Vasogen Provides an Update on ACCLAIM-II Pr...(for ACCLAIM-II the FDA has been reviewin...)

Date:12/17/2007

for ACCLAIM-II, the FDA has been reviewing Celacade in the context of their newly issued draft document entitled 'Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide' to assess whether this draft guidance is relevant to the Celacade technology. To date, the Celacade System has been regulated as a medical device with the Center for Devices and Radiological Health (CDRH) acting as lead reviewer with input from Center for Biologics Evaluation and Research (CBER). The FDA has recently informed the Company that they expect Celacade to remain regulated as a medical device; however, CBER may take the role of lead reviewer with CDRH providing input.

"We expect FDA clarification shortly and are looking forward to our formal agreement meeting with the agency. We are very pleased with the progress we have made in preparation of this important study and look forward to recruiting the first patient into ACCLAIM-II," commented Chris Waddick, President and CEO of Vasogen. "With today's announcement of the initial orders for Celacade in Europe, where Celacade is already approved, and the planned initiation of ACCLAIM-II, 2008 promises to be an exciting time for Vasogen."

About Vasogen:

Vasogen is a biotechnology company engaged in the research and commercial development of therapies designed to target the destructive inflammatory process associated with the development and progression of cardiovascular and neurodegenerative disorders. The Company's lead product, the Celacade System, is designed to activate the immune response to apoptosis - an important physiological process that regulates inflammation. Celacade is in late-stage development for the treatment of chronic heart failure and has received European regulatory approval under the CE Mark for this indication. Vasogen is also developing a new class of drugs for the treatment of certain neuro-inflammatory disorders. VP02
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SOURCE Vasogen Inc. Copyright©2007 PR Newswire. All rights reserved

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