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BioSphere advances on Embosphere filing:

This article was originally published in Clinica

Executive Summary

BioSphere Medical says it is on track to file its Embosphere Microsphere technology for FDA clearance by the second quarter of 2002 for use in treating uterine fibroids. The firm has completed enrolment for a trial of the product involving 50 patients who will undergo hysterectomy for the condition. The phase II trial will measure complications, adverse events, changes in symptoms, quality of life and patient satisfaction. The Rockland, Massachusetts firm already has FDA clearance to market the technology for hypervascularised tumours and vascular malformations.

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