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Vicor Technologies, Inc. (OTCBB: VCRT)
I want you to take a much closer look at Vicor. My team has prepared
the following information on the company that spells out the opportunity
here.
Vicor Technologies, Inc. (OTCBB: VCRT) is ON THE MAP. This
Company is MAKING IT and MAKING IT HAPPEN.
With Vicor we have a product being rolled out with important
recognition in the medical community – a tried and true business
model – three products available. Vicor’s reimbursement
is IN PLACE. Physicians and hospitals can bill under existing
codes.
This company has its roll out under way — revenue is being
generated now.
When a bio-tech company has as many studies and publications as
Vicor has – you KNOW this company is ON THE ROAD to becoming a
serious contender.
And I want to go over the publications and recognition Vicor has
received BUT at the same time note the business model here.
The technology is NEW. The business model is OLD – TRIED
and TRUE. It’s the old give them the razor and sell them the
razor blade plan.
Vicor sells the information, the mean, the method, the way the data is
analyzed: the PD2i Algorithm and software risk stratifies target
populations to predict future pathological events. As a predictor of
sudden cardiac death it has been shown to be highly accurate, with a
sensitivity approaching 100% and a specificity of ~86%.
Vicor is paid on the use of its Algorithm and software. This
represents a recurring source of revenue.
Vicor Has NOT ONE BUT THREE Products Employing the PD2i™
Nonlinear Algorithm.
PD2i Analyzer(TM) has FDA 510(k) marketing clearance. It measures
Heart Rate Variability. Physicians performing diagnostic tests with the
PD2i Analyzer™ are able to receive reimbursement under existing CPT
codes.
PD2i VS(TM) (Vital Sign) stratifies risk in combat and civilian
trauma victims and is in clinical trials under a collaborative effort with
the U.S. Army Institute for Surgical Research. ( http://www.usaisr.amedd.army.mil/ )
PD2i CA(TM) (Cardiac Analyzer) identifies patients at risk of sudden
cardiac death and is in multiple clinical trials.
Reimbursement IN PLACE
Physicians and hospitals can use existing CPT (current procedural
terminology) codes to obtain insurance company reimbursement – in
addition to direct payment by patients – for tests performed using
the PD2i Analyzer™. These codes are for the measurement of Heart
Rate Variability in response to controlled exercise and paced respiration
as well as recording and analyzing an EKG.
This is critical to ensure that all marketing activities for the PD2i
Analyzer™ to physicians and billing activities by them are performed
in accordance with FDA and Center for Medicare and Medicaid Services (CMS)
guidelines.
Current Field Trials and Applications
Vicor has determined the most appropriate rollout of their product is
in controlled environments which produce crucial feedback for product
enhancement.
PD2i™ Application in London
PD2i™ nonlinear algorithm has been selected by Dr. Sanjay Sharma
to be used in a cardiac screening initiative to be held in London and
Southeast England, commencing in April 2010. Dr. Sharma, consultant
cardiologist of Cardiac Risk in the Young (CRY), is spearheading the
screening initiative which will offer free cardiac screening to 14 year
olds (DOB 1995) living in London and Southeast England; fourteen is the
earliest post-puberty age for which proactive screening is considered
viable. Ten percent of the estimated seven million individuals fitting
this description are expected to participate.
The ultimate goal of this initiative is to develop a prototype for a
national screening program for young sudden cardiac death, which is an
extremely worthy goal, given that some 600 young people are struck down by
sudden cardiac death annually in the U.K.
Application Service Provider Distribution Model
A major U.S. cardiology practice serves as the Company’s beta
test site for Vicor’s Application Service Provider distribution
model which enables the seamless collection and transmission of patient
EKG data to the Vicor server for analysis.
Vicor’s software residing on the Company’s servers will
complete the analysis of the EKG data read by the PD2i Analyzer™.
The physician then receives an electronic medical record and report of the
PD2i Analyzer™ results.
