Cell-based human skin tissue maker Stratatech will receive up to $247 million over five years as part of a federal contract it signed in 2013 that has since been expanded, the company announced Monday.
Madison, WI-based Stratatech said it will use the money to continue Phase 3 clinical trials of StrataGraft, its flagship skin replacement product for burn victims, and submit a FDA application to market StrataGraft tissue commercially.
“The financial impact of this new award to Stratatech is unquestionably significant and will accelerate our transition into a fully integrated, operating company,” said B. Lynn Allen-Hoffman, Stratatech’s CEO and chief scientific officer. “But the real beneficiaries here are the severe burn patients who for the first time will have a therapeutic option available to them in lieu of painful skin transplantation.”
The agency behind the award is the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. BARDA is part of a government defense network preparing for the possibility of mass casualties due to terrorist attacks.
In accordance with the contract, Stratatech said it will stockpile skin tissue, which the federal government would purchase in the event of a terrorist attack, natural disaster, or other “mass casualty emergency.”
“In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care,” Stratatech said. “Successful completion of this contract would position the company’s StrataGraft skin tissue for rapid deployment as a medical countermeasure.”
In mid-2013, BARDA and the company inked a five-year, $47 million contract. Stratatech said Monday that $18 million of that sum had already been awarded, bringing BARDA’s total potential investment in the company to $265 million.
The latest contract is structured with a base period, for which Stratatech will receive $60 million, plus “defined contract options covering a series of clinical trials, product procurement, and other activities,” the company said.
In March, Stratatech announced results from a mid-stage clinical trial evaluating the safety and effectiveness of StrataGraft in patients with deep second-degree burns. Each patient received a graft of the company’s tissue at the site of a burn and an autograft—a graft of his or her own healthy skin taken from another part of the body—on another burn in order to compare results.
After 28 days, none of the wounds treated with Stratatech’s tissue required autografting. Within three months, the wounds were completely closed in 27 of the 28 patients who completed the trial.
In addition, StrataGraft DNA couldn’t be detected in any of the patients after three months, which the company said shows the patients’ skin had been regenerated with their own cells. Stratatech said there were no signs of infection from the StrataGraft treatment, and the wound sites had a “superior” comestic appearance compared to the autograft sites in some patients.
“Clinical trial outcomes to date have been compelling,” the company said Monday.