510(k) Filing for Cardiac Mortality
On Thursday July 1, 2010 Vicor Technologies, Inc. (VCRT) announced that it made a 510(k) filing to the FDA seeking a claim to market the company’s PD2i algorithm and related software (“Cardiac Analyzer”) for the identification of congestive heart failure (CHF) patients at elevated risk of cardiac mortality.
Data from the MUSIC (Merte Subita en Insufficiencia Cardiaca) trial was used as support for the filing. The University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona analyzed the data from the trial in a study named “Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure.” 537 patients with CHF were evaluated over 44 months in the MUSIC trial, which was billed as the largest heart failure population ever studied, and the first to document abnormal heart rhythm as a predictor of sudden cardiac death.
On May 19, 2010 Vicor announced that it received results of the MUSIC trial from the University of Rochester. 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). Based on the compilation of compelling trial data (including from the MUSIC trial as well as numerous company-sponsored studies) we expect FDA to grant marketing clearance for this indication.
Our prior expectations were that Vicor would receive marketing approval for this indication towards the end of the third quarter. However, based on the timing of the filing and longer FDA turnaround times, we believe this is now unlikely and now look for approval to come around the middle of the fourth quarter 2010.
As we have detailed in our 25 page report on Vicor, we expect additional marketing indications (such as cardiac mortality and trauma) to fuel growth of the system installed base. The CHF/cardiac mortality indication will provide the company with a very potent marketing message with which to target cardiologists and other physicians.
There are roughly five million CHF sufferers in the U.S. and 400,000 new cases every year. The Cardiac Analyzer may be the most accurate diagnostic device in prediction of cardiac mortality. We believe this offers tremendous opportunity not only for Vicor to ramp system placements and testing revenue but for heart failure patients to receive better standard of care.
We initiated coverage of Vicor Technologies on April 12, 2010 with an Outperform rating. Our price target is $2.61.
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