Fesarius Therapeutics Inc. recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its DermiSphere Hydrogel Dermal Regeneration Template (DermiSphere hDRT).
This innovative product represents a new class of collagen-based dermal matrices designed to facilitate tissue integration, promote revascularization for enhanced wound healing, reduce healing time, and improve patient outcomes in the treatment of full-thickness wounds.
Full-thickness wounds pose significant challenges to medical practitioners, as they involve the complete loss of both the dermal and epidermal layers of the skin. These wounds lack the cellular components and structural support necessary to regenerate the missing tissue. If not addressed promptly, they risk delayed closure, infection, and severe scarring.
DermiSphere hDRT is a true hydrogel-based dermal template that acts as a scaffold for cellular infiltration and tissue regeneration. With its unique collagen composition, it closely mimics the natural extracellular matrix, promoting faster and more effective healing of dermal wounds.
Tom Roueche, CEO of Fesarius Therapeutics Inc., stated, “We are thrilled to receive FDA clearance for DermiSphere hDRT. 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.”
Fesarius Therapeutics Inc. plans to market and distribute DermiSphere hDRT in the U.S., with the product set to launch in the coming months.
Source:
- FESARIUSTHERAPEUTICS INC ANNOUNCES FDA 510(K) CLEARANCE FOR DERMISPHERE HYDROGEL DERMAL REGENERATION TEMPLATE. (n.d.). [Press release]. https://www.prnewswire.com/news-releases/fesariustherapeutics-inc-announces-fda-510k-clearance-for-dermisphere-hydrogel-dermal-regeneration-template-302346137.html
