AOTI, Inc.
24 July 2026
24 July 2026
AOTI, INC. (the "Company" or "Group" or "AOTI")
AOTI achieves transformational milestone that will dramatically expand the US addressable market and growth potential for its TWO2® therapy
CMS issues proposed LCD affirming topical oxygen therapy coverage for Medicare enrollees for the treatment of diabetic foot ulcers
TWO2® therapy is already the clear market leader in topical oxygen therapy, and the LCD will also help accelerate obtaining broader coverage and reimbursement in all other market segments, including Medicaid
AOTI, INC. (AIM: AOTI), a medical technology group focused on delivering outcomes-based care at home, by more durable healing of wounds and the prevention of amputations, announces that the Centers for Medicare & Medicaid Services (CMS) has issued a proposed Local Coverage Determination (LCD) (applicable to the whole of the US) indicating that topical oxygen therapy is reasonable and necessary for the treatment of diabetic foot ulcers that have failed to heal with four consecutive weeks of optimized diabetic foot ulcer care.
After the 45-day public comment period, CMS will review comments and finalise the LCD within a year.
The Final LCD will dramatically expand the US addressable market, support obtaining broader coverage and de-risk reimbursement in all other market segments, including Medicaid
The Final LCD will mandate Medicare treatment coverage criteria and reimbursement for AOTI's unique Topical Wound Oxygen (TWO2®) therapy and will provide the Company with access to the c. 69 million Medicare enrollees (Americans over 65 years of age) who have as high as a 32 per cent. prevalence rate of diabetes and disproportionally higher (c. 13%) rate of diabetic foot ulcers.
The Final LCD will not only increase momentum and unlock revenues from Medicare recipients it will also accelerate access to Medicaid and other US commercial and managed care market segments.
AOTI is already the clear market leader in the topical oxygen segment with a 75% market share driven by the unique and differentiated value proposition of its intermittent topical oxygen (TWO2®) therapy, which has demonstrated in multiple substantive peer reviewed clinical studies to deliver superior durable healing outcomes when compared to continuous topical oxygen therapy and other advanced wound care treatments. AOTI's TWO2® therapy is the only intermittent topical oxygen wound therapy on the market.
Sufficient infrastructure and cash resources to exploit enlarged opportunity
The Company's existing commercial infrastructure, which currently spans across 26 states, gives AOTI access to c. 86% of the US population and can be leveraged to immediately capitalise on this opportunity without the need for a significant ramp-up of sales operations in the medium term.
The market opportunity for TWO2® is considerable. As previously published, a clearly defined Serviceable Obtainable Market where payer coverage is already in place (VA & New York Medicaid) underpins a near- to medium-term revenue opportunity of c. $400m and where currently our penetration is approximately only mid-teens, providing significant additional upside potential. Beyond this, the Serviceable Addressable Market expands by as much as 65-fold (or c. $26bn) as CMS and broader coverage is obtained, underpinning our enormous longer-term growth potential.
The Company will announce its half year trading update on 27 July 2026.
Dr. Mike Griffiths, Chief Executive Officer & President of AOTI, said: "This positive CMS decision is a significant milestone in our market access and growth strategy, reflecting CMS's recognition of the role of topical oxygen therapy in effectively treating diabetic foot ulcers. AOTI's standalone intermittent topical oxygen therapy, TWO2®, is differentiated by the most compelling RCT, real-world evidence and a value proposition that uniquely demonstrates improved long-term outcomes and resultant cost savings.
"Once the LCD is finalised, the resulting mandated Medicare coverage will be transformative for AOTI, significantly expanding access to our therapy for US seniors, while also accelerating TWO2® therapy coverage and adoption across Medicaid, commercial, and other market segments. We are already well positioned to drive growth with our expansive team footprint that encompasses the vast majority of the US population.
"AOTI is the market leader in topical oxygen therapy, and we look forward to capitalising on our differentiated outcome-based position and the significant opportunity we have created, by bringing our unique therapy and value-based care at home to all patients across the US and beyond."
END
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AOTI, INC. Dr. Mike Griffiths, Chief Executive Officer Jayesh Pankhania, Chief Financial Officer |
+44 (0)20 3727 1000 |
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Peel Hunt LLP (Nominated Adviser and Joint Broker) Dr. Christopher Golden, James Steel |
+44 (0)20 7418 8900 |
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Panmure Liberum Limited (Joint Broker) Emma Earl, Will Goode, Mark Rogers Rupert Dearden |
+44 (0)20 3100 2000 |
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FTI Consulting (Financial PR & IR) Ben Atwell, Simon Conway, Natalie Garland-Collins |
+44 (0)20 3727 1000 |
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 randomized 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 hospitalizations 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. TWO2® therapy has also recently received positive coverage recommendations from the Federal Joint Committee (G-BA) in Germany and National Institute for Health and Care Excellence (NICE) in the United Kingdom. Also see www.aotinc.net
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