Published:
Vicor Technologies Reviews Positive Developments for Its Risk Stratification Device for Sudden Cardiac Death and Collaboration With U.S. Army for Trauma and Emergency Response at Annual Meeting
Intends to Apply for and Receive FDA 510(k) Approval in 2008
Vicor Technologies, Inc. (OTCBB: VCRT),
reviewed strategies and developments to (i) commercialize its patented
device, the PD2i Cardiac Analyzer, for risk stratification of patients for
Sudden Cardiac Death (SCD); (ii) its collaboration with the U.S. Army to
assess severity of injury, and probability of survival, for critically
injured combat casualties and critically ill civilian patients and (iii)
other milestones at its Annual Meeting of Stockholders today in Boca Raton,
Florida.
Vicor President and CEO, Mr. David H. Fater, discussed the exciting, and
rapid, developments with the U.S. Army's Institute of Surgical Research,
since signing a Collaborative Research and Development Agreement in January
2008.
Importantly, Mr. Fater noted that this effort could lead to a U.S. FDA
510(k) device approval late this year of Vicor's PD2i to triage wounded
soldiers which can also be used in both military and civilian applications
in the assessment of trauma victims, which would be a significant milestone
in Vicor's history.
The collaborative effort is envisioned to lead to the development of new
comprehensive decision support tools, and or devices that may incorporate
the PD2i algorithm alone, or in association with other metrics currently
under investigation, with the goal to monitor, assess status and predict
outcome in critically injured humans. The study is entitled "Prediction of
Injury Severity and Outcome in the Critically Ill Using the Point
Correlation Dimension Algorithm."
Mr. Fater discussed with shareholders management's strategies to maintain
Vicor 's state-of-the-art platform technology leadership in risk
stratification diagnosis, and to position the company to initiate
commercialization of its PD2i device for trauma and emergency response in
2008, anticipating FDA 510(k) approval. Vicor would also seek to get CE
Mark approval in the European Union for the PD2i.
The status of Vicor's progress of its VITAL Trial, to risk stratify
individuals for Sudden Cardiac Death (SCD), and the related application
seeking FDA 510(k) approval for its PD2i Cardiac Analyzer, was reviewed in
detail. Vicor believes its PD2i accurately risk stratifies patients who
are at high or low risk of suffering SCD within a six-month time frame, and
who may need a costly Implantable Cardioverter Defibrillator (ICD).
Mr. Fater emphasized that the issue of ICD implantation and risk
stratification is extremely important to the Company since Vicor is
confident it is in the right place at the right time with the PD2i Cardiac
Analyzer. He offered as support a recent Wall Street Journal article in
which a Duke University cardiologist described the diagnostic situation for
SCD as in 'chaos.'
In order to solidify Vicor's place in risk stratification technology, four
new members have been added to Vicor's Scientific Advisory Board (SAB)
since July 2007 when Vicor became a public company.
In October, Edward F. Lundy, M.D., Ph.D., a Cardiothoracic Surgeon with a
Ph.D. in Physiology, with a primary focus on altered-state physiologies
such as hibernation joined the SAB. Mr. Fater noted his background in both
cardiology and altered-state physiologies provides him with a unique
perspective with which to assist Vicor in the expansion of several of its
platform technologies.
In April 2008, Dr. Robert Hauser, Senior Consulting Cardiologist at the
Minneapolis Heart Institute and Chairman of the Cardiovascular Services
Division at the Abbott Northwestern Hospital, joined the SAB. His
background includes being the CEO of Cardiac Pacemakers, Inc. from
1988-1992, then a subsidiary of Eli Lilly, later acquired by Guidant
Corporation. His background as a physician and inventor of implantable
cardiac devices provides him with a unique perspective with which to assist
Vicor in the expansion and commercialization of the PD2i Cardiac Analyzer
platform technology. Dr. Hauser holds multiple patents in the field of
implantable cardiac devices.
In May, Dr. Jonathan Kaplan, Medical Director for Fidelis Care New York,
one of the largest government program-based health plans in New York state,
providing managed health care coverage for 350,000 Medicaid, Child Health
Plus and Family Health Plus members, joined the SAB. Mr. Fater noted his
background, both as a physician and medical director in a managed care
environment, provides a unique payor perspective with which to assist Vicor
in its commercialization and expansion.
In early June, Mr. Chazanovitz, currently serving as President, CEO and a
Director of Alveolus, Inc., a medical device company, and who previously
served as CEO of Cambridge Heart, Inc., a publicly traded company and
competitor of Vicor, from February 2001-October 2006 also joined the SAB.
Mr. Fater noted that his background in the medical device industry, in
general, and with Cambridge Heart, in particular, provides Mr. Chazanovitz
with a unique perspective with which to assist Vicor in the
commercialization and expansion of its platform technology. His advice and
insight could make very meaningful contributions, especially in such
important areas as the FDA approval process and obtaining reimbursement for
physicians.
