OCEANSIDE, Calif., May 10, 2017 /PRNewswire/ — AOTI Inc. announced today that its revolutionary patented Topical Wound Oxygen (TWO2) homecare therapy has received a Strong GRADE 1B Treatment recommendation in the European Wound Management Association (EWMA) guidance document, entitled: Use of oxygen therapies in wound healing, with special focus on topical and hyperbaric oxygen treatment, published in the Journal of Wound Care, 2017; 26(5), Suppl, S1–S42.
The editorial board of the guidance document, made up of leading Wound Care clinicians from around the world, utilized a health technology assessment (HTA) approach to assess all Topical and Hyperbaric oxygen therapies, culminating in a GRADE classification recommendation as to the level of evidence for each. The GRADE classification is a commonly utilized system that rates the strength of clinical evidence from 1A (highest) to 2C (lowest).
During the Key session releasing the document at the recent EWMA Congress in Amsterdam on May 3rd 2017, one of the co-editors of the document, Prof. Dr. Joachim Dissemond of the University Hospital of Essen, highlighted Topical Wound Oxygen (TWO2) therapy in his presentation as the only device to receive a converted 1B rating.
“We are delighted that the already published peer reviewed clinical evidence for TWO2 therapy has received such a strong treatment recommendation in this detailed review by Europe’s leading wound care association. This is just another incredible endorsement of the benefits and clinical efficacy of our approach, which will only strengthen further as we complete our ongoing Randomized Controlled Trial (RCT), helping drive even greater adoption of its use in the future,” stated Dr. Mike Griffiths, CEO and President of AOTI.
Additionally, AOTI Inc. also announced that in its recent Decision Memorandum on Topical Oxygen, the Centers for Medicare & Medicaid Services (CMS) cited AOTI’s ongoing clinical study, entitled: Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers, as an example of a randomized, double blinded, parallel group, sham-controlled, multi-center study design that they encourage to increase the overall strength of evidence in making coverage decisions.
Dr. Griffiths added, “AOTI is dedicated to developing the strongest scientific evidence to support the outcomes achieved by our unique TWO2 therapy. It is flattering that the world’s leading reimbursement body recognizes the robustness of our ongoing clinical trial protocol, that we have developed to meet the evidence bar required for coverage upon the study’s successful completion. We further applaud CMS for its thorough review of the existing evidence concerning the use of topical oxygen for the treatment of chronic wounds, and for removing this approach from the Hyperbaric oxygen section of the national coverage determination manual, allowing for coverage to be determined by the local contractors moving forward.”
AOTI Inc. is a leading international company providing 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. AOTI is a private company based in Oceanside, California USA and Galway, Ireland with offices throughout the globe. For more information, see: www.aotinc.net.