REG - AOTI, Inc. - AOTI unlocks broad market access in Germany

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RNS Number : 9329N  AOTI, Inc.  23 June 2025

23 June 2025

 

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

 

AOTI unlocks broad market access in Germany for TWO(2)(®) Therapy

 

Germany set to become first country to grant TWO(2) 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 (TWO(2)(®)) 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 TWO(2)(®) 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 TWO(2)(®) 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

 

 AOTI, INC.

 Dr. Mike Griffiths, Chief Executive Officer   +44 (0)20 3727 1000

 Jayesh Pankhania, Chief Financial Officer     ir@aotinc.net (mailto:ir@aotinc.net)

 Peel Hunt LLP (Nominated Adviser and Broker)

 Dr. Christopher Golden, James Steel           +44 (0)20 7418 8900

 FTI Consulting (Financial PR & IR)

 Ben Atwell, Simon Conway,                     +44 (0)20 3727 1000

 Natalie Garland-Collins, Alex Davis           AOTI@fticonsulting.com (mailto:AOTI@fticonsulting.com)

 

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 (TWO(2)(®)) 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. TWO(2)(®) therapy can be administered by the
patient at home, improving access to care and enhancing treatment compliance.
TWO(2)(®) 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
(http://www.aotinc.net)

 

 

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