Vicor Technologies, Inc. Exclusive Update

Posted on: June 21, 2011

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Vicor Technologies, Inc. Exclusive Update

Vicor Technologies, Inc.
Website: http://www.VicorTech.com
2300 NW Corporate Blvd. Suite 123
Boca Raton, FL  33431
Phone: 877-528-PD2i (7324)


Vicor Technologies, Inc. (OTCBB: VCRT) is a medical diagnostics company focused on commercializing noninvasive diagnostic technology products based on its patented, proprietary point correlation dimension algorithm the PD2i ® Algorithm and software.

With the second FDA approval under its belt in April, Vicor is fully in the process of transforming itself into a commercial company with a national sales force and international reach.

The Company has all of the regulatory approvals in place already with regards to PD2i ® to generate substantial revenues.

FDA Approval of PD2i Analyzer™ for BOTH Heart Rate Variability and Cardiovascular Disease Testing

Vicor’s PD2i Analyzer™ has FDA 510(k) marketing clearance to both:

  • Measure heart rate variability (HRV) for physician-determined use which can assess autonomic nervous system dysfunction in diabetics.
  • And be used specifically in patients undergoing cardiovascular disease testing.

Potential Market PD2i Analyzer™

The potential market for the PD2i Analyzer™ with 77 million potential patients could be in the multi-billions of dollars. This market is supported by the recent FDA approval to market the PD2i Analyzer™ for cardiovascular disease testing is anticipated to spur market acceptance of the PD2i Analyzer™ as a valuable new diagnostic.

The groundbreaking 510(k) obtained in April of 2011, for the use of the PD2i® metric includes the classical Ewing maneuvers with the PD2i® metric in patients undergoing cardiovascular disease testing.

This FDA Approval is an accomplishment of incredible significance for VCRT as both national and international acceptance begin to accelerate. This landmark approval has been sought since the first introduction of the PD2i ® technology by Vicor in 2003.

These populations are significant:

  • 23.6 million diabetics
  • 15 million at-risk cardiac patients
  • 38 million trauma incidents

PD2i ® Analyzer Provides Additional Revenue Source for Physicians and Improves Patient Care

Physicians can now expect a higher return on investment with the April 2011 FDA 501(k) for cardiovascular disease testing.

Vicor is now able to broaden its marketing message and could significantly increase interest in the Analyzer particularly with cardiologists. Physicians are able to use the Analyzer for indications believed to be useful. FDA clearance of specific indications allows Vicor to explicitly market for those indications.

Current procedural terminology (CPT) codes enable physicians using the PD2i® Analyzer to be reimbursed by insurance carriers, creating a recurring source of revenue from test analysis for Vicor.

The PD2i® Analyzer is used as a diagnostic for heart rate variability, which is a widely-accepted measure of autonomic nervous system health and by extension cardiac health.

The PD2i ® Algorithm facilitates the ability of physicians to accurately risk stratify a specific target population to predict future pathological events such as autonomic nervous system dysfunction, cardiac mortality (either from arrhythmic death or congestive heart failure) and imminent death from trauma.

PD2i ® Algorithm New and Accurate Vital Sign

The Company believes that the PD2i ® Algorithm represents a noninvasive monitoring technology that physicians and other members of the medical community can use as a new and accurate vital sign.

Two proprietary diagnostic medical products are being commercialized which employ software utilizing the PD2i ® Algorithm:

  • First – the PD2i® Analyzer
  • Second - the PD2i Cardiac Analyzer ™
  • The PD2i VS ™ Vital Sign Monitor for trauma, triage, and other hospital uses in still  under development.

 

FDA Clearance

In April 2011 the Company received 510(k) clearance from the U.S. Food and Drug Administration for its PD2i® nonlinear algorithm and software to be used as a measure of heart rate variability at rest and in response to controlled exercise and paced respiration (Ewing Maneuvers) in patients specifically undergoing cardiovascular disease testing.

