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 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.
Vicor’s PD2i™ Nonlinear Algorithm is:
- 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
Vicor’s 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.
Vicor anticipates additional applications employing the PD2i™ nonlinear algorithm to enable early detection and risk stratification for a variety of other disorders and diseases.
The PD2i Analyzer™ twenty-minute test is composed of recording a sequence of one thousand heartbeats. The PD2i™ nonlinear algorithm is subsequently applied to that recording in order to find subtle patterns in the resulting data, yielding the final result which is expressed as a minimum PD2i™ value.
Business Model: Application Service Provider
Vicor’s Application Service Provider distribution model enables the seamless collection and transmission of patient EKG data to the Vicor server for analysis via the internet. This business model allows the proprietary algorithm to reside exclusively with Vicor.
An EKG file is captured using the Vicor PD2i Analyzer™. The EKG file is automatically uploaded via the internet to the Company’s server for analysis. The analysis is performed and within minutes the results are automatically transmitted back to the physician along with the required information for billing by the physician to the insurance company.
Each physician use will be recorded on the website which will enable Vicor to directly bill the analysis fees to the physician monthly. In this manner, the Company’s proprietary software remains continuously under the Company’s control and protection, and Vicor has a record of which physicians are conducting tests and how often.
This model also facilitates engagement with prospective international customers and the different methods by which Vicor expect to be paid by them. Importantly, in physician and hospital settings this activity is currently reimbursable under existing CPT codes for physicians and hospitals.
Application Server Provider distribution is over the Internet. The doctor or hospitals using the PD2i Analyzer™ pay a pre-determined and reimbursable fee. Physicians and hospitals are able to precisely understand their cost and understand the value to their patients, practice and business model while focusing on their core expertise.
Reimbursement
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.
Revised labeling for the measurement of HRV during paced respiration and controlled exercise as well as at rest will enable this.
Advantage and Advance over Conventional Diagnostics
Vicor’s PD2i tests offer several advantages over other measures:
- More predictive than competing tests
- Non-invasive
- May be performed by a nurse or technician
- Tests done at rest
- Use inexpensive, non-proprietary EKG electrodes
- Provide results in less than twenty minutes
- Easy to use with a simple Positive/Negative resuCompact and portable
- Forgiving of data issues plaguing other diagnostics
- Not derailed by irregular or ectopic beats
- Performed on patients taking beta-blockers
- Low up-front cost
- Low per test cost
Large Total Potential Market Opportunity
The PD2i™ diagnostics enable inexpensive, accurate, and early identification of disease states in at-risk populations prior to costly treatments for advanced disease or inaccurate identifications which are garnering increased attention in the current healthcare debate.
These populations are significant, representing:
- 12 million at-risk cardiac patients,
- 23.7 million diabetics, and
- 38 million trauma incidents
This represents 70 million potential patient encounters translating into a more than a $5 Billion annual market.
Vicor anticipates that the PD2i-VS™ will play a role in the over 38 million emergency response calls annually in the United States.
It should prove invaluable by enabling paramedics to assign a level of severity to patients being transported to the emergency room. At the E.R. the PD2i-VS™ is expected to play an important role in helping ER personnel triage patients in-hospital.
Diabetic Autonomic Neuropathy Market
Studies indicate that as many as a quarter of the 23.6 million diabetics in the U.S. may be suffering nerve damage from Diabetic Autonomic Neuropathy and many of them are without the symptoms which would alert them to seek treatment.*
Diabetic Autonomic Neuropathy is best diagnosed by measuring a patient’s Heart Rate Variability (HRV). Vicor’s PD2i Analyzer™ measures HRV quickly, accurately and inexpensively.
Though gradual in onset, Diabetic Autonomic Neuropathy has grave consequences. Since the autonomic nervous system undergirds so many of the Company’s body’s key functions, damage to these nerves can result in:
- Heart disease and sudden death
- Loss of urinary and bowel control
- Kidney failure
- Impotence
- Blindness
* Source: Full Accounting of Diabetes and Pre-Diabetes in the U.S. Population in 1988–1994 & 2005–2006. Diabetes Care, 32:287-294, 2009
Diabetic autonomic neuropathy is gradual in onset so the disease may be fairly well advanced by the time symptoms are detectable by conventional means. Thus, tragically, treatment is often not commenced until the patient is already experiencing vision problems, incontinence or sexual dysfunction. At this point, nerve damage is well underway, and patients are at significantly increased risk of sudden cardiac death
A diagnostic is needed which can detect diabetic autonomic neuropathy long before significant nerve damage has occurred. Vicor believes that PD2i Analyzer™ is that diagnostic.
