BioSphere submits an IDE to the FDA for its QuadraSphere Microsphere product

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.

Richard Faleschini, chief executive officer of BioSphere Medical, said, “Only a small percentage, about 25%, of the more than 600,000 patients diagnosed each year with hepatocellular cancer worldwide can be treated with surgery or transplant. For the majority of patients with hepatocellular cancer, conventional transarterial chemoembolization (cTACE) is the standard of care. At the present time, there is not an embolic in the United States with FDA market clearance for the treatment of hepatocellular cancer.”

Mr. Faleschini added, “Independent studies in Europe of our embolic loaded with doxorubicin have generated positive results, and the pivotal study is designed to further evaluate clinical performance. The QuadraSphere with doxorubicin clinical trial is an important milestone for BioSphere, and if the trial is successful and the PMA is approved by the FDA, it is expected to be the first FDA approval for hepatocellular carcinoma using chemoembolization, providing further demonstration of our leadership position in embolotherapy.”