FDA Approves Investigational Plan for Bio-Bandage

Arteriocyte is set to kick off a Phase I trial of its Magellan Bio-Bandage for acute deep partial thickness thermal injuries, following FDA approval of the company’s investigational plan.

The multicenter trial will enroll patients between the ages of 18 and 85 who have sustained a deep partial thickness thermal burn injury to 25 percent or less of their total body surface area within the previous 48 hours, Arteriocyte spokeswoman Maria Urso said. All of the trial sites are in the U.S.

The trial is being funded by HHS’ Biomedical Advanced Research and Development Authority, which is responsible for emergency preparedness and response. The contract, signed in September, provides Arteriocyte with $11.8 million over two years to evaluate the bio-bandage’s ability to enhance and accelerate recovery of severe deep burns in combination with other available treatments following a radiation or nuclear accident or attack.

The bandage consists of platelet-rich plasma from the patient’s own blood that is sprayed over a wound, creating a gel-like substance in a matter of minutes. This accelerates new tissue growth, while eliminating infections and other donor-site complications associated with skin grafts.

A mass casualty situation with many burn patients could quickly overwhelm the system, due to the large number of personnel and donor tissue required to respond appropriately. If the bio-bandage proves effective, it could substantially minimize the burden on first responders, Urso said. — Lena Freund

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