The Application Server Provider distribution model records physician
use to Vicor’s website to enable automated monthly billing of
physicians using its PD2i Analyzer™ and reimbursable under existing
CPT codes.
Normal Range Study for the PD2i Analyzer™ Will Serve As Basis
For Test Interpretation.
Vicor will be performing a normal range study for the PD2i
Analyzer™ at the University of Mississippi Medical Center as soon as
routine Institutional Review Board approval is received. This study of
approximately 400 age and gender matched “normal” patients will
enable us to identify and establish normal ranges of PD2i™ values
for these groups, for both a resting patient and a patient performing
paced respiration and/or controlled exercise. Vicor will then file a
510(k) with the FDA to establish normal ranges for PD2i™ values. The
ability to identify normal ranges will help physicians interpret the
results of a PD2i Analyzer™ test as abnormal or normal, which will
facilitate accurate diagnosis and appropriate treatment.
Collaborative Studies Continue to Show the PD2i™ Nonlinear
Algorithm Enables Accurate Triage of the Seriously Wounded
Testing of the PD2i VS™ by the U.S. Army is continuing under the
Company’s collaborative agreement. In the completed study of 325
civilian trauma patients, researchers found that analysis of complex heart
rate complexity using the PD2i™ nonlinear algorithm and software
identifies trauma patients with good sensitivity (low percentage of false
negatives) and that results are similar using both “raw” or
“clean” electrocardiograms (“EKG’s”). This
latter point is especially important considering the real world – on
the battlefield or in civilian trauma settings – in which EKG data
is collected. This data for the PD2i VS™ will be used to file a
510(k) to establish a claim for a more accurate triaging of trauma
patients.
Additionally, Vicor has completed the programming necessary for the
PD2i VS™ to operate as a continuous vital sign monitor. In this mode,
the PD2i VS™ provides an initial PD2i™ result within three
minutes of collected data and then an updated status every minute
thereafter. Each result is accompanied by an audible tone, and a green,
yellow, or red light to indicate the patient’s change in status and
alert the emergency response team of a need for aggressive and immediate
lifesaving intervention. Vicor is completing the modification of the R-R
detector in the Company’s software to improve its already high
sensitivity and accuracy. (The accuracy of the time intervals between each
heart beat “the R-R interval” is critical to the calculation of
a PD2i™ value.)
The enhanced version of the continuous PD2i VS™, together with
the improved RR detector should enable the USAISR to utilize the
Company’s technology in an important prospective human trial.
The PD2i CA™ (Cardiac Analyzer) Expected to Utilize MUSIC
Trial Data for New 510(k)
Under a collaborative agreement with the University of Rochester and
the Catala Institute of Cardiovascular Science, the PD2i CA™ is being
used to study the data files of 651 individuals who participated in the
Merte Subita en Insufficiencia Cardiaca (MUSIC) congestive heart
failure trial. Vicor has completed analysis of the data files, and expects
to have the Company’s collaborators unlock the clinical data and
compare the PD2i CA™ results with the actual clinical outcomes in
the next six to eight weeks. This time period will permit Vicor to modify
the R-R detection software in order to re-analyze the files. This second
analysis will enable Vicor to maximize the already high probability of
success of this important trial data set. This data set is then expected
to serve as the basis for submission of a 510(k) to the FDA for the
application of sudden cardiac death (SCD).
Publications, Presentations and Papers
During the past year, the results of the Company’s efforts have
appeared in trade media reaching important target audiences, prestigious
medical journals, and presentations by USAISR medical personnel.
Trade Media
Dr. Daniel N. Weiss, the Company’s Chief Medical Officer, was
interviewed by EP Lab Digest. Medical Device Daily included Dr.
Weiss’s comments in an article entitled “Vicor’s heart
metric used as an identifier for trauma in patients” (September 25,
2009).