Conventional tests can only detect the nerve damage Diabetic Autonomic Neuropathy leaves in its wake; the PD2i™ nonlinear algorithm uses advanced mathematics to directly measure the health of a patient’s autonomic system. A PD2i™ score can be simply and painlessly determined within minutes and will reveal if a patient has developed diabetic autonomic neuropathy, enabling doctors to intervene to protect their patients from further debilitating disease.
Vicor’s PD2i Analyzer™ has already received FDA 510(k) marketing clearance as a measure of Heart Rate Variability. Vicor expects to secure an expanded claim through the 510(k) application process for a diabetic autonomic neuropathy indication.
PD2i ™ Marketing
International Marketing
Vicor has signed a distributorship agreement with Glotecx, Inc. (Coral Springs, FL) covering India and four other countries in East Africa. The agreement, which employs the Company’s ASP model, is expected to generate revenue in early 2010. This agreement calls for payment of a guaranteed minimum number of collection devices and tests per month paid in advance.
While the agreement was intended to commence late in the fourth quarter, there is a delay due to situations beyond the Company’s control.
Vicor is in discussions with distributors in other countries including Israel, Ecuador, Brazil, Philippines, United Kingdom, Thailand, and China. Vicor believes the value of the Company’s technology, per test pricing, and alternative regulatory climate (non-U.S.) in these countries create the opportunity to realize significant future international revenues and possibly sooner revenues than would be realized in the United States.
Domestic Physician Market
In anticipation of a product launch in early 2010, Vicor has identified several of the Company’s physician shareholders and their practices for early adoption of the PD2i Analyzer™.
Physician acceptance is a critical success factor. The Company’s strategy has always been to establish a large physician base – 350 shareholders and 450 members of the Company’s National Cardiac Panel – as early adopters of the Company’s technology to ensure that:
The product is well received by physicians interested in Vicor’s success
Product enhancement suggestions provided by these early adopters can be incorporated into the technology before a national rollout.
The PD2i test offers several advantages over competing diagnostics:
- More predictive than competing tests
- Non-invasive
- Performed by nurse or technician on resting patient
- Uses inexpensive, non-proprietary EKG electrodes
- Result available in less than twenty minutes
- Easy to use
- Yields simple Positive/Negative result
- Compact and no treadmill required
- Forgiving of data issues plaguing other diagnostics; not derailed by irregular or ectopic beats
- Can be performed on patients taking beta-blockers
- Low up-front cost
- Low per test cost
Pre-Hospital and Hospital Markets
The PD2i VS™ is expected to be rolled out initially with the U.S. Army and several international armed forces. Ultimately, the Company’s goal is to license the technology for inclusion in existing vital sign monitors for pre-hospital and hospital use and combat care.
Inclusion in vital sign monitors will not preclude the development of the Company’s own hardware in a size permitting easy battlefield transport by combat care providers.
High Incentive for Physician Use
- More definitive and higher quality patient care
- Minimal disruption to office patient flow
- Simple to use with Positive/Negative result
Short-term Business Milestones
1. Commencement of revenue in January 2010, from physician market in the United States.
2. International revenue is scheduled to commence during the first half of 2010.
3. Submit 510K for claim for Sudden Cardiac Death in Q1 2010. While the claim for Sudden Cardiac Death will enhance marketing efforts, it will not impact currently existing CPT codes and revenue recognition prospects.
4. Submit 510K for claim for Trauma in 2010 upon receipt of data from U.S. Army Institute of Surgical Research
5. Complete Normal Range Study and 510(k) submission to enable identification of normal ranges of PD2i values for physicians.
Manufacturing Nasiff Associates, Inc.
Vicor Technologies entered into an OEM product agreement with Nasiff Associates, Inc. to integrate Vicor’s PD2i™ data collection software into Nasiff’s CardioCard EKG in May 2009. Under the agreement, Nasiff will manufacture the PD2i Cardiac Analyzer™ EKG for sale to physicians by Vicor and Nasiff under joint marketing rights.
A leading producer of medical diagnostic products, Nasiff developed the world’s first PC based digital EKG.
