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This article was originally published in The Gray Sheet

Executive Summary

Salt Lake City-based firm is reducing its payroll "by approximately 33% along with related expense reductions," the company says March 19. The firm is attempting to conserve financial resources because of anticipated delays in the FDA approval process for its Ivox intravascular oxygenator. CardioPulmonics projects that a PMA for the Ivox will be filed by the end of May. In response to the "Temple Report" on FDA's device approval process ("The Gray Sheet" March 8, p. 4), the firm has revised its planned PMA submission to include a "comparison group against which Ivox treated patients can be measured" and expects that FDA review of the application will be "lengthy." The company also reported financial results for the fiscal year ended Dec. 31. The firm had a net loss of $6.3 mil., compared to a loss of $4.2 mil. for fiscal year 1991. Revenues were $133,198, down from $376,366 in 1991. CardioPulmonics notes that the decreased revenues reflect the "wind down" of Ivox clinicals in the U.S. and Europe.

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