Colonel Leopoldo Cancio of the USAISR identified the PD2i™ as a
heart-rate complexity metric to be tested on trauma patients in the
Army’s new Critical Combat Care Engineering (C3E) program in
“Bridging the Critical Care Chasm,” an article describing the
C3E that appeared in the August 2009 issue of Military Medical/CBRN
Technology (Volume 13, Issue 5).
The C3E is a new program area within the U.S. Army Medical Research
and Materiel Command’s Combat Casualty Care Research Area Directorate
(RAD II) that was created to improve battlefield care and, specifically,
address the “critical care technology gap.”
Peer-Reviewed Medical Journals
A manuscript of Vicor’s study, “Comparison of
linear-stochastic and nonlinear deterministic algorithms in the analysis
of 15-minute clinical EKGs to predict risk of arrhythmic death,”
appeared in Therapeutics and Clinical Risk Management (2009-5, 1-12).
The manuscript chronicles the study of 397 patients admitted to three
emergency room departments for chest pain and determined to be at
low-to-high risk of acute myocardial infarction (MI). Fifteen-minute EKGs
were recorded and R-R intervals assessed by three non-linear algorithms
(PD2i™, DFA, and ApEn) and four conventional linear-stochastic
measures (SDNN, MNN, 1/f-Slope, LF/HF). The sensitivity and relative risk
for predicting arrhythmic death was highest at all time-points for the
PD2i™ algorithm.
“New Measures of Heart-Rate Complexity: Effect of Chest Trauma
and Hemorrhage” is in press in the Journal of Trauma. This USAISR
study analyzed the complex beat-to-beat variability present in the
heart-rate time series, which has been proposed as a “new vital
sign.”
The effect of chest trauma and hemorrhagic shock on heart-rate
complexity (HRC) was examined in an animal model. The study concluded that
heart rate complexity may be useful for diagnosis of trauma and
hemorrhagic shock, and for monitoring resuscitation efforts.
University of Rochester/Catalan Institute of Cardiovascular
Sciences
Vicor is working with the University of Rochester and the Catalan
Institute of Cardiovascular Sciences to use the PD2i CA™ to
retrospectively predict sudden cardiac death in the 651 congestive heart
failure patients studied by the Muerte Subita en Insuficiencia Cardiaca
(MUSIC) trial, in which 52 actually died from SCD.
Vicor expects that
the results of this analysis will be sufficient to support FDA 510(k)
clearance for sudden cardiac death in 2010.
University of Mississippi Medical Center
Vicor is collaborating with the University of Mississippi Medical
Center on several trials:
Brain Injury Risk Stratification Trial
The BIRST trial will determine the ability of the PD2i™
nonlinear algorithm to predict mortality in victims of brain trauma.
PD2i™ will also be assessed for its ability to track the clinical
status of neuro-trauma ICU patients.
Brain trauma is a serious public health challenge. In the U.S. over
300,000 sport-related traumatic brain injuries occur annually, and
according to the Brain Trauma Foundation, approximately 52,000 will
die.
Cardiac Arrhythmia Assessment and Safety in Athletes
(CAASA)
Sudden cardiac death is a leading cause of death among student
athletes. The CAASA trial will test the ability of the PD2i CA™ to
identify those at risk.
The CAASA trial will commence at the University of Mississippi, with
follow-on studies at other prestigious universities.
Complexity Analysis Studies of Trauma in the Emergency Department
(CASTED)
Vicor is in discussions with the University of Mississippi Medical
Center Trauma Center to identify a means of transmitting PD2i-VS™
data during Medivac transport of civilian trauma victims.
Complexity Analysis during Blood Donation (CABLD)
In cooperation with the University of Mississippi Medical Center Blood
Bank, the CABLD trial is testing the ability of the PD2i-VS™ to
detect mild-to-moderate blood loss as determined during blood
donations.
Complexity Analysis during Renal Dialysis (CARD) Trial
CARD will test the use of Heart Rate Variability to evaluate the effect
of fluid loss during dialysis.
