On June 22, the Circulatory System Device Panel of the FDA Medical Devices Advisory Committee will review a pre-market approval application for the CorCap Cardiac Support Device (CSD), a heart failure therapy developed byAcorn Cardiovascular(St. Paul, Minnesota)

The meeting will include discussion of updated results from the Acorn clinical trial, first presented at the 2004 American Heart Association (Dallas) scientific sessions, which was conducted to evaluate safety and effectiveness of the CorCap CSD.

The CorCap CSD is a compliant mesh wrap that is placed around the heart to stop the unhealthy enlargement of the heart caused by heart failure. It is the first medical device specifically designed to address the problem of cardiac enlargement by providing direct support to the heart. In this way, the CorCap CSD is intended to improve the heart’s structure and function, leading to improvements in the patient’s quality of life.

BioSource subject to Nasdaq delisting

BioSource International (Camarillo, California) said that it received a notice from the Listing Qualifications Department of the Nasdaq market indicating that the company is not in compliance with Nasdaq requirements for continued listing, due to its failure to timely file its Form 10-Q for the quarter ended March 31.

As previously disclosed on May 16, the company said it delayed the filing of its Form 10-Q because it was considering and discussing with its external auditors at KPMG possible changes to its long-standing accounting policy of reserving for 100% of the costs of manufactured antibody inventory. Following discussion on these matters, BioSource said it intends to restate its financial statements for the three years ended Dec. 31, 2004, 2003 and 2002.

The company said it does not expect that to have any material impact on its previously reported cash flows and expects a net increase in stockholders’ equity as of Dec. 31, 2004.

BioSource is focused on providing integrated solutions in the areas of functional genomics, proteomics and drug discovery through the manufacture of biologically active reagent systems that facilitate drug development and biomedical research.