**Summary**
AOTI, Inc., a medical technology company focused on wound healing and amputation prevention, has received a fast-track treatment recommendation from the National Institute for Health and Care Excellence (NICE) for its Topical Wound Oxygen (TWO2®) therapy in the UK. This recommendation is part of NICEs updated guidelines for diabetic foot problems, specifically for non-responsive diabetic foot ulcers. Additionally, TWO2® therapy is now listed on the NHS Supply Chains Advanced Wound Care Framework, enabling accelerated marketing and streamlined access for NHS organizations.
The inclusion in NICE guidelines and the NHS framework marks a significant milestone, providing easier access to TWO2® therapy for clinicians and patients. Professor Michael Edmonds highlighted the therapys potential to reduce amputations and healthcare costs, while Dr. Mike Griffiths, AOTIs CEO, emphasized the positive impact on patient quality of life and healthcare resource utilization. Recent health economic research supports the cost-effectiveness of TWO2® therapy, aligning with recommendations from other European healthcare bodies like Germanys G-BA.
AOTIs TWO2® therapy has demonstrated robust clinical outcomes, including an 88% reduction in hospitalizations and 71% reduction in amputations over 12 months, and has received regulatory approvals in multiple countries. The NICE recommendation is not expected to materially impact AOTIs financial outlook for the year but reinforces the companys clinical and value proposition, particularly ahead of a potential CMS coverage determination in the United States.