Vicor Technologies, Inc. Submits 510(k) Application to FDA for Cardiac Marketing Claim

BOCA RATON, FL--(Marketwire - July 01, 2010) - David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced that the company has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its PD2i® algorithm and software to secure a claim for identifying, in conjunction with patient medical history and other tests, congestive heart failure patients at elevated risk of cardiac mortality. 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 develops diagnostics that accurately risk stratify specific target populations for future pathological events including cardiac death and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.

This filing is based on findings obtained from “Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure,” a study conducted under a collaborative agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona. The goal of the study was to evaluate the ability of Vicor’s PD2i® nonlinear algorithm to predict cardiac events in the 537 chronic heart failure patients enrolled in the Merte Subita en Insufficiencia Cardiaca (MUSIC) Trial; MUSIC Trial participants were followed for an average period of 44 months. The conclusion of the University of Rochester researchers who conducted the study is that the PD2i® nonlinear algorithm and software is predictive of total mortality, cardiac death, and heart failure death in patients with left ventricular ejection fraction of less than or equal to 35%. With a P value of 0.004 the study results are highly statistically significant.

“This filing brings us one step closer to being able to market our PD2i algorithm and software to cardiologists, thus enabling them to more effectively identify their congestive heart failure patients at elevated risk of cardiac mortality,” stated Mr. Fater.

About Vicor Technologies, Inc.
Vicor Technologies is focused on commercializing 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.

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 (http://www.usaisr.amedd.army.mil/), risk stratifies combat and civilian trauma victims. The PD2i CA™ (Cardiac Analyzer), in various clinical trials, identifies patients with elevated risk of cardiac death, including sudden 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 www.vicortech.com.

Disclaimer
The appearance of name-brand institutions or products in this media release does not constitute endorsement by the U.S. Army Medical Research and Materiel Command, the Department of the Army, Department of Defense or the U.S. Government 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 obtain FDA approval of our 510(k) submission to secure a claim for the PD2i CA™(Cardiac Analyzer) for risk stratifying congestive heart failure patients at elevated risk of cardiac mortality and our ability to obtain marketing clearance from the FDA for the PD2i VS™ (Vital Sign) for military and civilian applications; 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.

Release 10-11

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Technorati: biotechnology medical devices diagnostics congestive heart failure cardiac death