UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549

Form 10-KSB

 

| (Mark One) |
|------------|
|       | [_] | ANNUAL REPORT UNDER SECTION 13      OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|       |   |   |

For the fiscal year ended                                                                            

|   | [X]    | TRANSITION REPORT UNDER      SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       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|   |   | For the transition period from September 30, 2004 to      December 31, 2004      
Commission file number: 000-49635.  
MINRAD INTERNATIONAL, INC.
(Name of small business issuer in its charter)  
Nevada 
870299034
(State or other jurisdiction of incorporation or      organization) 
(I.R.S. Employer Identification No.)   
847 Main Street, Buffalo, New York 
14203
(Address of principal executive offices) 
(Zip Code) 
Issuer's Telephone Number (716) 855-1068
Securities registered under Section 12(b) of the ExchangeAct: None****
Securities registered under Section 12(g) of the ExchangeAct: Common Stock, $.01 par value
          Check whether the issuer (1) filed all reports required to be filedby Section 13 or 15(d) of the Exchange Act during the past 12 months (or forsuch shorter period that the registrant was required to file such reports), and(2) has been subject to such filing requirements for the past 90 days. Yes [X]No [ ]

          Check if there is no disclosure of delinquent filers in response toItem 405 of Regulation S-B is not contained in this form, and no disclosure willbe contained, to the best of registrant's knowledge, in definitive proxy orinformation statements incorporated by reference in Part III of this Form 10-KSBor any amendment to this Form 10-KSB. [X]

          The Registrant had $460,276 of revenue for the transition periodcovered by this report. The Registrant had $4,116,995 of revenue for its fiscalyear ended September 30, 2004.

          The aggregate market value of the Registrant's voting andnon-voting common equity held by non-affiliates, computed by reference to theaverage bid and asked price of the common equity, as of March 15, 2005 was$39,684,964. Solely for the purposes of this calculation, all persons who areexecutive officers or directors of the Registrant and all persons known to theRegistrant to hold more than 5% of the Registrant's outstanding common stockhave been deemed to be affiliates. 

           The total number of shares of common stock of the Registrant thatwere outstanding on March 15, 2005 was 28,340,867.

          Transitional Small Business Disclosure Format (Check one):     Yes [ ]     No [ X ]
**PART I

Item 1. Description of Business.**General Business Overview

        On December 16, 2004, Minrad International, Inc., formerly known asTechnology Acquisition Corporation, acquired Minrad Inc., a Delawarecorporation, through a reverse merger of a wholly owned subsidiary into MinradInc. As a result, Minrad Inc. became a wholly owned subsidiary of MinradInternational, and the stockholders of Minrad Inc. became the beneficial ownersof approximately 83% of Minrad International's then-outstanding common stock. Inthis Form 10-KSB report, unless otherwise indicated or the context otherwiserequires, "we," "us," and "our" refer to Minrad International, Inc. and itssubsidiary. 

        Through Minrad Inc., we operate an acute care business with two productlines: (1) real-time image guidance and (2) anesthesia and analgesia. Wecurrently sell patented real-time image guidance technologies that enablemedical professionals to improve the accuracy of interventional procedures andreduce the exposure to radiation. We recently launched SabreSourceTM,a second-generation real-time image guidance system. Our real-time imageguidance products have broad applications in orthopedics, neurosurgery,interventional radiology and anesthesia. We manufacture and market genericinhalation anesthetics for use in connection with human and veterinary surgicalinterventions. We are also developing a drug/drug delivery system for conscioussedation, which, similar to nitrous oxide used in dental surgery, provides apatient with pain relief without loss of consciousness.

        Minrad International, Inc. was incorporated in the State of Nevada in 1996under the name Roatan Medical Technologies, Inc. While Minrad Internationalengaged in various businesses over the years, it had no operations immediatelyprior to its acquisition of Minrad Inc. Minrad Inc. was incorporated in Delawarein 1994. 

        In 1998, we introduced our initial product, the Dual Radiation TargetingSystem, or DRTS®. Today, our real-time image guidanceproduct is SabreSourceTM. SabreSourceTMuses unique x-ray and laser technology to enable medical professionals toprecisely visualize both the surface point of entry and true angle of approachrequired to reach an internal treatment area or biopsy site. We also manufacturea line of hand held surgical instruments called Light SabreTM. Theseproducts use the inherent accuracy of the SabreSourceTM laser toenable a medical professional to accurately position the handheld instrument atthe point of incision and then to accurately guide the instrument to thetargeted internal treatment or biopsy site. 

        We entered into the anesthesia and analgesia business in December 2000through our $1.4 million acquisition of the inhalation anesthetic business of Celltech-Medeva. The Bethlehem, Pennsylvaniamanufacturing facility that we acquired in the acquisition is FDA registered andcGMP compliant. This facility has the capacity to manufacture, package anddistribute isoflurane, enflurane, sevoflurane and other halogenated ethers.

        We currently sell isoflurane and enflurane, two of the four modernhalogenated inhalation anesthetics in use in the world today. We also haveexisting contracts under which we plan to sell sevoflurane as early as thesecond quarter of 2005 and desflurane as early as 2007 in select internationalmarkets.

-1-

        We currently are developing a drug delivery system for the use of halogenatedethers as *inhalation analgesics*. This initiative seeks to leverage ourtwo core competencies: precision medical devices and inhalation anesthetics. Wehave filed patent application 10/272,794, "Drug Delivery for Conscious Sedation"(Burns, McNeirney and Terrell), for a new system for administering conscioussedation that would compete with the widespread use of nitrous oxide, sedativehypnotics and narcotic analgesics in both the pre-hospital and critical carehospital markets. We believe that sevoflurane is a halogenated ether that may beused effectively in conscious sedation systems.
**Real Time Image Guidance

Overview**
        We are a developer of enabling technology for minimally invasive surgicalprocedures. We believe several factors currently drive the market for surgicalsystems and their related products, including:
 •aging of the population;    •development of minimally invasive surgical    procedures;    •focus on increased productivity and lower    costs;    •transition from hospital-based to outpatients    procedures; and    •demand for improved therapeutic outcomes.
        We believe that approximately 15% of all surgical procedures currently usefluoroscopy, CT-scans or other forms of imaging. Additionally, we estimate thatthe number of minimally-invasive spine procedures are growing at an annualoverall rate of 40% and pain management is growing at an annual rate of about20%. The corresponding increased use of fluoroscopy, CT scans and other forms ofimaging increases the risk of radiation exposure.

        We believe that the use of our real-time image guidance products can minimizehealthcare costs and improve patient outcomes by:
 •decreasing operating time;    •enabling additional procedures to be performed    on a minimally invasive basis;    •minimizing patient trauma and recovery time;    •improving surgical accuracy; and    •reducing radiation exposure in    fluoroscopically-guided procedures.
-2-

        SabreSourceTM, our second generation imageguidance system, which we recently launched, uses patented x-ray and lasertechnology to enable medical professionals to visualize both the surface pointof entry and the true angle of approach required to precisely target an internaltreatment area or biopsy site. SabreSourceTM, like ourfirst-generation product, DRTS®, significantly reduces radiation exposure topatients and operating room personnel. In addition, the SabreSourceTMsystem significantly improves "ease of use," provides a much larger targetingarea and gives the medical professional improved control and visibility overtarget acquisition.

        We also manufacture a line of handheld surgical instruments. Light SabreTMuses the inherent accuracy of the SabreSourceTM laser to enable amedical professional to precisely position the hand-held instrument at the pointof incision and to accurately guide the instrument to the targeted internaltreatment or biopsy site. Presently, our Light SabreTM line includessix disposable products, including syringes, aspirating needles, spinal needles,bone and core tissue biopsy needles and a catheter introducer.
**Our Real-Time Image Guidance Products**
        We are developing real-time image guidance systems that have broadapplications in orthopedics, neurosurgery, interventional radiology andanesthesia. Our first-generation image guidance system, DRTS®, enables medicalprofessionals to improve the accuracy of interventional procedures and reducesignificantly the exposure of patients and medical professionals to radiation.DRTS® technology uses a laser beam to target a single point with FDA-acceptedaccuracy of plus or minus 1mm at a distance of 1 meter. Physicians using DRTS®cited several features of the system: 
 •a reduction in radiation of 50 - 90%    depending on the type of procedure;    •the elimination of multiple instrument    penetrations in attempts to locate subsurface target    and corresponding reduction in time, expense and trauma; and    •improved surgical accuracy and corresponding    reduction in complications.
        In a study entitled, "Accuracy of Fluoroscopically Assisted Laser Targetingof the Cadaveric Spine to Place Transpedicular Screws", Journal of SpinalDisorders 2000:13; 412-418 by R.M. Schwend et al.,our DRTS® platform was used by surgical residents forpedicle screw implantation into 184 pedicles. Although none of these residentshad previously performed the procedure, the residents had an average error rateof 1.6%, with all errors deemed "non-critical."

        R. Hugate et al. from Hershey Medical Center, Hershey, Pennsylvania presenteda "mirror" study of Dr. Schwend's paper as a poster at the American Academy ofOrthopedic Surgeons conference held in Dallas, Texas in February 2002. Routinefluoroscopic technique was compared to alternative sophisticated image guidancesystems in the performance of the same pedicle screw procedure that wasperformed by residents in the study described in the previous paragraph.Experienced surgeons participated in this study. The results of the study showedthat fluoroscopy alone had a critically malpositioned error rate of 15.3%. Thealternative systems had higher critical error rates of 22.2% and 36.0%respectively. The results of this study compare to the non-critical 1.6% errorrate for the DRTS® platform reported in Dr. Schwend's study discussed above. 

-3-

        Another peer-reviewed scientific study,"Vertebroplasty: techniques to avoid complications,"was written by D.B. Moreland, M.D., Michael K. Landi, M.D. and Walter Grand,M.D., and published in The Spine Journal (2001) 66-71. He statedin his summary that significantcomplications can occur in vertebroplasty procedures andare likely underreported. In this study, Dr. Morelanddescribed his technique ofperforming vertebroplasties and avoiding serious complications by using the DRTS®system. Dr. Moreland is a shareholder in our company and is a member of ourScientific Advisory Board. Dr. Landi is a co-founder of and shareholder in ourcompany, and is a member of our Scientific Advisory Board. Dr. Grand is ashareholder in our company.

        While we designed the DRTS® system to retrofit existing mobile C-Armfluoroscopes, ultimately the size of the system and the need for repositioningwhen locating multiple targets led to only moderate adoption of the product.

        We now offer SabreSourceTM, our second-generation image guidancesystem, which uses patented X-ray and laser technology to enable medicalprofessionals to visualize both the surface point of entry and the true angle ofapproach required to precisely target an internal area or biopsy site. Like DRTS®,SabreSourceTM significantly reduces radiationexposure to patients and operating room personnel, yet it is smaller, canacquire multiple targets without repositioning, incorporates a quick-release andalignment system, can be used in a wider range of surgical procedures and canreduce surgical time. As in the case of DRTS®, the FDA accepts our accuracyclaim of plus or minus 1 mm at a distance of 1 meter.

        SabreSourceTM is designed to retrofit to existing mobile C-Armfluoroscopes with a "glove fit" thereby adding greater stability. Based on newtechnology (patent allowed), the SabreSourceTM is aligned to theentire X-ray beam instead of a single ray, enabling the physician tosuccessfully target multiple subcutaneous sites of interest using a hand-heldremote control unit. Unlike the more costly navigation systems currently on themarket that rely on archival data, the SabreSourceTM system uses"real-time" fluoroscopic images to accurately guide a physician while the X-raybeam is turned off.

        Three accessories are integral parts of the SabreSourceTM system:(1) the three-compartment Tri-KnewTM battery charger and 12-voltNiCad battery packs that power the device; (2) a patented sterile disposabledrape that covers the SabreSourceTM and C-Arm fluoroscope so that thesystem can be placed in the sterile field, and (3) a sterile drape that is usedto cover the SabreSourceTM remote control. The patented platformdrape has an optically correct window and must be used with the SabreSource toensure that the accuracy of the laser beam is not compromised.

        We estimate that the market for image guidance systems, such as SabreSourceTM,was approximately $1.7 billion in 2004 with an anticipated annual growth rate of6%. Upon reaching a targeted scale of production, we believe that a sale of oneSabreSourceTM per month should generally cover the sales expense ofthe sales representative who sells the product.

        With its additional features and benefits, we believe thatour SabreSourceTM image guidance systemaddresses most of the issues thatlimited the success of our DRTS® system. We believe that the new features willmake it easier for medical professionals to incorporate the SabreSourceTMsystem into their everyday procedures.
**Light SabreTM
        We also manufacture a line of handheld surgical instruments. Light SabreTMuses the inherent accuracy of the SabreSourceTM laser to enable amedical professional to guide the handheld instrument from the point of incisionto the targeted internal treatment or biopsy site. Presently, our Light SabreTMline includes six disposable products, including FDA accepted syringes,aspirating needles, spinal needles, bone and core tissue biopsy needles and acatheter inducer, which "light up" when properly aligned to access asubcutaneous site, thereby giving the medical professional a visual verificationwhen the subcutaneous site is properly targeted. In 1998, the FDA accepted anaccuracy claim for Light SabreTM products of plus or minus 3 mm at adepth of 100 mm.

