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BOCA RATON, FL -- May 22, 2009 -- Vicor Technologies, Inc. (OTCBB: VCRT) today announced that David H. Fater, President and CEO, participated in a comprehensive, in-depth interview with online publication CEOCFO. Vicor Technologies is a development-stage biotechnology company focused on the commercialization of non-invasive diagnostic products using its patented, proprietary PD2i algorithm and software to analyze heart rate variability and identify individuals at risk of sudden cardiac death, trauma victims requiring immediate life saving intervention, and diabetics at risk of developing diabetic autonomic neuropathy.
In the interview, Mr. Fater discussed recent activities involving Vicor's three diagnostic products. The Company received FDA 510(k) marketing approval late last year for its PD2i Analyzer. Under an OEM agreement with a leading manufacturer of medical diagnostic products linked to PCs, Vicor has developed the Vicor PD2i Cardiac Analyzer EKG, a state-of-the-art diagnostic tool to measure heart rate variability. Vicor will co-market the new PD2i Cardiac Analyzer ECG and receive revenue from both the sale of the equipment and from analysis of the test results. The PD2i Analyzer is also currently in clinical trials to establish it as a diagnostic tool for diabetic autonomic neuropathy. The American Diabetes Association recommends that diabetics -- approximately 18 million in the U.S. alone -- receive annual screenings for this "silent killer" disease.
Under a collaborative research and development agreement (CRADA) with the U.S. Army Institute for Surgical Research, Vicor is developing the PD2i VS (Vital Sign) for use in triaging combat and civilian trauma victims. Mr. Fater anticipates FDA approval for a modification to Vicor's existing 510(k) for application in the trauma and emergency response arenas later this year, with revenue generation expected shortly thereafter.
Vicor's PD2i CA (Cardiac Analyzer), which is currently involved in multiple clinical trials, accurately identifies individuals at high risk of suffering sudden cardiac death (SCD) within a six-month time frame and could benefit from an implantable cardioverter defibrillator (ICD). Mr. Fater anticipates FDA approval for an application to risk stratify SCD during the second half of 2009.
"This is a very exciting time for Vicor," stated Mr. Fater. "Given the relatively short regulatory process of modifying our existing 510(k) and the ease of use of our product platform, we expect revenue generation to commence during the second half of this year. We believe Vicor is extremely well-positioned to grow revenues and profits quickly, as each of our products addresses a vital need of sizable at-risk populations. This is especially true of the diagnostic situation for SCD, which has been described as 'in chaos' by cardiologists," Mr. Fater concluded.
With as many as 500,000 reported cases annually, SCD is a leading cause of death in the U.S. Approximately 12 million U.S. cardiac patients meet the criteria for being at an elevated risk of SCD and receiving an ICD as a preventive measure. Recent studies reveal that 76 percent of ICDs implanted using currently-available criteria never deliver an appropriate shock, suggesting a lack of true need in those patients and resulting in unnecessary ICD implantations with all of the associated health risks and costs. Conversely, only 20-30 percent of those who do have an episode of SCD would have met the current criteria for an ICD, leaving the remaining 70-80 percent unprotected.
Mr. Fater's CEOCFO interview may be accessed directly at: http://ceocfointerviews.com/interviews/VCRT-Vicor09.htm
About Vicor Technologies, Inc.
Vicor Technologies is a development-stage biotechnology company creating innovative non-invasive diagnostics employing its patented, proprietary point correlation dimension algorithm (PD2i) and software. The PD2i is a deterministic, non-linear measure that accurately evaluates biological signals to predict with high sensitivity and high specificity future pathological events in target populations.
Vicor currently has three products employing the PD2i algorithm. The PD2i Analyzer, now in commercialization, 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. The PD2i CA (Cardiac Analyzer), in multiple clinical trials, identifies patients at risk of suffering sudden cardiac death.
Vicor anticipates additional applications employing 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.
About CEOCFO
CEOCFO is a daily online publication/marketing engine featuring interviews and news of publicly traded and venture capital companies listed on the U.S. (NYSE, NASDAQ, AMEX, OTC: BB, Pink Sheets), Canadian (TSX, TSX-V), and international stock exchanges. To access the website, please go to www.CEOCFO.biz.
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 to continue to receive financing sufficient to 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 changes in laws and regulations and other matters that are described in Vicor's Annual Report on Form 10-K for the fiscal year ended Deecmber 31, 2008 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 09-08
Corporate Contact David H. Fater Vicor Technologies, Inc. 561.995.7313 dfater@vicortech.com Media Contact Robin Schoen Robin Schoen Public Relations 215.504.2122 schoenpr@comcast.net Investor Contact Richard Moyer Cameron Associates 212.554 5466 richard@cameronassoc.com
SOURCE: Vicor Technologies, Inc.
mailto:dfater@vicortech.com mailto:schoenpr@comcast.net mailto:richard@cameronassoc.com
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