Massachusetts General Hospital MGH PD2i-VS Trial
In this study, Massachusetts General Hospital will test the
PD2i-VS™ for real-time mobile
& ICU triage in an extremely demanding emergency medical
environment.
The teaching hospital for Harvard Medical School, MGH is a Level 1
Adult, Pediatric and Burn Trauma Center admitting over 4,000 trauma and
emergency surgery patients annually.
Dr. Alfred Buxton and Heart Rate Variability
Vicor will be working with renowned electrophysiologist, Dr. Alfred
Buxton, on two trials to learn if measuring Heart Rate Variability is
useful in tracking the progress of cardiac patients undergoing various
rehabilitative treatments following ICD implantation.
Dr. Buxton is a Professor of Medicine at Brown Medical School and
Director of the Cardiology Division at Brown Medical School, and Rhode
Island and Miriam hospitals. He is also the Director of Arrhythmia
Services and the Clinical Cardiac Electrophysiology Laboratory at Rhode
Island and Miriam hospitals.
CARE-t Trial
Vicor’s PD2i Analyzer™ will be used to measure Heart Rate
Variability as a means of determining the efficacy of cognitive behavioral
therapy on cardiac patients with ICDs.
CARE-e Trial
Vicor’s PD2i CA™ is being used to determine the ability of
exercise to reduce arrhythmias in cardiac patients with ICDs.
Target Health, Inc.
Target Health, Inc. is working as the Company’s Contract Research
Organization in regulatory matters as strategic advisors and clinical
consultants for meetings with the FDA.
The Sudden Cardiac Arrest Association
Vicor supports the work of the Sudden Cardiac Arrest Association. The
SCAA identifies and unites survivors, those at risk of sudden cardiac
arrest, and those interested in advocating for SCAA issues in their
communities and beyond. The Sudden Cardiac Arrest Association and Vicor
share a mission: to prevent loss of life from Sudden Cardiac Arrest.
PD2i VS™ Presentations and Publications 2009 ATACCC Conference
/ Smart Monitoring 2009 Forum
Vicor’s technology was presented in August at the 2009 Advanced
Technology Applications for Combat Casualty Care (ATACCC) conference and
the 2009 Smart Monitoring Forum in St. Petersburg Beach, Florida.
Andriy Batchinsky, MD, a researcher with the U.S. Army Institute of
Surgical Research (USAISR), made two presentations. The first, Toward
Automated Detection of Life-threatening Injury Using Comprehensive
Assessment of the Electrocardiogram, was presented at Smart Monitoring
2009 during the New Vital Signs, Predictive Variables and Indices
panel.
At ATACCC, Dr. Batchinsky presented Does Heart Rate Complexity Add to
Traditional Vital Signs for Trauma Patient Triage Both presentations
reviewed findings from trials the USAISR has done with Vicor and described
use of the PD2i-VS™ as a new vital sign in trauma triage.
The premier scientific meeting of the Department of Defense, ATACCC
addresses advances in trauma medicine and the unique medical needs of the
war fighter, identifying technologies that can meet increasingly complex
operational issues.
Sponsored by the Resuscitation Research Laboratory of the University
of Texas Medical Branch, Smart Monitoring is a forum on vital sign
monitoring for combat casualty care, facilitating communication between
industry representatives and medical experts from government, academia,
and the private sector.
2008 International Shock Congress
Exploration of Heart-Rate Complexity to Determine the Need for
Lifesaving Intervention in Combat Casualties was also presented by the
U.S. Army in June, 2008 at the International Shock Congress in Cologne,
Germany. The abstract concerned the initial experiment for trial performed
by the U.S.Army on battlefield wounded soldiers utilizing Vicor’s
PD2i™ technology.
PD2i ™Technology. Journal of Critical Care
Exploration of Heart-Rate Complexity to Determine the Need for
Lifesaving Intervention in Combat Casualties was published in the June,
2008 Journal of Critical Care.
The Company’s first collaborative effort with the U.S. Army, this
study involved combat casualties for whom EKG files were analyzed by
several competing methods. Vicor’s PD2i™ technology correctly
identified the need for immediate life-saving intervention.
