The proposed investigation will be a prospective, randomized, double-blinded clinical trial conducted at approximately 15 sites in the US, the EU and Brazil. The clinical trial will focus on treating patients with advanced hepatocellular carcinoma, also known as primary liver cancer, and will compare QuadraSphere with doxorubicin against conventional transarterial chemoembolization with doxorubicin.

BioSphere anticipates that patient enrollment will take approximately 12 months, and that it will file a pre-market approval application with the FDA approximately 12 months after the final patient is enrolled. The company expects to fund trial costs from current working capital and cash flow from operations.

QuadraSphere's technical attributes are designed to provide a unique and versatile embolization platform. Its spherical shape is designed to allow for a predictable, flow-directed occlusion. The product has been demonstrated to expand to four times its dry-state diameter. Also, QuadraSphere is designed to afford atraumatic conformability to the vessel architecture, leading to a more complete vessel occlusion, BioSphere Medical said.

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Expected next investor conference call information:
Conference Call Date: 10/29/2009
Conference Call Time (ET): 8:30 AM
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Expected next investor conference call information:
Conference Call Date: 10/29/2009
Conference Call Time (ET): 9:30 AM
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Expected next investor conference call information:
Conference Call Date: 10/29/2009
Conference Call Time (ET): 9:30 AM
Conference Call URL: http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=102442&eventID=2504733