A large real-world study has demonstrated that AOTI Inc's (AIM:AOTI) Topical Wound Oxygen therapy healed nearly two-thirds of patients with chronic lower extremity wounds that had resisted other treatments for an average of seven months.
The AIM-listed medical technology group published the retrospective cohort study in the Journal of Vascular Surgery-Vascular Insights, covering 3,126 patients with wound types including diabetic foot ulcers, venous leg ulcers, arterial ulcers and atypical wounds.
Complete wound healing was achieved in 64.8% of patients in a mean time of 4.2 months, with a recurrence rate of just 2.7% over a mean follow-up period of 13.9 months.
The results compare favourably with population-based benchmarks: the U.S. Wound Registry, which tracked more than 160,000 patients treated with standard and advanced therapies, recorded healing rates of 45% for diabetic foot ulcers and 57% for venous leg ulcers.
AOTI's TWO2 therapy also drove significant reductions in hospitalisations and amputations among the high-risk patient group, with rates of 3.7% and 6.1%, respectively, against historical norms of 54.1% for hospitalisations and 41.4% for amputations in patients with diabetic foot ulcers who did not receive the treatment.
TWO2, which delivers intermittent pressurised oxygen directly to wounds, is designed for use at home as an adjunct to standard care.
Chief executive Mike Griffiths said the findings built on a growing body of randomised controlled trial and real-world evidence, and that broader adoption of the therapy would deliver meaningful clinical and economic benefits to healthcare systems.
He added: "Given the significant and increasing global burden of chronic wounds, we believe broader adoption of TWO2 therapy would deliver meaningful clinical and economic benefits to healthcare systems."
Multiple peer-reviewed studies have separately highlighted the cost-saving potential of TWO2 as a home treatment for lower extremity wounds.
Chronic wounds represent a significant and growing global health burden, with diabetic foot ulcers alone accounting for a substantial proportion of lower limb amputations worldwide.