EDMONTON, May 11 /PRNewswire/ - 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."
About IMBio
IMBio is a privately held Canadian biotechnology company focused on developing medical device products for use in the area of embolotherapy. Lead product, OCL 500 microspheres for the treatment of unresectable/inoperable hypervascularized tumours has received marketing clearance from the FDA in the U.S. Other products in development include rapidly-dissolving, drug-eluting and/or radio-labelled microspheres as well as biodegradable coils and stents for use in aneurysms that are not conducive to treatment with microspheres.
About Embolotherapy
Embolotherapy works by cutting off blood flow to benign and malignant hypervascular tumours. The procedure is performed by injecting agents through a catheter into the blood vessels that feed the target tumour. By selectively blocking blood supply, the deprived tumour is either destroyed or devitalized, resulting in therapeutic benefit. Hypervascular tumours are characterized by having an excessive number of blood vessels. Embolotherapy is a minimally invasive treatment for hypervascular tumours such as liver and kidney cancers as well as uterine fibroids. According to the National Cancer Institute, there are approximately 25,000 Americans with liver and intrahepatic bile duct cancer, and approximately 266,000 with kidney and renal pelvic cancer. Across the U.S., approximately 300,000 hysterectomies and 70,000 myomectomies are performed annually to treat uterine fibroids.
This press release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiary, may ultimately prove to be incorrect. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law.
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SOURCE IMBiotechnologies Ltd