Health & Fitness
Health and Fitness
Health and Fitness 
Tue, January 13, 2009
Vicor Technologies, Inc.: Vicor Technologies' Chief Medical Officer Interviewed by EP Lab Digest
BOCA RATON, FL--(Marketwire - January 13, 2009) - Vicor Technologies, Inc., today announced that Chief Medical Officer Daniel N. Weiss, MD, FACC, was interviewed by EP Lab Digest about Vicor's PD2i algorithm and its approach to sudden cardiac death risk stratification. Vicor Technologies, Inc. (
New Paradigm in Sudden Cardiac Death Risk Stratification: Interview with Daniel N. Weiss, MD, FACC appears in the January 2009 edition ([ http://www.eplabdigest.com/articles/New-Paradigm-Sudden-Cardiac-Death-Risk-Stratification ]). EP Lab Digest is published for physicians and lab professionals specializing in cardiology and electrophysiology.
In the interview, Dr. Weiss explains Vicor's patented, proprietary PD2i algorithm and how it was created. Additionally, he identifies Vicor's current applications for the PD2i -- the PD2i CA (Cardiac Analyzer) for sudden cardiac death (SCD) risk stratification and the PD2i VS (Vital Sign) for identifying those in need of immediate life-saving intervention -- and the status of clinical trials of and FDA 510(k) approval to market these applications.
"We are pleased to note the cardiology and electrophysiology community's growing interest in Vicor's clinically proven approach to identifying patients at risk of SCD, as reflected by the EP Lab Digest interview of Dr. Weiss," stated David H. Fater, Vicor President and Chief Executive Officer. "With more than 500,000 deaths annually, SCD is a leading cause of death in the U.S., yet there is currently no accurate method to identify those at risk of SCD. While approximately 12 million U.S. cardiac patients meet the criteria for being at elevated risk of SCD -- and are able to receive a preventive implantable cardioverter defibrillator (ICD) as a result -- studies reveal that 76% of ICDs never fire, suggesting a lack of true need in those patients with ICDs and resulting in unnecessary implantations with all the associated health risks and costs -- approximately $75,000 per person. Conversely, and perhaps more importantly, only 20 to 30% of those who've suffered SCD -- such as Tim Russert -- would have met the current criteria for an ICD, leaving 70 to 80% unprotected," concluded Mr. Fater.
About Vicor Technologies, Inc.
Vicor is a development-stage biotechnology company focused on the commercialization of innovative non-invasive diagnostics employing operational software and its patented, proprietary PD2i algorithm, a deterministic, non-linear analytic measure that accurately evaluates electrophysiological potentials with high sensitivity and high specificity to predict future pathological events in target populations.
Vicor currently has three products employing the PD2i algorithm. The PD2i Analyzer, which has received FDA 510(k) approval, measures heart rate variability. 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. FDA 510(k) approval to market the PD2i VS is expected in 2009. The PD2i CA (Cardiac Analyzer), in a multi-site, multi-year trial (the VITAL Trial) being conducted by the Harvard Clinical Research Institute, identifies patients at risk of suffering sudden cardiac death. FDA 510(k) approval to market the PD2i CA is expected in early 2010.
Vicor anticipates developing additional applications using the PD2i to enable early detection and risk stratification for a variety of other disorders and diseases.
Additional information is available at [ www.vicortech.com ].
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 the PD2i VS for military and civilian applications and the PD2i Cardiac Analyzer, our ability continue to receive financing sufficient to continue operations and complete the 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-KSB for the fiscal year ended December 31, 2007 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 09-04