Aoti, Inc. Regulatory News (AOTI)

23 June 2025

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

AOTI unlocks broad market access in Germany for TWO2® Therapy

Germany set to become first country to grant TWO2 therapy full national reimbursement coverage

This G-BA positive recommendation is also potentially transformative with respect to penetrating healthcare markets across Europe and beyond

AOTI, INC. (AIM: AOTI), a medical technology group focused on the durable healing of wounds and the prevention of amputations, announces that its unique multi-modality Topical Wound Oxygen (TWO2®) therapy has received a positive recommendation from the Federal Joint Committee of Gemeinsamer Bundesausschuss (G-BA) in Germany, the largest potential national market in Europe for its therapy.1 This decision is a major validating milestone for the Company and also supports one of AOTI's stated 2025 business goals of expanding international sales channels in the second half of the year.

The G-BA is now committed to immediately begin formulating guidelines for the reimbursement of TWO2® therapy for the treatment of Diabetic Foot Ulcers (DFUs) by the German statutory health insurance system, the Gesetzliche Krankenversicherung (GKV), which covers around 90% of the German population (c.85 million people). AOTI estimates these guidelines could take at least nine months to be published.2 This recommendation also provides the Company with a framework to work with private healthcare providers and insurers in Germany on a case-by-case basis to reimburse TWO2® therapy while the GKV process is ongoing. Germany has 10.5 million diabetics with an estimated 500,000 Diabetic Foot Ulcers (DFUs).3

Ahead of the G-BA formulating its guidelines for reimbursement the Company expects to continue to invest prudently in this space to maximize its opportunity. The impact of the G-BA recommendation is not expected to materially change the financial outlook for this year.

Dr. Mike Griffiths, Chief Executive Officer & President of AOTI, commented: "This is the first market to grant us full national coverage and the G-BA has a reputation of setting an extremely high bar for reimbursement. Therefore, we believe this positive recommendation is a key, and potentially transformative, decision with respect to our prospects for penetrating healthcare markets across Europe and beyond. Not only does it provide a strong reference point for other national reimbursement bodies, including the CMS in the US, but also further validates our market access strategy and commercial model. We look forward to building a strong commercial presence in Germany, Europe's largest healthcare market."

1 This is similar to the Centers for Medicare and Medicaid Services (CMS) providing a Local Coverage Determination in the USA.

2 Based on timeline of other therapies that have received a G-BA positive recommendation in recent years and for which GKV guidelines have subsequently then been published.

3 Wernecke Jet al. Epidemiology and the Medical Burden of Diabetic Foot Ulcers Especially in Patients with Infection-A Population-Based Analysis from Germany. Int Wound J. 2025 Apr;22(4):e70157. doi: 10.1111/iwj.70157.

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 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. 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. Also see www.aotinc.net