Vicor Technologies, Inc. PD2i(R) Garners Interest From Researchers, Physicians at American College of Cardiology 60th Annual Scientific Session
Published: Apr 21, 2011
BOCA RATON, FL--(Marketwire - April 21, 2011) - David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced that a poster presentation of a study confirming the predictive value of the Company's PD2i® nonlinear algorithm and software for cardiac mortality made during the recent American College of Cardiology 60th Annual Scientific Session garnered interest from researchers and clinicians. Researchers attending the poster presentation expressed interest in using the Company's PD2i® nonlinear algorithm and software in new studies with the goal of determining its applicability for other cardiovascular disease states. Clinicians queried Company representatives about its use in the clinical setting. Vicor Technologies is a biotechnology company focused on the commercialization of its PD2i Analyzer™, an innovative, non-invasive diagnostic employing its patented, proprietary PD2i® nonlinear algorithm. Physician use of the PD2i Analyzer™ is supported by an expanding body of literature demonstrating the value of the PD2i® nonlinear algorithm as a metric for risk stratifying specific target populations for future pathological events, including diabetics for the presence of diabetic autonomic neuropathy (DAN), cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and trauma victims for imminent death absent immediate lifesaving intervention.
The poster presentation -- "Prognostic Significance of PD2i, Novel Risk Marker in Heart Failure Patients" -- was made by Wojciech Zareba, MD, PhD, Professor of Medicine, Director of Cardiology Clinical Research, and Director of the Heart Research Follow-up Program at the University of Rochester Medical Center. The presentation, made on April 4, 2011, is based on a study titled "Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure," which was conducted under a collaborative agreement between Vicor Technologies, and the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona. Dr. Zareba was the Principal Investigator on that study. Commenting on the study results, Dr. Zareba said, "These results are of major importance for risk stratifying heart failure patients who are eligible for therapy with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillator (CRT-D). Testing heart failure patients using the PD2i® should enhance risk stratification and motivate physicians to implant these devices in ICD/CRT-D eligible patients with abnormal PD2i® test results."
This presentation preceded Vicor's receipt of 510(k) clearance from the U.S. Food and Drug Administration for its PD2i® nonlinear algorithm and software to be used as a measure of heart rate variability at rest, and in response to controlled exercise and paced respiration in patients specifically undergoing cardiovascular disease testing.
In addition to Mr. Fater, Vicor Technologies' representatives in attendance during Dr. Zareba's poster presentation were Jerry Anchin, PhD, Vicor Vice President and Director of Product Development; Daniel Weiss, MD, FACC, Vicor Chief Medical Officer; and Edward Lundy, MD, PhD, Chief of Cardiothoracic Surgery, Active International Cardiovascular Institute at Good Samaritan Hospital and Chairman of Vicor's Scientific Advisory Board.
"We're extremely pleased and honored to have had Dr. Zareba, a world-renowned researcher and enthusiastic supporter of our PD2i® nonlinear algorithm and software, make this presentation of our MUSIC Trial data at the American College of Cardiology 60th Annual Scientific Session and i2 Summit. We are excited by the attention the PD2i® nonlinear algorithm and software received from researchers interested in exploring its use for applications in other cardiac disease states and from clinicians interested in adding a diagnostic that enables accurate measurement of heart rate variability to determine the health of the autonomic nervous system as a means of identifying potential health risks," Mr. Fater stated.
"Throughout the Scientific Session, there was a focus on the importance of risk stratification, the need for accurate risk stratification, and the importance of the autonomic nervous system in cardiac disease. The PD2i® has demonstrated the ability to accurately measure heart rate variability -- a measure for autonomic nervous system health -- which suggests it is well positioned to provide the cardiology community with a valuable new diagnostic for risk stratifying heart failure patients," stated Dr. Weiss.
"The MUSIC Trial study results presented by Dr. Zareba represent good news for congestive heart failure patients who would benefit from a diagnostic that accurately identifies those at greatest risk for death and thus derive maximal benefit from more comprehensive care and possible earlier initiation of resynchronization therapy. Importantly, they are not the only population that will benefit from Vicor's PD2i® nonlinear algorithm; this is just another one of more than 45 independent studies documenting the predictive value of the PD2i® nonlinear algorithm for use in risk stratifying patients for a variety of clinical disorders and conditions," stated Dr. Lundy.
Dr. Anchin noted that the Company received requests from multiple organizations in Latin America for the PD2i® nonlinear algorithm and software for research and use in clinical settings.
The goal of "Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure" was to evaluate the ability of Vicor's PD2i® nonlinear algorithm to predict cardiac events in the 537 chronic heart failure patients enrolled in the MUSIC Trial; MUSIC Trial participants were followed for an average period of 44 months. The conclusion of the University of Rochester researchers who conducted the study is that the PD2i® nonlinear algorithm and software is predictive of total mortality, cardiac death, and heart failure death in patients with left ventricular ejection fraction of less than or equal to 35%. With a hazard ratio of 2.34 and a P value of 0.023 for congestive heart failure mortality, a hazard ratio of 1.89 and a p value of .013 for cardiac mortality and a hazard ration of 1.95 and a p value of .004 for total mortality, the study results are highly statistically significant and demonstrated the ability of the PD2i Analyzer™ to identify those patients at an elevated risk of total mortality, cardiac mortality and congestive heart failure death.
About Vicor Technologies, Inc.
Vicor Technologies' PD2i Analyzer™ employs its patented, proprietary point correlation dimension algorithm (PD2i®), a deterministic, nonlinear measure of electrophysiological potentials that predicts future pathological events with a high degree of accuracy in target populations. Vicor anticipates use of its PD2i Analyzer™ 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, such as the American College of Cardiology, the Heart Research Follow-up Program at the University of Rochester Medical Center and Active International Cardiovascular Institute at Good Samaritan Hospital, in this media release does not constitute endorsement by institutions 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 successfully complete the normal range study for PD2i® values; our ability to generate revenues from the sale of the PD2i Analyzer™; our ability to obtain the necessary regulatory approvals to market the PD2i Analyzer™; our ability to develop additional applications for the PD2i 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, 2010 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.
David H. Fater
Vicor Technologies, Inc.
Robin Schoen Public Relations