Vicor Technologies, Inc. (VCRT: OTCBB) Roll Out Underway – Time to Get on Board
Written by StockGuru on February 8, 2010
Vicor Technologies, Inc. (OTCBB: VCRT)
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
Disclaimer and Forward-Looking Statements
The appearance of name-brand institutions or products in this profile does not constitute endorsement by the U.S. Army Institute of Surgical Research, 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.
Forward-looking statements in this profile are based on current plans and expectations that are subject to uncertainties and risks, which could cause the Company’s future results to differ materially. The following factors, among others, could cause the Company’s actual results to differ: the Company’s ability to obtain FDA approval of the PD2i VS™ (Vital Sign) for military and civilian applications and the PD2i CA™ (Cardiac Analyzer), the Company’s ability to continue to receive financing sufficient to continue operations and complete the critical clinical trials; the Company’s ability to continue as a going concern; the Company’s ability to successfully develop products based on the Company’s technologies, included but not limited to the Company’s ASP distribution model for the PD2i Analyzer™; the Company’s ability to obtain and maintain adequate levels of third-party reimbursement for the Company’s products; the impact of competitive products and pricing; the Company’s ability to receive regulatory approval for the Company’s products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for the Company’s technologies; the ability of third-party manufacturers to manufacture the Company’s products; the Company’s ability to retain the services of the Company’s key personnel; the Company’s ability to market and sell the Company’s products successfully; the Company’s ability to protect the Company’s 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, 2008 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 Vicor assume no obligation to update forward-looking statements or the reasons why actual results could differ.
Pentony Enterprises LLC is STOCKGURU.COM. 10604 Robincreek Lane; Frisco, Texas 75035. (469) 252-3030. Disclosure: Pentony Enterprises LLC was compensated fifty thousand restricted common shares and seventy-two hundred dollars by the company for profile coverage for the period ending March 31, 2010. Pentony Enterprises is not a registered investment adviser or a broker/dealer. Pentony Enterprises LLC makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person, or that an investment in such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk. We will not be buying or selling shares of Vicor during the promotional period.
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