Physician use of the PD2i® Analyzer is supported by an expanding body of literature demonstrating the value of the PD2i® nonlinear algorithm as a metric for risk stratifying specific target populations for future pathological events.

Physician Use Includes :

  • Diabetics for the presence of diabetic autonomic neuropathy (DAN),
  • Cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and
  • Trauma victims for imminent death absent immediate lifesaving intervention.

Sales

The Company has engaged various independent sales agents and sales representatives to market and sell its products in selected geographic areas in the United States.

Revenues will be predominately the result of equipment sales, fees from physicians and other health-care providers related to the analysis of test results and licensing fees.


 

 

Revenue Sources

A national sales manager with a long and successful history in medical device sales has been retained. The sales force has expanded geographically. Vicor expects to continue to increase the size of its domestic sales force throughout 2011, to approximately 70 Sales Representatives by the end of 2011

Equipment sales: Sales to physicians and other health care providers through both sales representatives employed by the Company and also independent sales agents.

Leasing option: Agreement with equipment leasing company signed in early 2011 allows physicians to obtain the Analyzer without the upfront cost.

International Distribution: An agreement with a distributor for Asia and Israel has been reached. Vicor currently is negotiating contracts for distribution in Middle East and Europe.

Current procedural terminology: (CPT) codes enable physicians using the PD2i® Analyzer to measure HRV to be reimbursed by insurance carriers, creating a recurring source of revenue from test analysis for Vicor.

Direct Marketing to Cardiologists

FDA approval enables Vicor to market the PD2i® Analyzer directly to cardiologists as a diagnostic specifically targeted for use in cardiovascular disease testing.

VCRT is focused on spurring market acceptance of the PD2i® Analyzer as a valuable new diagnostic for cardiovascular disease testing.

Including the Ewing Maneuvers which are performed during PD2i Analyzer™ ECG data collection.

This recognition represents the PD2i® Analyzer as a meaningful metric for cardiovascular testing and validation of, from a regulatory perspective, our use of the Internet for the delivery of test data and analyses.

While cardiologists are already among users of the PD2i® Analyzer as a diagnostic for heart rate variability, which is a widely-accepted measure of autonomic nervous system health and by extension cardiac health, the Company anticipates this new clearance will contribute positively to the cardiologist-directed marketing efforts of the PD2i® Analyzer.

Plan of Operations

1. Increasing sales of the PD2i® Analyzer to physicians and health care facilities in the United States through the use of independent sales agents and direct sales personnel.

2. Raising additional capital with which to expand the sales and administrative infrastructure and fund ongoing operations until our operations generate positive cash flow.

3. Completing various clinical trials and 510(k) submissions to secure additional marketing claims for the PD2i® Analyzer to enhance and accelerate marketing efforts.

4. Initiating international sales of the PD2i® Analyzer and PD2i-VS® (Vital Sign), including securing CE Mark Clearance.

Diagnostics that enable inexpensive, accurate, and early identification of disease states in at-risk populations prior to costly treatments for advanced disease or resulting from inaccurate identification are garnering increased attention in the current health care reform environment.

Conference Exposure

Exposure through presentations at prestigious events and publication in prominent journals is one of the most influential forms of marketing and Vicor has extensive participation conference plans for 2011.

This direct exposure to physicians and the medical community represents a potential catalyst for sales and growth.

 

The Company has attended recent conferences including:

  • The American Heart Association in November of 2010
  • The American College of Cardiology in April of 2011.  One of Vicor’s congestive heart failure studies was presented by the researcher.
  • Vicor was just in attendance at the Heart Rhythes Society Conference in May
  • Vicor’s Chief Medical Officer is due to make a presentation to the Israeli Trauma Society meeting this summer.

 

Clinical Studies

Clinical studies completed or initiated have been conclusive concerning the ability of the PD2i ® metric to be predictive of future pathological events.

