AOTI Inc (AIM:AOTI) told investors that proposed nationwide Medicare coverage for topical oxygen therapy could expand the addressable market for its TWO2 wound treatment as much as 65-fold to around US$26 billion.
The US Centers for Medicare & Medicaid Services issued a proposed Local Coverage Determination covering diabetic foot ulcers that fail to heal following four consecutive weeks of optimised care. Finalisation would give AOTI access to roughly 69 million Medicare enrollees while supporting wider reimbursement through Medicaid and commercial insurers.
AOTI said its currently covered serviceable market, including Veterans Affairs and New York Medicaid, represents a near- to medium-term revenue opportunity of around US$400 million. Penetration remains in the mid-teens. The company claims a 75% share of the topical oxygen segment and operates across 26 states, giving it access to about 86% of the US population without requiring a significant medium-term expansion of its sales infrastructure.
Chief executive Dr Mike Griffiths said mandated Medicare coverage would be “transformative for AOTI”.
CMS will hold a 45-day public comment period before reviewing submissions and finalising the determination within a year. AOTI is due to release its half-year trading update on 27 July.
