SOURCE: Vicor Technologies, Inc.

Vicor Technologies, Inc.

January 12, 2011 08:30 ET

Study of Vicor Technologies' PD2i® Nonlinear Algorithm as Measure of Diabetic Autonomic Neuropathy to Be Published in Clinical Neurophysiology

BOCA RATON, FL--(Marketwire - January 12, 2011) - David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced that Vicor has received notice that a manuscript detailing a study of the ability of its PD2i Analyzer™ to detect the presence of autonomic neuropathy in individuals with type 1 diabetes mellitus has been accepted for publication in Clinical Neurophysiology. Vicor Technologies ( is a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i® nonlinear algorithm and software. Vicor is currently in the process of commercializing diagnostics that enable physicians to accurately risk stratify specific target populations for future pathological events, including diabetics for the presence of diabetic autonomic neuropathy (DAN), cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and trauma victims for imminent death absent immediate lifesaving intervention.

"Nonlinear PD2i® heart rate complexity algorithm detects autonomic neuropathy in patients with type 1 diabetes mellitus," authored by James Skinner, PhD, Vicor's Vice President and Director of Research, in collaboration with Daniel Weiss, MD, Vicor's Chief Medical Officer, and Jerry Anchin, PhD, Vicor's Vice President and Director of Product Development, details a study to test the ability of Vicor's PD2i Analyzer™, which measures heart rate variability with a PD2i® nonlinear algorithm score, to detect early subclinical autonomic dysfunction in young (12.9-31.5 years) asymptomatic individuals with type 1 diabetes mellitus (DM). The PD2i Analyzer™ demonstrated the ability to detect autonomic nervous system dysfunction very early in asymptomatic type 1 DM patients similar to the best discriminative power of previously published complexity measures. With a P value of 0.0006, the study results are highly statistically significant.

 "We are pleased to learn that Dr. Skinner's manuscript, co-authored by our scientific and medical team members, has been accepted for publication in Clinical Neurophysiology, the official journal of the International Federation of Clinical Neurophysiology. The clinical study on which this manuscript is based has once again proven the value of our PD2i Analyzer as a diagnostic that provides physicians with the ability to identify those at risk of future pathological events -- in this case, diabetic autonomic neuropathy -- that might otherwise remain unidentified, and untreated, using traditional diagnostics. More importantly, the PD2i Analyzer™ was able to identify those patients with early subclinical autonomic dysfunction with the results of a resting ECG. To date, the standard of care for diagnosing these patients with a measure of heart rate variability depended on ECGs taken during controlled exercise and paced respiration. Given its accuracy, ease of use, and minimal data requirements, the PD2i Analyzer™ may prove to be a valuable clinical tool for the early detection of autonomic neuropathy in type 1 DM patients," stated Mr. Fater.

Clinical Neurophysiology is the official journal of the International Federation of Clinical Neurophysiology. It is dedicated to fostering research and disseminating information on all aspects of clinical neurophysiology, both normal and abnormal. The journal aims at publishing scholarly reports on human physiology and pathophysiology of both the central and the peripheral nervous system.

About Vicor Technologies, Inc.
Vicor Technologies is a biotechnology company creating innovative non-invasive diagnostics employing its patented, proprietary point correlation dimension algorithm (PD2i®). The PD2i® nonlinear algorithm is a deterministic, nonlinear measure of electrophysiological potentials that predicts future pathological events with a high degree of accuracy in target populations.

Vicor currently has three products employing the PD2i® nonlinear algorithm. The PD2i Analyzer™, which has FDA 510(k) marketing clearance, measures heart rate variability; physicians performing diagnostic tests with the PD2i Analyzer™ are able to receive reimbursement under existing CPT codes. The PD2i VS™ (Vital Sign), in clinical trials under a collaborative effort with the U.S. Army Institute for Surgical Research, risk stratifies combat and civilian trauma victims. The PD2i CA™ (Cardiac Analyzer), in multiple clinical trials, identifies patients at risk of cardiac death.

Vicor anticipates additional applications employing the PD2i® nonlinear algorithm to enable early detection and risk stratification for a variety of other disorders and diseases. Additional information is available at

The appearance of name-brand institutions, such as the International Federation of Clinical Neurophysiology and the U.S. Army Institute for Surgical Research, in this media release does not constitute endorsement by institutions of the information, products or services contained therein.

Caution Regarding Forward-Looking Statements
Forward-looking statements in this press release are based on current plans and expectations that are subject to uncertainties and risks, which could cause our future results to differ materially. The following factors, among others, could cause our actual results to differ: our ability to successfully complete the normal range study for PD2i® values; our ability to generate revenues from the sale of the PD2i Analyzer™; our ability to obtain FDA approval of our 510(k) submission to secure a marketing claim for the PD2i CA™ (Cardiac Analyzer) for testing patients for cardiovascular disease and our ability to obtain marketing clearance from the FDA for the PD2i VS™ (Vital Sign) for military and civilian applications; our ability to obtain the necessary regulatory approvals to market in the People's Republic of China; our ability to develop additional applications for the PD2i® algorithm; our ability to continue to receive financing sufficient to continue operations and complete critical clinical trials; our ability to continue as a going concern; our ability to successfully develop products based on our technologies; our ability to obtain and maintain adequate levels of third-party reimbursement for our products; the impact of competitive products and pricing; our ability to receive regulatory approval for our products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for our technologies; the ability of third-party manufacturers to manufacture our products; our ability to retain the services of our key personnel; our ability to market and sell our products successfully; our ability to protect our intellectual property; product liability; changes in federal income tax laws and regulations; general market conditions in the medical device and pharmaceutical industries; and other matters that are described in Vicor's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and subsequent filings with the Securities and Exchange Commission. Forward-looking statements in this press release speak only as of the date of the press release, and we assume no obligation to update forward-looking statements or the reasons why actual results could differ.

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