“This is another enormous milestone for our company and a testament to the ease-of use and durable clinical efficacy of TWO2 therapy, as well as to the tenacity of our entire dedicated care team. AOTI is proud to have been able to help heal the Diabetic Foot Ulcers and Venous Leg Ulcers of so many high-risk patients safely at home. Effective homecare therapeutics, such as provided by TWO2, have become vital in maintaining continuity-of-care by caregivers for their patients, especially during the recent COVID-19 pandemic,” stated Dr. Mike Griffiths, CEO and Medical Director of AOTI … read more
Tag: topical oxygen
Can Topical Oxygen Have An Impact On DFU Healing?
Data continue to accumulate for some role of topical oxygen (TOT) in tissue repair and wound healing. A study from Golledge and colleagues in Australia reveals some interesting developments.1 Their systematic review and meta-analysis examined evidence for the benefit of topical oxygen therapy in healing diabetic foot ulcers (DFUs) … read more
Decision Memo for Hyperbaric Oxygen (HBO) Therapy
(Section C, Topical Oxygen) (CAG-00060R)
The Centers for Medicare & Medicaid Services (CMS) received a reconsideration request to remove the coverage exclusion of Continuous Diffusion of Oxygen Therapy (CDO) from NCD Manual 20.29, Section C. This section of the NCD (Topical Application of Oxygen) considers treatment known as CDO as the application of topical oxygen and nationally non-covers this treatment.
After examining the evidence, CMS has decided that no National Coverage Determination is appropriate at this time concerning the use of topical oxygen for the treatment of chronic wounds. We will amend NCD 20.29 by removing Section C, Topical Application of Oxygen and Medicare coverage of topical oxygen for the treatment of chronic wounds will be determined by the local contractors.
Summary:
Chronic wounds are prevalent in the Medicare population and cause a disproportionate burden on beneficiaries and their families and caretakers. CMS recognizes the need for new therapies that will heal wounds and the standardization of wound care in general. Overall, since the evidence on chronic wound healing from topical oxygen therapies has increased over the past few years, CMS believes a national non-coverage decision is no longer appropriate. CMS received 17 public comments and most of the commenters support this position. However, given the inability to identify the characteristics of chronic wounds that best respond to topical oxygen therapy and the type of patients’ best suited to use this therapy, we are not able to define a patient population that would benefit from topical oxygen therapy in a national coverage determination at the present time. Ongoing research in the US and Europe and pending publications may provide additional evidence that may support a national determination in the future. CMS realizes that double blinded RCTs cannot always be used in order to answer questions regarding the outcomes of exposure to various treatment regimens in the wound care space. However we acknowledge that various investigative groups have, and are currently, studying the treatment of chronic wounds by TOT through randomized controlled trials. CMS reviewed a number of articles from commenters, considered all additional information and has determined to finalize the proposed decision.
Conclusion
The Centers for Medicare & Medicaid Services (CMS) received a reconsideration request to remove the coverage exclusion of Continuous Diffusion of Oxygen Therapy (CDO) from NCD Manual 20.29, Section C. This section of the NCD (Topical Application of Oxygen) considers treatment known as CDO as the application of topical oxygen and nationally non-covers this treatment.
After examining the evidence, CMS has decided that no National Coverage Determination is appropriate at this time concerning the use of topical oxygen for the treatment of chronic wounds. We will amend NCD 20.29 by removing Section C, Topical Application of Oxygen and Medicare coverage of topical oxygen for the treatment of chronic wounds will be determined by the local contractors.
OxyGenesys Dissolved Oxygen Dressing at Northwestern University
Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days.
At least 12 study visits will occur over a 3 month timeframe. Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days (follow up assessments include wound photography, pain scores, wound biopsies, exudate collection, gene expression and proteomic analysis, scar assessment and adverse event collections. Study visits will occur at:
Prescreening Visit; Day of wounding; Day 2; Day 7; Day 8-14 (until all wounds have healed); Day 28; Day 42; Abdominoplasty Surgery. An abdominoplasty will occur after day 42.
What would our health care system look like if doctors spoke the same
language as engineers?
Medical school students today are trained to diagnose complicated diseases, but they are rarely trained to engineer the solutions themselves. To change that, soon Texas A&M University will start training doctors and nurses to also be engineers.
“Our technology [is] is a bandage that generates oxygen from the chemical decomposition of hydrogen peroxide,” Frey said. A chemical reaction between the layers of the bandage creates a concentrated oxygen gas which Frey said helps a wound heal. MedNoxa is seeking FDA clearance to sell the bandages by prescription and over the counter … read more
related: Purdue startup developing restorative oxygenation wound dressings receives $30,000 investment