This is of great significance to the medical community in terms of enabling physicians to easily risk stratify their patients as well as use these results to better manage their care.

The body of literature documenting the PD2i(R) nonlinear algorithm as a metric for risk stratifying specific target populations for future pathological events is constantly expanding.

Over 60 published manuscripts exist regarding the use of the PD2i® by physicians and scientists around the world in a multitude of disease states and modalities exist . Many of the researchers are well published and respected internationally.

These independent studies, which are not for FDA-approved indications, include the use of Vicor’s PD2i® nonlinear algorithm to:

  • Predict seizure
  • Monitor transplant rejection
  • Analyze ventricular fibrillation
  • Identify depression
  • Determine risk in Sleep apnea
  • Autoimmune system imbalance detection
  • See the increased neural complexity in schizophrenic patients
  • Determine the impact of ECT therapy on depression
  • Monitor the effect of estrogen and testosterone on convergent and divergent thinking
  • Locate seizure focus for epileptic surgery.

These independent studies attest that Vicor’s PD2i® nonlinear algorithm has successfully demonstrated the ability to accurately measure heart rate variability to predict and identify a variety of medical conditions and disorders.

The range of human conditions and disorders that can be identified early in their arc and thereby provide physicians with the ability to enhance patient treatment and outcomes.

Continuing clinical studies are ongoing in a variety of areas — chief among these, sudden cardiac death and head trauma in athletes — to establish the PD2i® Analyzer as a widely used diagnostic in the clinical setting.

 

Patent and Proprietary Rights

Vicor has issued patents covering the core systems with the PD2i® Algorithm and methods of identifying biological anomalies using this algorithm as well as issued patents covering machines and methods for data manipulation for use with the PD2i® Algorithm from United States of America (5,709,214), United States of America (5,720,294), Azerbaijan (008979), Armenia (008979), Belarus (008979), Kazakhstan (008979), Kyrgyzstan (008979), Moldova, Republic of (008979), New Zealand (54202), Russian Federation (008979), South Africa (2005/06909), Tajikistan (008979), Turkmenistan (008979), United States of America (7,076,288) and United States of America (7,276,026). It has been allowed in Australia (Australian Patent Application 2004208161) and Israel (Israel Patent Application 169988). There are also a number of patent applications around the world covering additional aspects and uses of the PD2i® technology, which if issued will increase the coverage around technologies utilizing the PD2i® Algorithm.

 

Scientific Advisory Board

Vicor has assembled a Scientific Advisory Board consisting of medical doctors and other professionals with experience in relevant scientific and medical fields. The advisory board provides thought-leader guidance to management regarding science, research and product development.

Edward F. Lundy, M.D., Ph.D.
Chief of Cardiothoracic Surgery at Good Samaritan Hospital
Ph.D. in Physiology with focus on altered-state physiologies (hibernation)

Mark E. Josephson, M.D.
Chief of Cardiology at Beth Israel Deaconness Medical Center
Author of “Clinical Cardiac Electrophysiology”
Scientific Advisor to over 20 companies

Hein J. J. Wellens, M.D.
Professor & Chairman of Department of Cardiology Academisch Ziekenhuis Maastricht
Director of Interuniversity Cardiology Institute of the Netherlands

Richard M. Luceri, M.D., F.A.C.C.
Director Interventional Arrhythmia Center, Holy Cross Hospital
Clinical investigator in MADIT II Trial
Clinical investigator & Principal Author SCD-HeFT Trial

Jules Mitchel, Ph.D., MBA
Founder and President/CEO Target Health Inc. NYC

Robert G. Hauser, M.D., F.A.C.C., FHRS
Senior Consulting Cardiologist – Minneapolis Heart Institute
Chairman Cardiovascular Services Division at Abbott Northwestern Hospital
Chief Executive Officer of Cardiac Pacemakers, Inc –acquired by Guidant

Jonathan Kaplan, M.D., M.P.H.
Medical Director of Fidelis Care in New York
Former Medical Director for Excellus Blue Cross Blue Shield

David Chazanovitz
Former CEO of Cambridge Heart, Inc.

