWO2® 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

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.

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.

ENDS

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 (TWO2®) 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. TWO2® therapy can be administered by the patient at home, improving access to care and enhancing treatment compliance. TWO2® 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. TWO2® 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