AOTI Notes That Topical Oxygen Has Been Awarded Highest “Level I” Treatment Recommendation for Diabetic Foot Ulcers (DFUs) by the Wound Healing Society

AOTI’s at-home TWO2® therapy is able to deliver oxygen topically into chronic wounds, including DFUs, and to encourage high-quality, durable wound healing

OCEANSIDE, Calif., Dec. 4, 2023 /PRNewswire/ — AOTI Inc., the global leader in multimodality topical wound oxygen therapy, announces that the Wound Healing Society (WHS) has awarded topical oxygen a Level I adjunctive treatment recommendation in its 2023 diabetic foot ulcer (DFU) treatment guidelines.

The WHS guidelines, which have been published in the leading peer reviewed journal Wound Repair and Regeneration, state that: “Topical oxygen has been shown to increase the incidence of healing and decrease the time to heal”.1 AOTI’s innovative, at-home TWO2 therapy is able to deliver oxygen topically into chronic wounds, including DFUs, and to encourage high-quality, durable wound healing over a period of 12 months and longer.

The WHS is the preeminent international society composed of clinical and basic scientists as well as wound care specialists dedicated to improving wound healing outcomes through science, education and communication. The objectives of the WHS DFU guidelines are to systematically evaluate the medical literature to assist clinicians in making health care decisions, identify areas that need additional research, and to clarify controversial diagnosis and treatment strategies. The strength of evidence supporting a guideline is listed as either Level I, Level II, or Level III. Level I is the highest recommendation.

Dr Mike Griffiths, CEO and President of AOTI, commented: It is encouraging to see the WHS has provided expert updated guidelines supporting the adjunctive use of topical oxygen in healing DFUs, with its highest “Level I” recommendation. This is in line with the “A” grade recommendation made by the American Diabetes Association (ADA) in its 2023 Standard of Care in Diabetes2 and consistent with the updated 2023 guidelines from the International Working Group on the Diabetic Foot (IWGDF)3. We are delighted that our unique TWO2 therapy, that can be applied by patients in a home-care setting, is receiving the treatment recommendations it deserves based on the quality of its supporting clinical evidence. Importantly, this evidence includes the ability of TWO2 to achieve complete and long-lasting wound healing, with significant proven reductions in wound reoccurrence, hospitalisations and amputations over the long term.4,5

About AOTI

AOTI is a privately-owned company based in Oceanside, California U.S.A. and Galway, Ireland that provides innovative solutions to resolve severe and chronic wounds worldwide. Our products reduce healthcare costs and improve the quality of life for patients with these debilitating conditions. Our patented non-invasive Topical Wound Oxygen (TWO2) therapy is the only device that has demonstrated in Randomized Controlled Trial (RCT) and Real-World Evidence (RWE) studies to more durably heal Diabetic Foot Ulcers (DFUs), resulting in an unprecedented 88 percent reduction in hospitalizations and 71 percent reduction in amputations over 12 months.4, 5 TWO2 therapy can be administered by the patient at home, improving access to care and enhancing treatment compliance. TWO2 therapy has received regulatory approvals from the USA (FDA), Europe (CE Mark), UK (MHRA), Health Canada, the Chinese National Medical Products Administration, and certain Middle Eastern countries.

For more information see:

1 Wound Repair and Regeneration 2023

2 Diabetes Care 2023;46(Supplement_1):S203–S215


4 Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers; The TWO2 Study. Robert G. Frykberg et al, Diabetics Care 2020; 43:616-624.

5 Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes; Jessica Izhakoff Yellin, et al; Advances in Wound Care 2022;


Dr. Mike Griffiths
CEO & President

(760) 672 1920