BOCA RATON, FL--(Marketwire - April 20, 2010) - David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced the results of a pilot study to test the ability of its PD2i® nonlinear algorithm to detect acute hypovolemia. The study was conducted in cooperation with the University of Mississippi Medical Center and Mississippi Blood Services on December 12, 2009 in Smithdale, MS. 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 accurately risk stratify specific target populations for future pathological events including sudden cardiac death and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.
The goal of the pilot study was to test the ability of Vicor’s PD2i® nonlinear algorithm to identify acute hypovolemia in blood donors as a preliminary step toward ascertaining whether it could be a useful noninvasive diagnostic for detecting blood loss from internal bleeding. All 18 participants in the pilot study were tested prior to donation to determine a baseline PD2i® value, and re-tested during and after collection. The average PD2i® value of participants prior to donation was 2.60; the average PD2i® value following donation was 1.80. With a P value of 0.001, the study results are highly statistically significant; this indicates a better than 99% probability that the results were not achieved randomly.
“We’re extremely grateful to our colleagues at the University of Mississippi Medical Center and Mississippi Blood Services for their efforts in making this pilot study possible. We’re also very encouraged by the results achieved by the PD2i® in this small pilot study, which suggest the prospect of incorporating the PD2i® nonlinear algorithm into a noninvasive diagnostic for use in identifying patients who are bleeding internally. However, as this pilot study measures internal blood loss resulting from external blood donation, we anticipate further studies as part of our progress in commercializing a noninvasive diagnostic to detect acute hypovolemia,” 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 multiple clinical trials, identifies patients at risk of 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.
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™ (Vital Sign) for military and civilian applications and the PD2i CA™(Cardiac Analyzer); 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 10-06
CORPORATE CONTACT
David H. Fater
Vicor Technologies, Inc.
561.995.7313
dfater@vicortech.com
INVESTOR CONTACT
Richard Moyer
Cameron Associates
212.554.5466
richard@cameronassoc.com
MEDIA CONTACT
Robin Schoen
Robin Schoen Public Relations
215.504.2122
schoenpr@comcast.net