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Growth Within the Embolotherapy Market The embolotherapy market is projected to grow substantially over the next five years. We believe that this growth will be driven by the emergence of high volume procedures including uterine fibroid embolization (UFE) and targeted liver embolization (TLE). UFE is the occlusion of the blood supply to uterine fibroids to reduce their size and alleviate associated symptoms. Uterine fibroids afflict approximately 25 million women in the U.S., cause mild to moderate symptoms in approximately 6 million, and over 200,000 to undergo surgical procedures. The primary surgical procedures for uterine fibroids are hysterectomy and myomectomy, both of which often are accompanied by complications and long recovery periods. Driven by demand from women for minimally invasive procedures, the UFE market is projected to grow from 5,000 procedures and under $10 million in 1998 to more than 300,000 procedures and over $500 million by 2004. TLE is the occlusion of the blood supply to liver tumors to deprive them of the nutrients they require to survive. Over four million people in the U.S. are positive for Hepatitis C which is thought to be a precursor to liver cancer in 10 to 20 percent of these individuals. As a result, we believe that there will be a significant increase in the incidence of liver cancer in the U.S. in the coming years. Embosphere microspheres can be used to block the flow of blood to liver tumors. Embolization is also used in neurointerventions (in the brain and spinal cord) and other parts of the body to occlude the blood flow to hypervascularized tumors. While not high volume, these are often intricate procedures, especially in the brain, that require an embolic material that can pass through a microcatheter easily and be targeted precisely. Embosphere Microspheres were first used in Europe in neurointerventions. Product Overview Products Indications Controlled, Targeted Embolization BioSphere Medical's microspheres are precisely calibrated, spherical, hydrophilic, micro-porous beads made of an acrylic co-polymer (trisacryl) which is then cross-linked with gelatin. This proprietary and patented design allows a more complete and targeted occlusion of the blood vessels feeding a hypervascularized tumor or arteriovenous malformation. Furthermore, the hydrophilic surface and spherical shape prevent aggregation within the catheter lumen and in the vasculature, promoting ease and accuracy of delivery. Finally, the elastic properties of the microspheres also allow the temporary deformation of the sphere, which facilitates the passage through small delivery systems.
Preparation and Administration For details on how to Prepare and Administer
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