PD2i-VS™ Tested by U.S. Army Institute of Surgical Research (USAISR)
Determined to minimize mortality rate of battlefield casualties, the U.S. Army Institute of Surgical Research has been working with Vicor’s PD2i-VS system through a research collaboration and has tested it against the best methodologies currently
In Vicor’s most recent study with Army provided data, the PD2i-VS™ examined 325 civilian trauma injury victims, twenty of whom would later die of their injuries. Incredibly, the PD2i-VS™ correctly identified all twenty.
Even more importantly, of the twenty who died, conventional trauma triaging techniques had selected only six for lifesaving intervention in the field.
This suggests both that current trauma triage methods are woefully inadequate, and that the PD2i-VS™ is poised to make an extraordinary contribution to combat and trauma survival in the near future.
The very low PD2i™ values demonstrated in the chart at above right signify imminent risk of “crashing”, revealing dire need of aggressive medical intervention.
Heart Rate Variability as a Diagnostic
Several sensory-motor loops such as temperature, pH, baroreceptor reflex and others have been found to control heart rate. The degree of cooperation between those loops is reflected in the degrees of freedom of the heart rate’s variability — a phenomenon caused by the brain’s influence.
In healthy individuals, these loops tend to work in opposition and more or less independently. But when the loops begin to coordinate to a high degree, paradoxically, it’s a sign that the body is not doing well and that the brain is “marshalling the forces” to work together to keep the body alive. Yet this “hyper coordinated” condition is not sustainable and can lead to ventricular tachycardia, ventricular fibrillation, and sudden cardiac death.
Knowing the degrees of freedom permits far more accurate evaluation of near-term risk of death than previously possible. The PD2i™ nonlinear algorithm and software precisely calculate the degrees of freedom, even in the presence of data issues that confound other methods and is the results are exceedingly easy to interpret.
Sudden Cardiac Death is not a Heart Attack
- A Heart Attack is an “Internal Plumbing Problem”
- Sudden Cardiac Death is caused by breakdown of the heart-brain axis
- Sudden Cardiac Death is swift and unexpected
- 95% of victims of Sudden Cardiac Death die outside of hospital
- Sudden Cardiac Death often occurs in asymptomatic individuals
The PD2i™ CA is able to accurately risk stratify patients into those at high or low risk of suffering a fatal arrhythmic event, or Sudden Cardiac Death within a six to twelve month time frame.
Sudden Cardiac Death is the leading cause of natural death in the U.S. each year with more than 300,000 reported cases annually.
In multiple trials comparing the efficacy of various tools in measuring Heart Rate Variability for diagnostic purposes, Vicor’s PD2i™ nonlinear algorithm has consistently proven to be the most accurate diagnostic for identifying those at risk of sudden cardiac death and autonomic dysfunction, as well as trauma victims in need of lifesaving intervention.
Diagnostics that enable inexpensive, accurate, and early identification of disease states in at-risk populations prior to costly treatments for advanced disease or inaccurate identification are garnering increased attention.
These populations include:
- 12 million at-risk cardiac patients
- 23.7 million diabetics
- 38 million trauma incidents
Management and Scientific Advisory Board
David H. Fater
President, Chief Executive Officer, Chief Financial Officer, Director
Joined Vicor in 2002, from ALDA & Associates International Inc., a business and financial consulting firm specializing in healthcare and life sciences.
Prior to forming ALDA & Associates in 1993, Mr. Fater held senior executive positions with three public healthcare companies. He led the initial public offering process for BMJ Medical Management, Inc. (1997-1999) and Community Care of America (1995-1996), and led Coastal Physician Group, Inc. (1993-1995) to a NYSE listing and $1 Billion market capitalization. Before this, Mr. Fater was employed by Ernst & Young, where he completed his 24-year tenure as a Senior International Partner advising senior management and boards of directors (1969-1992).
Mr. Fater is a certified public accountant in Georgia, Illinois, North Carolina, and New York. He holds a BS in Accounting from the University of North Carolina.
James E. Skinner, Ph.D.
Vice President, Director of Grant Research, Director
Founding Vicor in August, 2000, Dr. Skinner has extensive experience both as a scientist and manager of large research and development projects. He is the Director of the Delaware Water Gap Science Institute, a non-profit medical research organization devoted to the development of medical devices and pharmaceuticals. Prior to founding the Delaware Water Gap Science Institute, Dr. Skinner was Associate Director of the Totts Gap Medical Research Laboratories, Inc. (1969-1997). Earlier, he was a Professor and Researcher at Baylor College of Medicine in Houston (1969-1993) and recipient of numerous research grants from the National Institutes of Health.
