Vicor Technologies, Inc. (OTCBB: VCRT)
Vicor Technologies Receives Institutional Review Board Approval for Study to Identify Normal Ranges for PD2i(R) Values Obtained From Tests Performed With Its PD2i Analyzer(TM)
BOCA RATON, FL, Sep 28, 2010 (MARKETWIRE via COMTEX) — David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced that the Company has received approval from the Institutional Review Board (IRB) for a study to identify normal ranges for PD2i(R) values obtained from tests performed with its PD2i Analyzer(TM) on patients at rest, and in response to controlled exercise and paced respiration. The study will be conducted in collaboration with the University of Mississippi Medical Center. Vicor Technologies is a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i(R) nonlinear algorithm and software. Vicor is currently in the process of commercializing diagnostics that accurately risk stratify specific target populations for future pathological events including cardiac death resulting from arrhythmia or pump failure, and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.
“We’re pleased to have IRB approval permitting us to commence this important study. Being able to identify normal ranges for values obtained from tests performed with the PD2i Analyzer(TM) will enhance the ability of those physicians using the PD2i Analyzer(TM) to identify — and treat — their at-risk patients. With this approval, we will begin enrolling patients and our intention is to include these results in a revised 510(k) submission to the FDA at the conclusion of the study,” stated Mr. Fater.
The IRB reviews research to ensure that the federal regulations for protecting human research participants outlined in UMMC policy, the Department of Health and Human Services (DHHS) regulations (45 CFR 46) and the Food and Drug Administration (FDA) regulations (21 CFR Parts 50 & 56), as well as other requirements, are met.
About Vicor Technologies, Inc. Vicor Technologies is a biotechnology company creating innovative non-invasive diagnostics employing its patented, proprietary point correlation dimension algorithm (PD2i(R)). The PD2i(R) 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(R) nonlinear algorithm. The PD2i Analyzer(TM), which has FDA 510(k) marketing clearance, measures heart rate variability; physicians performing diagnostic tests with the PD2i Analyzer(TM) are able to receive reimbursement under existing CPT codes. The PD2i VS(TM) (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(TM) (Cardiac Analyzer), in multiple clinical trials, identifies patients at risk of sudden cardiac death.
Vicor anticipates additional applications employing the PD2i(R) 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, such as the Institutional Review Board 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(R)values; our ability to generate revenues from the sale of the PD2i Analyzer(TM); our ability to obtain FDA approval of our 510(k) submission to secure a claim for the PD2i CA(TM)(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(TM) (Vital Sign) for military and civilian applications; our ability to develop additional applications for the PD2i(R) 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.
Vicor Technologies, Inc. (OTCBB: VCRT)
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