-4-

        We believe that the level of accuracy produced by Light SabreTMproducts is critical in minimally invasive procedures, including biopsies andother procedures in pain management, in applied oncology, spinal applications,trauma and urology. Light SabreTM products can also be used asminimally invasive, precisely targeted drug delivery systems.

        We plan to continue to develop and introduce additional Light SabreTMproducts over the remaining 13 years of the life of the Light SabreTMpatent. Our six existing FDA-accepted Light SabreTM products focus onpain management and spinal procedures. We are currently prototyping designs fortherapeutic applications with two medical device companies and we have hadpreliminary discussions with several other manufacturers of medical devices.Pending successful cadaver trials, we anticipate granting product-specificlicenses for the technology. 

        Our future plans include the exploration of partnerships with imagingmanufacturers to incorporate SabreSourceTM technology into theirequipment. We believe that other imaging manufacturers will find our technologyto be attractive because we have received an FDA Master File acceptance of ourLight SabreTM Collimator, the portion of our product that, when usedin conjunction with the SabreSourceTM technology, puts the light inLight SabreTM.

        FDA Master file acceptance allows other manufacturers who incorporate ourLight SaberTM technology into their equipment to use our FDAacceptance and our accuracy claims for our Light SabreTM productswhen used with their equipment in conjunction with our SabreSourceTMtechnology. Manufacturers who license our Light SabreTM Collimatortechnology will only need to provide the FDA with a 30-day notice ofutilization, thus accelerating time to market of their new products. 
**Our Real-Time Image Guidance Strategy**
        The principle elements of our business strategy are designed to create arecognized standard of care for our SabreSourceTM system and relatedLight SabreTM line of products. We plan to focus on the following:
 •***Create a recognized standard of care***.    We believe the high degree of accuracy, limited exposure to radiation and    ease of use of our SabreSourceTM system positions it potentially    to become the standard of care for fluoroscopically-guided, minimally    invasive, acute care procedures.    •***Develop the use of consumables***.
    -- Our initial marketing emphasis will be directed at anesthesiologists at    pain management clinics because of the call point similarities with our    anesthetics and analgesics business. Pain management clinics have a higher    patient volume with shorter procedures and patient recovery time than    hospitals. In a typical clinic, a physician will perform many procedures per    day that involve fluoroscopic guidance. We believe the potential for Light    SabreTM products will be higher in these clinics and the selling    cycle from initial evaluation to actual purchase would generally involve    fewer people and be more rapid.

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  -- We also expect to focus our marketing efforts on hospitals. Hospital    purchasing departments like to minimize the number of similar products in    their inventory. Light SabreTM products and commodity products    with similar uses are priced competitively, and both may be used in    procedures that do not use SabreSourceTM technology. Unlike the    competing commodity products, however, Light SabreTM products    also provide "light up"-targeted guidance when used with a SabreSourceTM    system. We believe that hospitals may be motivated to use Light SabreTM    products in place of commodity products in order to take advantage of the    multiple uses of Light SabreTM products and in order to reduce    the number of similar products in their inventories.    •***Establish therapy partners***. We    believe that our Light SabreTM technology could enhance the    competitive advantage of medical devices manufactured by other companies.    The introduction of third party products that use Light SabreTM    technology could spur sales of our SabreSourceTM systems, which    could in turn spur sales of additional Light SabreTM products. We    also believe that the interventional accuracy and reduced exposure to    radiation that our SabreSourceTM technology provides could    enhance the competitive advantage of imaging equipment manufactured by other    companies. We believe that the development of third party imaging equipment    that includes SabreSourceTM technology would promote sales of    Light SabreTM products. To these ends, we intend to establish    relationships with therapy partners to develop new Light SabreTM    applications. We also may partner with equipment manufacturers to include    our SabreSourceTM technology in third-party imaging equipment.    ** 

Anesthesia and Analgesia

Overview**
        Four primary halegenated inhalation ethers are used in surgical procedures:isoflurane, enflurane, sevoflurane, and desflurane. We currently manufacture andsell isoflurane and enflurane, and we have existing contracts under which weexpect to manufacture and sell sevoflurane as early as the second quarter of2005 and desflurane as early as 2007 into select international markets.

        Our retired Vice President of Research, Ross Terrell, Ph.D., is the inventorof the majority of inhalation anesthetics sold in the world today. Dr. Terrelloriginally synthesized and patented isoflurane, enflurane and desflurane. Healso holds an expired patent on the six compounds in the isoflurane, andsevoflurane family. We have retained Dr. Terrell as a Research Fellow and amember of our Scientific Advisory Board.

        We estimate, based on IMS data and other publicly available filings of othercompanies, that the market for inhalation anesthetics was approximately $925million in 2004, a 10% increase from the prior year. We believe that the marketwill continue to grow primarily as a result of an anticipated increase ingeneral surgeries (1.8% in the****United States and 3.5% internationallyduring 2003 according to the American Hospital Association), and thesubstitution of more expensive anesthetic agents for lower cost anestheticagents, resulting in an increased cost per surgery. 

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        We manufacture our pharmaceutical products in our Bethlehem facility. Wepurchased this facility from Celltech-Medeva in December 2000 for $1.4 million.According to public records, Celltech-Medeva purchased the facility six yearsearlier for approximately $54 million. Although the Bethlehem facility containsstate-of-the-art equipment, it was operating substantially below capacity. Weacquired the business for four reasons:
 •The operating room ("OR") call point for    anesthesia and analgesia products matched that of our real-time image    guidance system. In addition, we anticipated that the same sales partner    would sell both product lines in many international markets.    •As a result of our management's prior business    experience, we were intimately familiar with the Celltech-Medeva line of    inhalation products. Our know-how in producing inhalation anesthetics    combined with our substantial operations and turn-around experience and our    international industry relationships, provided us with the opportunity to    improve plant operations.    •We believed that the inhalation anesthetic    business could provide a revenue and cash generation platform.    •We believed that halogenated ethers could be    used in conscious sedation.
        Over a four-year period, our management has:
 •installed a new plant management team;    •increased production capacity by 120%, while    reducing plant employment and without capital investment;    •added RxElite as a partner for the distribution    of our inhalation anesthetic products in the United States;    •added over 20 key international customers    including E. Merck and General Electric;    •resourced key raw materials at substantial cost    reductions;    •developed procedures and programs under which    we will produce sevoflurane and desflurane, following regulatory approval;    and    •applied for patents on a conscious sedation    system which, if approved by the appropriate regulatory authorities, may    provide a springboard for the eventual transformation of our anesthesia and    analgesia business to principally a proprietary product business.
        Today, as a result of process improvements, successful programs to improveyield and reduced energy consumption per kilo, we have achieved a 65% averagecost reduction at the plant from the time of acquisition in December 2000.

        Inhalation anesthetics are sold as 99.9% pure compounds. There are noadditives or excipients. They are naturally aseptic and go through a phasechange from liquid to vapor in their delivery. As such, the principal FDAregulation issues from a cGMP perspective are in the packaging of pure, finalproduct. This is markedly different from a capsule or parenteral operation. 

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**Our Anesthesia and Analgesia Products**
        Currently, our primary products are isoflurane and enflurane. 

        Isoflurane is sold throughout the world for use in a wide range of surgeries.It is of particular use in neurosurgery due to its minimal impact onintracranial pressure and can be used to induce hypotension and reduce bleeding.Isoflurane is also used in the veterinary market, where it is the standard ofcare for procedures involving companion animals. Management estimates thatpresent annual worldwide sales of isoflurane in 2004 exceeded $150 million,including approximately $50 million of sales in the veterinary market. We sellisoflurane for human use under the TerrellTMbrand name and for veterinary use under the AttaneTM brand name.

        Enflurane is a niche product with principal applications in labor anddelivery and where myocardial depression and related myocardial oxygenconsumption is beneficial, such as coronary by-pass. It is the only inhalationanesthetic agent approved for labor and delivery and,as a result, its sales volume is highest in countries with higher birth rates.Management estimates that the present annual worldwide market for enflurane in2004 was approximately $12 million. We sell enflurane under the Compound 347TMbrand name.

        We have made improvements to the Bethlehem facility and can now manufacturesevoflurane. Following the receipt of additional regulatory approvals, we expectto begin selling sevoflurane in select international markets in 2005, and inadditional international markets each year between 2006 and 2008. We will beginselling in domestic markets following the receipt of appropriate regulatoryapprovals, which we expect to receive in late 2006. Sevoflurane is the largestselling inhalation agent in the world. It is the agent of choice for pediatricand outpatient procedures because of its induction and recovery properties.Management estimates that the annual market for sevoflurane in 2004 approached$600 million. Abbott markets sevoflurane in the United States, Europe and LatinAmerica. Maruishi markets sevoflurane in Japan and has marketing rights inChina. We have one process patent that has been issued onthe manufacture of sevoflurane and four other patents pending.
**MR Tested Laryngoscope Blades & Handles**
        To complement our inhalant anesthetic offerings, we have introduced magneticresonance ("MR") tested laryngoscope blades and handles. Many patients,particularly children, claustrophobic adults and patients in pain, cannot remainstill in an MRI magnet for the required time. The MR-tested laryngoscope bladesand handles allow an anesthetist to safely intubate a patient very near(within fifteen centimeters)a 1.5 Tesla MRI magnet withoutferro-magnetic or radio frequency interference. We have two U.S. patentson these specialty products.
**Anesthesia and Analgesia Competitive Strategy**
        Our two primary competitors in the supply of anestheticagents are Abbott Laboratories and Baxter International, Inc., both of which aremulti-national pharmaceutical and medical device companies. We believe thatAbbott and Baxter will face increased competition when sevoflurane anddesflurane become generic. 

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We have a five-part strategy to compete in key global marketplaces:
 •partner with national pharmaceutical firms    prominent in the business;    •provide a full line of products;    •maintain our status as the low-cost producer by    leveraging our Bethlehem manufacturing facility through high volume and    capacity expansion;    •identify niches that allow segmentation and    branding; and    •develop proprietary anesthesia and analgesia    products for conscious sedation, while maintaining generic volume.
        Our marketing partners are often among the leadingpharmaceutical manufacturing and distribution companies in their respectivecountry or region. Partners include:E. Merck in Japan, Germany, France, the United Kingdom, and Scandinavia; L&W inChina; Panion in Taiwan; RxElite in the United States; Laboratorios PiSA inMexico and Central America; Richmond Labs in Argentina and Spain; and Novartisin the United Kingdom veterinary market.We also supply enflurane directly to Baxter, which itmarkets worldwide.

        Our international marketing strategy is to firstidentify and establish a distribution partner relationship in a country orregion. Following the execution of an agreement with each partner, we then filea registration for the sale of these products in a country or region. Theregistration process on average takes 12 to 24 months. Upon receipt ofregulatory approval for new products in a country or region, we can leverage ourexisting distribution partnerships to accelerate our speed to market. Uponregistration, we begin to sell our products to our international partner underthe existing contracts. Presently, we have 15 partnerships under which we havemanufactured and delivered inhalation anesthetics. We have targeted countries orregions to enter as the patents expire. As a result, our initial focus has beenon the Pacific Rim and Latin America.

        Under our exclusivedistribution agreements, a sales partner will maintain the exclusive right todistribute specified inhalation anesthetics in its respective sales region solong as it purchases specified minimum annual quantities of inhalationanesthetics at prices specified in the agreement.

        As of February 28, 2005, we had 28 active distribution contracts with salespartners that require, after anticipated regulatory approvals are obtained inthe respective countries, increasing minimum annual purchases for the contractsto remain exclusive. By 2009, the annual minimum purchases for the distributorsto maintain exclusivity by product and territory under existing agreements willreach $92.9 million.
*$ Millions***Annual Minimums       **2005**2006**2007**2008**2009North America
5.8
18.4
43.6
56.2
56.2Europe
0.8
2.5
8.7
11.6
15.2Latin America
2.7
5.2
6.9
7.0
7.2Pacific
1.4
7.6
13.9
14.1
14.3
Total
10.7
33.7
73.1
88.9
92.9                                  Totals for Isoflurane/Enflurane:
9.5
 
12.0
 
12.9
 
13.1
 
13.1
 
        Approvals for foreign registrations of generic drugs generally require a12-24 month review period, depending on the country. In most cases, localgovernment guidance is available on the average time required for approval. Inaddition to drug registration time, regulators in certain markets provide aperiod of years of exclusivity for the original manufacturer, and patentprotection -- either composition or process -- is available in certain othermarkets for one or more of the participants. The respective parties to thedistribution agreements agreed to these annual minimums after assessing thesituation in the respective markets. The annual minimums are best viewed asproviding a trend on the uptake of our inhalation anesthetic business.