To further enhance Vicor's image and recognition within the medical and
health care communities, Vicor has published in peer reviewed,
professionally accredited journals and publications, various studies with
regard to its PD2i technology.
In February, Vicor announced that Therapeutics and Clinical Risk Management
had accepted for publication in April 2008 a study titled "Nonlinear
Analysis of the Heartbeats in Public Patient ECG's Using An Automated PD2i
Algorithm for Risk Stratification of Arrhythmic Death." The study enrolled
37 patients (30 of which completed the study) and achieved a sensitivity of
100% and a specificity of 81%.
The study highlighted Vicor's proprietary PD2i Analyzer technology and
demonstrated the ability to accurately risk stratify patients into those
who require Implantable Cardioverter Defibrillator (ICD) intervention and
those who do not.
In May, Vicor announced that Therapeutics and Clinical Risk Management also
accepted for publication in its August 2008 issue, positive results of a
clinical study conducted by the Company 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%, for the PD2i
Cardiac Analyzer.
Mr. Fater stated the study further increased the company's high degree of
confidence that the pivotal VITAL Trial will be successfully completed and
serve as the basis for Vicor to obtain FDA clearance through the 510(k)
process at the conclusion of the trial.
In October, 2007, Vicor announced issuance of its fourth patent entitled
"Method and system for detecting and/or predicting cerebral disorders."
Issuance of this patent expanded Vicor's future product portfolio and
validated its platform technology. Importantly, it will also serve as the
catalyst for the commencement of a pilot study for the early detection of
Alzheimer's Disease to be conducted in collaboration with Florida Atlantic
University and their Louis and Anne Green Memory and Wellness Center. The
study is anticipated to commence during 2008, and other applications
covered by this patent may also be initiated in the near future.
The Company continues to seek patent protection for its platform
technologies, and anticipates additional patents to be issued in the
future.
To strengthen its financial position, in April the Company announced the
conversion of $2,998,000 of its corporate debt into shares of its common
and preferred stock and warrants to purchase shares of its common stock.
Mr. Fater noted the Company was pleased it was able to substantially reduce
its outstanding indebtedness and increase its equity through this exchange
and conversion. He indicated management of Vicor appreciated the
confidence in the Company's future that stockholders expressed by their
conversion and exchange of indebtedness for additional equity.
Mr. Fater, on behalf of Vicor management, expressed confidence that the
Company would be successful in its efforts to receive FDA approval of its
PD2i technology during 2008 for trauma and introduce the PD2i device for
commercialization shortly thereafter.
About Sudden Cardiac Death (SCD)
SCD is the leading killer in the U.S. with over 500,000 annual deaths. It
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's medical device, the PD2i Cardiac Analyzer, is based on a patented,
proprietary algorithm. Vicor believes the 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 a significant health care 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
Implantable Cardioverter Defibrillator (ICD) as life-saving therapy.
However, recent registry studies have noted that over 70% of implanted
ICD's never have an appropriate firing. This over-implantation has led to a
substantial and unnecessary medical cost burden. There is also the risk of
not identifying patients who need this life-saving therapy because current
criteria do not provide physicians the ability to accurately risk stratify
their 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
The FDA, in a pre-Investigational Device Exemption (IDE) meeting, 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, is responsible for developing the electronic case report form to
permit the gathering of patient data via the Internet, and will be
responsible for preparing and submitting Vicor's 510(k) application.
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.
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: (i) our ability to
continue to receive financing sufficient to complete the VITAL Trial and
other critical clinical trials; (ii) the uncertainty of successful
completion of the VITAL Trial and other clinical trials or adverse results
in any of these trails, (iii) our ability to obtain FDA approval of the
PD2i Cardiac Analyzer ("Analyzer") for trauma, emergency and other
applications specified in the 501(k) application; (iv) even, if we obtain
FDA approval of the Analyzer, our ability to obtain approval by our
projected date of late 2008; (v) our ability to continue as a going
concern; (vi) our ability to successfully develop and commercialize the
Analyzer and other products based on our technologies; (vii) our ability to
market and sell the Analyzer and other products; (viii) our ability to
achieve broad market acceptance of the Analyzer and other products; (ix)
the impact of competitive products and pricing; (x) our ability to receive
any other required regulatory approval for our products (in addition to FDA
approval); (xi) the ability of third-party contract research organizations
to complete the VITAL Trial and other clinical trials for our technologies;
(xii) our ability to retain the services of our key personnel; (xiii) our
ability to protect our intellectual property; (xiv) our ability to obtain
product liability insurance and legal issues related to product liability
for medical device products; (xv) general market conditions in the medical
device and pharmaceutical industries; and (xvi) other factors identified in
our Annual Report on Form 10-K for the year ended December 31, 2007 under
"Risk Factors," which is on file with the SEC and available at
www.edgar.com and subsequent filings with the SEC. 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.
{FT495542;2}
Release 08-09
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