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0000950123-10-073342.txt : 201008050000950123-10-073342.hdr.sgml : 2010080520100805161040ACCESSION NUMBER:0000950123-10-073342CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:38CONFORMED PERIOD OF REPORT:20100805ITEM INFORMATION:Regulation FD DisclosureITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20100805DATE AS OF CHANGE:20100805

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:Vicor Technologies, Inc.CENTRAL INDEX KEY:0001335104STANDARD INDUSTRIAL CLASSIFICATION:SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]IRS NUMBER:651032053STATE OF INCORPORATION:DEFISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:000-51475FILM NUMBER:10994582

BUSINESS ADDRESS:STREET 1:2300 CORPORATE BOULEVARD NWSTREET 2:SUITE 123CITY:BOCA RATONSTATE:FLZIP:33432BUSINESS PHONE:561 995-7313

MAIL ADDRESS:STREET 1:2300 CORPORATE BOULEVARD NWSTREET 2:SUITE 123CITY:BOCA RATONSTATE:FLZIP:33432

FORMER COMPANY:FORMER CONFORMED NAME:SRKP 6 INCDATE OF NAME CHANGE:20050803

8-K1y03817e8vk.htmFORM 8-K

e8vk

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section13 or 15(d) of the
Securities Exchange Act of 1934

Dateof Report (Date of earliest event reported): August5, 2010

VICOR TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

Delaware

000-51475

20-2903491

(State or other jurisdiction
of Incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

2300 Corporate Blvd., N.W., Suite123

Boca Raton, Florida

33431

(Address of principal executive offices)

(Zip Code)

Registrants telephone number, including area code: (561)995-7313

NONE
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy thefiling obligation of the Registrant under any of the following provisions:

o Written communications pursuant to Rule425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR240.14d-2(b))

o Pre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR240.13e-4(c))

Item7.01. RegulationFD Disclosure.

Beginning on August5, 2010, representatives of Vicor Technologies, Inc. (the Company) willbe making presentations to investor groups using slides containing the information attached tothis Form 8-K as Exhibit99.1. The Company expects to use such slides, possibly with variations,for other groups at various informational meetings as part of its ongoing investor relationsprogram.

The information furnished under Item7.01 of this Current Report, including the Exhibitattached hereto, shall not be deemed filed for purposes of Section18 of the Securities ExchangeAct of 1934, nor shall it be deemed incorporated by reference in any filing under the SecuritiesAct of 1933, except as shall be expressly set forth by specific reference in such filing.

Item9.01 Financial Statements and Exhibits.

(d)Exhibits.

99.1 Slide Presentation of Vicor Technologies, Inc.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly causedthis report to be signed on its behalf by the undersigned hereunto duly authorized.

VICOR TECHNOLOGIES, INC.

Date: August 5, 2010 By: /s/ David H. Fater

David H. Fater

President and Chief Executive and
Financial Officer

EX-99.12y03817exv99w1.htmEX-99.1

exv99w1

Exhibit 99.1

Vicor Technologies, Inc. (OTCBB: VCRT)

A Medical Diagnostic Company Dedicated to theCommercialization Of Breakthrough Risk Stratification Technology

2

Safe Harbor Statement

Forward-looking statements in this presentation are based on current plans and expectations that aresubject to uncertainties and risks, which could cause our future results to differ materially. The followingfactors, among others, could cause our actual results to differ: our ability to generate revenues from the saleof the PD2i Analyzer(tm), our ability to obtain FDA approval of our 510(k) submission to secure a claim for thePD2i CA(tm)(Cardiac Analyzer) for risk stratifying congestive heart failure patients at elevated risk of cardiacmortality and our ability to obtain marketing clearance from the FDA for the PD2i VS(tm) (Vital Sign) formilitary and civilian applications; our ability to continue to receive financing sufficient to continueoperations and complete critical clinical trials; our ability to continue as a going concern; our ability tosuccessfully develop products based on our technologies; our ability to obtain and maintain adequate levelsof third-party reimbursement for our products; the impact of competitive products and pricing; our ability toreceive regulatory approval for our products; the ability of third-party contract research organizations toperform preclinical testing and clinical trials for our technologies; the ability of third-party manufacturers tomanufacture our products; our ability to retain the services of our key personnel; our ability to market andsell our products successfully; our ability to protect our intellectual property; product liability; changes infederal income tax laws and regulations; general market conditions in the medical device andpharmaceutical industries; and other matters that are described in Vicor's Annual Report on Form 10-K forthe fiscal year ended December 31, 2009 and subsequent filings with the Securities and ExchangeCommission. Forward-looking statements in this presentation speak only as of the date of the presentationand we assume no obligation to update forward-looking statements or the reasons why actual results coulddiffer.

