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Focal's FocalSeal-S

This article was originally published in The Gray Sheet

Executive Summary

Firm awaits investigational device exemption approval for the neurosurgical sealant following agreement with FDA on a study protocol. The agreement calls for a prospective, randomized, controlled multi-center trial to evaluate use of the device in management of postoperative cerebrospinal fluid following brain surgery. The device has been available in Europe since November 1999. Genzyme Biosurgery agreed April 26 to acquire the 78% of Focal it does not already own for about $10 mil. in stock (1"The Gray Sheet" April 30, 2001, p. 18)
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