Vicor Technologies announces publication of positive results in study conducted in collaboration with U.S. Army

Sep 15 2008

Vicor Technologies, Inc. today announced publication of the results of its first clinical study conducted in collaboration with the U.S. Army Institute of Surgical Research (USAISR).

Vicor Technologies is a biotechnology company that has developed the PD2i, a patented, proprietary algorithm that is now in trials for FDA 510 (k) approval for a) measuring heart rate variability (PD2i Analyzer), b) risk stratifying combat and civilian trauma victims (PD2i VS), and c) identifying patients at risk of suffering sudden cardiac death (PD2i CA).

The study is an analysis of data obtained from electrocardiograms of 11 combat casualty victims using nonlinear methods including Vicor's PD2i Analyzer All of the wounded soldiers demonstrated abnormal heart rate variability (HRV). Those requiring immediate life saving intervention all had minimum PD2i values less than one. Entitled "Exploration of Heart-rate complexity to determine the need for lifesaving interventions in combat casualties", the study appears in the Journal of Critical Care (Volume 23, Issue 2, Pages 265-266).

"This study clearly demonstrates the unique ability of Vicor's PD2i Analyzer to accurately measure heart rate variability and the utility of HRV measure in diagnosing the need for immediate life saving intervention," stated Mr. David Fater, Vicor Technologies' President and CEO. "We expect that future studies of the PD2i Analyzer's effectiveness will prove equally positive and further our efforts to commercialize the PD2i Analyzer, for measuring heart rate variability, generally, and the PD2i VS, for risk stratifying combat and civilian trauma victims, specifically," Mr. Fater concluded.

Vicor Technologies and the U.S. Army Institute of Surgical Research (USAISR) entered into a Collaborative Research and Development Agreement (CRADA) for the "Prediction of Injury Severity and Outcome in the Critically Ill Using the Point Correlation Dimension Algorithm, or PD2i" in January 2008. Under the CRADA, the USAISR and Vicor are testing the efficacy of the PD2i Analyzer as a vital sign application on four distinct cohorts: animal trauma, human trauma, combat casualties, and burn victims.

About Vicor Technologies, Inc.

Vicor Technologies, Inc. (OTCBB: VCRT) is a development-stage biotechnology company focused on the development of innovative diagnostics. Vicor's PD2i Analyzer, PD2i Vital Sign (PD2i VS), and PD2i Cardiac Analyzer (PD2i CA) employ the firm's patented, proprietary point correlation dimension algorithm (PD2i), a deterministic, non-linear analytic measure that accurately evaluates electrophysiological potentials with high sensitivity and high specificity to predict future pathological events.

The PD2i Analyzer measures heart rate variability (HRV) through the analysis of electrocardiographic data. The clinical significance of HRV and use of the PD2i Analyzer as a diagnostic tool is physician-determined. Vicor Technologies expects to receive FDA approval for the PD2i Analyzer in 4Q08. Such approval will enable Vicor Technologies to market and distribute the PD2i Analyzer for use while completing clinical trials and the FDA approval process for its PD2i VS and PD2i CA.

The PD2i VS enables risk stratification of trauma severity to identify those in need of immediate life saving intervention and improve emergency triage efforts. The PD2i VS is currently in clinical trials under a collaborative effort with the U.S. Army Institute for Surgical Research.

The PD2i CA identifies patients at risk of suffering a fatal arrhythmic event or sudden cardiac death within six months. The PD2i CA is currently involved in a multi-site, multi-year trial (the VITAL Trial) being conducted by the Harvard Clinical Research Institute.

Vicor Technologies anticipates developing additional applications using the PD2i algorithm to enable early detection of Alzheimer's Disease, and a variety of other disorders and diseases.