AOTI hails "transformational milestone" of US CMS nod

AOTI Inc on Friday announced that the US Centers for Medicare & Medicaid Services has issued a proposed local coverage determination which "will dramatically expand" its US market.

Shares in AOTI were 21% higher at 80.00 pence in London on Friday afternoon.

The proposed LCD, which AOTI called a "transformational milestone", indicated 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 optimised diabetic foot ulcer care, it said.

The final LCD, AOTI continued, will mandate Medicare treatment coverage criteria and reimbursement for AOTI's topical wound oxygen or TWO2 therapy, and provide access to approximately 69 million Medicare enrollees.

It said this "will dramatically expand the US addressable market, support obtaining broader coverage and de-risk reimbursement in all other market segments, including Medicaid."

This will "increase momentum and unlock revenues from Medicare recipients," as well as accelerating access to "Medicaid and other US commercial and managed care market segments."

AOTI said it is already "the clear market leader in the topical oxygen segment with a 75% market share," and highlighted its existing commercial infrastructure, which currently spans across 26 states or around 86% of the US population.

AOTI said it can leverage this "to immediately capitalise on this opportunity without the need for a significant ramp-up of sales operations in the medium term."

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