AOTI achieves broad market access in Germany for diabetic foot ulcer therapy
Ella Day | June 23, 2025 | News story | Market Access, Medical Communications, Sales and Marketing | AOTI, Diabetes, European pharma market, German pharma market, Wound Healing, diabetic foot ulcers, market access, positive recommendation
AOTI, focused on solutions for severe and chronic wounds, has announced that its unique 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. This marks a major milestone in its goal for international expansion across European markets and beyond.
Under the recommendation, the German statutory health insurance system, Gesetzliche Krankenversicherung, will draft guidelines for the reimbursement of TWO2 therapy for the treatment of diabetic foot ulcers (DFUs). While this process is ongoing, the company will also access a framework to work with private healthcare providers.
“This positive recommendation is a key decision with respect to our prospects for penetrating healthcare markets across Europe,” stated Mike Griffiths, CEO and president of AOTI. “It provides a strong reference point for other national reimbursement bodies, including the Centers for Medicare & Medicaid Services in the US.”
Through clinical trials and real-world evidence, TWO2 therapy has been shown to reduce recurrence of DFUs, resulting in an unprecedented 88% reduction in hospitalisations and 71% reduction in amputations over 12 months.
Ahead of the G-BA formulating its guidelines, the company expects to continue to invest in this space to maximise its opportunity.
Ella Day
23/6/25
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