MonoGen, Inc.
TSX : MOG

MonoGen, Inc.

August 12, 2008 08:30 ET

MonoGen Announces Facility Approval

LINCOLNSHIRE, ILLINOIS--(Marketwire - Aug. 12, 2008) - MonoGen, Inc. (TSX:MOG) today announced that it has received FDA approval to distribute its products from its new manufacturing facility in Waukegan, Illinois. The company has been awaiting this approval since its relocation and subsequent PMA supplement, both of which occurred in 2007.

Ted S. Geiselman, MonoGen's President and CEO commented, "We are extremely pleased and very excited to have received this approval from the FDA as it clears our way for the commercial launch of the MonoPrep Processor and associated products. Our staff has worked tirelessly to make this happen and the approval will certainly assist our sales team in their efforts of attracting and closing prospective customers. With our first order in hand, we will begin distribution of the MonoPrep system immediately."

About MonoGen, Inc.

MonoGen, Inc., headquartered in the Chicago area, is a medical device and diagnostics company providing high-quality and cost-effective cytological screening and diagnostic products to healthcare providers in the anatomic pathology industry.

Forward-Looking Statements

This press release contains forward-looking statements. Statements preceded by the words believe, expect, anticipate, plan, intend, continue, estimate, may, will, and similar expressions are forward-looking statements. Forward-looking statements are based on our beliefs and assumptions based on information available at the time the assumptions were made. Forward-looking statements relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, new services, market forces, commitments and technological developments. By its nature, such forward-looking information is subject to various risks and uncertainties, which could cause our actual results to differ materially from the anticipated results or other expectations expressed. Those risks and uncertainties include, but are not limited to, our ability to raise additional capital, our ability to execute our business plan while maintaining at all times our various regulatory approvals, and the response from existing and potential competitors. Additional discussions of the various risks are contained in our Annual Information Form dated March 19, 2008, which is available on SEDAR (www.sedar.com). Readers are cautioned not to place undue reliance on this forward-looking information, which is given as of the date it is expressed in this document.

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