SOURCE: Vicor Technologies, Inc.

Vicor Technologies, Inc.

November 16, 2009 08:30 ET

Vicor Technologies Announces Filing of 10-Q on November 13, 2009

Ends Quarter With Strongest Balance Sheet in Several Years

BOCA RATON, FL--(Marketwire - November 16, 2009) - David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced that the company has filed its 10-Q for the third quarter of 2009. 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 trauma victims in need of lifesaving intervention.

"We've hit the fourth quarter on a high note," stated Mr. Fater. "As of September 30, 2009, we believe we have sufficient liquidity to fund operations through the commencement of revenue generation in 2010; at which point, the business climate should be much more advantageous, should we need to raise additional capital. Additionally, we are experiencing accelerated forward momentum in many areas as we near completion of our in-process clinical trials. Our existing 510(k) marketing approval will have amended labeling for the expanded use of our non-invasive PD2i® diagnostic for enhanced treatment of cardiac, trauma, and diabetes patients and reimbursement of physicians by insurance carriers under existing CPT codes. We are finalizing beta test sites and distributor agreements in U.S. and international markets in anticipation of being able to direct all of our efforts toward the marketing of our products and resulting revenue generation," Mr. Fater concluded.

During the 4Q09 and 1Q10, Mr. Fater anticipates achievement of the following milestones:

--  software programming updates and improvements that will enable the
    PD2i Analyzer™ to capture and display heart rate variability (HRV)
    information during paced respiration and controlled maneuvers;
--  implementation of a normal range study for the PD2i Analyzer™ at
    the University of Mississippi Medical Center;
--  completion of analysis of the MUSIC Trial data and filing with the FDA
    for 510(k) marketing approval for the PD2i CA™ (Cardiac Analyzer) for
    use in detecting sudden cardiac death;
--  installation of Vicor's completed application service provider (ASP)
    distribution model for beta testing in cardiology practices in California
    and other U.S. physician practices;
--  roll-out of early adopter distribution program to Vicor's physician
    shareholders (350) and National Cardiac Panel members (450);
--  finalization of distributorship agreements currently in process for
    certain countries;
--  completion of analysis of USAISR trauma data; and
--  commencement of human clinical trials of Vicor's PD2i VS™ (Vital
    Sign) by the U.S. Army Institute of Surgical Research (USAISR) with
    modified R-R detector and filing with the FDA for 510(k) marketing approval
    for PD2i VS™ for use in detecting trauma and the need for lifesaving

In addition to the in-process trials under collaborative research agreements with the USAISR, and the University of Rochester and Catalan Institute of Cardiovascular Sciences (MUSIC Trial data analysis), Vicor will be engaging in the following clinical trials during 4Q09 and 1Q10:

University of Mississippi Medical Center

--  Complexity Analysis During Blood Donation (CABLD) Trial - to determine
    the efficacy of the PD2i® to identify the presence of mild to moderate
    blood loss.
--  Brain Injury Risk Stratification Trial (BIRST) - to determine the
    efficacy of the PD2i® to predict 1) mortality and 2) track the clinical
    status of patients with brain trauma; there are approximately 52,000 deaths
    annually from traumatic brain injury (Brian Trauma Foundation).
--  Complexity Analysis Studies of Trauma in the Emergency Department
    (CASTED) Trial - to determine the efficacy of the PD2i® to 1) aid in
    trauma triage and 2) track the clinical status of trauma patients
    presenting to emergency departments.

Brown University

Vicor will also be working with the renowned electrophysiologist Dr. Alfred Buxton and his colleague, Dr. Peter Tuckmeier, on two trials to learn whether measuring heart rate variability is useful in tracking the progress of cardiac patients undergoing a variety of rehabilitative treatments following a myocardial infarction (MI). Dr. Buxton is a Professor of Medicine at Brown Medical School and Director of the Cardiology Division at Brown Medical School, Rhode Island Hospital, and The Miriam Hospital. He is also the Director of Arrhythmia Services and the Clinical Cardiac Electrophysiology Laboratory at Rhode Island Hospital, and The Miriam Hospital.

--  CARE-t Trial - to determine the ability of the PD2i Analyzer™ to
    measure the impact of cognitive behavioral therapy on post-MI patients.
--  CARE-e Trial - to test the ability of the PD2i CA™  to determine
    the impact of cardiac rehabilitation on reducing arrhythmias in post-MI

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 to predict 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 and Vicor will be commencing a clinical trial to determine its efficacy to detect the presence of diabetic autonomic neuropathy (DAN). The PD2i VS™ (Vital Sign), in clinical trials under a collaborative effort with the U.S. Army Institute for Surgical Research (, 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

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; 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 09-19

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