3

Company OverviewMarket Opportunity OverviewPD2i Technology OverviewProduct Overview

Company Overview

Vicor is a medical diagnostics company, focused on commercializing non-invasive diagnostictechnology products based on its patented, proprietary algorithm (the "PD2i(r) Algorithm")and softwareThe PD2i Algorithm and related software facilitates the ability of a physician to accuratelyrisk stratify a specific target population to predict future pathological events. The initialtargeted markets are:Diabetics with autonomic nervous system dysfunctionCardiology patients at risk of cardiac events and cardiac mortalityTrauma patients in need of life saving interventionVicor is currently commercializing three proprietary diagnostic medical products based onthe PD2i(r) Algorithm and software:PD2i Analyzer(tm): Identifies diabetic patients suffering from autonomic nervous system dysfunctionPD2i Cardiac Analyzer(tm): Identifies patients at an elevated risk of suffering cardiac mortalityPD2i-VS(tm) (Vital Sign): Quickly evaluates the severity of critically-injured soldiers and civilians todetermine the need for immediate life saving interventionBased in Boca Raton, FL, Vicor was founded in 2000 and currently employs 12 employees

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Market Opportunity

The total initial domestic target market for diagnostic products utilizing the PD2i Algorithm is77 million people:23.6 million diabetics (autonomic nervous system testing) - $1.9 billion market15 million immediate at-risk cardiac patients (cardiac mortality) - $1.2 billion market38 million annual trauma events (car accidents, etc) - $0.8 billion market

5

77 Million PotentialPatientPopulation

$3.9 Billion Market for PD2i

Results in:High (~100%) sensitivityCorrectly identifying those not at riskHigh (~86%) specificityCorrectly identifying those at riskHigh statistical certainty ofresults

PD2i Technology Overview

What is the PD2i Algorithm?A non-invasive, proprietary, patented software and algorithm predictive of future pathologicalevents, including autonomic nervous system dysfunction, cardiac mortality and imminentdeath from traumaHow does the algorithm work?The PD2i Algorithm measures Heart Rate Variability (HRV)Non-linear, non-stochastic mathematical modelHeart rate variation is controlled by sensory motor loops (temperature, pH level, blood pressure, etc.)If the body is threatened by disease or trauma, the brain tries to marshal the forces in the body to act in concert The PD2i metric measures the degrees-of-freedom of the heart rate variability signalA low PD2i score indicates the body is threatenedWhy is it superior to other HRV and vital sign technologies?More accurate predictive ability (not affected by irregularities in heart rhythm or intrinsic heart disease)Short data collection window: 2-20 minutes depending upon applicationPerformed on a resting patient (less risky)User friendly and non-invasive

6

Product Overview

PD2i Analyzer and Cardiac AnalyzerProduct4-lead (12-lead at physician's option) ECG cable with automatedblood pressure device paired via USB with a laptopUser-friendly Windows-integrated device that is lighweight andportableProcessLaptop utilizes proprietary collection software, accesses the internetand sends recorded ECG data to Vicor's remote secure server foranalysis by the PD2i proprietary algorithm and softwarePhysician instantly receives electronic medical record and a reportthat the physician interprets to determine whether the patient is atriskSoftware records physician use to enable monthly automated billingPD2i-VSPD2i-VS is a product under developmentECG measurement only (no blood pressure collection)Will be used as a diagnostic/triage tool in trauma patientsWhile the data collection window for the Analyzer and the Cardiac Analyzer is 20 minutes, the PD2i-VS canidentify those trauma victims at risk of imminent death and in need of a life saving intervention in under 3minutes

7

8

Autonomic Nervous System (ANS) - PD2i Analyzer(tm)Market OpportunityMilestones and Marketing PlanCompetitive Advantages

Autonomic Nervous System (ANS) - PD2i Analyzer(tm)

Market Opportunity

What is the Autonomic Nervous System (ANS)? ANS acts as a control system for the body. It is part of both the central and peripheral nervous system,controlling organs and muscles involuntarily (heart rate, blood pressure, respiration, salivation, etc.)ANS Dysfunction is a complication of diabetes: if left untreated, leads to potentially deadly diabeticautonomic neuropathy (DAN)Cardiovascular autonomic neuropathy (CAN) is a form of DAN (17% of type I and 22% of type II diabetics)Large untapped market23.6 million diabetic patientsGrowing obesity epidemic contributes to increase in the prevalence of diabetes47.2 million tests annually: $1.9 billion market for the PD2i AnalyzerHow is DAN tested?Patient history and physical examinations proved ineffective in the early detection of DANHeart Rate Variability (HRV) measurement is now considered the standard of care for diagnosingDAN/CAN in diabeticsEarly ANS Dysfunction diagnosis:Permits physicians to properly diagnose the cause of many presenting symptoms (dizziness, palpitations,etc.)Permits physicians to adjust/select medications appropriatelyReduces/eliminates effects of ANS dysfunctionANS/DAN testing reimbursable under currently existing CPT codes

