BioSphere Medical, Inc. (NASDAQ:BSMD) (“BioSphere” or the “Company”) – the leader in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy – today announced the submission to the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) application for a clinical trial for the use of BioSphere’s QuadraSphere® Microsphere product (QuadraSphere) to deliver the chemotherapeutic agent doxorubicin for the treatment of primary liver cancer. Provided that the FDA accepts the planned clinical protocol, the Company plans to begin enrolling patients into the study within 60 days of FDA approval.
The proposed investigation will be a prospective, randomized, double-blinded clinical trial conducted at approximately 15 sites in the U.S., European Union and Brazil. The clinical trial will focus on treating patients with advanced hepatocellular carcinoma (HCC), also known as primary liver cancer, and will compare QuadraSphere with doxorubicin against conventional transarterial chemoembolization (cTACE) with doxorubicin. BioSphere anticipates that patient enrollment will take approximately 12 months, and that it will file a premarket approval application (PMA) 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.