Wound healing just got a boost: The US Food and Drug Administration (FDA) has cleared BioTime Inc’s Premvia for marketing.
Premvia™ is the first FDA-cleared member of BioTime’s HyStem® family of hydrogels, which mimic the natural structures of the body’s extracellular matrix. This allows for the cross-linking of collagen and Hyaluronic acid, and is compatible with cells and tissues.
The product can help treat wounds including: partial thickness, full-thickness, and tunneling wounds; pressure, venous, diabetic, and chronic vascular ulcers; donor skin graft sites; post-Moh’s surgery; post-laser surgery; podiatric wounds; wound dehiscence; abrasions; lacerations; second-degree burns; skin tears; and draining wounds.
Clinical trials of the company’s second HyStem®-based product, Renevia™, are expected to begin later this year in Europe, where BioTime is seeking a CE Mark for the use of Renevia™ in combination with cells for the lipotransfer in the treatment of HIV-related lipoatrophy. BioTime is also developing stem cell and other products for research, therapeutic, and diagnostic use through its subsidiaries.