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        Beyond these agreements, we are currently negotiating distribution contractswith four prospective partners. These agreements may or may not becomefinalized. In addition, we are actively seeking representation in several majormarkets including, but not limited to, Italy, Australia, significant portions ofEastern Europe, South Korea, the Middle East, and the Indian Sub-continent.
**        Also under the exclusive distribution agreements, each sales partner hasagreed to purchase inhalation anesthetics only from us for distribution in itsrespective region, provided that we timely deliver inhalation anesthetics inaccordance with the terms of the applicable agreement.

        In July 2004, we signed a contract with RxElite, Inc., a United Statesdistributor of inhalation respiratory products. Assuming RxElite meets volumemilestones in the contract to remain an exclusive distributor in the UnitedStates, U.S. sales under the contract with RxElite would approach $55 million incalendar year 2008. RxElite began purchasing human inhalation anesthetics underthis contract on September 30, 2004.

        We believe that there are significant barriers to entry into the business ofproducing and selling inhalation anesthetics. These drugs are essentiallyspecialty chemicals that must be manufactured in dedicated facilities, usingproprietary intellectual property and operated by a highly skilled managementteam and work force.
**Conscious Sedation**
        We have under development a drug/drug delivery systemfor the use of halogenated ethers as inhalation analgesics, which we call"conscious sedation." This initiative seeks to leverage our two product lines:real-time image guidance systems and inhalation anesthetics. We have filed apatent application, "Drug Delivery for Conscious Sedation" (Burns, McNeirney andTerrell), for a new system for administering conscious sedation that wouldcompete with the widespread use of nitrous oxide, sedative hypnotics andnarcotic analgesics in both the pre-hospital and critical care hospital markets.

        Nitrous oxide and sedative hypnotics have been used with varying degrees ofsuccess as analgesics for centuries. Nitrous oxide, however, can produce sideeffects in patient and medical personnel alike, and can be addictive. Sedativehypnotics remain in the system for an extended period of time, even when used inconjunction with a reversal agent. In addition, in a small number of patientsthe reversal agent is ineffective. Constant monitoring of these patients isrequired, and productivity and cost management can suffer as a result. Finally,sedative hypnotics are scheduled substances according to the U.S. DrugEnforcement Administration ("DEA"), and appropriate controls, safeguards andrecord-keeping are required.

        We believe that if administered safely, modern inhalation agents have thepotential to be an attractive alternative to nitrous oxide and sedativehypnotics in conscious sedation. Modern inhalation agents meet the keyrequirements for conscious sedation as they are proven safe and effective athigher doses, reverse themselves through exhalation, have a very rapid uptake toanalgesic levels and are not addictive or DEA-controlled substances. In thepast, inhalation anesthetics were not used as analgesics due to the absence ofequipment to accurately deliver the agents and the fact that the manufacturersof inhalation agents also made and sold anesthesia equipment costing$100,000-$200,000 per unit.

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        We plan to produce a device that will "freeze" the delivered concentration atan analgesic level and not allow additional agent to be delivered. In October2002, we filed an application for a U.S. Patent that covers the use ofinhalation anesthetics as inhalation analgesics. On February 11, 2004, wereceived our preliminary report under the Patent Cooperation Treaty ("PCT"). All43 claims on our patent were accepted.

        To preserve patient safety, the FDA does not allow the testing of both a newdevice and a new drug simultaneously. Pursuant to regulatory approvals, we planto file a 510(k) application on the device in the fourth quarter of 2005 andsubsequently file Investigational New Drug ("IND") applications for review byhospital and university Institutional Review Boards ("IRB") contingent on 510(k)acceptance. The predicate device on which our conscious sedation product isbased is the electronically metered administration of nitrous oxide. Because theinhalation agents are already approved at a higher dose and have been safelyadministered, we plan to commence Phase III testing immediately following 510(k)acceptance and an IND filing on the agent. Presuming the agent was sevoflurane,this would allow our ANDA application for the manufacture and marketing ofsevoflurane. We believe our conscious sedation product can be on the market togenerate sales in a number of countries in 2007.

        We believe that the market for inhalation analgesics, including drugs anddevices, could approximate $5 billion worldwide based on our market researchestimates. Procedures that could benefit from this treatment include, but arenot limited to, colonoscopy, burn dressing changes, pain relief pre-diagnosis inambulance and emergency room, ICU/CCU sedation, dental and oral surgeryprocedures, relaxation for MRI diagnosis, office based dermatological orpodiatric procedures, and certain catheterizations.
**United States Regulatory Approvals for our Business**
        The following table shows United States regulatory acceptances/approvals andpatents related to our products.
**Trade Name**510(k) no.**510(k) Acceptance

Date**Patent Number
SabreSourceÔ    Targeting System
K022935
10/11/2002
6,694,169

APP#60/516,039-pending
SabreSourceÔ    Drape
K041846
8/26/2004
6,283,125

6,679,267
Light SabreÔ    Aspiration Needle
K982018
8/7/1998
5,810,841

6,096,049

6,264,168
Light SabreÔ    Bone Biopsy Needle
K982735
09/09/1998
5,810,841

6,096,049

6,264,168
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Light SabreÔ    Core Tissue Biopsy Needle
K981796
08/05/1998
5,810,841

6,096,049

6,264,168
Light SabreÔ    Introducer Needle
K013040
12/07/2001
5,810,841

6,096,049

6,264,168
Light SabreÔ    Spinal Needle
K021084
07/03/2002
5,810,841

6,096,049

6,264,168
Light SabreÔ    Syringe
K981140
06/25/1998
5,810,841

6,096,049

6,264,168
Light SabreÔ    Collimator
K013161
09/21/2001
5,810,841

6,096,049

6,264,168
Light SabreÔ    Collimator (Master File)
MAF-1155
09/21/2001
5,810,841

6,096,049

6,264,168
DRTS® - Light Beam Patient Positron    Indicator
K972852
09/15/1997
n/a
DRTS® Drape - Remote Control Drape
K973067
10/16/1997
n/a
Alignment verification devise 
n/a

6,297,502
Removable Needle Rule
n/a

6,200,274
Method/device for subsurface target
To be filed

6,829,500**Anesthetic and Analgesic Drugs**
**Product**
**Use**
**Trade Name**
**Approval**
**Process Patent Number**
Enflurane, USP
Human Anesthetic
Compound 347TM 
ANDA 74-396
n/a
Isoflurane, USP
Human Anesthetic
TerrellTM 
ANDA 74-416
n/a
Isoflurane, USP
Veterinary Anesthetic
AttaneTM 
ANADA 200-141-E0001
n/a
Sevoflurane
Human Anesthetic
TBD
To be filed
5,969,193

App#10/19/1999-pending

APP#10/644,500-pending

APP#60/628,708-pending

APP#60/628,707-pending
Conscious Sedation
Human Use

Drug(s) and Device
TBD
To be filed
APP#10/272,794-pending
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**Anesthetic and Analgesic Devices****Trade Name**510(k) no.**510(k) Acceptance

Date**Patent Number
MR Tested Fiber Optic Laryngoscope    Handle
K970619
11/19/1997
6,036,639

6,444,358

6,056,415
MR Tested Fiber Optic Short    Laryngoscope Handle
K041852
11/15/2004
6,036,639

6,444,358

6,056,415
MR Tested Laryngoscope
K971377
4/30/1998
6,036,639

6,444,358

6,056,415
MR Tested Flashlight
K970747
5/20/1997

Carbon Dioxide Removal
Human Anesthesia Equipment
To be filed
APP#60,559,659-pending
We also have a number of product approvals in other countries and expectadditional approvals in the coming year.
**Government Regulation**
        We manufacture active anesthesia and analgesia ingredients, specifically thechemical synthesis of inhalation anesthetic compounds, and we produce finishedanesthesia and analgesia products using the compounds manufactured at ourfacility in Bethlehem, PA. These manufacturing operations are regulated by theFDA and performed in compliance with cGMP as set out by the FDA. The facility isregistered with the FDA as a pharmaceutical manufacturer and distributor. It isalso registered as a pharmaceutical distributor with the states of Pennsylvania,Texas, Idaho and Kentucky. In addition, we believe that the operations at theBethlehem facility are in compliance with the federal and state regulationsregarding environmental protection, occupational safety and health, labor law,and state and local fire safety codes, building codes, and the covenants of theindustrial park in which the facility is located. On average, the cost ofenvironmental compliance at our Bethlehem facility averages between 1.75% and2.25% of revenue generated by the facility.

        Our Buffalo facility houses the general headquarters personnel, the real-timeimage guidance system design and development technical staff, and themanufacturing operations associated with certain critical portions of ourreal-time image guidance systems. The facility also warehouses and distributesreal-time image guidance systems. As such, the facility is registered with theFDA as a manufacturer and distributor of medical devices. We expect thisfacility to be registered under the EN13485 Device Directive in July 2005.Current activities at this facility are not subject to any federal, state orlocal environmental restrictions.

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**Employees**
        As of February 28, 2005, we had 58 full time employees. None of our employeesare represented by labor unions or covered by collective bargaining agreements.We have not experienced any work stoppages and consider our employee relationsto be good.
**Manufacturing**
        At this time, we rely on third-party contract manufacturers to produce manyof the components for our real-time image guidance system, SabreSourceTM.Critical sub-assemblies that involve proprietary materials and methods may bemanufactured in-house or contracted out. Final device assembly is done at ourBuffalo facility. Light SabreTM components are manufactured,assembled and sterilized by third parties (all of whom are ISO 9001 certified)and are subject to our acceptance. 

        At our Bethlehem facility, we currently produce bulk isoflurane and enflurane,which are manufactured from raw materials. Upon completion of production, theseanesthetics and analgesics are packaged on site into 100mL and 250mL bottles andprepared for distribution. We expect to begin producing and shipping sevofluranein the second quarter of 2005. We also have an existing contract under which weexpect to sell desflurane as early as 2007.
**Raw Materials**
        Many of the raw materials used in our anesthesia and analgesia business arereadily available from multiple sources. Four of the raw materials, however, areonly available from a few suppliers. We have qualified three suppliers for eachof CTFE ( chlorotrifluoro ethylene), CDFM (chloro difluoro methane) and TFE (trifluoroethanol).  HFMOP (hexafluoro isopropyl methyl ether), used in makingsevoflurane, is a custom synthesis and currently is available from only onesource, the Daiken Industries, Ltd. plant in Japan. If we were unable to obtainHFMOP, we have the technology to produce this chemical; however, if we have toproduce HFMOP it would require a significant capital investment and diversion ofresources. Interruption in the supply of raw materials for anesthesia andanalgesia synthesis could adversely affect our ability to supply finishedproduct in the short-term. 

        For our real-time image guidance system business, there are multiplequalified suppliers for all components and outsourced services necessary toproduce our real-time image guidance line of products.**  
Risk Factors**
        We are subject to a number of risks, including those enumerated below. Any orall of these risks could have a material adverse effect on our business,financial condition, results of operations, and cash flows and on the marketprice of our common stock.

 
**Risks Related to Our Business

We are currently in a growth stage and may experience setbacks in bothbusiness and product development.**
        We currently manufacture and market generic inhalation anesthetics andrecently launched SabreSourceTM, our second generation real-timeimage guidance system. We also are developing a drug/drug delivery system forconscious sedation. We are subject to all of the risks inherent in both thecreation of a new business and the development of new and existing products,including the absence of a history of significant operations. Our operations,especially in our real-time image guidance line of business, have been limited,and, as a result, we must establish many functions that are necessary to conductbusiness. These areas include managerial and administrative structure, sales andmarketing activities, financial systems and personnel recruitment. 

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**We have historically experienced operating losses and expect to continue toexperience losses in the future.**
        Our operating subsidiary has not been profitable since its inception in 1994.As of December 31, 2004, after giving effect to the merger, we had anaccumulated deficit of approximately $24 million. We may continue to incuradditional losses in the future as a result of a high level of operatingexpenses, significant up-front expenditures in the production and marketingactivities and very limited revenue from the sale of our products.

        We currently sell the generic inhalation anesthetics, isoflurane andenflurane, and recently launched our SabreSourceTM real-time imageguidance system and related products. We may never realize significant revenues,or be profitable, from the sale of our products. Each of the following factors,among others, may influence the timing and extent of our profitability, if any:
 •regulatory approval or clearance of our    products;    •market acceptance of our products and    innovations;    •our ability to effectively manufacture our    products; and    •our ability to efficiently market and    distribute our products to customers.**We will need to raise additional capital to fulfill our business strategies.We may also incur unforeseen costs. Failure to attract additional capital wouldadversely affect our business.**
        We currently operate at a loss and intend to increase our operating expensessignificantly due to the ongoing growth of our anesthetics and analgesicsbusiness and the expansion of our sales and marketing functions in connectionwith the recent launch of SaberSourceTM and the related line of LightSabreTM products. In addition, our future capital needs will besubstantial. Most notably, we must expand our Bethlehem facility to provide thecapacity to produce in a timely manner the quantities of isoflurane, enflurane,sevoflurane and desflurane that we may be required to deliver to ourinternational sales partners in the future under existing contracts in order toallow us to remain the exclusive provider of these inhalation anesthetics tothose sales partners in their respective sales regions and to avoid damagesunder those contracts. We also expect to incur substantial costs related to theresearch and development of our conscious sedation program. The long sales cyclein our real-time image guidance product line from initial customer contact toactual revenue generation, if any, also may place a significant burden on ourliquidity position. Finally, unforeseen costs could require us to seekadditional capital.