Reference: Exploration of heart-rate complexity to determine the need
for lifesaving interventions in combat casualties. Journal of Critical
Care 2008 Jun;(Vol. 23, Issue 2, Pages 265-266)
Presentations
Andriy Batchinsky, MD, a USAISR researcher, presented findings from a
study of Vicor’s PD2i VS™ at the American Heart
Association’s Resuscitation Science Symposium 2009 (November 14-15,
2009). Dr. Batchinsky presented “Does Heart-Rate Complexity Analysis
Work in the Real World Changes in the Point Correlation Dimension of
Heart Rate during Prehospital Lifesaving Interventions.”
This was the first presentation at a major scientific conference
featuring Vicor’s proprietary PD2i™ nonlinear algorithm. The
objective of “Does Heart-Rate Complexity Analysis Work in the Real
World” was to evaluate the ability of the PD2i VS™ to
distinguish trauma patients receiving lifesaving interventions from those
who did not based on analysis of EKGs from 325 pre-hospital trauma
patients. The PD2i™ nonlinear algorithm value was calculated on both
unedited (raw) and on manually verified, noise-and ectopy-free (clean) EKG
sections. In conclusion, researchers found that analysis of heart rate
complexity using the PD2i™ nonlinear algorithm and software
identifies trauma patients with good sensitivity (low percentage of false
negatives) and that results are similar using either “raw” or
“clean” EKGs. Additional studies of automated trauma triage
using the PD2i VS™ are planned
Additionally, Dr. Batchinsky made the following presentations of the
USAISR’s continuing studies of the PD2i VS™:
“Are We Listening to Music or Noise Use of the Lyapunov
Exponent for Comprehensive Assessment of Heart Rate Complexity during
Hemorrhage in Sedated Conscious Miniature Swine” 8th International
Conference on Complexity in Acute Illness – August 28-30, 2009
– Palo Alto, CA
“Complexity in Animal Models” and “Continuous
Complexity Analysis and Remote Battlefield Triage” International
Experts of Complexity and Variability at the Bedside Round Table –
August 24-25, 2009 – Wakefield, CA
“Does Heart Rate Complexity Add to Traditional Vital Signs for
Trauma Patient Triage” ATACCC 2009 Conference – August 10-12,
2009 – St. Petersburg Beach, FL
“Toward Automated Detection of Life-threatening Injury Using
Comprehensive Assessment of the Electrocardiogram” Smart Monitoring
2009 Conference – August 9, 2009 – St. Petersburg Beach,
FL
Papers
Therapeutics & Clinical Risk Management
Vicor’s study, Nonlinear Analysis of the Heartbeats in Public
Patient EKGs Using An Automated PD2i™ Algorithm for Risk
Stratification of Arrhythmic Death was published in the April 2006
Therapeutics and Clinical Risk Management. This study demonstrated the
ability of the PD2i CA™ to risk-stratify patients’ risk for
sudden cardiac death and identify those who require ICD’s
(implantable cardioverter defibrillator) and those who do not.
The study enrolled 37 patients and showed the PD2i test to have a
sensitivity of 100% and a specificity of 85%. In other words, Vicor’s
PD2i™ nonlinear algorithm correctly identified every patient who
went on to suffer a cardiac arrest or sudden cardiac death, while only
recommending over-treatment of 15%. Current risk-stratification criteria
results in over-treatment of 76% of cases,1,2 while only identifying a
fraction of “true-positives” — patients who will go on to
experience cardiac arrests or sudden cardiac death.
Risk Stratification for Arrhythmic Death in an Emergency Department
Cohort: A New Method of Non-Linear PD2i Analysis of the EKG
The Company’s study of 918 patients in six emergency departments,
appeared in the August 2008 issue of Therapeutics and Clinical Risk
Management. Vicor’s PD2i® algorithm and software achieved a
sensitivity of 96% and a specificity of 85% with a negative predictive
value of 99%.
