Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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...

CMR Surgical Names New CEO

CMR Surgical CEO Martin Frost is making way for a new boss to lead the surgical robotics company. Per Vegard Nerseth is set to join CMR Surgical in January 2020 as the company gears up for its most ambitious year yet.

As Bluebird’s CAR-T Competition Intensifies, Sickle Cell Therapy Brings Upside

While the BCMA-targeting CAR-T competition is grabbing attention, bluebird has good news in sickle cell therapy.

Scottish HTA body OKs Lynparza For Earlier Use In Ovarian Cancer

AstraZeneca’s Lynparza can now be used on the Scottish National Health Service for newly diagnosed advanced ovarian cancer.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts