Positive top-line results from Grifols Phase IIIb study of its fibrin sealant
Spanish plasma-derived medicines specialist Grifols (MCE: GRF) has announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding obtained positive top-line results from a Phase IIIb clinical trial in pediatric patients.
Having met all primary and secondary endpoints, the study is expected to facilitate regulatory approval to expand the use of the FS-based biosurgery treatment, currently indicated for adults, to children and adolescents as well.
Known commercially as VistaSeal in the USA and VeraSeal in Europe, Grifols FS is marketed and distributed by Ethicon, a Johnson & Johnson (NYSE: JNJ) medtech company, as part of a strategic collaboration between the two companies announced in 2019.
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