        We do not have any permanent arrangements or credit facilities in place as asource of funds. Accordingly, we will need to raise additional funds in thefuture through private or public sales of equity securities or the incurrence ofadditional indebtedness. Additional funding may not be available on favorableterms, or at all. Any additional equity financing may result in significantdilution to our company's existing stockholders. If we fail to obtain sufficientadditional capital in the future, we could be forced to curtail our growthstrategy by reducing or delaying capital expenditures and acquisitions, sellingassets or downsizing or restructuring our operations.

-15-
**The loss of the services of key personnel would adversely affect ourbusiness.**
        Our future success depends to a significant degree on the skills, experienceand efforts of our executive officers and senior management staff. The loss ofthe services of existing personnel, particularly William Burns and, prior to thecompletion of the conscious sedation program, John McNeirney, would bedetrimental to our research and development programs and to our overallbusiness. 
**We must hire and retain skilled technical and managerial personnel.**
        Qualified personnel are in great demand among acute care companies. Oursuccess depends in large part on our ability to attract, train and retainqualified management and highly-skilled employees, particularly technical, salesand marketing personnel and assembly technicians. Any failure to attract andretain the highly-trained technical personnel that are integral to direct sales,technology development and technical support teams may limit the rate at whichwe can generate sales and develop new products or product enhancements.Similarly, the failure to recruit key scientific and managerial personnel in atimely manner would be detrimental to our research and development programs andto our overall business. If we are unable to attract and retain skilled personsor we lose skilled technical personnel, our business, results of operations andfinancial condition would be adversely affected. 
**We may be unable to execute our business strategy.**
        Our business strategy in the real-time image guidance line relies heavilyupon the sale of our Light SabreTM products, a family of patenteddisposable products that is used with our SabreSourceTM system. Whilesome of our Light SabreTM products have been accepted by the FDA, atthis time we have fully developed only a portion of the tooling necessary tomanufacture these products. Bringing these products to market involves thedesign and fabrication of sophisticated tooling for plastic injection molding.Since tooling manufacture is inherently expensive, the designs must beconsidered carefully to avoid costly mistakes. Unforeseen difficulties in thedevelopment of these products, as well as other medical device products, maylead to significant delays in the production of tooling and the subsequentgeneration of revenue. 

        Market acceptance of our real-time image guidance products depends in part onour ability to demonstrate that our products are cost-effective and easier touse, and that they offer technological advantages. Additionally, we mayexperience design, manufacturing, marketing or other difficulties that coulddelay or prevent our development, introduction or marketing of new versions ofour products. As a result of these types of difficulties and delays, ourdevelopment expenses may increase and, as a consequence, our business, resultsof operations and financial condition could suffer. 

        Our strategy in our anesthesia and analgesia line of business relies heavilyon our ability to expand our product offerings in the anesthesia market, mostnotably through the launch of sevoflurane. All of our planned product offeringsrequire some form of regulatory acceptance in both the domestic andinternational markets. Unforeseen difficulties in the development, regulatoryacceptance, production, or distribution of these products may lead tosignificant delays in the generation of revenue.

        The development of our conscious sedation system is dependent upon ourability to recruit and retain competent technical staff to complete the projectand the further development, prototyping and testing of the device that wouldadminister the drug component of the system in conformance with FDArequirements.  Additionally, unforeseen delays in regulatoryacceptance/approval could adversely affect the market introduction of thesystem.

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**We depend on strategic partnerships and relationships.**
        Our success depends largely upon our ability to create and maintain importantrelationships with commercial partners, particularly in internationaldistribution. We currently rely on 30 international sales partners to market ouranesthesia and analgesia products, and we intend to co-market our real-timeimage guidance products with therapy partners. If we are unable to maintainstrategic partnerships currently in place and develop additional strategicpartnerships in critical areas, such as international sales, our business,results of operations and financial condition may be adversely affected.
**We face competition in our industry, and many of our competitors havesubstantially greater experience and resources.**
        We compete with other companies within the image guidance market, many ofwhich have more capital, more extensive research and development capabilitiesand greater marketing and human resources than we do. Some of these imageguidance competitors include Medtronic, Inc., BrainLAB, Inc., StrykerCorporation, and Biopsys Medical, a division of Johnson & Johnson. We believe weare the only company with a real-time image guidance system with an accuracy ofplus or minus 1 mm at a distance of 1 meter. In the image guidance arena,however, radiation exposure from fluoroscopy and the need for accuracy ininterventional procedures are well-recognized concerns. As a result, there is noguarantee that present fluoroscope manufacturers, radiological suppliers, biopsyvendors and suppliers of minimally-invasive medical devices are not alreadyengaged in research and product development to address these concerns or willnot become engaged in these areas of research and product development. We expectcompetition to increase as technological advances are made and commercialapplications broaden. Our competitors may develop new or enhanced products orprocesses that may be more effective, less expensive, safer or more readilyavailable than any products or processes developed by us, and we may not be ableto compete successfully.

        Similarly, in the anesthesia and analgesia product line, our company directlycompetes with larger and more established companies, such as Abbott Laboratoriesand Baxter International, Inc., that have more capital, more extensive researchand development capabilities and greater marketing and human resources than wedo. Competitors may develop new or enhanced products or processes that may bemore effective, less expensive, safer or more readily available than anyproducts or processes that we develop. Our products or processes may not competesuccessfully, and research and development by others may render our products orprocesses obsolete or uneconomical. 
**We rely upon third-party manufacturers and suppliers, which puts us at riskfor supplier business interruptions.**
        We believe that success in our real-time image guidance line of businessdepends in part on our ability to retain third parties to sub-assemble ourproducts in accordance with established quality and cost standards in sufficientquantities and in a timely manner. Third-party manufacturers may not perform aswe expect. If third-party manufacturers fail to perform, our ability to marketproducts and to generate revenue would be adversely affected. 

        We manufacture our product line of inhalation anesthetics at our Bethlehemfacility. We rely on the continuing availability of certain specialty rawmaterials from a small number of suppliers. Our policy is to qualify threesuppliers for each specialty raw material where possible. See "Raw Materials,"below. In some instances, if we were unable to acquire these materials whenneeded our production capacity would be adversely affected. 

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**We may face future product liability claims that may result from the use ofour products.**
        We are subject to potential product liability claims relating to ourreal-time image guidance and anesthesia and analgesia line of products. Wecurrently maintain product liability insurance with coverage limits of$3,000,000****in the aggregate annually. This coverage and any coverageobtained in the future may be inadequate to protect us in the event of asuccessful product liability claim, and we may not be able to increase theamount of such insurance coverage or even renew it. Our insurance does notcover, and we are not aware of any suitable insurance that would cover, productliability claims for any of our products undergoing clinical trials. Asuccessful product liability claim could have a material adverse effect on ourbusiness, results of operations and financial condition. In addition,substantial, complex or extended litigation could cause us to incur largeexpenditures and divert the attention of management and other significantresources. We also do not carry insurance to cover the costs of recalling any ofour products. If we need to recall a product, we may incur substantial costs andproduct liability claims. 
**Business interruptions beyond our control have occurred in the past and maytake place in the future, forcing a decrease in production and diminishedoperational capabilities.**
        In February 2003, storm damage forced a significant business interruption atour Bethlehem facility. We filed a multi-million dollar claim for damages inconnection with the interruption with our insurance carrier, The Chubb Group ofInsurance Companies. To date, we have received a progress payment of $500,000.There can be no assurance that we will receive additional funds from Chubb orthe timing of the receipt of such funds, if any. 
**We face significant risks associated with our international operations, whichcould have a material adverse effect on our business, results of operations andfinancial condition.**
        We market our products in select markets outside of the United States. Wegenerated 56% of our revenue for the period ended December 31, 2004, and 72% ofour revenue in the year ended September 30, 2004, from international sales. Weexpect that our revenues in select international markets will continue toaccount for a significant portion of our revenues. Our international operationsare subject to a number of risks. Recently, restrictions of the Venezuelangovernment on the repatriation of United States dollars from Venezuela adverselyaffected our sales of inhalation anesthetics in Venezuela. While we have takenmeasures to mitigate the impact of these restrictions on our business, there canbe no assurance that restrictions of the Venezuelan and other governments willnot adversely affect our business, financial condition or results of operationsin the future. Also, customers in the Middle East have recently shown reluctanceto purchase products from U.S. companies as a result of negative sentimentstoward the U.S. government following the commencement of the war in Iraq. Theseand the following risks associated with our international operations, amongothers, may materially adversely affect our business, financial condition orresults of operations: 
 •difficulties in enforcing and collecting    accounts receivable under some countries' legal systems; •local regulations may restrict our ability to    sell our products or conduct other operations; •political instability could disrupt our    operations;
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 •longer payment cycles in some markets, with    resulting adverse effects on our cash flow; •the imposition of additional trade barriers,    tariffs, taxes or restrict the import of our products; and •fluctuations in exchange rates of the United    States dollar could adversely affect our results of operations.**Significant additional governmental regulation could subject us tounanticipated delays, which would adversely affect our revenues.**
        Our business strategy depends in part on our ability to get our products intothe market as quickly as possible. Additional laws and regulations, or changesto existing laws and regulations, that are applicable to our business may beenacted or promulgated and the interpretation, application or enforcement ofexisting laws and regulations may change. We cannot predict the nature of anyfuture laws, regulations, interpretations, applications or enforcements, or thespecific effects any of these might have on our business. Any future laws,regulations, interpretations, applications, or enforcements could delay orprevent regulatory approval or clearance of our products and our ability tomarket our products. Moreover, if we do not comply with existing or future lawsor regulations we could be subject to the following types of enforcement actionsby the FDA and other agencies:
 •fines;    •injunctions;    •civil penalties;    •recalls or seizures of our products;    •total or partial suspension of the production    of our products;    •withdrawal of existing approvals or premarket    clearances of our products;    •refusal to approve or clear new applications or    notices relating to our products;    •recommendations by the FDA that we not be    allowed to enter into government contracts; and    •criminal prosecution.**Failure to obtain regulatory approval for our products in the future mayadversely affect our business.**
        Under the provisions of the U.S. Food, Drug and Cosmetic Act, we must obtainclearance from the FDA prior to commercial use in the United States of some ofthe products that we may develop. 

       Medical Devices. The production and marketing of our real-time imageguidance products and our ongoing research and development activities relatingthereto are subject to regulation by numerous governmental authorities in theUnited States and other countries. Additionally, sales of medical devicesoutside the United States are subject to foreign regulatory requirements thatvary widely from country to country. The time required to obtain approval forsale in each respective country may be longer or shorter than that required forFDA approval in the United States. To sell our products inside European Unionmember countries and an increasing number of other countries, we will berequired to obtain EN13485 certification. We expect that we will obtain thecertification for our Buffalo facility in July 2005; however we can give you noassurance that we will obtain the certification when planned, or at all.

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       Pharmaceutical Products. The production and marketing of ourpharmaceutical products, including our conscious sedation system, are alsosubject to significant regulation by the FDA in the United States and bynumerous governmental authorities under the laws of other countries. Although wehave satisfied these regulatory requirements for our current products in theUnited States and in the other countries in which we currently market ourproducts, we will need to satisfy all governmental regulations before we canintroduce any new pharmaceutical products in the United States or extend thesale of our existing inhalation anesthetics to additional foreign countries. Thetime required to obtain any of these additional regulatory approvals isuncertain and we may not be able to obtain them in a timely manner, or at all.

       Manufacturing Guidelines. Regulations regarding the manufacture and saleof our products are subject to change. We cannot predict what impact, if any,such changes may have on our business, financial condition or results ofoperation. Failure to comply with applicable regulatory requirements could havematerial adverse effect on our business, financial condition and results ofoperations.

        Additionally, the time required for obtaining regulatory approval isuncertain. We may encounter delays or product rejections based upon changes inFDA policies, including cGMP standards, during periods of product development.We may encounter similar delays in countries outside of the United States. Wemay not be able to obtain these regulatory acceptances on a timely basis, or atall. 

        The failure to obtain timely regulatory acceptance of our products, anyproduct marketing limitations, or any product withdrawal would have a materialadverse effect on our business, financial condition and results of operations.In addition, before it grants approvals, the FDA or any foreign regulatoryauthority may impose numerous other requirements with which we must comply.Regulatory acceptance, if granted, may include significant limitations on theindicated uses for which the product may be marketed. FDA enforcement policystrictly prohibits the marketing of accepted products for unapproved uses.Product acceptance could be withdrawn, or civil or criminal sanctions could beimposed, for our failure to comply with regulatory standards or the occurrenceof unforeseen problems following initial marketing. 

        The third party manufacturers and suppliers that we depend on to manufactureour products are required to adhere to FDA regulations regarding cGMP standardsand similar regulations in other countries, which include testing, control anddocumentation requirements. Ongoing compliance with cGMP regulations and otherregulatory requirements is monitored by periodic inspection by the FDA andcomparable agencies in other countries. If we fail to comply with regulatoryrequirements, including marketing or promoting products for unapproved uses, wecould be subject, among other things, to the enforcement actions discussed aboveunder the risk factor entitled "Significant additional governmental regulationcould subject us to unanticipated delays, which would adversely affect ourrevenues."

