AOTI unlocks broad market access in Germany

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.

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