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Cryolife BioGlue bioadhesive IDE submission slated for fourth quarter.

This article was originally published in The Gray Sheet

Executive Summary

CRYOLIFE PLANS TO SUBMIT BIOGLUE PLASMA-PROTEIN BIOADHESIVE IDE to FDA in the fourth quarter of 1997, Cryolife President and CEO Steven Anderson said during an April 22 teleconference. In addition to the investigational device exemption, the company is targeting a late-1997 IND (investigational new drug application) filing for its fibrin-based FibRx bioadhesive product, which will be regulated by FDA as a biologic.

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