Dr. Skinner holds a PhD in Neuroscience from the University of California at Los Angeles and a BA in Pre-Med, Physics, and Physiological Psychology from Pomona College.
Jerry M. Anchin, Ph.D.
Vice President, Director of Research and Development, Director
Dr. Anchin has more than 30 years of experience in the fields of immunology, molecular biology, drug discovery and protein chemistry. Prior to founding Vicor in 2000, Dr. Anchin was employed by Ciblex Pharmaceuticals (1998-2000), where he became group leader of the drug discovery program that led to the discovery of novel small molecules for use in the prevention of asthma. Earlier, he held positions at Prism Pharmaceuticals (1996-1998), and Immuno Pharmaceuticals (1993-1996). Before that, he was Head of Assay Development and Manufacturing at International Immunoassay Labs (1991-1998), where he was instrumental in designing a novel assay for the detection of the protein creatine kinase released during acute myocardial infarction.
Dr. Anchin holds patents for 14 immunoassay and drug discovery platforms; he has an additional 16 patents pending. Dr. Anchin earned a PhD in Immunology from Texas A&M University and a BA in Cell Biology from the University of California at Santa Barbara.
Daniel N. Weiss, M.D., F.A.C.C.
Chief Medical Officer
With Vicor since 2004, Dr. Weiss has extensive experience as a practicing cardiologist and electrophysiologist. He is a partner in Florida Arrhythmia Consultants and was the director of several hospital electrophysiology laboratories. He has also served as a consultant to several Fortune 500 medical device companies, including Medtronic, St. Jude Medical and Guidant. In addition, he served as clinical investigator in the MADIT-II (MultiCenter Automatic Defibrillator Implantation Trial) and SCDHeFT (Sudden Cardiac Death Heart Failure Trial) clinical trials.
Dr. Weiss received his MD with Distinction in Research from the Mount Sinai School of Medicine where he received the Nathan A. Seltz Award for research in Cardiovascular and Renal Disease. He holds a BSE cum laude in Electrical Engineering and Computer Science from Princeton University.
Thomas J. Bohannon
Chief Accounting Officer
Thomas J. Bohannon was appointed to serve as the Chief Accounting Officer of the Company effective as of December 28, 2008. Mr. Bohannon has been in the accounting and financial field for more than 40 years. Mr. Bohannon worked as a senior manager at Ernst & Young in Atlanta from 1968 until 1978 where he specialized in financial and SEC reporting before becoming the partner in charge of audit and review services for Pappadakis, Nelson & Bohannon from 1978-1991. Since 1992, he has focused on his own consulting practice, serving as the financial officer for a variety of companies in the Southeast United States.
The current directors of the Company are David H. Fater (2002) and James E. Skinner (2000) (Class I), Jerry M. Anchin (2003) and Frederick M. Hudson (2008) (Class II), and Dr. Edward Wiesmeier (2004)and Joseph C. Franchetti (2008) (Class III). The Class I Directors’ term expires at the 2011 Annual Meeting. The Class II Directors’ term expires at the 2012 Annual Meeting. The Class III Directors’ term expires at the 2010 Annual Meeting.
Edward Wiesmeier, MD
Dr. Wiesmeier has been a member of the Company’s board of directors since October 2004. From 1974 to 2007, Dr. Wiesmeier was at UCLA where during that time he served as Clinical Professor of Obstetrics & Gynecology at the UCLA School of Medicine and Assistant Vice Chancellor for Student Development and Health. Presently he is Clinical Professor/Voluntary in the Dept. of Reproductive Medicine at the UCSD School of Medicine. Dr. Wiesmeier serves as Chairman of the Company’s Scientific Advisory Board.
Frederick M. Hudson
At the time of his retirement from KPMG, Mr. Hudson was a partner in charge of the firm’s Mid-Atlantic Health Care Practice (1969-2006). He is a Director on the Board of Financial Administration of the Catholic Archdiocese of Baltimore, the Board of Sponsors of Loyola College Sellinger School of Business and Management, and the Board of Trustees of the Maryland Historical Society. He is Chairman of the Audit Committee of the Board of Directors of Paradigm Management Services, LLC, and Remedi Health Services, Inc., and a member of the Audit and Finance Committee of the Board of Directors of GBMC Healthcare, Inc., and its affiliate, the Greater Baltimore Medical Center. Mr. Hudson is a graduate of Loyola College.
