Key Developments For BioSphere Medical Inc
BioSphere Medical Inc (BSMD.O) (Consolidated Issue listed on NASDAQ Global Market)
BioSphere Medical, Inc. Submits Investigational Device Exemption To FDA For QuadraSphere Microspheres For Use With Doxorubicin For Treatment of Primary Liver Cancer
BioSphere Medical, Inc. 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 the Company'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. The Company 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.
BioSphere Medical, Inc. Announces Study Shows Uterine Artery Embolization Compares Favorably To Laparoscopic Bilateral Occlusion for Treating Uterine Fibroids
BioSphere Medical, Inc. announced that uterine artery embolization (UAE) compares favorably to laparoscopic occlusion of uterine arteries in the treatment of uterine leiomyomas (fibroids) in cases where hysterectomy or myomectomy are not options. Clinical failure and symptom recurrence occurred in 14 patients after laparoscopy (48%) and in five patients (17%) after UAE (p=0.02). Hysterectomy was performed in two patients after UAE (7%) and in eight patients (28%) after laparoscopy (p=0.041). Six-month MR imaging results were available for 26 patients treated with UAE and 22 treated with laparoscopy, and showed that mean uterine volume was reduced by 51% after UAE treatment, compared with 33% after laparoscopy (p=0.001). Complete leiomyoma infarction was seen in all 26 patients in the UAE group and in only five patients in the laparoscopy group (p<0.001). Eleven patients (three UAE, eight occlusion) experienced symptom recurrence later than six months. Uterine volume reduction at six months was 24% in this group, compared with 48% in the 37 patients with no recurrence (p=0.004). Incomplete infarction of leiomyomas was seen in eight of the 11 cases of recurrence (73%) versus nine of 37 cases without recurrence (24%) (p=0.009).
BioSphere Medical, Inc. Enters Into Exclusive Distribution Agreement With Nippon Kayaku For Japanese Market
BioSphere Medical, Inc. announced that it has signed an exclusive agreement with Nippon Kayaku Co., Ltd. for the planned distribution of HepaSphere Microspheres and Embosphere Microspheres in Japan. According to the agreed-upon terms, Nippon Kayaku will be responsible for regulatory strategy and seeking to obtain requisite product registrations, including performing any clinical studies that may be required as a condition to product registration, and will bear the related cost for these activities. Assuming either or both of the products receive market clearance and the government reimbursement rate is set, BioSphere will provide the approved product to Nippon Kayaku for distribution and sale based on a predetermined formula indexed to the final Japanese government reimbursement rate. The agreement calls for BioSphere to receive a $1.0 million payment in 2009. Also, Nippon Kayaku has agreed to pay up to $3.0 million in additional payments in subsequent periods based on achievement of product registration goals and revenue targets.
BioSphere Medical, Inc. Receives CE Mark Approval for Transarterial Chemoembolization Using HepaSphere Microspheres
BioSphere Medical, Inc. announced that it has received CE Mark approval for Transarterial Chemoembolization (TACE) of Hepatocellular Carcinoma (HCC) using HepaSphere Microspheres (HepaSphere) and Doxorubicin. As a condition of the CE Mark approval, BioSphere will conduct a 100-patient, post-market registry study in 10-15 European centers. CE Mark approval denotes conformity with European standards for safety and allows certified devices to be placed in the market in European Union countries.
BioSphere Medical, Inc. Receives FDA Approval For QuadraSphere Microspheres
BioSphere Medical, Inc. announced that the U.S. Food and Drug Administration has cleared the 510(k) notification for the Company's QuadraSphere Microspheres, permitting the sale of this product in the United States. U.S. shipments through the Company's direct sales force are expected to begin immediately.
