IMBio receives regulatory concurrence from FDA to market OCL 500 microspheres in the U.S.

IMBiotechnologies Ltd. ("IMBio"), a privately held biotechnology company focused on developing medical device products for use in the area of embolotherapy, today announced that it has received regulatory concurrence from the United States Food and Drug Administration (FDA) to market its lead product, Occlusin(R) 500 Artificial Embolization Device (OCL 500) in the U.S. for the treatment of unresectable/inoperable hypervascularized tumours. IMBio filed the 510(k) submission in December 2009. OCL 500 is the first biodegradable embolization device cleared for marketing by the FDA.

OCL 500 is a patented, first in class embolization agent that represents a paradigm shift in treatment compared to currently marketed embolic agents. OCL 500 is a microspherical agent in development for the treatment of highly vascularised tumours, including hepatocellular carcinoma (HCC; liver cancer), renal cell carcinoma (RCC; kidney cancer) and uterine fibroids. OCL 500 microspheres rapidly form a tight, efficient, site-specific and platelet-rich clot that cuts off the blood supply to tumours. The OCL 500 microspheres then completely biodegrade over time, allowing the treated blood vessels to re-open and restore normal blood flow. This is important because it enables multiple embolization treatments of unresectable hypervascularized tumours, such as those associated with liver and kidney cancer, through the same vascular pathway.

Mike Stewart, CEO of IMBio, stated, "No other embolization agent on the market today offers the advantages that OCL 500 microspheres offer. We believe that OCL 500 has the potential to broadly expand the number of embolization treatments conducted each year, and we are delighted to bring this very exciting product to the U.S. market. We plan to launch OCL 500 with a commercialization partner in the latter half of this year."