Published:
Vicor Technologies Announces Additional Positive Clinical Trial Results

Vicor Technologies, Inc. (OTCBB: VCRT) is
pleased to announce positive results of a clinical study conducted by the
Company, and accepted for publication in the August 2008 issue of
Therapeutics and Clinical Risk Management. The study is titled "Risk
Stratification for Arrhythmic Death in an Emergency Department Cohort: a
new method of nonlinear PD2i analysis of the ECG."
The study enrolled 918 patients (876 of which completed the study) in six
emergency departments. The study achieved a sensitivity of 96% and a
specificity of 85% with a negative predictive value of 99%. Vicor, a
development-stage company, is developing the PD2i Cardiac Analyzer, a
patented device utilized in risk stratification of patients for Sudden
Cardiac Death (SCD).
Mr. David Fater, Vicor President and CEO, stated, "This study further
increases our high degree of confidence our pivotal VITAL Trial will be
successfully completed and serve as the basis for us to obtain FDA
clearance through the 510(k) process for medical devices. We are delighted
that we continue to demonstrate, through our clinical efforts, the ability
of our proprietary PD2i Analyzer to accurately risk stratify patients into
those who require Implantable Cardioverter Defibrillation (ICD)
intervention and those who do not."
Mr. Fater added, "We are continuing to also demonstrate positive results
with our collaboration with the U.S. Army with the stated objective of
being in a position to file a 510(k) with the FDA this summer for Trauma
and Emergency Response applications."
On January 23, 2008, Vicor signed a Collaborative Research and Development
Agreement (CRADA) with the U.S. Army Institute of Surgical Research
(USAISR), a division of the U.S. Army, to cooperate on the Prediction of
Injury Severity and Outcome in the Critically Ill Using the Point
Correlation Dimension Algorithm. The USAISR is exploring ways to assess
the severity of injury, and probability of survival, of critically injured
combat casualties and critically ill civilian patients. The USAISR, in
conjunction with Vicor, will test Vicor's PD2i algorithm in several diverse
cohorts of animal data, as well as in human trauma, ICU patients and combat
casualties. It is anticipated that deterioration in status due to trauma
and/or hemorrhage will lead to dimensional reductions reflected by the PD2i
value.
About Sudden Cardiac Death (SCD)
SCD (the leading killer in the U.S. with over 500,000 annual deaths) is a
fatal arrhythmic event and is different than a heart attack. A heart
attack is analogous to a plumbing problem, where the blood supply to a part
of the heart is choked off, leading to the death of that portion of the
heart muscle. SCD is theorized to be caused by a breakdown of the normal
neurological communication pattern between the heart and brain, more like
an electrical problem, which can lead to a rapid, life threatening heart
rhythm that is usually fatal within minutes, if untreated. It is swift,
unexpected, and often has no advance warning or symptoms.
About Vicor Technologies, Inc.
Vicor Technologies' (OTCBB: VCRT) diagnostic platform is based on a
patented, proprietary algorithm. Vicor believes its PD2i Cardiac Analyzer
accurately risk stratifies patients who are at high or low risk of
suffering a fatal arrhythmic event or SCD within a six-month time frame.
Vicor's PD2i Cardiac Analyzer addresses an issue involving a patient cohort
of at least 12,000,000 patients. This patient cohort is composed of the
MADIT-II (Multicenter Automatic Defibrillator Implantation Trial
II)/SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) patient
population. Many in this patient cohort may need an ICD as life-saving
therapy. However, recent registry studies have noted that over 70% of
implanted ICDs never have an appropriate firing leading to an
over-implantation in these patients as well as the risk of not identifying
patients who need this
life-saving therapy because current criteria do not provide physicians an
ability to accurately risk stratify these patients.
The PD2i Cardiac Analyzer contains the patented PD2i algorithm which
provides a method for evaluating electrophysiological potentials with a
high sensitivity and high specificity used to predict future pathological
events i.e. fatal cardiac arrhythmias. The PD2i algorithm detects
deterministic, low-dimensional excursions in nonstationary heartbeat
intervals. The PD2i algorithm uses an analytic measure that is
deterministic and nonlinear. It is based on caused variation in data; does
not require data stationarity and actually tracks nonstationary changes in
the data. It is sensitive to chaotic as well as nonchaotic, linear data.
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.
For more information visit the Vicor Technologies web site
www.vicortech.com.
About the VITAL Trial
Vicor's VITAL Trial (acronym for "Prospective, Multi-Center Study of the
Ability of the PD2i Cardiac Analyzer to Predict Risk of VentrIcular
TachyArrhytmic Events such as Sudden Cardiac Death (SCD), VentricuLar
Fibrillation (VF) or Ventricular Tachycardia (VT) in High Risk Patients")
was initiated in August 2006 and is being conducted by Harvard Clinical
Research Institute (HCRI) which is responsible for the overall coordination
and monitoring of the trial. The Principal Investigator for the VITAL trial
is Matthew R. Reynolds, M.D., M.Sc., from HCRI and the Boston V.A. Medical
Center. The FDA, in pre-IDE (Investigational Device Exemption) meetings,
agreed to the final PD2i protocol and study design for the pivotal VITAL
study. Target Health, Inc., a full service contract research organization
based in New York, developed the web-based capture of patient data and
will be responsible for preparing Vicor's 510(k) application.
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 Cardiac Analyzer for military and civilian
applications, our ability continue to receive financing sufficient to
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-KSB for the fiscal year ended December 31, 2007
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.
Copyright © 2009, MarketWire
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