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.”
Acera commercialized its first electrospun scaffold in 2016 with the FDA clearance of the Cerafix® Dura Substitute, used in neurosurgical settings. The benefits of nanofabricated electrospun scaffolds as wound dressings and skin substitutes have been studied in academic labs extensively with much promise, but had not been available commercially. “We are proud of our ability to accomplish the lab-to-market process with our technology, and we look forward to exploring the clinical use of the technology platform in the future,” said Dr. Matthew MacEwan, Acera’s Co-Founder and Chief Science Officer. “We are grateful of the support we have received from physicians and the medical community, and we’re always on the lookout for new advisors, investors and partners.”
About Restrata™ Wound Matrix
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. Restrata™ is a porous matrix made from synthetic biocompatible materials that provide a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal-based materials or tissues.
About Acera Surgical Inc.
Acera Surgical Inc. (“Acera,” St. Louis, Missouri) is a bioscience company developing and commercializing a portfolio of fully synthetic electrospun scaffolds for regenerative medical applications. Acera’s products exhibit a structure similar to native extracellular matrix (ECM) and thus support rapid and effective healing. The FDA cleared Acera’s first product in March 2016 and its second product in April 2017, both via 510(k). Acera is currently raising Series A financing, as well as seeking strategic partners for product development and commercialization.