DiaMedica Inc.
TSX VENTURE : DMA

DiaMedica Inc.

May 14, 2008 09:32 ET

DiaMedica Receives pre-IND FDA Guidance on DM-71

WINNIPEG, MANITOBA--(Marketwire - May 14, 2008) - DiaMedica Inc. (TSX VENTURE:DMA), a drug discovery and development company focused on novel treatments for Type 2 diabetes, today announced that it has received feedback from the U.S. Food and Drug and Administration (FDA) on its pre-IND filing for DM-71, the Company's lead compound.

The FDA has recommended a standard 90 day in vitro toxicology study comparing the combination product with each active component in separate arms to support the proposed phase IIb trial. This will provide further support for the safety of the compound which was well tolerated in the Company's Phase IIa human study.

"The FDA's response provides welcomed feedback on our pre-IND filing", stated Mr. Rick Pauls, President and CEO of DiaMedica. "We will conduct the recommended 90 day study in concurrence with other preparations for our IND filing in support of the larger phase II trial. Based on results of the 12 week human trial of DM-71, the Company expects the 90 day toxicity study will reaffirm the safety of the two drugs in combination."

DiaMedica is represented by Dr. Robert Schiff, President of Schiff & Company, in its correspondence with the FDA. Schiff & Company is an international Regulatory Affairs and Clinical Research Organization with over 35 years of experience in the health care industry and regulatory affairs.

About Dr. Robert Schiff and Schiff & Company

Dr. Robert Schiff is CEO and founder of Schiff & Company and is an accomplished business executive and scientist with over 36 years of experience in the heath care industry. In addition to authoring over 50 publications and holding several patents on medical products, he is board certified in Regulatory Affairs (R.A.C) and is a Certified Quality Auditor (ASQC). During his career Dr. Schiff has held major management positions in several leading health care and consumer products companies.

Schiff & Company was founded in 1982 and is an international Regulatory Affairs and Clinical Research Organization. The Company handles all aspects of the regulatory process in product development, from preclinical to post-approval by assisting companies in bringing to market both prescription and over the counter drugs, biologics, devices and in vitro diagnostics. The organization has extensive experience in obtaining FDA approval of manufacturing and distribution sites in the U.S., Canada and overseas.

About DiaMedica

DiaMedica is developing novel treatments for various stages of type 2 diabetes. The Company recently completed a phase II clinical trial with its lead product DM-71 which demonstrated the ability to reduce HbA1c levels and weight in man. The Company has two other drugs in its clinical pipeline, DM-83 and DM-99, which are moving through phase II proof of concept clinical studies.

Caution Regarding Forward-Looking Information

Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, our anticipated future operating results, and can, in some cases, be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.

These statements reflect management's current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: DiaMedica's early stage of development, lack of product revenues and history of operating losses, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition, potential product liability, additional financing requirements and access to capital, unproven markets, supply of raw materials, income tax matters, management of growth, partnerships for development and commercialization of technology, effects of insurers' willingness to pay for products, system failures, dependence on key personnel, foreign currency risk, risks related to regulatory matters and risks related to intellectual property and other risks detailed from time to time in DiaMedica's filings with Canadian securities regulatory authorities, as well as DiaMedica's ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release, as well as under the heading "Risk Factors" contained in DiaMedica's final long-form prospectus dated March 12, 2007. DiaMedica cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on DiaMedica's forward-looking statements to make decisions with respect to DiaMedica, investors and others should carefully consider the foregoing factors and other uncertainties and potential events.

These risks and uncertainties should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, DiaMedica cannot provide assurance that actual results will be consistent with these forward-looking statements. DiaMedica undertakes no obligation to update or revise any forward-looking statement.

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

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