Joseph C. Franchetti
Mr. Franchetti is, and has been, a consultant, director, and advisor to several healthcare/medical device companies, including start-ups, in the cardiology/cardiovascular and life sciences areas. He is currently Vice Chairman of CVAC Health Systems, Inc. Earlier, he was President and Chief Executive Officer of Cohn Medical Instruments Corp. (now Omron), a Japanese-owned, global leader in non-invasive blood pressure, and physiological and vital sign monitoring and diagnosis. He founded and was Chief Executive Officer of Bio-Chem Laboratory Systems Inc., and a Corporate and International Vice President and General Manager for Technicon (now Siemens) and Narco Scientific (now Respirionics). He is a Trustee Emeritus of Southwest Research Institute of Texas. Mr. Franchetti is a graduate of the Wharton School of the University of Pennsylvania.
Scientific Advisory Board
Vicor’s Scientific Advisory Board gives it access to some of the most accomplished professionals in the life sciences. In addition to others, Vicor’s Scientific Advisory Board includes such significant thought leaders as:
Mark E. Josephson, MD
• Chief of Cardiology, Beth Israel Deaconess Medical Center
• One of the world’s leading experts on arrhythmias
• Author, Clinical Cardiac Electrophysiology
• Scientific advisor to over twenty companies
Hein J. J. Wellens, MD
• Chairman & Professor, Cardiology Department, Academisch Ziekenhuis Maastricht, the Netherlands
• Director, Interuniversity Cardiology Institute
• Member, Netherlands Academy of Arts and Sciences
• Visiting Lecturer, Harvard Medical School.
Richard M. Luceri, MD, FACC
• Recently retired Director, Interventional Arrhythmia Center, Holy Cross Hospital
• Clinical Investigator, MADIT-II (MultiCenter Automatic Defibrillator Implantation Trial)
• Author, SCD-HeFT (Sudden Cardiac Death Heart Failure Trial).
Robert G. Hauser, MD, FACC, FHRS
• Senior Consulting Cardiologist, Minneapolis Heart Institute
• Chairman, Cardiovascular Services Division, Abbott Northwestern Hospital.
• Former CEO, Cardiac Pacemakers, Inc. (Eli Lilly subsidiary acquired by Guidant Corporation)
Jonathan Kaplan, MD, MPH
• Medical Director, Fidelis Care New York
• Former Corporate Medical Director, Excellus Blue Cross Blue Shield.
David Chazanovitz
• Former President/CEO, Alveolus, Inc.
• Former CEO, Cambridge Heart, Inc.
Edward F. Lundy, MD, PhD
• Chief of Cardiothoracic Surgery, Active International Cardiovascular Institute at Good Samaritan Hospital
• Ph.D. in physiology with focus on altered states physiologies (hibernation)
• Accomplished trauma surgeon
Intellectual Property
1. U.S. Patent No. 5,709,214, Patent issued 1/20/1998, PD2i Electrophysiological Analyzer
2. U.S. Patent No. 5,720,294, Patent issued 2/24/1998, PD2i Electrophysiological Analyzer
3. U.S. Patent No. 7,076,288, Patent issued 7/11/2006, Method and System for Detecting and/or Predicting Biological Anomalies (applications filed in Armenia, Australia, Azerbaijan, Belarus, Brazil, Canada, China, Costa Rica, Europe, Hong Kong, India, Israel, Japan, Kazakhstan, Kyrgyzstan, Mexico, Moldova, New Zealand, Russia, South Africa, South Korea, Tajikistan, and Turkmenistan – patents have begun to issue)
4. U.S. Patent No. 7,276,026, Patent issued 10/2/2007, Method and system for detecting and/or predicting cerebral disorders
5. Patent applied for 1/14/2005, PCT/US2006/001176, Knowledge Determination System (Lie Detection) (applications filed in Australia, Canada and Europe)
6. Patent applied for 8/2006, PCT/US07/077175, Automated Noise Reduction System for Predicting Arrhythmic Deaths (applications filed in Canada, China, Europe, India, Israel, Japan, Mexico, and South Korea)
7. Other patent applications, which are not yet public, have also been filed.
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.
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
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