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FDA grants priority review for Stratatech tissue to treat burns

FDA grants priority review for Stratatech tissue to treat burns

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Stratatech Stratagraft, company photo (copy) (copy)

StrataGraft, skin tissue to treat burn wounds that was developed in Madison, will get a stepped-up review, the FDA says. 

The Food and Drug Administration has granted priority review to an application for StrataGraft, a regenerative tissue developed by a Madison company as an alternative to skin grafts in treating burns.

The FDA plans to decide whether to approve StrataGraft, a tissue product using human cells derived from discarded foreskins after circumcision, by Feb. 2, according to England-based Mallinckrodt, which bought Madison-based Stratatech in 2016 for $76 million.

Stratatech submitted its biologics license application to the FDA in June. The company, started in 2000, is based on research from the UW-Madison lab of pathologist Lynn Allen-Hoffmann.

Stratatech, which has about 100 employees, is located at University Research Park on Madison's West Side. 

The goal for StrataGraft is to prevent or reduce the need to use painful autografts, or skin grafts from a patient's own body, to cover up burn wounds and help them heal.

The FDA had designated StrataGraft an "orphan drug" and a "regenerative medicine advanced therapy," which was expected to put it on a fast track for consideration.


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