Press Releases

September 25, 2002
Stratatech Approved for Clinical Trial

Stratatech Corporation has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I/II Clinical Trial of its StrataGraft™ skin tissue. Currently, there is no fully effective, sterile, therapeutic skin product for the temporary treatment of serious skin indications, including severe burns, diabetic ulcers, bed sores, and other skin wounds.

The Company believes that StrataGraft™ skin tissue will address this need. It is cultured from a human cell line—NIKS™ cells, and was discovered by Lynn Allen-Hoffmann Ph.D., a professor in the University of Wisconsin Medical School, Department of Pathology. The Wisconsin Alumni Research Foundation, Madison, WI, holds patents on the technology that have been licensed exclusively to Stratatech Corporation.

StrataGraft™ skin tissue is the first product of its kind to be assessed by the Center for Biologics Evaluation and Research (CBER) at the FDA, which has developed a pre-market review of wound healing products made by combining living human cells with a matrix.

During the trial, StrataGraft™ skin tissue will be used as a wound covering to protect against infection and water loss during the first critical days after a severe burn or other life-threatening wounds. The trial initially will be conducted at the University of Wisconsin Hospital Burn Center, in Madison, WI, under the direction of Dr. Michael Schurr.

“The ultimate goal in starting the company was to provide life-saving skin grafts to patients suffering from acute or chronic skin loss such as burn victims. This is an exciting and important step in the process of achieving FDA approval for this new life-saving technology.” said Dr. Allen-Hoffmann, President of Stratatech Corporation.

Located in University Research Park, Madison, WI, Stratatech Corporation combines technology and products at the cutting-edge of tissue engineering and biotechnology.