BOCA RATON, FL--(Marketwire - August 26, 2010) - David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced that abstracts of three studies involving its PD2i® nonlinear algorithm have been accepted for presentation during the Poster Session of the 2010 Heart-Brain Summit. 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 cardiac death resulting from arrhythmia or pump failure, and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.
"We're honored to have three abstracts selected for presentation before this prestigious group, especially during the distinguished Poster Session. We believe the results achieved by the PD2i® in each of these studies suggest the prospect of incorporating the PD2i® nonlinear algorithm into a noninvasive diagnostic that will significantly contribute to the identification and treatment of at-risk patients. We hope that having the opportunity to share these results with those active in the field of heart-brain medicine worldwide will further opportunities to advance study of the PD2i® as a noninvasive diagnostic to identify at-risk populations and further our commercialization efforts for the PD2i®," stated Mr. Fater.
Dr. James E. Skinner, Vicor Vice President and Director of Grant Research, will present the following abstracts at the 2010 Heart-Brain Summit, which will be held at the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, September 23-24. The Poster Session is on September 23, from 5:00 to 7:00pm.
Short-Term Heart Rate Complexity Determined by the PD2i® Algorithm is Reduced in Patients with Type 1 Diabetes Melitus -- The objective of this study was to test the ability of PD2i® to discriminate between young DM patients without neuropathy and age- and gender-matched controls. Seventeen DM patients with known autonomic dysfunction and 17 age- and gender-matched controls were studied. The same R-R interval data (3,200 heartbeats per subject) were analyzed (blinded) to determine the PD2i® values. The study revealed that the PD2i® was able to detect ANS dysfunction with p = 0.0006.
Prognostic Significance of PD2i® in Heart Failure Patients -- The goal of this effort was to determine the PD2i®'s ability to predict cardiac events in chronic heart failure patients. The study population was a group of chronic heart failure patients, who had been studied for 44 months, on average, with total mortality as primary endpoint and cardiac mortality, sudden cardiac death, and heart failure death as secondary endpoints. The PD2i® was computed based on 20-minute supine high-resolution Holter recording and was categorized as positive (PD2i® less than or equal to 1.4) or negative (pD2i® greater than 1.4) based on pre-specified criteria. Of the 651 chronic heart failure patients studied, 537 had successful PD2i® analyses resulting in 144 (27%) patients showing positive results and 393 (73%) negative results. After adjustment for clinical covariates PD2i®, was found predictive for total mortality (HR=1.55; p=0.026). Predictive value of PD2i® was observed in heart failure patients with left ventricular ejection fraction less than or equal to 35% (HR=1.95; p=0.004) whereas not in patients with greater than 35% (HR=0.87; p=0.716); p for interaction 0.072. Further analyses revealed that among patients with ejection fraction less than or equal to 35%, PD2i® was also predictive for cardiac death and for heart failure death.
Mild Hypovolemia and PD2i® -- The goal of this pilot study was to test the ability of the PD2i® 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. Study subjects were volunteers who presented for a standard single unit whole blood donation. A 15-minute ECG recording was made pre-donation and the recording was then continued during the donation period and a rest afterwards. Eighteen subjects participated with a mean age of 48+/-18 years. Three were on beta blockers, 2 on antidepressants, and 1 had diabetes. At baseline the minimum PD2i® had a mean of 2.6+/-0.8 dimensions, whereas after donation it fell to 1.8+/-0.5 dimensions (p=0.0011). The minimum PD2i® was found to be a sensitive metric for the detection of mild blood loss, as seen in the controlled environment of donation of a whole unit of blood. Thus, PD2i® may serve as a marker for mild hemorrhage in hospital (e.g., surgery) and trauma environments. In addition, given PD2i®'s association with autonomic activity, these results suggest significant sympathetic activation with even standard blood donation, suggesting that PD2i® can be used to track a patient's autonomic response to insult.
The Heart-Brain Summit, now in its fifth year, is the annual event of The Society for Heart Brain Medicine. More than 200 physicians, researchers, scientists, and industry professionals from around the world attended the 4th Annual Heart-Brain Summit in 2009.
The Society for Heart Brain Medicine was officially established as a 501(c) (3) organization in June of 2008, with the purpose of:
- educating clinicians and scientists about the physiology, pathophysiology, and medical aspects of heart-brain interactions;
- educating the public about these aspects; and
- promoting and fostering research into heart-brain relationships.
The Society for Heart-Brain Medicine provides a forum for researchers and clinicians from different disciplines, both clinical and laboratory, to present, discuss, and evaluate data, and promotes the study of heart-brain medicine as a discipline in its own right. Additional information about the Society for Heart-Brain Medicine is available at www.heartbrain.org.
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 various clinical trials, identifies patients at elevated risk of cardiac death resulting from arrhythmia or pump failure.
Vicor anticipates developing additional applications utilizing 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, the U.S. Government, or the AABB 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 generate revenues from the sale of the PD2i Analyzer™; our ability to obtain FDA approval of our 510(k) submission to secure a claim for the PD2i CA™(Cardiac Analyzer) for risk stratifying congestive heart failure patients at elevated risk of cardiac mortality and our ability to obtain marketing clearance from the FDA for the PD2i VS™ (Vital Sign) for military and civilian applications; 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.