CardioPulmonics
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.
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.