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        Changes in existing regulations or adoption of new governmental regulationsor policies could prevent or delay regulatory acceptance of our products. Somematerial changes to medical devices are also subject to FDA review andacceptance. Delays in receipt of, or failure to obtain, acceptances, or the lossof previously obtained acceptances, or failure to comply with existing or futureregulatory requirements could have a material adverse effect on our business,financial condition and results of operations. 
**We are subject to environmental regulations, and any failure to comply mayresult in substantial fines and sanctions.**
        Our operations are subject to United States and international environmentallaws and regulations governing, among other things, emissions to air, dischargesto waters and the generation, handling, storage, transportation, treatment anddisposal of raw materials, waste and other materials. We believe that we are andhave been operating our businesses and facilities in a manner that complies inall material respects with environmental, health and safety laws andregulations. Many of these laws and regulations provide for substantial finesand criminal sanctions for violations. Generally, the operation of an inhalantpharmaceutical manufacturing plant and the handling of specialty raw materialsentail risks of failure to comply with many regulatory requirements, and we mayincur material costs or liabilities if we fail to maintain our operations infull compliance.

        We may have to make significant expenditures in the future to comply withevolving environmental, health and safety requirements, including newrequirements that may be adopted or imposed in the future. To meet changinglicensing and regulatory standards, we may have to make significant additionalsite or operational modifications that could involve substantial expenditures orreduction or suspension of certain operations. We cannot be certain that we haveidentified all environmental and health and safety matters affecting ouractivities and in the future our environmental, health and safety problems andthe costs to remediate them, may be materially greater than we expect.
**Future acquisitions may divert management and may involve risk of undisclosedliabilities.**
        We may from time to time pursue acquisitions that we believe complement ourexisting operations.****Growth by acquisition involves risks that couldadversely affect our business, including the diversion of management time fromoperations to pursue and complete acquisitions, and difficulties in integratingadditional operations and personnel of acquired companies. In addition, anyfuture acquisitions could result in significant costs, the incurrence ofadditional indebtedness or issuance of equity securities to fund theacquisition, and contingent or undisclosed liabilities, all of which couldmaterially adversely affect our business, financial condition and results ofoperations.

        In connection with any future acquisition, we generally will seek to minimizethe impact of contingent and undisclosed liabilities by obtaining indemnitiesand warranties from the seller that may be supported by deferring payment of aportion of the purchase price. However, these indemnities and warranties, ifobtained, may not fully cover the liabilities due to their limited scope, amountof duration, the financial limitations of the indemnitor or warrantor, or otherreasons.
**We became public by means of a reverse merger, and as a result we are subjectto the risks associated with the prior activities of the public company. Inaddition, we may not be able to attract the attention of major brokerage firmsor institutional buyers.**
        Additional risks may exist because we became public through a "reversemerger" with a shell corporation that did not have significant recent operationsor assets, but which has had operations in the past. Although we performed a duediligence review of the public company, there can be no assurance that we willnot be exposed to undisclosed liabilities resulting from the prior operations ofour company. 

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        Security analysts of major brokerage firms and securities institutions maynot cover us since there are no broker-dealers who sold our stock in a publicoffering who would have an incentive to follow or recommend the purchase of ourcommon stock. No assurance can be given that established brokerage firms willwant to conduct any financings for us in the future.
**We have recently been in default under obligations with various serviceproviders, vendors and lenders.**
        Due to cash flow constraints, we are in significant arrears to some of ourservice providers and other vendors, and we have been unable to pay all of ourfinancial obligations as they became due. In some cases, we have been in defaultfor many months.

        As a result of these defaults, creditors have asserted claims against us fromtime to time. Although we have negotiated forbearance or other arrangements withour creditors, the risk of claims by creditors will continue until we are ableto generate positive cash flow on a consistent basis. Any default under ourobligations could have a material adverse effect on our business, results ofoperations and financial condition.
**We incur significant costs as a result of being a public company.**
        As a public company, we are subject to significant legal, accounting andother expenses to which Minrad Inc. was not subject prior to the reverse merger.We incur costs associated with our public company reporting requirements underthe Securities and Exchange Act of 1934, costs associated with recently adoptedcorporate governance standards and internal control requirements, includingstandards and requirements under the Sarbanes-Oxley Act of 2002, as well as newrules implemented by the SEC. These rules and regulations increase our legal andfinancial compliance costs and make some activities more time-consuming andcostly. These new rules and regulations also make it more difficult and moreexpensive for us to obtain director and officer liability insurance. We may berequired to accept reduced policy limits and coverage or incur substantiallyhigher costs to obtain the same or similar coverage. As a result, it may be moredifficult for us to attract and retain qualified individuals to serve on ourboard of directors or as executive officers. We are currently evaluating andmonitoring developments with respect to these new rules and we cannot predict orestimate the amount of additional costs we may incur or the timing of suchcosts.
**Investor confidence and the price of our common stock may be adverselyimpacted if we are unable to comply with Section 404 of the Sarbanes-Oxley Actof 2002.**
        As an SEC registrant, we are subject to the rules adopted by the SEC pursuantto Section 404 of the Sarbanes-Oxley Act of 2002, which require us to include inour annual report on Form 10-KSB our management's report on, and assessment ofthe effectiveness of, our internal control over financial reporting. Inaddition, our independent registered public accounting firm must attest to andreport on management's assessment of the effectiveness of our internal controlover financial reporting. These requirements will first apply to our annualreport for the fiscal year ending December 31, 2006. If we fail to achieve andmaintain adequate internal control over financial reporting, there is a riskthat we will not comply with all of the requirements imposed by Section 404.Moreover, effective internal control over financial reporting, particularly thatrelated to revenue recognition, is necessary for us to produce reliablefinancial reports and is important in helping to prevent financial fraud. Any ofthese possible outcomes could result in an adverse reaction in the financialmarketplace due to a loss of investor confidence in the reliability of ourfinancial statements, which ultimately could harm our business and couldnegatively impact the market price of our common stock.

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**Risks Related to Our Intellectual Property

If we are not able to adequately protect our intellectual property, we maynot be able to compete effectively.**
        Our success depends, to a significant degree, upon the protection of ourproprietary technologies. While we currently own 13 U.S. patents and numerousforeign counterparts that protect our products, we will need to pursueadditional protections for our intellectual property as we develop new productsand enhance existing products. We may not be able to obtain appropriateprotections for our intellectual property in a timely manner, or at all. 

        The filing and maintenance fees and the legal and other expenses necessaryfor us to obtain and maintain appropriate patent protection in the United Statesand important foreign countries are significant. If we do not have sufficientfunds, we may not be able to maintain appropriate protections. In addition, ifwe are forced to resort to legal proceedings to enforce our intellectualproperty rights, the proceedings could be burdensome and expensive. In addition,our proprietary rights could be at risk if we are unsuccessful in, or cannotafford to pursue, those proceedings. We also rely on trade secrets and contractlaw to protect some of our proprietary technology. We have entered intoconfidentiality and invention agreements with our employees and consultants.Nevertheless, these agreements may not be honored and they may not effectivelyprotect our right to our unpatented trade secrets and know-how. Moreover, othersmay independently develop substantially equivalent proprietary information andtechniques or otherwise gain access to our trade secrets and know-how.

        In 1995, the U.S. Patent and Trademark Office adopted changes to the U.S.patent law that made the term of issued patents 20 years from the date of filingrather than 17 years from the date of issuance, subject to specified transitionperiods. Beginning in June 1995, the patent term became 20 years from theearliest effective filing date of the underlying patent application. Thesechanges may reduce the effective term of protection for patents that are pendingfor more than three years. In addition, as of January 1996, all inventors whowork outside of the United States are able to establish a date of invention onthe same basis as those working in the United States. This change couldadversely affect our ability to prevail in a priority of invention dispute witha third party located or doing work outside of the United States. While wecannot predict the effect that these changes will have on our business, theycould have a material adverse effect on our ability to protect our proprietaryinformation. Furthermore, the possibility of extensive delays in the patentissuance****process could effectively reduce the term during which amarketed product is protected by patents. 

        We may need to obtain licenses to patents or other proprietary rights fromthird parties. We may not be able to obtain the licenses required under anypatents or proprietary rights, or they may not be available on acceptable terms.If we do not obtain required licenses, we may encounter delays in productdevelopment or find that the development, manufacture or sale of productsrequiring licenses could be foreclosed. We may, from time to time, support andcollaborate in research conducted by universities and governmental researchorganizations. We may not be able to acquire exclusive rights to the inventionsor technical information derived from these collaborations, and disputes mayarise over rights in derivative or related research programs conducted by us orour collaborators.

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**If we infringe on the rights of third parties, we may not be able to sell ourproducts, and we may have to defend against litigation and pay damages.**
        If a competitor were to assert that our products infringe on its patent orother intellectual property rights, we could incur substantial litigation costsand be forced to pay substantial damages. Third-party infringement claims,regardless of their outcome, would not only consume significant financialresources, but would also divert our management's time and attention. Suchclaims could also cause our customers or potential customers to purchasecompetitors' products or defer or limit their purchase or use of our affectedproducts until resolution of the claim. If any of our products are found toviolate third-party intellectual property rights, we may have to re-engineer oneor more of our products, or we may have to obtain licenses from third parties tocontinue offering our products without substantial re-engineering. Our effortsto re-engineer or obtain licenses could require significant expenditures and maynot be successful.
**If our trademarks and trade names are not adequately protected, we may not beable to build brand loyalty and our sales and revenues may suffer.**
        Our registered or unregistered trademarks or trade names may be challenged,cancelled, infringed, circumvented or declared generic or determined to beinfringing on other marks. We may not be able to protect our rights to thesetrademarks and trade names, which we need to build brand loyalty. Over the longterm, if we are unable to establish a brand based on our trademarks and tradenames, then we may not be able to compete effectively and our sales and revenuesmay suffer.
**Risks Related to Our Securities

We have a concentration of stock ownership and control.**
        Our common stock ownership is highly concentrated. See Item 12 of thisreport, "Security Ownership of Certain Beneficial Owners and Management andRelated Stockholder Matters." As a result, a relatively small number ofstockholders, acting together, will be able to control all matters requiringstockholder approval, including the election of directors and approval ofmergers and other significant corporate transactions. This concentration ofownership may have the effect of delaying, preventing or deterring a change incontrol of our company. It could also deprive our stockholders of an opportunityto receive a premium for their shares as part of a sale of our company and itmay affect the market price of our common stock. 
**Our stock price may be volatile because of factors beyond our control and youmay lose all or a part of your investment.**
        Any of the following factors could affect the market price of our commonstock: 
 •our failure to achieve and maintain    profitability;    •our failure to meet financial analysts'    performance expectations;    •changes in earnings estimates and    recommendations by financial analysts;
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 •actual or anticipated variations in our    quarterly results of operations;    •changes in market valuations of similar    companies;    •announcements by us or our competitors of    significant contracts, new products, acquisitions, commercial relationships,    joint ventures or capital commitments;    •the loss of major customers or product or    component suppliers;    •the loss of significant partnering    relationships;    •product liability lawsuits or product recalls;    and    •general market, political and economic    conditions.
        In the past, following periods of volatility in the market price of acompany's securities, securities class action litigation has often beeninstituted. A securities class action suit against us could result insubstantial costs and divert our management's time and attention, which wouldotherwise be used to benefit our business.
**We may experience future sales of large amounts of common stock by existingshareholders.**
        Future sales of large amounts of our common stock by existing stockholderspursuant to Rule 144 under the Securities Act of 1933 or otherwise couldadversely affect the market price of our common stock. Certain of ouraffiliates, who beneficially own large amounts of our common stock, are notsubject to lockup letters or other forms of restriction on the sale of theirshares. Sales of a large number of shares of common stock in the public marketcould adversely affect the market price and could materially impair our futureability to generate funds through sales of common stock or other equitysecurities. 
**We are subject to penny stock regulations and restrictions.**
        Our common stock is approved for quotation on the OTC Bulletin Board. Sinceour common stock trades below $5.00 per share, it is considered a "penny stock"and is subject to SEC rules and regulations that impose limitations on themanner in which it can be publicly traded.

        These regulations require thedelivery, prior to any transaction involving a penny stock, of a disclosureschedule explaining the penny stock market and the associated risks. Potentialinvestors in our common stock are urged to obtain and read this disclosurecarefully before purchasing any shares that are deemed to be "penny stock." Alsounder these regulations, certain brokers who recommend a penny stock to personsother than established customers or certain accredited investors must make aspecial written suitability determination regarding the purchaser and receivethe purchaser's written agreement to a transaction prior to sale. 