Management

David H. Fater

President and  Chief Executive Officer, Director

Joining Vicor in 2002, Mr. Fater serves as President, Chief Executive Officer.

Mr. Fater is also the founder and Chief Executive Officer of ALDA & Associates International Inc., a business and financial consulting firm providing capital formation, capital allocation, and profit optimization services to small companies, primarily in the health care and life sciences industries. Since ALDA’s formation in 1993, Mr. Fater has worked with more than 50 entrepreneur-founded companies. As a company senior executive, he led BMJ Medical Management, Inc. (1997-1999) and Community Care of America (1995-1996) through the IPO process, and led Coastal Physician Group, Inc. (1993-1995) to a NYSE listing and $1.0 billion market capitalization.

Prior to forming ALDA & Associates, Mr. Fater was employed by Ernst & Young. 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, PhD

Interim Chairman, 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 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, PhD

Vice President, Director of Product 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 joining 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 used 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, MD, FACC

Chief Medical Officer

With Vicor since 2004, Dr. Weiss has extensive experience in the practice of cardiology and electrophysiology. Dr. Weiss is a partner with Florida Arrythmia Consultants and a former director of the Jim Moran Heart and Vascular Center. He has served as a consultant to Fortune 500 medical device manufacturers, including Medtronics, St. Jude Medical, and Guidant. He also served as the clinical investigator on the two most important clinical trials involving the study of ICDs and SCD (MADIT-II (MultiCenter Automatic Defibrillator Implantation Trial) and SCD HeFT (Sudden Cardiac Death Heart Failure Trial).

Dr. Weiss received a MD with Distinction in Research from the Mount Sinai School of Medicine, from which he also received the Nathan A. Setz Award for Research in Cardiovascular and Renal Disease. He holds a BSE cum laude in Electrical Engineering and Computer Science from Princeton University.

Richard M. Cohen, PhD

Vice President of Corporate and Business Development, Chief Operating Officer

Richard Cohen was appointed to serve as Vice President of Business Development on January 1, 2008. Since 2001, Dr. Cohen has been the Chief Operating Officer of ALDA & Associates International, Inc., a business and consulting firm providing capital formation, capital allocation, and profit optimization services to small companies, primarily in the healthcare and life sciences industries. In his capacity as ALDA’s Chief Operating Officer and in connection with certain consulting engagements, Dr. Cohen has served as the Chief Executive Officer of two healthcare companies and two medical device companies. He has more than 30 years of experience in international manufacturing and operations, predominantly in the Far East and South America.

Dr. Cohen holds a PhD in International Business from Buxton University and a BS in Business Marketing from Kentucky Wesleyan University.

Thomas J. Bohannon, CPA

Chief Financial Officer, Chief Accounting Officer

Mr. Bohannon was appointed to serve as the Chief Accounting Officer of the Company effective December 28, 2008. Mr. Bohannon has been in the accounting and financial field for more than 40 years. Prior to joining Vicor, Mr. Bohannon ran an independent consulting practice from which he served as financial officer for a variety of companies in the Southeast United States. Earlier, he was partner in charge of audit and review services for Pappadakis, Nelson & Bohannon (1978—1991). Before that, he was a senior manager specializing in financial and SEC reporting at Ernst & Young in Atlanta.

Board of Directors

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 Joseph C. Franchetti (2008), Ronald A. Malone (2010), and Frank B. Wheeler (2010) (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 2013 Annual Meeting.

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 has been on the board since 2008.  He 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.

