AOTI (AIM:AOTI), the AIM-listed medical technology group focused on wound healing and amputation prevention, said all commenters unanimously supported its proposed Medicare coverage terms at a virtual public meeting held as part of the 45-day comment period.
The proposed Local Coverage Determination (LCD) would set reimbursement criteria for topical oxygen therapy (TOT) for Medicare beneficiaries with diabetic foot ulcers that fail to heal after four weeks of optimised standard care.
The Durable Medical Equipment Medicare Administrative Contractors (DME MACs), tasked by the Centers for Medicare & Medicaid Services (CMS) with developing coverage rules for durable medical equipment, hosted the meeting to gather stakeholder feedback ahead of finalisation.
Formal public comment closes on 5 September, after which the DME MACs have up to 365 days from publication to finalise the LCD.
"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," said Dr. Mike Griffiths, chief executive officer of AOTI.
He added that the company is "the market leader in topical oxygen therapy" and intends to expand its TWO2 multi-modality therapy and home-based care model across the US and beyond.
The next milestone falls when the comment period closes on 5 September, ahead of the DME MACs' final determination.
News Intelligence what this means for the company
AOTI secured unanimous stakeholder support at a public hearing for its proposed Medicare Local Coverage Determination on topical oxygen therapy for diabetic foot ulcers, clearing a key regulatory hurdle. The 45-day comment period closes 5 September, after which the DME MACs have up to 365 days to finalise the LCD—a material step toward unlocking Medicare reimbursement for the company's core product across the US.
AOTI holds a 75% share of the topical oxygen therapy segment, positioning it to capture the bulk of any Medicare-driven demand expansion once the LCD is finalised. The unanimous support removes a significant execution risk from the reimbursement pathway and materially de-risks the company's US growth trajectory, which reported 10% revenue growth to approximately $35 million in the first half of 2026.
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