A Medical Device Daily

Prognostix (Cleveland), a Cleveland Clinic spin-out company focused on cardiovascular disease testing and management, reported that it has been awarded a $550,000 grant to support the continuing development and commercialization of its FDA-cleared CardioMPO test and its dysfunctional HDL product candidate.

The grant was made by the Global Cardiovascular Innovation Center (GCIC), a $250-million Ohio-based product commercialization consortium led by the Cleveland Clinic. The grant award reported this week is the second made to the company by GCIC, with the second award coming after the company met a series of product development milestones identified as part of the first grant.

"We are delighted and grateful to have the continuing support of GCIC," said Jake Orville, president/CEO of Prognostix. "GCIC's first grant enabled Prognostix to make significant progress with both our CardioMPO and dysfunctional HDL products. We were pleased to have completed each of the milestones laid out for us by GCIC for the first grant and look forward to a strong, ongoing relationship with the center."

With the assistance of GCIC's second grant, Prognostix will complete its FDA 510(k) submission to expand the use of its CardioMPO product outside of acute-care settings and advance the development of its valuable dysfunctional HDL biomarker, which it expects to launch in 2009.