SAN ANTONIO--(BUSINESS WIRE)--Medicare and Medicaid recipients who suffer from wounds such as diabetic foot ulcers, venous leg ulcers, incision wounds and others, could soon have access to a promising new technology that demonstrated positive outcomes in a recent double-blind study.
The Centers for Medicare and Medicaid Services (CMS) will decide by April 12 whether to allow regional Medicare administrative contractors to cover the cost of topically applied oxygen for non-healing wounds, including EO2 Concepts’ TransCu O2® System, which provides continuous diffusion of oxygen (CDO) therapy. CMS has also created a new national coverage code for technologies in this class which meet specific efficacy criteria.
“In January CMS proposed a rule change that would allow its regional contractors to each make their own decisions about covering the cost of topically applied oxygen therapies, based on favorable comments they received last summer and a growing body of encouraging research,” said Joe Moffett, President of EO2 Concepts. “They have also proposed that national coverage could be a possibility. We have seen a major and very positive shift in CMS’ view of this innovative technology based on the recent research and outcomes afforded patients with these debilitating wounds.”
The Journal of Diabetes Science and Technology on Feb. 15 published results of a recently completed, double-blind study demonstrating positive outcomes for patients with chronic wounds who received (CDO) therapy using the TransCu O2® System. The study – fully-blinded with a sham (placebo) device in a prospective, parallel, randomly controlled trial – showed that CDO over a wound leads to significantly higher rates of closure, and faster time to closure, compared to the placebo control group. The outcomes are statistically significant, meaning they have been shown to be repeatable or have predictable effects that can be repeated.
“This study was the first of its kind, we believe,” said Dr. Mark Q. Niederauer, Chief Operating Officer for EO2. “The study provides top-level clinical evidence of better wound closure and faster healing. It showed CDO to be much more effective than the standard-of-care moist wound therapy (MWT) for wounds deemed chronic. We believe CDO could also be quite beneficial to non-chronic wound healing.”
Niederauer will present the results of the study on March 24 at the DFCon Diabetic Foot Global Conference in Houston. Joining Niederauer in the presentation will be Dr. Klearchos Papas, Professor of Surgery at the University of Arizona, and Dr. Mark Couture, DPM, of the Central Texas Veterans Health Care System.
About Trans O2® System
TransCu O2 is a wearable system that provides a continuous flow of humidified oxygen to a moist wound 24 hours a day. It is small, simple, and can be worn discretely, allowing for constant treatment without limiting mobility.
EO2 is a privately held, advanced wound-care technology company and the developer of a progressive, FDA-cleared Class II medical device that provides therapy to difficult-to-heal wounds. The TransCu O2 System is an electrochemical tissue oxygenation and wound monitoring system for use with OxySpur® Oxygen Diffusion Dressings as an adjunctive therapy to continuously treat oxygen-compromised wounds. For more information, visit www.eo2.com.