FESARIUSTHERAPEUTICS INC ANNOUNCES FDA 510(K) CLEARANCE FOR DERMISPHERE HYDROGEL DERMAL REGENERATION TEMPLATE

NEW YORK, Jan. 8, 2025 /PRNewswire/ -- FesariusTherapeutics Inc, an emerging bioregenerative technology company focused on the development, manufacture and commercialization of solutions for the Advanced Wound Care, Reconstructive Surgery and Regenerative Medicine markets, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its DermiSphere hydrogel Dermal Regeneration Template (DermiSphere hDRT). This groundbreaking technology represents an entirely 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.

Full-thickness wounds occur when both the dermal and epidermal layers of the skin are lost; unlike superficial/partial thickness wounds, full-thickness wounds lack the cellular components and structural support necessary to regenerate missing tissue. Without timely surgical intervention, there is a heightened risk of delayed closure, infection, and severe scarring. Dermal matrices are essential for treatment of these wounds (currently in two surgical procedures), as they induce new dermal tissue generation which then allows for successful split thickness skin grafting and improved healing outcomes.

DermiSphere hDRT is a true hydrogel-based (i.e. not fibrillar like other products) dermal template that provides a scaffold for cellular infiltration and tissue regeneration. Its unique collagen composition more closely mimics the natural extracellular matrix, promoting faster and more effective healing of dermal wounds in pre-clinical models.

"We are thrilled to receive FDA clearance for DermiSphere hDRT," said Tom Roueche, CEO of FesariusTherapeutics Inc. "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."

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, with a focus on providing surgeons with a transformative tool to revolutionize patient care.

For more information about FesariusTherapeutics Inc and DermiSphere hydrogel Dermal Regeneration Template (DermiSphere hDRT), please visit www.FesariusTherapeutics.com or contact Tom Roueche at [email protected]

About FesariusTherapeutics Inc.
FesariusTherapeutics Inc was founded in 2015 to leverage the unique technology developed by Jason A. Spector, MD, at his Laboratory of Bioregenerative Medicine and Surgery at Weill Cornell Medicine in NYC where he also serves as Chief of the Division of Plastic and Reconstructive Surgery. Dr. Spector was inspired to develop DermiSphere™ after experiencing the many limitations of products available for treating full thickness skin loss and the negative impact they had on his patients.

SOURCE FesariusTherapeutics Inc