EO2 Announces Publication of Randomized Clinical Trial Data

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San Antonio, TX – September 19, 2019 – EO2 Concepts announced today the publication of a post hoc analysis from its randomized, double-blind, multi-center study published last year in the Journal of Wound Care. The latest study, published in this month's Wounds journal, evaluates the positive impact of continuous diffusion of oxygen (CDO), with the wearable EO2 Oxygen Delivery System (EO2 System), has on patients suffering from diabetic foot ulcers when coupled with frequent wound debridement.

The results of the 146-patient study demonstrate a significantly greater percentage of wound closure in patients receiving active CDO therapy than those receiving a placebo device in addition to standard wound care with identical dressings, debridement recommendations and offloading. Sites that debrided ulcers in nearly every visit experienced a 240% improvement in the treatment arm over the placebo arm, supporting the importance of debridement as a component of the overall diabetic foot ulcer treatment strategy.

"These results confirm that frequent debridement allows for greater access of the continuous flow of oxygen to the affected tissues supporting enhanced wound healing," stated Dr. Lawrence A. Lavery, DPM, MPH, co-author on the publication and Professor of Plastic Surgery at University of Texas Southwestern Medical Center. "This builds on the body of evidence that aggressive debridement facilitates wounds healing."

David G. Armstrong, Professor of Surgery and Director of the Southwestern Academic Limb Salvage Alliance (SALSA) at University of Southern California noted, "This therapy now has undergone a rigorous randomized controlled trial, where the data were not only surprising, but compelling. I think that this therapy should now be considered as a potential adjunct for optimizing the wound healing environment once the wound has received good quality debridement and offloading."

Diabetic foot ulcers are a common complication associated with the worldwide epidemic of diabetes, leading to amputations and hospitalizations.1 The wearable EO2 System is the world's first wound healing technology that continuously (24/7) delivers, and monitors delivery of, consistent, precise levels of pure, humidified oxygen to effect full wound closure. Results from its randomized, double-blind study published last year demonstrate that CDO therapy with the EO2 System substantially improves the healing process in chronic wounds by providing faster, complete healing, particularly in patients with more complex wounds. Current data suggests that the relative performance of CDO appears to increase with the use of frequent debridement.

"We have anecdotally believed that more frequent debridement in combination with the known benefits of CDO therapy and this data supports those assertions," stated Joe Moffett, President of EO2 Concepts. "These results will help to support current guidelines and improve outcomes in this highly undeserved patient population."

1. Lavery L, Niederauer M, et al. Does Debridement Improve Clinical Outcomes in People with Diabetic Foot Ulcers Treated With Continuous Diffusion of Oxygen? Wounds. Epub July 2019.

About EO2
EO2 Concepts is a privately held, advanced wound-care technology company and innovator of an FDA-cleared, Class II medical device system that provides continuous oxygen therapy to difficult-to-heal wounds.

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