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Transcript
Vicor Technologies’ PD2i® Garners Interest from Researchers, Physicians
at American College of Cardiology 60th Annual Scientific Session
Boca Raton, FL – 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.
Disclaimer
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.
Release 11-13
# # #
CORPORATE CONTACT
David H. Fater
Vicor Technologies, Inc.
561.995.7313
[email protected]
INVESTOR CONTACT
Richard Moyer
Cameron Associates
212.554.5466
[email protected]
MEDIA CONTACT
Robin Schoen
Robin Schoen Public Relations
215.504.2122
[email protected]