MUSIC Data Analysis Released - Analyst Blog

On May 19, 2010 Vicor Technologies (VCRT) announced that it received results of the analysis of the MUSIC trial data from the University of Rochester.

The trial, which was billed as the largest heart failure population ever studied and the first trial to document abnormal heart rhythm as a predictor of sudden cardiac death (SCD), studied the efficacy of Vicor’s Cardiac Analyzer in the prediction of SCD in congestive heart failure patients. 537 of the over 1,000 patients that enrolled in the study completed the trial, which were followed for an average of 44 months.

Results showed that the Cardiac Analyzer was effective in predicting total mortality, cardiac death and heart failure death. The results were highly statistically significant (p value = .004). Vicor, along with the University of Rochester, are analyzing the results to determine whether they will be used to support a 510(k) filing for the prediction of SCD in congestive heart failure patients.

As we pointed out in our recent (May 14th) note to investors, we had expected a positive outcome from the MUSIC data. We expect Vicor/UofR to conclude their analysis of the data by the first half of June 2010, and believe that the trial data will be used to support a 510(k) filing shortly afterwards.

Assuming a 90-day FDA approval timeline, Vicor could be marketing for this indication late in the third quarter or early in the fourth quarter of this year. We expect the SCD indication to offer Vicor a very potent marketing message with which to target cardiologists and other physicians, which could significantly ramp instrument placements beginning in the back half of 2010.

With waning faith in previous unproven technologies in determining risk of SCD and the continuing problem of over- and under-implantation of implantable cardioverter defibrillators, we expect the Cardiac Analyzer to receive significant interest from cardiologists.
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