Breakthrough Randomized Controlled Trial Demonstrating TWO2

     Efficacy in Healing Diabetic Foot Ulcers Unveiled at the American Diabetes Association 78th Scientific Sessions Conference


OCEANSIDE, Calif.June 26, 2018 /PRNewswire/ — AOTI Inc. announced today that initial results from its recently concluded Randomized Controlled Trial (RCT) demonstrating the efficacy of its patented multi-modality Topical Wound Oxygen (TWO2) homecare therapy in healing Diabetic Foot Ulcers were presented as a prestigious Late Breaking Abstract this weekend at the American Diabetes Association (ADA) 78th Scientific Sessions conference in Orlando, Florida.


The ADA estimates that Diabetes costs the USA$327 billion annually with a large portion of this cost related to treating comorbidities such as Diabetic Foot Ulcers (DFU)1. Non-healing DFU lead to increased mortality, morbidity & health economic burden as well as decreased QOL for the sufferers.


The study was conducted at seventeen Diabetic Foot Centers of Excellence spread across the USA and Europe, with a “who’s who” of expert Opinion Leaders as its investigators. The authors of the abstract highlighted the robustness of the study protocol that was of the highest scientific level ever seen in DFU studies, being not only conducted multi-center and multi-nationally, but being also double-blinded and placebo controlled. Additionally, the study protocol included the unprecedented step of a run-in of gold standard-of-care (SOC) for all subjects meeting enrollment eligibility criteria, ensuring that only those that truly failed to heal with SOC alone would be randomized into the active phase of the study.

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