Acera Surgical Inc., (“Acera”) a bioscience company located in St. Louis, MO received 510(k) clearance from the Food and Drug Administration (FDA) for its innovative wound care product, the Restrata™ Wound Matrix on April 26th. Restrata™ is a fully-synthetic electrospun wound dressing composed of randomly oriented nanofibers that create a highly porous scaffold for cellular infiltration and vascularization during wound repair. Its structure was engineered to be similar to that of native extracellular matrix, one of the key building blocks of newly forming tissue.
“In pre-clinical testing, our product showed promising results compared to commercially available wound matrices. Acera’s scaffold allowed for the rapid formation of healthy, vascularized granulation tissue and effective wound closure with minimal inflammatory response,” said Tamas Kovacs, Acera’s Senior Director of Product Management. “We’re excited to provide an alternative solution in wound healing that has potential to address many of the shortcomings of biologic products.”Read Full Article