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Biopure Announces 2007 Fourth Quarter and Year-End Financial Results
Date:1/28/2008

hat at some point in the future it would ultimately exceed its existing plant capacity and require the construction of the designed facility.

Financial Condition

At October 31, 2007, Biopure had $1.9 million in cash on hand. On November 16, 2007, the company completed a public offering of common stock and warrants that raised net proceeds to Biopure of approximately $14.9 million.

Recent Developments

Pending Market Authorization Application

In July 2006, the Company submitted a marketing authorization application to the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to market Hemopure in the United Kingdom. In December 2006, the U.K. commission that reviews such applications rendered a provisional opinion letter containing comments and questions on the application. Biopure met with the MHRA during 2007 and responded in full to its letter in early November. The time period for the MHRA's final decision is not prescribed by law or regulation and can vary. A time period of four to six months is typical. If a marketing authorization is granted in the U.K., Biopure would have the option to seek registration of Hemopure for the same indication in other states in the European Economic Area through a mutual recognition procedure.

Clinical Program

Cardiopulmonary Bypass Surgery Trial. This trial, begun in 2006, is a Phase 2 clinical trial in patients undergoing multi-vessel coronary artery bypass graft (CABG) surgery. The objective of this trial is to assess the safety and feasibility of Hemopure in reducing heart damage, as measured by cardiac enzyme elevation, and enhancing tissue preservation during CABG surgery. Secondary endpoints include measurements of major adverse cardiac events, kidney function, transfusion requirements, cognitive impairment and length of hospital stay. The trial has enrolled 52 patients, of a total of 60 provided for in the protocol.

Cardiac Procedures -- PCI Tria
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SOURCE Biopure Corporation
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