        These procedures require thebroker-dealer to:
 •our exposure to product liability claims    resulting from the use of our products;    •obtain from the investor information concerning    his or her financial situation, investment experience and investment    objectives;
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 •reasonably determine, based on that    information, that transactions in penny stocks are suitable for the investor    and that the investor has sufficient knowledge and experience as to be    reasonably capable of evaluating the risks of penny stock transactions;    •provide the investor with a written statement    setting forth the basis on which the broker-dealer made their determination    of suitability; and    •receive a signed and dated copy of the    statement from the investor, confirming that it accurately reflects the    investor's financial situation, investment experience and investment    objectives.
        These regulations have the effect of limiting the trading activity of ourcommon stock and reducing the liquidity of an investment in our common stock.

        Stockholders should be aware that, according to SEC Release No. 34-29093, themarket for penny stocks has suffered in recent years from patterns of fraud andabuse.

        Our "penny stock" designation may adversely affect the development orcontinuation of the public market for our common stock.
**We have not paid and have no plans to pay cash dividends.**
        Since our inception, we have not paid any cash dividends on our common stockand we do not anticipate paying any cash dividends in the foreseeable future.
** 

Item 2. Description of Property.**
        Our principal offices are located at 847 Main Street, Buffalo, New York wherewe lease approximately 17,500 square feet of laboratory and office space at acost of approximately $193,480 per year under a lease that expires in December2006, with a five-year renewal option. 

        We also own a 28,687 square-foot anesthesia and analgesia manufacturingfacility on four acres in Bethlehem, Pennsylvania that consists of approximately11,500 square feet of finished office and laboratory space and 17,064 squarefeet of manufacturing space.

        We believe that we maintain adequate insurance for our facilities.

        We do not invest in real estate other than for use in or business.Accordingly, we have not adopted any specific policies regarding investments inreal estate, interests in real estate, or investment in real estate mortgages.
**Item 3. Legal Proceedings.**
        On December 10, 2004, a Notice of Mechanic's Lien claim for $86,902 was filedon behalf of H.T. Lyons, Inc. in the Court of Common Pleas of NorthhamptonCounty, Pennsylvania. This claim relates to process-piping work performed by H.T.Lyons, Inc. at Minrad Inc.'s manufacturing plant in Bethlehem, Pennsylvania.Subsequently, a civil action against Minrad Inc. was filed by H.T. Lyons, Inc.on February 1, 2005. We intend to contest both the mechanic's lien claim and thecivil action.

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**Item 4. Submission of Matters to a Vote of Security Holders.**
Not applicable.
** 

PART II

Item 5. Market for Common Equity And Related Stockholder Matters.

Market Information**
        Our common stock is quoted under the symbol, "MNRD.OB" on the OTC BulletinBoard, a service maintained by the National Association of Securities Dealers,Inc. Trading in the common stock in the over-the-counter market has been limitedand sporadic and the quotations set forth below are not necessarily indicativeof actual market conditions. All prices prior to the quarter ended September 30,2004 reflect activity in our common stock prior to the announcement of ouragreement to acquire Minrad Inc.. Further, all prices reflect inter-dealerprices without retail mark-up, mark-down, or commission and may not necessarilyreflect actual transactions. The high and low sales prices for the periodspresented have been adjusted to reflect stock splits:
 
High
Low2003  March 31, 2003
*
*June 30, 2003
.04
.01September 30, 2003
.06
.04December 31, 2003
.06
.05   2004  March 31, 2004
.11
.06June 30, 2004
.11
.11September 30, 2004
10.05
.11 December 31, 2004
4.25
2.50*no available quoted prices during these    periods**Holders**
        As of March 15, 2005, there were approximately 800 stockholders of record ofour common stock.
**Dividends**
        We have not paid any dividends since inception and do not anticipate payingany dividends in the foreseeable future. Additionally, one of our loanagreements prohibits us from paying or declaring a dividend until the loan ispaid in full. We currently intend to retain all available funds and any futureearnings of our business for use in the operation of our business. Thedeclaration, payment and amount of future dividends, if any, will depend uponour future earnings, results of operations, financial position and capitalrequirements, among other factors, and will be at the sole discretion of ourBoard of Directors.

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**Securities authorized for issuance under equity compensation plan**
        As of December 31, 2004, our only equity compensation plan was our 2004 StockOption Plan, which was previously approved by our stockholders. The followingtable provides information about the plan as of that date.
**Equity Compensation Plan Information       
(a) 
(b) 
(c) **Number of securities to be issued upon exercise of    outstanding options, warrants and rights **Weighted-average exercise price of outstanding options,    warrants and rights **Number of Securities remaining available for future    issuance under equity compensation plans (excluding securities reflected in    column (a))      **Plan Category**     Equity compensation plans approved by    security      holders    .........................................................................
2,360,917 
$1.50 
4,794,583                                     ****(1) Reflects shares issuable upon exercise of options issued and issuable    under the Company's 2004 Stock Option Plan.**Purchase of shares

        During the three month transition period ended December 31, 2004, we didnot purchase any of our shares.

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**Item 6. Management's Discussion and Analysis or Plan of Operation.****Cautionary Factors That May Affect Future Results**
        All statements, other than statements of historical fact, contained in thisForm 10-KSB constitute forward-looking statements. In some cases you canidentify forward-looking statements by terms such as "may," "intend," "might,""will," "should," "could," "would," "expect," "believe," "estimate,""anticipate," "predict," "project," "potential," or the negative of these termsand similar expressions intended to identify forward-looking statements.

        Forward-looking statements are based on assumptions and estimates and aresubject to risks and uncertainties. We have identified in this Form 10-KSB someof the factors that may cause actual results to differ materially from thoseexpressed or assumed in any of our forward-looking statements. There may beother factors not so identified. You should not place undue reliance on ourforward-looking statements. Further, any forward-looking statement speaks onlyas of the date on which it is made and, except as required by law, we undertakeno obligation to update any forward-looking statement to reflect events orcircumstances after the date on which it is made or to reflect the occurrence ofanticipated or unanticipated events or circumstances. New factors emerge fromtime to time that may cause our business not to develop as we expect and it isnot possible for us to predict all of them. Factors that may cause actualresults to differ materially from those expressed or implied by ourforward-looking statements include, but are not limited to, those describedunder the heading "Risk Factors" in Item 1 of this Form 10-KSB, including thefollowing:
 •our limited operating history and business    development associated with being a growth stage company;    •our history of operating losses, which we    expect to continue;    •our need to obtain future funding through    equity or debt financings;    •our dependence on key personnel;    •our need to attract and retain technical and    managerial personnel;    •our ability to execute our business strategy;    •our dependence on our strategic partnerships;    •intense competition with established leaders in    the medical devices industry;    •our reliance on third-party suppliers;    •our exposure to product liability claims    resulting from the use of our products;   •our exposure to unanticipated and    uncontrollable business interruptions;    •changes in international economic, political    and regulatory conditions, interest rates and currency movements;    •the costs and effects of complying with changes    to existing laws and regulations;    •the effect of failing to receive regulatory    approval for new and existing products;    •the costs and effects of complying with laws    and regulations relating to the environment and to the manufacture, storage,    distribution and regulation of our products;
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 •our ability to successfully complete the    integration of any future acquisitions;    •our ability to project the market for our    products based upon estimates and assumptions;    •our exposure to undisclosed liabilities of the    public shell corporation and the lack of established broker-dealer    relationships for our stock;    •our ability to generate enough positive cash    flow to pay our creditors;    •the increase in legal, accounting and insurance    expenses related to being a public company;    •our ability to achieve and maintain adequate    internal controls necessary to comply with regulations governing financial    reporting;    •our ability to protect our intellectual    property and proprietary technologies;    •costs associated with potential intellectual    property infringement claims asserted by a third party; and•our ability to protect, and build    recognition of, our trademarks and tradenames.** 

Management's Discussion and Analysis of Financial Conditionand Results of Operations**
        You should read the following description of our results of operations andfinancial condition in conjunction with the audited financial statementspresented in the this Form 10-KSB.
**Overview

Merger**
        On December 16, 2004, we acquired Minrad Inc. through a reverse merger of ournewly formed subsidiary into Minrad Inc., with the result that Minrad Inc.became our wholly owned subsidiary and the stockholders of Minrad Inc. becamethe beneficial owners of approximately 83% of our common stock. Because we didnot have any substantial assets or operations during the two fiscal years priorto the acquisition, Minrad Inc. is deemed to be the accounting acquirer ofMinrad International, and the discussion of operations below relates to theoperations of Minrad Inc. References in this discussion to "fiscal 2003" are toMinrad Inc.'s fiscal year ended September 30, 2003, and references to "fiscal2004" are to Minrad Inc.'s fiscal year ended September 30, 2004. On January 19,2005, we changed our fiscal year end to December 31. 
**Company Background**
Through our wholly owned subsidiary, Minrad Inc., we operate an acute carebusiness with twoproduct lines: (1) real-time image guidance and (2) anesthesiaand analgesia. We currently sell patented real-time image guidance technologiesthat enable medical professionals to improve the accuracy if interventionalprocedures and reduce the exposure to radiation. We recently launchedSabreSourceTM, our second-generation real-time image guidance system.Our real-time image guidance products have broad applications in orthopedics,neurosurgery, interventional radiology and anesthesia. We manufacture and marketour generic inhalation anesthetics for use in connection with human andveterinary surgical interventions. We are also developing a drug/drug deliverysystem for conscious sedation, which, similar to nitrous oxide used in dentalsurgery, provides a patient with pain relief without loss of consciousness. Forthe fiscal year ended September 30, 2004, we had revenue of $4.1 million.

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*Key Success Factors*
        Four factors are the principal drivers of success in the MINRAD businessmodel:
 1)*Expanded Product Commercialization* including existing product      growth in present and new markets and the development and introduction of      new products. 2)*Manufacturing Efficiency* facilitating maximum margin realization. 3)*The Attraction of Talented Personnel* accelerating product and      market plan implementation. 4)*Funding of the Business*to insure successful on-going operations.
        Management believes that significant progress was made in these areas overthe quarter. However, on a short-term basis, the individual goals areoccasionally in conflict - such as the production of sevoflurane validationbatches in the Bethlehem plant during the quarter, which was in competition withuse of the production equipment for manufacturing our other anesthesia andanalgesia products - isoflurane and sevoflurane. Delays in completion of theregulated batch, approximately six weeks, resulted in sharply under-absorbedoverhead and a shippable backlog of $1.0 million at the end of the quarter.

        Each of these success factors will be addressed in the discussion ofoperations.
**Results of Operations - Three month period ending December 31, 2003 comparedto the three month period ending December 31, 2004:**
Increase/
2003
2004    (Decrease)
%    Revenue
$ 1,049,362 
$ 460,276 
$(589,086)
(56%)    Gross Margin 
143,506 
(156,115)
(299,621)
(209%)    Gross Margin %
13.6%
(33.9%)
(47.6) pts
(2880%)    Research and development
368,026 
308,670 
(59,356)
(16%)    Sales and marketing
193,680 
230,348 
36,668 
19%    Finance and administration
454,523 
486,970 
32,447 
7%    Operating loss
(872,723)
(1,182,103)
(309,380)
(35%)    Interest expense
    276,481 
198,280 
(78,201)
(28%)Net    loss
$(1,149,204)
$(1,380,383)
$231,179
20%
-31-
**Net Revenue**
        For the quarter ended December 31, 2004, the company generated revenue of$460,276 as compared to $1,049,362 for the quarter ended December 31, 2003. Thedecrease of $589,086, or 56%, was not reflective of market conditions as weended the quarter with $1,037,000 in immediately shippable backlog. Rather thedecrease reflected delays resulting from the completion of previously mentionedsevoflurane validation batches which postponed our resumption of isofluraneproduction.

        Customer impact of these backlogs was partially mitigated by our ability towork with the various parties and balance their inventory levels. We will becontinuing this practice through the end of the first calendar quarter endingMarch 31, 2005 when we expect to have shipped the backlog from the priorquarter.
**Gross Profit**
        Gross Profit for the quarter ended December 31, 2004 was ($156,115) ascompared with $143,506 for quarter ended December 31, 2003, representing areduction of $299,621. Gross margin was (33.9%) as compared with 13.7% in theprior period. The unfavorable gross margin variance in the quarter endedDecember 31, 2004 was a function of lower volumes due to the plant's inactivityduring the sevoflurane validation campaign. The lower volumes resulted inunfavorable manufacturing absorption variances of $406,200. 

        Shipment of the $1,037,000 in immediately shippable backlog during thequarter ended December 31, 2004 would have had a positive impact on gross profitfor this period. We expect to experience fluctuations in gross margins in futureperiods, primarily resulting from fluctuations in production volume based onincreasing demand and the introduction of new products during 2005.
**Research and Development**
        Research and development expenses for the quarter ended December 31, 2004were $308,670, representing a reduction of $59,356, or 16%, from the periodended December 31, 2003. The year-over-year decrease is composed of atiming-related reduction in prototype expenses of $96,525. Partially offsettingthis were increased wage and benefit expenses of $50,788 which were related toadditional personnel in the image-guidance engineering staff. 

