Vicor Technologies Submits Analysis of MUSIC Trial Dataset to University of Rochester for Final Determination of Results
Press Release Source: Vicor Technologies, Inc. On Wednesday March 17, 2010, 8:30 am
BOCA RATON, FL--(Marketwire - 03/17/10) - David H. Fater, CEO of Vicor Technologies, Inc. (OTC.BB:VCRT - News), today announced that the Company has completed reanalysis of the Merte Subita en Insufficiencia Cardiaca (MUSIC) Trial dataset using its PD2i CA™ (Cardiac Analyzer) diagnostic with a newly refined R-R detector. Vicor Technologies is a biotechnology company focused on the commercialization of innovative, non-invasive medical devices and diagnostics using its patented, proprietary PD2i® nonlinear algorithm and software to stratify patients at risk of sudden cardiac death and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.
Modifications have been successfully made to the R-R detector in Vicor's PD2i® nonlinear algorithm and software to improve its already high level of accuracy. The R-R detector measures the intervals between heart beats, which is the required input data for analysis by the PD2i CA™. The completion of this modification enabled Vicor to reanalyze the ECG files. The results of this reanalysis (for which Vicor is still blinded) has been submitted to the University of Rochester, which will make the final determination of the efficacy of the PD2i CA™ in identifying the actual patient participants who died from sudden cardiac death during the course of the MUSIC Trial.
As announced on March 18, 2009, Vicor entered into a collaborative research agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona to study sudden cardiac death. According to the agreement, titled "Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure," Vicor's PD2i CA™ would be used by Vicor scientists and University of Rochester personnel to identify which of the 651 congestive heart failure patients who participated in the Merte Subita en Insufficiencia Cardiaca (MUSIC) Trial suffered sudden cardiac death. During the average 44 months MUSIC Trial participants were followed: 52 died from sudden cardiac death.
"We are extremely excited to be at this juncture in the commercialization process of our PD2i CA™. Access to an archive of analyzable data such as that provided by the MUSIC Trial -- which is fairly uncommon -- provided us with the tremendous opportunity to quickly and cost-effectively produce a dataset, which we optimistically hope will be of sufficient statistical significance to support an application for sudden cardiac death in a claim to the FDA for 510(k) marketing clearance. We continue to execute our business plan for ongoing marketing efforts and sales of the PD2i Analyzer™, which is being well received among physicians. We are also on target for the completion of clinical efforts directed at additional 510(k) submissions, which should enable us to accelerate our marketing efforts once granted," stated Mr. Fater.
About Vicor Technologies, Inc.
Vicor Technologies is a biotechnology company creating 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.
Vicor currently has three products employing the PD2i® nonlinear algorithm. 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 the critical clinical trials; our ability to continue as a going concern; our ability to successfully develop products based on our technologies, included but not limited to our ASP distribution model for the PD2i Analyzer™; 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, 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 10-04
Vicor Technologies, Inc. (OTCBB: VCRT) is in the crucial transformative stage for a biotechnology company on the verge of becoming a viable commercial enterprise.
This biotechnology company is focused on the commercialization of innovative, non-invasive medical devices and diagnostics using its patented, proprietary PD2i™ nonlinear algorithm and software which is:
The advantage of the PD2i™ nonlinear algorithm is that it typically uses recordings made at rest and does not require stress-testing or any active participation from the patient. The test is relatively impervious to data non-stationarities and artifacts, setting it apart from other measures with unparalleled sensitivity.
A large physician shareholder base represents the early adoptees of this Company.
The PD2i Algorithm and software risk stratifies target populations to predict future pathological events. As a predictor of sudden cardiac death it has been shown to be highly accurate, with a sensitivity approaching 100% and a specificity of ~86%.
