Arteriocyte has obtained the US Food and Drug Administration (FDA) approval to begin a Phase I clinical trial using its Magellan Bio-Bandage technology in the treatment of Acute Deep Partial Thickness Thermal Injuries.
The Bio-Bandage is an autologous intervention designed to minimize the severity of the burn wound, reduce the immediate need for surgical intervention when a skin graft is required, and improve the wound’s healing trajectory.
The FDA Investigational Device Exemption (IDE 15921) allows the company to initiate clinical evaluation of Autologous Platelet Rich Plasma use in thermal injuries.
The IDE approval marks another major milestone in Arteriocyte’s partnership with the Biomedical Advanced Research and Development Authority (BARDA), to advance the use of PRP in the setting of mass casualty thermal injuries.
Arteriocyte CEO Don Brown said the company’s current IDE approval represents another important step along the pathway toward helping patients with thermal injury.
"The use of PRP has the potential to improve the quality of burn care and clinical outcome, with the added benefit of reducing the stress on resources in a mass casualty," Brown added.
"We expect that successful clinical outcomes will result in more patients having access to MAGELLAN Bio-Bandage and we are honored to be assisting BARDA in their readiness efforts to mobilize rapid medical care in the setting of mass casualty that results in thermal injuries"
Image: Arteriocyte wins FDA approval to begin Phase I trial of Magellan Bio-Bandage. Photo: courtesy of FreeDigitalPhotos.net