MonoGen Withdraws HPV Supplement
CHICAGO, ILLINOIS -- Aug 10, 2007 -- MonoGen today announced that after further review and discussions with the FDA, MonoGen has decided to withdraw its HPV Supplement submitted to the FDA in June 2007. MonoGen currently intends to perform a new clinical study post market launch of its MonoPrep system with a different design to meet FDA requirements.Ted S. Geiselman, MonoGen's President and CEO commented "After several discussions with the FDA, it has become clear that its approval requirements for the HPV Supplement will likely not be met with the information provided in our current submission. We will work with the FDA in the new study design and protocol and will initiate the study as soon as is practical after market launch, as such a clinical trial cannot be performed prior to market launch of the MonoPrep system. Although we remain pleased with the performance of the MonoPrep system in the current study, we believe that taking this action will provide a faster route to approval by the FDA rather than continuing with the current submission."
With operational headquarters in the United States (Greater Chicago area), MonoGen is a medical device company developing an integrated suite of fully automated devices (the SAVANT LABORATORY SYSTEM(TM)) for anatomic and molecular pathology laboratories. The SAVANT LABORATORY SYSTEM(TM) is being designed to automate processes performed by clinical laboratories to reduce their costs, increase throughput, and improve the quality and consistency of results.
The common shares of the Corporation are listed for trading on the Toronto Stock Exchange under the trading symbol "MOG".
This press release contains statements that are forward-looking in nature. 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 the Corporation's beliefs and assumptions based on information available at the time the assumption was 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, relating to the Corporation. By its nature, such forward-looking information is subject to various risks and uncertainties which could cause the Corporation's actual results and experience to differ materially from the anticipated results or other expectations expressed. Those risks and uncertainties include, but are not limited to MonoGen's ability to raise additional capital, MonoGen's ability to execute its business plan while obtaining and maintaining at all times its various regulatory approvals, the performance of its strategic partners including the performance of Cardinal Health in the commercialization of the Corporation's products in the marketplace and the competitive response from existing and potential competitors. 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, and the Corporation undertakes no obligation to update publicly or revise any forward looking information, whether as a result of new information, future events or otherwise.