The study is slated to include patients with 3% to 49% total body surface area of severe thermal burns.
Researchers intend to evaluate outcomes including the area of StrataGraft treatment site that requires a subsequent autograft compared to the control site and the proportion of participants that achieve durable wound closure of the treatment site without autograft placement.
The company’s StrataGraft regenerative skin tissue was designed to mimic natural human skin and it can be stapled and sutured. The cell-based living tissue also provides critical barrier functionality during the wound healing process.
“Mallinckrodt is committed to providing treatment options for patients with unmet medical needs, and nowhere is that need more marked than in the burn unit,” Lynn Allen-Hoffmann, senior VP of regenerative medicine, said in prepared remarks. “We are pleased to enroll the 1st patient in our Phase III clinical trial.”
“We are honored to be working with the United States Biomedical Advanced Research and Development Authority (BARDA) which has been instrumental in the late-stage development of StrataGraft. This Phase III clinical trial is part of a larger, 5-year contract, and BARDA’s support has built on the critical, early-stage backing received from the National Institutes of Health and the Department of Defense. These organizations have long recognized the critical medical need for innovative products to address severe burns,” Allen-Hoffmann added.
Mallinckrodt said that BARDA’s support is a part of a larger initiative to boost emergency preparedness in repsonse to mass casualty events involving thermal burns.
“There have been few advancements in burn surgery in the last 2 to 3 decades,” lead investigator Dr. James Holmes said. “We are very excited to further study StrataGraft to learn how it could meet the needs of patients.”
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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