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Biorthex, Inc.
FDA approves start of clinical study on Actipore PLFx
July 30th, 2003
Biorthex, Inc., a medical device company specializing in the spine, announced the conditional approval from the U.S. Food and Drug Administration (FDA) for the initiation of a U.S. clinical study for it's Actipore PLFx Posterior Lumbar Fusion device. This conditional approval grants Biorthex the right to immediately initiate its study in the U.S. while adjusting its protocol to suit FDA requirements. The Actipore PLFx device is indicated for patients suffering from back pain associated with degenerative disc disease (DDD) in the lumbar spine. This study, to be initiated this summer, will be a randomized, prospective, multicenter clinical trial...
Source: Biotech Week (2003-07-30)
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