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Advanced Tissue Sciences gathering additional Dermagraft data; PMA submission on target for December.

This article was originally published in The Gray Sheet

Executive Summary

ADVANCED TISSUE SCIENCES GATHERING DERMAGRAFT DATA ON 20-30 MORE PATIENTS for use of the bioengineered skin replacement in the treatment of diabetic foot ulcers. The company is gathering the data at FDA's request to demonstrate that a version of the product that will be produced commercially is clinically equivalent to the product used in a pivotal clinical study that was produced by a pilot manufacturing process. The only obvious difference between the two is size: the commercial product will measure 2" x 3" while the size used in clinicals measured 4" x 6", ATS says.
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