The collagen-based dermal regeneration template is designed for improved patient outcomes in the treatment of full-thickness wounds.
FesariusTherapeutics Inc, a commercial-stage bioregenerative surgical company focused on delivering solutions for the wound care, reconstructive surgery, and regenerative medicine markets, announced it entered into a manufacturing and supply agreement with Regenity Bioscience to provide Regenity exclusive manufacturing responsibility for DermiSphere hDRT, a new class of collagen-based dermal regeneration templates designed for improved 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 delayed time to closure, a heightened risk of infection, and severe scarring and functional impairment.
Dermal regeneration templates are essential for management of these wounds to regenerate dermis. It is estimated that over 250,000 surgical procedures were performed in the United States last year to treat full-thickness skin loss.
Fesarius contracted with Regenity in 2022 to establish the transfer and development of the commercial manufacture of DermiSphere hDRT. “Regenity is the world’s leading manufacturer of regenerative technologies and is the optimal partner to provide a reliable and scalable supply of our unique hydrogel device,” says Tom Roueche, CEO of Fesarius, in a release. “Completing this manufacturing milestone sets the stage for Fesarius to transform the process of advanced wound care and the surgical treatment of full-thickness skin loss.”
Fesarius received FDA 510(k) marketing authorization for DermiSphere hDRT earlier this year to allow for commercial sale in the United States. Completing manufacturing enables surgeons to begin utilizing Fesarius’ hDRTs in the treatment of full-thickness skin loss.
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