Ronald A. Malone

Ronald A. Malone is the former chief executive officer (6/02-9/08) and current chairman of the Board (6/02-present) of Gentiva Health Services, Inc., the leading provider of home healthcare services in the U.S. Earlier, Mr. Malone served in various executive positions at Gentiva (3/00-6/02). Prior to joining Gentiva, Mr. Malone held various executive positions with Olsten Corporation, a world leader in staffing services and the leading provider of home healthcare and related services in North America. Mr. Malone also serves on the Board of Directors of Hill-Rom Holdings, Inc., a worldwide manufacturer and provider of medical technologies and related services for the healthcare industry, and Capital Senior Living Corporation, a leading operator of senior living communities in the U.S. Mr. Malone holds a bachelors degree from Furman University.

Frank B. Wheeler

Former Ambassador Frank B. Wheeler is an independent business consultant involved with health insurance and software companies. He currently serves as chairman of the British-Chilean Chamber of Commerce in London, and was international adviser to the English Football Association in its campaign to host the 2006 World Cup. Mr. Wheeler was a member of the British Diplomatic Service for 35 years until his retirement in 1997. During his tenure, he was Ambassador to Chile and Ecuador, Charge d’Affairs in Czechoslovakia, and foreign policy adviser on East-West affairs and Middle East issues. Mr. Wheeler holds an Advanced Level Certificate in French and German from the Mill Hill School in London. He is a graduate in Russian Studies from the Joint Services College for Linguists and obtained Diploma in Economics from the Treasury Centre for Administrative Studies in London.

Contact:
David H. Fater, CEO
Vicor Technologies, Inc.
561.995.7313
dfater@vicortech.com

Caution Regarding Forward-Looking Statements Forward-looking statements in this press release are based on current plans and expectations that are subject to uncertainties and risks, which could cause our future results to differ materially. The following factors, among others, could cause our actual results to differ: our ability to successfully complete the normal range study for PD2i(R) values; our ability to generate revenues from the sale of the PD2i Analyzer(TM); our ability to obtain the necessary regulatory approvals to market the PD2i Analyzer(TM); our ability to develop additional applications for the PD2i Analyzer(TM); our ability to continue to receive financing sufficient to continue operations and complete critical clinical trials; our ability to continue as a going concern; our ability to successfully develop products based on our technologies; our ability to obtain and maintain adequate levels of third-party reimbursement for our products; the impact of competitive products and pricing; our ability to receive regulatory approval for our products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for our technologies; the ability of third-party manufacturers to manufacture our products; our ability to retain the services of our key personnel; our ability to market and sell our products successfully; our ability to protect our intellectual property; product liability; changes in federal income tax laws and regulations; general market conditions in the medical device and pharmaceutical industries; and other matters that are described in Vicor’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and subsequent filings with the Securities and Exchange Commission. Forward-looking statements in this press release speak only as of the date of the press release, and we assume no obligation to update forward-looking statements or the reasons why actual results could differ Disclaimer The appearance of name-brand institutions, such as the American College of Cardiology, the Heart Research Follow-up Program at the University of Rochester Medical Center and Active International Cardiovascular Institute at Good Samaritan Hospital, in this media release does not constitute endorsement by institutions of the information, products or services contained therein.

 

VCRT Disclosure: Pentony Enterprises LLC entered into an investor relations consulting and market awareness contract with VCRT. We are also doing a video on ShareholderVision.com that will be released shortly.  The Company will pay us a total of seventy two hundred dollars and fifty thousand shares of restricted 144 stock for the period ending August 31, 2011. We still hold hold these shares.  To avoid all potential conflicts of interest, we never sell shares into the open market during an active market awareness or investor relations program. This means that as we release new information about a particular client company either on our site or otherwise authored by us, you can be confident we are not selling shares at the same time. 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 early 2010, the Company paid us seventy two hundred dollars and fifty thousand shares of restricted 144 stock for a prior round of coverage that ended.   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. Pentony Enterprises LLC – 1601 Berwick Drive – McKinney, Texas 75070 – (469) 252-3031.

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