Proposed Topical Oxygen Therapy LCD Progress

AOTI, Inc.

27 August 2026

 

27 August 2026

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

CMS/Medicare Proposed Topical Oxygen Therapy LCD Progress

Positive Virtual Open Public Meeting Concluded

AOTI, INC. (AIM: AOTI), a medical technology group focused on delivering outcomes-based care at home by the more durable healing of wounds and the prevention of amputations, announces that a  virtual public meeting was held yesterday as part of the 45-day public comment period in which all commenters were unanimously favourable in support of the previously announced proposed CMS Local Coverage Determination (LCD) proposing reasonable and necessary coverage criteria for topical oxygen therapy (TOT) for Medicare beneficiaries with diabetic foot ulcers that have failed to heal with four consecutive weeks of optimized diabetic foot ulcer care. This virtual open public meeting was intended to solicit stakeholder comments on the proposed language of the LCD ahead of its finalisation.

The meeting was hosted by the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) who are assigned by CMS the task of developing Local Coverage Determinations (LCDs), for Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS). The formal public comment process concludes on Saturday, 5 September 2026, after which, the DME MACs will review comments and finalise the LCD within 365 calendar days of its publication.

Dr. Mike Griffiths, Chief Executive Officer & President of AOTI, said: "We are delighted with the positive views expressed at the open meeting yesterday as the recent CMS proposed TOT LCD continues through its statutory process. Now the open meeting has concluded, which included many advocates of our unique intermittent topical oxygen therapy approach, we look forward to working with CMS as they work to finalise the LCD."  

"AOTI is the market leader in topical oxygen therapy, and we look forward to continuing to maximise this significant opportunity that we have created, by bringing our unique multi-modality TWO2 therapy and outcome-based care at home model to all patients across the US and beyond."

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AOTI, INC. Dr. Mike Griffiths, Chief Executive Officer Jayesh Pankhania, Chief Financial Officer	[phone] [e-mail]
Peel Hunt LLP (Nominated Adviser and Joint Broker) Dr. Christopher Golden, James Steel	[phone]
Panmure Liberum Limited (Joint Broker) Emma Earl, Will Goode, Mark Rogers Rupert Dearden	[phone]
FTI Consulting (Financial PR & IR) Ben Atwell, Simon Conway, Natalie Garland-Collins	[phone] [e-mail]

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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