International Overview

This section may describe clearances in countries other than the United States, and therefore may contain indications and information that are outside the scope of the FDA-cleared labeling.

In addition to the FDA 510(k) clearance, we have received CE approval in the European Union and approvals in Canada and Australia which allow BioSphere Medical to sell Embosphere® Microspheres for use in embolization of AVM's, and for the embolization of hypervascularized tumors, which include uterine fibroids, liver tumors, and brain tumors. As of March 22, 2002, we received CE approval and Canadian approval for EmboGold® Microspheres in pre-filled syringes. Thus, we are able to sell EmboGold Microspheres in the European Union and in Canada.

We have expanded our distribution in Europe, the Middle East, Africa, Asia and South America.

Applications

• Uterine Fibroid Embolization
• Arteriovenous Malformations
• Meningioma
• Targeted Liver Embolization