Proposed Topical Oxygen Therapy LCD Progress

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.

• 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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