AOTI diabetic foot ulcer therapy gets reimbursement nod in Germany

(Sharecast News) - AOTI announced on Monday that its Topical Wound Oxygen (TWO2) therapy has received a positive reimbursement recommendation from Germany's Federal Joint Committee (G-BA).

The AIM-traded firm said the G-BA decision meant Germany was set to become the first country to grant full national reimbursement coverage for TWO2 therapy for the treatment of diabetic foot ulcers.

It said the country's statutory health system, GKV, covers about 90% of Germany's population - around 85 million people.

AOTI said the G-BA would now begin developing formal guidelines for reimbursement, a process expected to take at least nine months.

In the interim, the decision gave the company a platform to negotiate case-by-case reimbursement with private payers and insurers.

"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," said Dr Mike Griffiths, chief executive officer and president of AOTI.

"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."

The company noted that Germany represented Europe's largest healthcare market and has an estimated 10.5 million diabetics, with around 500,000 diabetic foot ulcers.

While the financial impact of the G-BA recommendation was not expected to materially affect 2025 results, AOTI said it would continue to invest in the German market ahead of formal reimbursement approval.

Griffiths added that the decision provided a strong reference point for other national reimbursement bodies, including in the US, and reinforced the company's commercial model and international market access strategy.

At 0950 BST, shares in AOTI were up 2.78% at 92.5p.

Reporting by Josh White for Sharecast.com.