The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for FesariusTherapeutics Inc’s DermiSphere hydrogelDermal Regeneration Template (DermiSphere hDRT).
This technology represents a new class of collagen-based dermal matrices designed for tissue integration and revascularization for improved wound healing, reduction of time to healing, and better patient outcomes in the treatment of full-thickness wounds.
DermiSphere hDRT is a true hydrogel-based dermal template that provides a scaffold for cellular infiltration and tissue regeneration. Its collagen composition more closely mimics the natural extracellular matrix, promoting faster and more effective healing of dermal wounds in pre-clinical models.
The FDA’s 510(k) clearance allows FesariusTherapeutics Inc to market and distribute DermiSphere hDRT in the United States. The company plans to launch the product in the coming months.
“We are thrilled to receive FDA clearance for DermiSphere hDRT,” says Tom Roueche, CEO of FesariusTherapeutics Inc, in a news release.”This clearance marks a significant milestone in our mission to develop advanced regenerative solutions that improve patient outcomes. DermiSphere hDRT offers a truly novel approach to dermal regeneration, and we are excited about its potential to transform wound care.”
