CHICAGO, ILLINOIS --(Marketwire - July 24, 2007) - MonoGen, Inc. (“Corporation”) (TSX:MOG) today announced that the FDA has determined the relocation of its manufacturing facility will require a 180-day PMA supplement. The supplement is expected to be filed by the end of this quarter. Ted S. Geiselman, MonoGen’s President and CEO, commented that “We have been preparing for production to begin under the assumption that the new manufacturing facility would be evaluated by FDA through the Express PMA process. However, the FDA has determined that regulatory approval should be sought using a traditional 180-day PMA supplement. Based on management’s experience and our current state of preparedness, we are confident in our ability to meet this regulatory requirement and as such, we intend to continue with our plans for production in anticipation of approval. Although we are disappointed by this development, which will likely delay market launch until Q1 2008, we remain enthusiastic about our prospects based on our technology, progress to date, and the market opportunity which remains attractive.”