        During the quarter, the company was awarded one additional U.S. patent for astereo tactic device used in neuro surgical procedures that will provide futureproduct opportunities. Also received was a 510(k) device clearance for amodification to a Laryngoscope Handle.
**Sales and Marketing**
        Sales & Marketing expense increased from $193,680 in the quarter endedDecember 31, 2003 to $230,348 in the quarter ended December 31, 2004. This$36,668 or 19% increase is primarily attributed to trade show expensesassociated with the introduction of our new SabreSource technology.

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**Finance and Administration**
        Finance and Administration costs increased $32,447 from $454,523 in thequarter ended December 31, 2003 to $486,970 in the quarter ended December 31,2004. On an on-going basis, Finance and Administration costs increased byapproximately $218,000 from $379,000 in the quarter ended December 31, 2003 toapproximately $597,000 in the quarter ended December 31, 2004, a 58% increase.Three main factors contributed to the increase in Finance and Administrationexpenses: $126,000 in additional wages and benefits, $90,000 in legal andaccounting expenses, and $43,000 in increased insurance costs. Most of theseincreased costs relate to the cost to comply with being a public company. Inaddition, the Company reserves for bad debt expense based on specificidentification of doubtful accounts. In the quarter ended December 31, 2003, theCompany recognized $75,000 as bad debt expense, versus a $110,000 bad debtrecovery that occurred in the quarter ended December 31, 2004. This $185,000difference between periods offset a large portion of the increase in otherFinance and Administration costs.
**Interest Expense**
        Interest Expense declined from $276,481 in quarter ended December 31, 2003 to$198,280 in the quarter ended December 31, 2004. This reduction of $78,201 is aresult of the reduction in debt following the conversion of short-term demandnotes to equity during March of 2004. Interest levels in calendar 2005 areundeterminable at this time. Management's intentions, which are dependent uponfuture funding, are to lower cash based interest expense through reductions infactoring, mortgage and other liabilities. Interest of a non-cash nature shouldincrease due to valuations of two groups of warrants. The first is associatedwith the guarantee of the $997,000 Wachovia line of credit. The second is theamortization of the warrants associated with the $2.5 million convertible debtfinancing in February 2005. Additional non-cash basis interest expense is alsopossible if conditions are met that allow for the conversion to common stock ofthis same $2.5 million debt.
**Net Loss**
        The net loss for the quarter ended December 31, 2004 was $1,380,383 anincrease of $231,179 or 20% from the $1,149,204 net loss recorded in the quarterended December 31, 2003. The major contributors to the loss recorded in thequarter ended December 31, 2004 were a $299,621 reduction in gross marginpartially offset by a reduction in interest expense of $78,201.
**Liquidity and Capital Resources**
        As of December 31, 2004, we had current assets of approximately $2.2 million(including nominal amounts of cash) and current liabilities of approximately$6.1 million. As of December 31, 2003, we had current assets of approximately$1.8 million, including cash and equivalents and restricted cash of approximately $426.0 thousandand current liabilities of approximately $9.6 million. The net improvement inworking capital of approximately $3.8 million is attributed primarily to theconversion of approximately $3.0 million of short-term demand notes into equity.

        Net cash used by operating activities increased by approximately $625.0thousand, or 228% from approximately $274.0 thousand for the quarter endedDecember 31, 2003 to approximately $899.0 thousand for the quarter endedDecember 31, 2004. This increase was attributable primarily to the increased netloss from operations of approximately $231.0 thousand and reduced levels of cashgenerated from changes in working capital of approximately $325.0 thousand .******Net cash used by investing activities for the quarter ended December 31,2004 was $52.0 thousand, a decrease of approximately $383.0 thousand from the$435.0 thousand experienced in the quarter ended December 31, 2003. This wasprimarily due to a short term investment of $350.0 thousand at December 31, 2003generated from initial equity investments which was subsequently expended inoperations. There also was approximately a $40.0 thousand reduction in purchasesof property and equipment. Net cash provided by financing activities increasedby approximately $168.0 thousand from approximately $785.0 thousand at December31, 2003 to approximately $953.0 thousand at December 31, 2004. This increasewas largely due to debt******repayments of $106.0 thousand in thequarter ended December 31, 2003. In the quarter ended December 31, 2004, weraised approximately $971.0 thousand through borrowings under demand notespayable as opposed to approximately $925.0 thousand in the fourth quarter in2003. 

-33-

        Our future capital requirements will be substantial. Most notably, we mustexpand our Bethlehem facility to produce in a timely manner the quantities ofenflurane, isoflurane, sevoflurane and desflurane that international salespartners are required to purchase in the future under existing contracts tomaintain exclusivity in their respective sales regions. See "Anesthesia andAnalgesia Competitive Strategy." We expect to incur substantial costs related toour real time image guidance system and research and development costs forconscious sedation. Accordingly, we will need to raise additional funds in thefuture through the private or public sales of equity securities or theincurrence of additional indebtedness. Additional funding may not be availableon terms favorable to us, or at all. If we raise additional funds through theissuance of equity securities, the percentage ownership of our stockholders willbe reduced, stockholders may experience dilution and the issued equitysecurities may provide for rights, preferences and privileges senior to those ofthe existing holders of our common stock. In addition, any issuance ofindebtedness may require us to comply with restrictive covenants. Our inabilityto raise additional capital would have a material adverse effect on our resultsof operations and financial condition.

 
**Results of Operations -- Year Ended September 30, 2003 Compared to        Year Ended September 30, 2004** **2003**2004**Increase/    (Decrease)
**%Revenue
3,514,963
4,116,995
602,032
17%Gross Margin
1,422,980
966,516
(456,464)
(32%)Gross Margin %
40%
23%
(17%)
(43%)Research and development
1,269,842
1,175,570
(94,272)
(7%)Sales and marketing
645,805
736,266
90,461
14%Finance and administration
1,550,259
2,097,288
547,029
35%Interest expense
752,591
789,443
36,852
5%Debt conversion costs
-
713,000
(713,000)
n/aNet Loss
(2,795,517)
(4,545,051)
1,749,534
63%**Revenue**  **2003  **2004  **Increase/    (Decrease)
 **%North America$
909,305     
$
1,155,315     
$
246,010 
27%International$
2,605,658     
$
2,961,680     
$
356,022 
14%      Total$
3,514,963     
$
4,116,995     
$
602,032 
17%
        Revenue increased by $602,032, or 17%, to $4,116,995 for fiscal 2004 from$3,514,963 for fiscal 2003. North America showed the greater year-over-yearpercentage improvement. Essentially, all revenue was from our anesthesia andanalgesia line. North American sales rose sharply in the human inhalantanesthetic market due primarily to net sales of approximately $385,000 in thequarter ended September 30, 2004, generated from our partnership with RxElite,Inc. Exclusive of the one-time license fee for real-time image guidance of$150,000 received in fiscal 2003, North American revenue increased by $396,010,or 52%, to $1,155,315 for fiscal 2004 from $759,305 for fiscal 2003.

-34-

        International sales increased by 14% for fiscal 2004 from fiscal 2003. Salesgrowth generally was uniform across our sales regions with 14% growth in each ofEurope and the Pacific Rim, and 13% growth in Latin America. Our internationalbusiness benefited from increases in market share in the United Kingdom, Braziland Argentina, and the entry into the Thailand market and the veterinary marketsof Switzerland and Australia. Factors reducing growth in the various marketsincluded a slow down in sales to the Middle East as a result of anti-Americansentiments related to the war in Iraq, a decline in sales in South Koreaattributable to declining demand, and the required cessation of sales toVenezuela as a result of export exchange control issues. Subsequent to fiscal2004, we believe we have resolved the export exchange control issues inVenezuela by identifying alternative distribution channels that providerequisite import and export credits.
**Gross Margin**
        Gross margin declined by $456,464, or 32%, to $966,516 for fiscal 2004 from$1,422,980 for fiscal 2003, primarily as a result of sharply highermanufacturing variances in fiscal 2004. 

        In fiscal 2004, unfavorable manufacturing variances increased by $697,341, or127%, to $1,248,297 from $550,956 for fiscal 2003. Roughly $500,000 of thefiscal 2004 variance represented lost production associated with modificationsto our Bethlehem facility to allow for the production of sevoflurane. Thebalance is comprised of under-absorbed overhead and the cost of hiring andtraining additional staff in anticipation of continuous operations commencing in2005. The hiring and training of staff for a third shift generated $200,000 ofone-time costs. The unfavorable variance of $550,956 in fiscal 2003 was reducedby the receipt of a $500,000 progress payment from Chubb on a businessinterruption claim filed in connection with storm damage that negativelyaffected production at the Bethlehem facility from February 16, 2003 to mid-July2003. 

        Specialty anesthesia and analgesia facilities have intrinsically high fixedoverhead costs. Quality control, health, safety and environmental management,process engineering and maintenance, and management are all required on-site. Ifproduction at our Bethlehem facility slows due to new product qualification,business interruption, reduced volume or expansion, the impact on our resultscan be severe. 

        In fiscal 2004, we invested in the future of our business. We performed theinitial synthesis and process controls for sevoflurane, a process that wecompleted with our validation batches in December 2004. Because of the manner inwhich we use equipment in the facility for multiple purposes, the sevofluraneprojects resulted in substantial downtime in 80% of our production capacity. Inaddition, we began to hire and train staff in January 2004 which qualified us tomove to continuous operation. We expect that we will begin to see the benefitsfrom continuous operation and the related overhead absorption in the firstcalendar quarter of 2005. Further, we anticipate the validation batches ofsevoflurane will become saleable in the second quarter of 2005.
**Research and Development**
        Research and development expenses declined by $94,272, or 7%, to $1,175,570,or 29% of revenue, for fiscal 2004, from $1,269,842, or 36% of revenue, forfiscal 2003. Research and development costs were essentially flat betweenperiods. We expect to continue to spend significant amounts on research anddevelopment to fund our core product lines, new products and technologydevelopment in 2005 and beyond.

-35-
**Sales and Marketing**
        Sales and marketing expenses increased by $90,461, or 14%, to $736,266 forfiscal 2004 from $645,805 for fiscal 2003. As a percentage of product sales,costs remained relatively consistent at 18% of sales between periods. We expectthat in future periods, sales and marketing expenses, as a percentage of sales,will exceed the fiscal 2003 and 2004 levels as a result of our need to supportcontractual commitments for inhalation anesthetics with additional personnel andsignificant initial costs associated with the launch of SabreSourceTM.
**Finance and Administration**
        Finance and administration expenses increased by $547,029, or 35%, to$2,097,288 for fiscal 2004 from $1,550,259 for fiscal 2003. The increase wasattributable primarily to an increase in audit, legal and professional expensesof approximately $757,000 associated mainly with the merger of Minrad Inc. intoour company, and increased expenses of $125,000 associated primarily with anincreased headcount in our financial department. These increases were offsetpartially by a $131,000 decline in bad debt expense for fiscal 2004.
**Interest and Debt Conversion Costs**
        Interest expense increased by $36,852, or 5%, to $789,443 for fiscal 2004from $752,591 for fiscal 2003. Included in fiscal 2004 interest expense was$123,000 in non-cash interest costs associated with convertible debt. In fiscal2004, we incurred interest expenses of approximately $294,000 in connection witha factoring arrangement. In addition, we incurred $713,000 in debt conversioncosts related to the conversion of $3,026,000 of debt into equity at an averageprice per share of $0.79 in March 2004. The average conversion price was belowthe stated conversion price and, as a result, we booked a non-cash debtconversion cost.
**Net Loss**
        Net loss increased by $1,749,534, or 63%, to $4,545,051 for fiscal 2004 from$2,795,517 for fiscal 2003. This increase in net loss is due primarily to lowergross margins, increase in finance and administration costs, and a one-time,non-cash debt conversion cost, each as discussed above.
**Stockholders' Equity**
        The combination of fund raising and debt conversion, offset by our losses,over the period contributed to a net improvement in our stockholders equity of$2,881,000, or 49%, from $(5,887,000) in fiscal 2003 to $(3,006,000) in fiscal2004. In evaluating tangible net worth, however, it should be considered thatthe anesthesia and analgesia Bethlehem facility is recorded on our books atapproximately $355,000, reflecting the fact that the purchase in December 2000for $1.4 million generated no recorded value on our books for the building andequipment. 
**Liquidity and Capital Resources**
        As of September 30, 2004, we had current assets of approximately $1.8million, including nominal amounts of cash, and current liabilities ofapproximately $5.4 million. As of September 30, 2003, we had current assets ofapproximately $2.2 million, including nominal amounts of cash, and currentliabilities of approximately $8.5 million. The net improvement in workingcapital of approximately $2.7 million is primarily attributed to the conversionof approximately $3 million of short-term demand notes into equity.

-36-

        Net cash used by operating activities increased by approximately $1.3million, or 76%, to approximately $3.0 million for fiscal 2004 fromapproximately $1.7 million for fiscal 2003. The increase in net cash used byoperating activities was attributable primarily to the increase in the net lossfrom operations of approximately $1.7 million, which was offset by the one-time,non-cash charge for debt conversion costs of approximately $713.0 thousand, andimprovements in cash flow on payments of accounts receivable of approximately$970.0 thousand as a result of the utilization of a factoring company.

