Real-world study of AOTI’s TWO2® therapy

Large real-world study in 3,126 patients demonstrates superior durable healing of chronic wounds with AOTI's Topical Wound Oxygen (TWO2®) therapy

Study published in Journal of Vascular Surgery-Vascular Insights shows 64.8% overall complete healing rate and only 2.7% reoccurrence for chronic lower extremity wounds

AOTI, INC. (AIM: AOTI), a medical technology group focused on delivering outcomes-based care at home, by more durable healing of wounds and the prevention of amputations, announces findings from a large newly published multicentre retrospective cohort study in the Journal of Vascular Surgery-Vascular Insights (JVS-VI)1 evaluating the effectiveness of Topical Wound Oxygen (TWO2®) therapy in the treatment of chronic lower extremity wounds.

The study demonstrated a high rate of complete durable healing utilising AOTI's intermittent TWO2® therapy as an adjunct to standard of care in hard-to-heal wounds that had failed to heal with other advanced wound care for an average of 7 months. It encompassed 3,126 patients with broad wound types, including diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), arterial ulcers and atypical wounds, building on previously published randomised clinical trial data and real-world evidence as to the therapy's efficacy in healing DFUs.

Key findings:

• Treatment of chronic lower extremity wounds in a complex, comorbid patient population with TWO2® therapy resulted in superior and more durable complete wound healing outcomes, compared with those reported in population-based real-world studies2.
• The primary outcome of complete wound healing was achieved in 64.8% (n = 2,027) of patients, in a mean time of 4.2 months, despite a mean pre-treatment wound age of 7 months.
• The need for retreatment due to wound recurrence was only 2.7% (n=54), over a mean follow up time of 13.9 months.
• TWO2® therapy significantly reduced the rates of hospitalisations and amputations for this high-risk patient population when compared with historical norms3 reporting only 3.7% (n=115) and 6.1% (n=191) respectively.
• Mike Griffiths, Chief Executive Officer & President of AOTI, said: "This large real-world study demonstrated significantly improved durable healing and lower wound recurrence with the use of TWO2® therapy in complex comorbid patient populations. These results build on our growing body of robust randomised controlled trial and real-world evidence validating the role our unique therapy plays in improving patient outcomes in a meaningful way. In addition, multiple published peer-reviewed studies have highlighted the cost saving potential of using TWO2® as an adjunctive at home treatment for lower extremity wounds4. 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."

1 Joann M. Lohr, et al. Retrospective Review of 3126 Patients with Chronic Lower Extremity Wounds Treated with Intermittent Topical Oxygen Therapy JVS-Vascular Insights, 2026, 100404, ISSN 2949-9127: https://doi.org/10.1016/j.jvsvi.2026.100404.

2 Healing rates in the US Wound Registry (USWR) (included 62,964 DFUs and 97,420 VLUs, treated with both standard and advanced therapies). DFUs 45% in mean time of 20 weeks; VLUs 57% in mean time of 16 weeks. USWR data represents a less medically complex patient population to that examined in this study because it includes patients who healed without the need for advanced wound therapies.

3 In an earlier published real-world DFU study, 54.1% of patients that did not receive TWO2 therapy were Hospitalised and 41.4% had Amputations over 12 months. Yellin, et al. Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes. Advances in Wound Care. 2022;11(12):657-665. doi:10.1089/wound.2021.0118

4 Marion Kerr, Daisy Wild, Michael Edmonds, Andrew J.M. Boulton, Cost effectiveness of topical wound oxygen therapy for chronic diabetic foot ulcers, Journal of Diabetes and its Complications, Volume 39, Issue 5, 2025, 10901. https://doi.org/10.1016/j.jdiacomp.2025.109016.

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