Oxy-Band™ Receives FDA Clearance

Oxy-Band™ has received FDA 510(k) clearance for professional and OTC use

Bio-medical technology company OxyBand Technologies™ has received FDA 510(k) clearance for its oxygen delivery technology. Oxy-Band™ wound dressing targets oxygen delivery into the wound for faster healing.

The study demonstrated the safety and efficacy of the Oxy-Band™ wound dressing in superficial standardized burn wounds compared to a commonly used polyurethane dressing, Tegaderm™, by measuring the reduction in wound size, as an assessment of re-epithelialization. Results of this study showed a significantly greater wound area reduction for Oxy-Band™ treated wounds compared Tegaderm™ treated wounds during the same period of time on the same subjects (subjects served as their own control). All subjects in this study reported a significant difference in perceived pain with less pain perceived from the Oxy-Band™ treated wounds. These results demonstrated faster re-epithelialization for Oxy-Band™ treated wounds with concomitant reduction in perceived pain compared to a commonly used dressing.

OxyBand is the first company to package pure oxygen into a discrete wound dressing using its directionally permeable gas-emitting reservoir.

“We are very happy to have received FDA 510(k) clearance for Oxy-Band™ wound dressing,” said Amie Franklin, President and Chief Executive Officer of OxyBand Technologies™. “Oxy-Band™ is our inaugural device utilizing OxyBand Technologies™ patented directionally permeable gas-emitting technology. This is the beginning of a line of innovative healing technologies that rely on targeted delivery of therapeutic gases through clinically relevant designs.”