        Net cash used by investing activities for fiscal 2004 was approximately$299.0 thousand. For fiscal 2003, investing activities provided net cash ofapproximately $411.5 thousand. The additional use of cash by investingactivities for fiscal 2004 was due primarily to purchases of property andequipment and costs associated with patent applications.

        Net cash provided by financing activities increased by approximately $2.0million, or 156%, to approximately $3.3 million for fiscal 2004 fromapproximately $1.3 million for fiscal 2003. In fiscal, 2004, we raisedapproximately $3.6 million through private sales of common stock. We also madepayments of approximately $1.2 million on outstanding indebtedness, whileborrowing approximately $873.0 thousand under demand notes, including ouraccounts receivable factoring program, which we instituted in fiscal 2004 thatyielded approximately $161.4 thousand. In fiscal 2004, our financing activitiesconsisted primarily of borrowings and repayments under demand notes.

        Subsequent to September 30, 2004, in the three months ended December 31,2004, we raised net proceeds of approximately $1.2 million through private salesof common stock. In addition, on February 8, 2005, we raised $2.5 millionthrough the private sale of convertible promissory notes and warrants topurchase common stock. The proceeds of those sales have been and will be used tofund ongoing operations.
**Critical Accounting Policies And Estimates**
        The preparation of consolidated financial statements requires us to makeestimates and judgments that affect the reported amounts of assets, liabilities,revenues and expenses, and related disclosure of contingent assets andliabilities. On an on-going basis, we evaluate our estimates. We base ourestimates on current information, historical experience and on various otherassumptions that are believed to be reasonable under the circumstances, theresults of which form the basis for making judgments about the carrying valuesof assets and liabilities that are not readily apparent from other sources.Actual results may differ from the estimates we used under different assumptionsor conditions. We believe the following concentrations and critical accountingpolicies relate to our more significant judgments and estimates used in thepreparation of our consolidated financial statements.

-37-
*        Allowance for Doubtful Accounts*
        We maintain an allowance for doubtful accounts for estimated losses resultingfrom the inability of our customers to make required payments. We make a similarallowance for accounts receivable that we have sold with recourse to a financialinstitution. Our accounting for doubtful accounts contains uncertainty becausemanagement must use its judgment to assess the collectibility of these accounts.When preparing these estimates, management considers a number of factors,including the aging of a customer's account, past transactions with customers,creditworthiness of specific customers, historical trends and other information.We review our accounts receivable reserve policy monthly, based on currentrisks, trends and changes in industry conditions. The allowance for doubtfulaccounts was approximately $317,000 at December 31, 2004, and approximately$420,000 at September 30, 2004. Although we believe this allowance issufficient, if the financial condition of our customers were to unexpectedlydeteriorate, resulting in an impairment of their ability to make payments,additional allowances may be required that could materially impact ourconsolidated financial statements. Concentrations of credit risk can impact thisrisk considerably.****Approximately 56% of our revenues for the quarterended December 31, 2004, and approximately 72% of our revenues in fiscal 2004were derived from our customers located in foreign countries where it may bedifficult or impossible to commence legal proceedings to collect past dueaccounts, a situation that would impact collect ability. In addition, for fiscal2004 six customers comprised 58% of our revenues, a circumstance that increasesour collection risks. 
*        Inventory Valuation*
        Inventory is stated at the lower of cost or market using the first-in,first-out accounting method. As a part of the valuation process, excess,slow-moving and damaged inventories are reduced to their estimated netrealizable value. Our accounting for slow-moving and damaged inventory containsuncertainty because management must use judgment to estimate when the inventorywill be sold and the quantities and prices at which the inventory will be soldin the normal course of business. We review our changes in industry conditions.We had established valuation reserves associated with slow-moving inventory ofapproximately $725,000 at December 31, 2004.
*        Property, Equipment and Depreciation*
        Depreciation is computed over the estimated useful life of three to fiveyears using the straight-line depreciation method. Long-lived assets to be heldand used by the Company are reviewed for impairment whenever events or changesin circumstances indicate that the carrying amount of an asset may not berecoverable. We continuously evaluate the recoverability of our long-livedassets based on estimated future cash flows from and the estimated fair value ofsuch long-lived assets, and provide for impairment if such undiscounted cashflows are insufficient to recover the carrying amount of the long-lived asset.
*        Patents*
        Patent application costs in excess of $1,000 on patents that generateincremental revenue are carried at cost and will begin to be amortized whenplaced in service. As of December 31, 2004, the carrying value of capitalizedpatents were approximately $65,000. The patents will be amortized over theirestimated useful lives. The carrying value of patents is periodically reviewedand impairments, if any, are recognized when the expected future benefit to bederived from an individual patent is less than its carrying value.
*        Income Taxes*
        We have recorded deferred tax assets relating to net operating losscarryforwards for United States federal and state tax purposes, tax creditcarryforwards and non-deductible reserves, among other items. We recorded avaluation allowance equal to 100% of the carrying value of our net deferred taxassets to reduce our deferred tax assets to the amount that is more likely thannot to be realized. While we have considered future taxable income and ongoingtax planning strategies in assessing the need for the valuation allowance, inthe event we were to determine that we would be able to realize our deferred taxassets in the future in excess of their net recorded amounts, a resultingreduction of the valuation allowance would increase our income in the period thedetermination was made. At December 31, 2004, we had approximately $10.1 millionin gross deferred tax assets, which were fully offset by a valuation allowance.

-38-
*        Revenue Recognition*
        We recognize revenue from product sales when the goods are shipped to thecustomer and title has been transferred. We do not engage in bill and holdtransactions and do not enter into inventory consignment agreements. If we enterinto the future sale of licenses, we will classify all revenue that involves thefuture sale of a licensee's products as royalty revenue. Royalty revenue will begenerally recognized in the quarter in which a report is received from alicensee detailing the shipments of products incorporation our intellectualproperty components. License fees will be recognized upon the execution of thelicense agreement and transfer of intellectual property, provided no furthersignificant performance obligations exist and collectibility is deemed probable.
*        Research and Development Costs*
        All costs related to research and development are expensed as incurred. Thesecosts include labor and other operating expenses related to product development,as well as costs to obtain regulatory approval.

*        Stock Based Compensation*
        In the past several years we have issued warrants and options tonon-employees for services and in connection with obtaining debt. We haverecognized significant expense relating to the issuance of these equityinstruments. We estimated the fair value of those securities using the Black-Scholeswarrant and option pricing model, and expensed the estimated fair value over theservice period or through the debt maturity date. The Black-Scholes model usescritical assumptions that significantly affect the estimated fair value of thoseawards, such as an estimated volatility factor of our common stock and theestimated lives of the awards (which is equal to the maximum contractual termfor awards to non-employees). Additionally, as further discussed below under"Recent Accounting Pronouncements," we are required to recognize compensationexpense on options issued to employees beginning in 2006, and we expect that wewill use similar estimation methods. Changes in the volatility of our commonstock and other estimation factors used in the Black-Scholes model cansignificantly impact the estimated value and resultant compensation cost onsimilar equity instruments issued in the future.
**Recent Accounting Pronouncements**
        In December 2004, the FASB issued SFAS 151, "Inventory Costs." This Statementamends the guidance in Accounting Research Bulletin No. 43, Chapter 4,"Inventory Pricing," to clarify accounting for abnormal amounts of idle facilityexpense, freight, handling costs and wasted material (spoilage). SFAS 151requires that those items be recognized as current period charges regardless ofwhether they meet the criterion of "so abnormal." In addition, this Statementrequires that allocation of fixed production overheads to the costs ofconversion be based on the normal capacity of the production facilities.Statement 151 is effective for inventory costs incurred during fiscal yearsbeginning after June 15, 2005, with earlier application permitted in certaincircumstances. Adopting this new standard is not expected to have a significantimpact on the Company's financial statements.

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        In December 2004, the FASB issued SFAS No. 123 (revised 2004), "Share-BasedPayment" ("SFAS 123R"). SFAS 123R revised SFAS No. 123 and supersedes AccountingPrinciples Board Opinion No. 25, and its related implementation guidance. SFAS123R establishes standards for the accounting for transactions in which anentity exchanges its equity instruments for goods or services. It also addressestransactions in which an entity incurs liabilities in exchange for goods orservices that are based on the fair value of the entity's equity instruments, orthat may be settled by the issuance of those equity instruments. SFAS 123Rfocuses primarily on accounting for transactions in which an entity obtainsemployee services in share-based payment transactions. SFAS 123R does not changethe accounting guidance for share-based payment transactions with parties otherthan employees provided in SFAS 123 as originally issued, and as set forth inEITF Issue No. 96-18, which we already follow.

        SFAS 123R requires a public entity to measure the cost of employee servicesreceived in exchange for an award of equity instruments based on the grant-datefair value of the award (with limited exceptions) and to recognize that costover the period during which an employee is required to provide service inexchange for the award (usually the vesting period). Currently, we use theintrinsic value method for accounting for employee stock options and include apro forma disclosure, as allowed by SFAS No. 123, for this estimatedcompensation cost on employee stock options.

        As a small business issuer, we are required to adopt SFAS 123R on January 1,2006. SFAS 123R applies to all awards granted after the required effective dateand to awards modified, repurchased or cancelled after that date. Because thestatement was recently released, we have not yet assessed the potential impactof the adoption of SFAS 123R on our financial position or results of operations.
**Item 7. Financial Statements.**
-40-

 

 

 

 

 

 

 

 

 

 
** 

CONSOLIDATED

FINANCIAL STATEMENTS****MINRAD INTERNATIONAL, INC. AND SUBSIDIARY**
 
**DECEMBER 31, 2004

WITH

REPORT OF INDEPENDENT REGISTERED

PUBLIC ACCOUNTING FIRM

 

 

 

 

 

 

 **
F-1
**MINRAD INTERNATIONAL, INC. AND SUBSIDIARY

CONTENTS**   
Page
   
**Report of Independent Registered Public Accounting Firm**
 3     
 
 
**Consolidated Financial Statements:**
     
Balance Sheets 
    4    
Statements of Operations 
    5    
Statement of Changes in Stockholders' Deficit
    6    
Statements of Cash Flows 
    7     
 
 
**Notes to the Consolidated Financial Statements**
 6 - 35
 

 

F-2

 
**REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**
 

Board of DirectorsMinrad International, Inc. and Subsidiary

 

        We have audited the accompanying consolidated balance sheetsof Minrad International, Inc. and Subsidiary (Minrad) as of December 31, 2004and September 30, 2004 and 2003, and the related consolidated statements ofoperations, changes in stockholders' deficit, and cash flows for the three-monthperiod ended December 31, 2004 and years ended September 30, 2004 and 2003.These financial statements are the responsibility of the Company's management.Our responsibility is to express an opinion on these financial statements basedon our audits. 

        We conducted our audits in accordance with the standards ofthe Public Company Accounting Oversight Board (United States). Those standardsrequire that we plan and perform the audit to obtain reasonable assurance aboutwhether the financial statements are free of material misstatement. Minrad isnot required to have, nor were we engaged to perform, an audit of its internalcontrol over financial reporting. Our audits included consideration of internalcontrol over financial reporting as a basis for designing audit procedures thatare appropriate in the circumstances, but not for the purpose of expressing anopinion on the effectiveness of Minrad's internal control over financialreporting. Accordingly, we express no such opinion. An audit includes examining,on a test basis, evidence supporting the amounts and disclosures in thefinancial statements. An audit also includes assessing the accounting principlesused and significant estimates made by management, as well as evaluating theoverall financial statement presentation. We believe that our audits provide areasonable basis for our opinion.

        In our opinion, the consolidated financial statementsreferred to above present fairly, in all material respects, the financialposition of Minrad as of December 31, 2004 and September 30, 2004 and 2003, andthe results of its operations and its cash flows for the three-month periodended December 31, 2004 and years ended September 30, 2004 and 2003 inconformity with accounting principles generally accepted in the United States ofAmerica.

 

Freed Maxick & Battaglia, CPAs, PC

Buffalo, New YorkMarch 23, 2005

See accompanying notes.

F-3
**MINRAD INTERNATIONAL, INC. AND SUBSIDIARY

CONSOLIDATED BALANCE SHEETS**
 
 **December 31,**September 30,**ASSETS**2004**2004**2003       **Current assets:      
Cash**$****2,930 $
587 $
750 
Accounts receivable, net**606,229 
529,759 
819,446 
Inventories, net**1,069,565 
1,108,692 
1,328,935 
Prepaid expenses**472,049 
131,181 
45,765 
Total current assets**2,150,773 
1,770,219 
2,194,896        **Property and equipment:**      
Machinery and equipment**721,501 
721,501 
716,973 
Computers**128,949 
128,949 
108,254 
Furniture and fixtures**22,641 
22,641 
10,670 
Construction in progress**300,241 
255,019 
-  
 **1,173,332 
1,128,110 
835,897 
Less accumulated depreciation**674,126 
649,422 
509,811  **499,206 
478,688 
326,086        **Other assets****112,798 
101,127 
55,475         **$****2,762,777 $
2,350,034 $
2,576,457 **LIABILITIES AND STOCKHOLDERS' DEFICIT********************************************************************************************************** |