AOTI set for expanded Medicare coverage following positive CMS proposal

AOTI CEO Dr. Mike Griffiths joined Steve Darling from Proactive to discuss a major regulatory milestone after the Centers for Medicare & Medicaid Services (CMS) issued a proposed Local Coverage Determination (LCD) supporting the use of topical oxygen therapy for diabetic foot ulcers that have failed to heal after four weeks of optimized care. Griffiths said that following a 45-day public comment period, CMS is expected to finalize the LCD within the next year. Once approved, the policy would establish Medicare coverage and reimbursement criteria for AOTI's TWO2® intermittent topical wound oxygen therapy, significantly expanding patient access across the United States. Management believes the final LCD will be transformative, providing access to approximately 69 million Medicare beneficiaries, including a population with high rates of diabetes and diabetic foot ulcers. The company also expects the decision to accelerate reimbursement across Medicaid, commercial insurers, and managed care organizations, substantially reducing reimbursement risk. AOTI currently holds an estimated 75% share of the topical oxygen therapy market, driven by its TWO2® platform, which the company says is the only intermittent topical oxygen wound therapy available. Multiple peer-reviewed clinical studies have demonstrated improved long-term healing outcomes compared with continuous topical oxygen therapy and other advanced wound care treatments. The company believes it is well positioned to capitalize on the expanded opportunity, with an existing commercial infrastructure spanning 26 states and reaching approximately 86% of the U.S. population. Management estimates its current serviceable market represents a $400 million revenue opportunity, while broader CMS-driven reimbursement could expand the addressable market to approximately $26 billion over the longer term. Griffiths said the proposed CMS decision represents a significant milestone that could drive wider adoption of TWO2® therapy while improving access for Medicare patients suffering from chronic diabetic foot ulcers. #proactiveinvestors #aoti #aim #topicalwoundoxygen #two2 #woundcare #Healthcare #MedTech #OxygenTherapy #DiabeticFootUlcers #WoundCare #MedicalTechnology #HealthcareInnovation #TopicalOxygenTherapy #MedTech #Healthcare