Plan of Operation: Parkinson’s Disease

In October 2006, the Company announced that it had completed its Phase 1 clinical trial for Parkinson’s disease. The results of this trial indicate that the treatment appears to be safe and well-tolerated in trial participants with advanced Parkinson’s disease, with no evidence of adverse effects or immunologic reaction related to the study treatment. The trial, in which treatment was confined to only one side of the brain, also yielded statistically significant clinical efficacy and neuroimaging results. The results were peer-reviewed and published in the June 23, 2007 issue of the journal The Lancet and the online edition of the Proceedings of the National Academy of Sciences in November 2007 .

In December 2008, the Company initiated a Phase 2 clinical trial for Parkinson’s disease.

This trial is a randomized, controlled study designed to further establish the effectiveness and the safety of the treatment. The trial is being conducted in multiple medical centers throughout the U.S. with an expected 40 trial participants, 20 of which will be randomly selected to receive the treatment and 20 of which will be randomly selected to receive a sterile saline solution.

In June 2009, the Data Monitoring Committee (the “ DMC ”), a group of independent medical experts, selected by the Company, who are responsible for reviewing and evaluating the safety data generated from the Company’s Phase 2 clinical trial, recommended the continuation of the clinical trial. This recommendation was based on the DMC’s review of all data from the first 7 patients enrolled in the clinical trial with at least one month of data.

The Company expects to conclude the surgeries for its Phase 2 clinical trial in the second half of 2009 and announce initial efficacy data in the first half of 2010. The Company will take steps to move toward a pivotal trial for treatment of Parkinson’s disease, and hopes to be in a position to file its protocol with the U.S. Food and Drug Administration (“ FDA ”) in 2011.

The Company’s conduct of such trial will require, among other things, approval by the FDA.

Currently, the Company estimates that the pivotal trial could be completed in 2013 and the estimated total costs to reach that milestone are expected to be in excess of $20,000.
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