Cash-strapped Acorn Cardiovascular sees light at the end of the tunnel. As reported by the Star Tribune, the St. Paul, MN, company has come to an agreement with FDA to conduct a second, smaller scale clinical trial for its CorCap cardiac support device. Under the terms, a second trial will take place with just 50 patients, enabling Acorn to move forward with a device whose future was in jeopardy because of dwindling capital.
The saga of CorCap goes back to June 2005, when FDA first rejected Acorn’s application for the device, which the company originally tested in a large-scale clinical trial with 300 patients. The decision, CEO Richard Lunsford tells the Tribune, may have been influenced by heart defibrillator recalls and criticism over FDA’s handling of Vioxx around that time.
“Instead of proving the vast majority of the patients you’re treating would do well with a device and that there are some risks, the FDA now wants you to prove beyond the shadow of a doubt there’s no way anybody will ever get hurt,” he tells the paper. “It’s an impossible standard.”
Frustrated, Acorn requested that a dispute-resolution panel look at its case. Again the company was sent back to the drawing board, when the panel decided in December 2006 that more evidence of efficacy was needed before CorCap could be green lighted. Acorn has been in ongoing negotiations with FDA and its Center for Devices and Radiological Health ever since to determine a path for bringing the device to market.
Of the agency’s decision to allow a smaller second trial, Minneapolis attorney Mark DuVal tells the Tribune, which points out that only three other dispute-resolution panels have been held in FDA history, “This is highly unusual, a very big deal. The FDA must believe there’s something to the technology.”
Although bolstered, privately held Acorn, with no other products on the market, is not out of the woods. According to a statement released this afternoon, the company must immediately raise about $15 million to complete the confirmatory trial. Many of Acorn’s original investors have agreed to support the company through this next phase of the FDA approval process and the assumed commercial launch of CorCap. In addition, several cardio-focused med tech companies and venture capital firms have expressed interest in providing needed funding.
CorCap is a mesh wrap that is placed around the heart to prevent and reverse the progression of heart failure. Many heart failure patients develop oversized, dilated hearts as increasing pressure within the heart pushes out against the muscle wall; CorCap is designed to alleviate this pressure. Here’s an animation video of how it works.
The confirmatory trial will assess a patient population that demonstrated the greatest clinical benefit in the pivotal trial. If all goes well, FDA clearance for CorCap could come as early as the end of 2008.