Biopool International Files FDA 510-k Application for New Activated Protein C Test.

VENTURA, Calif.--(BUSINESS WIRE)--Nov. 5, 1998--Biopool International Inc. (Nasdaq:BIPL) Thursday reported the filing of a 510(k) application for its new test for determining sensitivity to activated protein C (APC) with the FDA.

APC resistance is a genetic defect in coagulation factor V that is the leading cause (nearly 40 percent of identified patients) of thrombotic (clot forming) diseases that affect nearly 25 million people in the United States and Europe. Patients with recurrent thrombosis should, therefore, be tested for resistance to activated protein C to determine its involvement in the disorder.

The frequency of activated protein C resistance has been reported to occur at least tenfold more frequently than deficiencies of protein C, protein S and antithrombin III combined.

Michael D. Bick Ph.D., chairman and chief executive officer, commented: "Assuming only 10 percent of those affected by thrombophilia have an episode requiring diagnostic work-up, the potential market for this product could be approximately $10 million per annum. At present, there is only one other comparable product on the market."

In addition, the company announced that it expects to take delivery in late November of a new point-of-care analyzer for quantitative D-dimer identification, which will be the platform for using Biopool's new MiniQuant D-dimer test.

Bick stated, "This new test system is a welcome supplement to our Minutex D-dimer test, currently Biopool's largest selling hemostasis product, a key indicator of thrombotic disorders such as deep vein thrombosis (DVT)."

Recent studies have shown Biopool's D-dimer kit to be extremely effective in helping to rule out the diagnosis of DVT, which can significantly reduce needless hospitalization and associated costs. The company expects to file its 510(k) application for the MiniQuant D-dimer latex in the first quarter of 1999. The MiniQuant test, as well as the APC assay, should contribute to revenues by late second quarter 1999.

Founded in 1987, Biopool International develops, manufactures and markets a full range of test kits to assess and diagnose disorders of blood coagulation, thrombotic risk factors, fibrinolysis, platelet function and the vascular system; specialty chemistry controls used to monitor and measure the presence of drugs of abuse; and blood group serology products used to screen for antibodies and group and type whole blood.

The company's product line of more than 150 FDA-approved products is sold to hospitals, blood bank facilities, and clinical and reference laboratories on a worldwide basis by the company's own sales representatives, as well as through an extensive network of distributors. To learn more about Biopool, visit the company's Web site at http://www.biopool.com.

This news release contains forward-looking statements regarding the potential market for a new product, an expected 510(k) submission, and the time frame in which two new products are expected to contribute to revenues, which are based upon current expectations that involve a number of risks and uncertainties including, but not limited to, technological innovations of competitors, changes in health-care regulations, litigation claims, foreign currency fluctuation, product acceptance or changes in government regulation of the company's products, as well as other factors discussed in the company's last report on Form 10-K-SB under "Risk Factors."