TWO2 Randomized Controlled Trial Chosen as One of the Best Abstracts Presented at the Leading Diabetic Foot Global Conference

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Oct 11, 2018, 08:32 ET

OCEANSIDE, Calif., Oct. 11, 2018 /PRNewswire/ -- AOTI Inc. announced today that expanded 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, has been chosen as one of the three best poster abstracts at the leading DFCon - Diabetic Foot Global Conference, being held from October 11-13, 2018 in Houston, Texas, USA.

DFCon is the premier international, interdisciplinary diabetic foot conference in North America focused on diagnostic and interventional strategies for diabetic foot ulcers and amputation prevention, now in its 18^th year. The conference program is designed for the wide spectrum of generalists and specialists who diagnose and manage the diabetic foot, and features a world-renowned international faculty. Further details can be found at: http://dfcon.com.

The abstract, entitled: Healing Chronic Diabetic Foot Ulcers (DFU) with Cyclical Pressurized Topical Wound Oxygen Therapy: Results of the TWO2 Multi-National, Multi-Center, Randomized, Double Blinded, Placebo Controlled Trial, details the outcomes from the company's pivotal study that was conducted at seventeen Diabetic Foot Centers spread across the USA and Europe. The authors of the abstract highlighted the robustness of the study protocol that was of the highest scientific level seen in DFU studies, being not only conducted multi-center and multi-nationally, but also double-blinded and placebo controlled. Additionally, the study protocol included the unprecedented step of a run-in of a controlled gold standard-of-care (SOC) for all subjects meeting enrollment eligibility criteria, ensuring that only those ulcers that truly failed to heal with SOC alone would be randomized into the active phase of the study.

The authors highlighted a number of statistically significant results related to the primary outcome of the study that was ulcers completely healed at 12 weeks, namely, that:

TWO2 showed nearly 4 times the likelihood to completely heal ulcers compared to gold standard-of-care alone: HR 3.88 (95% CI 1.4, 10.71), p = 0.009.
41.7% of TWO2 treated ulcers were completely healed compared to just 13.5% of ulcers treated with gold standard-of-care alone: Pearson Chi² = 7.2707, p = 0.007.
Larger TWO2 treated ulcers that had not completely healed at 12 weeks were on a trajectory to heal, unlike ulcers treated with just gold standard-of-care alone that increased in size.

"We are delighted that our breakthrough study has been awarded this accolade by the scientific committee of such a prestigious conference. This further endorses the robustness of the study design and its outcomes." stated Dr. Robert Frykberg, the Chief Principle Investigator and lead author of the study. "Having now completed the follow-up phase of the study that includes looking at ulcer reoccurrence rates up to 12 months, health economic and quality of life outcomes, we can finalize the drafting of our full paper for submission to a leading peer reviewed journal for publication." he added.

About AOTI

AOTI Inc. is a private company based in Oceanside, California USA 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 illnesses. Our patented non-invasive Topical Wound Oxygen (TWO₂) therapy is unsurpassed in fully closing Diabetic, Venous and Pressure ulcers alike.

For more information see: www.aotinc.net.

Media Contact:
Dr. Mike Griffiths
CEO and President
[email protected]
(760) 672 1920

SOURCE AOTI Inc.