Acorn Asks For More Help From Investors After FDA Panel Denies CorCap PMA
This article was originally published in The Gray Sheet
Executive Summary
Acorn Cardiovascular says it will ask its current investors to fund a confirmatory trial of its CorCap Cardiac Support Device after an FDA advisory panel decided more research is needed before it could support premarket approval
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CorCap gets another shot
FDA will reconsider approval of Acorn Cardiovascular's CorCap mesh wrap treatment for heart failure following completion of a 50-patient confirmatory trial, the firm announces May 9. In December, FDA's Medical Device Dispute Resolution Panel supported the agency's decision not to approve the cardiac support device, based on the firm's 2004 submission of a 300-patient randomized trial (1"The Gray Sheet" Jan. 1, 2007, p. 14). Acorn says it plans to begin the new study, which will have six-month follow-up, this summer, potentially leading to CorCap approval in late 2008 or early 2009. Completion of the trial will require Acorn to "immediately" raise $15 million, the firm says...
CorCap gets another shot
FDA will reconsider approval of Acorn Cardiovascular's CorCap mesh wrap treatment for heart failure following completion of a 50-patient confirmatory trial, the firm announces May 9. In December, FDA's Medical Device Dispute Resolution Panel supported the agency's decision not to approve the cardiac support device, based on the firm's 2004 submission of a 300-patient randomized trial (1"The Gray Sheet" Jan. 1, 2007, p. 14). Acorn says it plans to begin the new study, which will have six-month follow-up, this summer, potentially leading to CorCap approval in late 2008 or early 2009. Completion of the trial will require Acorn to "immediately" raise $15 million, the firm says...