Comparison of Linear–Stochastic and Nonlinear Deterministic
Algorithms in the Analysis of 15-Minute Clinical EKGs to Predict Risk of
Arrhythmic Death
Published August 17th in Therapeutics & Clinical Risk
Management.
The paper describes a study in which 397 emergency room
patients presenting with chest pain were evaluated by seven methodologies:
the PD2i™ nonlinear algorithm, DFA, ApEn, SDNN, MNN, 1/f-Slope, and
LF/HF. The study demonstrated that the PD2i™ nonlinear algorithm,
based on a deterministic model, provided superior assessment of Heart Rate
Variability in brief EKGs compared to measures based on either the linear
stochastic model or other nonlinear ones, and thus provides the basis for
a rapid, accurate, and cost-effective stratification of risk of AD among
patients presenting in an Emergency Department.
Journal of Critical Care Exploration of Heart-Rate
Complexity to Determine the Need for Lifesaving Intervention in Combat
Casualties was published in the June 2008 Journal of Critical Care. The
Company’s first collaborative effort with the U.S. Army, this study
involved combat casualties for whom EKG files were analyzed by several
competing methods. Vicor’s PD2i™ nonlinear algorithm was the
only method that correctly identified the need for immediate life-saving
intervention in all cases.
American Heart Journal A Reduction in the Correlation
Dimension of Heartbeat Intervals Precedes Imminent Ventricular
Fibrillation in Human Subjects appeared in Elsevier’s American Heart
Journal. In this study, the PD2i™ nonlinear algorithm and software
demonstrated a sensitivity of 100% and a specificity of 83%.
Ongoing Studies In addition, Vicor is currently involved
in several ongoing studies which will be submitted to appropriate
publications when complete.
Vicor Technologies, Inc.
2300 NW Corporate Blvd.
Suite 123 Boca Raton, FL 33431 877.528-PD2i (7324) info@vicortech.com
Vicor Technologies, Inc. (OTCBB: VCRT)
Introduction
Vicor Technologies, Inc. (OTCBB: VCRT) is in the crucial
transformative stage for a biotechnology company on the verge of becoming
a viable commercial enterprise.
This biotechnology company is focused on the commercialization of
innovative, non-invasive medical devices and diagnostics using its
patented, proprietary PD2i™ nonlinear algorithm and software which
is:
Highly accurate
Provides user friendly data acquisition
Effective for trauma triage easily deployed in a portable
monitor
Provides a simple noninvasive test for identifying patients at risk of
sudden cardiac death
Provides a simple noninvasive test for identifying patients with
Diabetic Autonomic Neuropathy
The PD2i Algorithm and software risk stratifies target
populations to predict future pathological events. As a predictor of
sudden cardiac death it has been shown to be highly accurate, with a
sensitivity approaching 100% and a specificity of ~86%.
The advantage of the PD2i™ nonlinear algorithm is that it
typically uses recordings made at rest and does not require stress-testing
or any active participation from the patient. The test is relatively
impervious to data non-stationarities and artifacts, setting it apart from
other measures with unparalleled sensitivity.
A large physician shareholder base represents the early adoptees of
this Company.
A new vital sign with the ability to actually save lives in both
combat and civilian setting
The PD2i Analyzer™ can capture and display Heart Rate
Variability (see defined below) in patients at rest and during paced
respiration and controlled exercise.
Able to identify trauma victims in need of an immediate lifesaving
intervention
Able to be used along with other clinical data to identify patients at
risk of sudden cardiac death
Able to be used along with other clinical data to identify patients
who have autonomic dysfunction
Able to improve trauma triage in real world situations and on the
battlefield where time is of the essence and the collection of
‘clean’ data is never guaranteed
Able to provide consistently accurate results which requires just one
to two minutes of EKG data in a trauma setting
Not derailed in delivering actionable results by noisy raw EKG
data
Functional in trauma environments and battlefield situations
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