9

Autonomic Nervous System (ANS) - PD2i Analyzer(tm)

Milestones and Marketing Plan

Received 510(k) marketing clearance from the FDA in December 2008Enables Vicor to market and distribute the PD2i Analyzer(tm) for measurement of Heart Rate VariabilityClinical significance of the data determined by physicianPD2i Analyzer(tm) product sales launch in January 2010PD2i currently in use for ANS dysfunction testing in diabetic patientsReimbursement by Medicare, Medicaid and private insurers through existing CPT codes510(k) for Normal Range Study to be submitted in 2H 2010Study will enable Vicor to establish "normal" rangesPhysicians will be able to interpret results as abnormal or normalMarketing PlanSubstantial revenue generation capability with existing 510(k)Initial distribution agreement with VF Medical (25 independent sales reps in NC and SC)In-house sales efforts to initially focus on stockholder physicians and members of its National CardiacPanel Roll out in Q2 and Q3 2010 in other states (sales personnel, additional distributors)

10

Autonomic Nervous System (ANS) - PD2i Analyzer(tm)

Competitive Advantages

Heart Rate Variability (HRV) testing is the most common non-invasive method to determinepatients at risk of Autonomic Nervous System (ANS) dysfunctionAnsar Group is Vicor's principal competitor to the PD2i AnalyzerAnsar developed the ANX 3.0, a noninvasive, real time digital analyzer of autonomic nervous systemfunctioningANX 3.0 monitor costs ~$40,000 compared to $5,125 for the PD2i Analyzer(tm)Management believes that the PD2i(r) metric is a more sensitive measure of HRV in diabetic patientsthan the metric used by the ANX 3.0 - the Normal Range Study in conjunction with several studies indiabetics will be used as proofTraditional clinical screening tests (i.e. patient's history, physical exams) are ineffective forearly detection of diabetic and cardiac autonomic neuropathy (DAN/CAN)

11

12

Cardiac Mortality - PD2i Cardiac Analyzer(tm)Market OpportunityMilestones and Marketing PlanMUSIC TrialCompetitive Advantages

Cardiac Mortality - PD2i Cardiac Analyzer(tm)

Market Opportunity

81 million people affected by cardiovascular diseases in the United States:Cardiac Ischemia (heart attack): lack of blood flow and oxygen to the heartCongestive Heart Failure: heart cannot pump enough blood to organs15 million immediate at-risk patient population with cardiac disease:Sudden Cardiac Death (SCD or arrhythmic death): swift and unexpected loss of heart function, largestcause of natural death in United States (>300,000 / year)Post myocardial infarction (MI or heart attack): 8 millionCongestive heart failure (pump failure): 5 millionSyncope (fainting/dizziness) and non-ischemic dilated cardiomyopathy (damaged/enlarged heart): 2 million30 million tests annually: $1.2 billion market for the PD2i Cardiac AnalyzerAccurate identification of at-risk patients needed to implant ICDs or CRT-DsImplantable cardioverter defibrillators (ICDs) monitor heart rate and rhythm and provide a shock toprevent arrhythmic deathICDs enabled with Cardiac Resynchronization Therapy (CRT) provide assistance to the heart's pumpingability as well as a shock to prevent arrhythmic death Conventional diagnostics misidentifiy at-risk patients:Many people who don't need ICDs get implanted - 20 ICDs need to be implanted to save a single life~80% of those who do die from arrhythmic death would not even qualify for implantation under currentcriteria/methodologyThe PD2i Algorithm is the most accurate and effective easy-to-use technology in predicting the risk ofcardiac mortality: it directly addresses the over- and under-implantation of devices

13

Cardiac Mortality - PD2i Cardiac Analyzer(tm)

Milestones and Marketing Plan

Submitted 510(k) premarket notification for cardiac mortality on July 1, 2010Once approved for cardiac claim, the "PD2i Cardiac Analyzer" can be marketed for theprediction of cardiac mortality in at-risk patients Expect 510(k) clearance in 2H 2010Able to accurately risk stratify patients into those at high or low risk of suffering a fatal cardiac eventsuch as arrhythmic death or pump failure deathResults should be reviewed by qualified medical personnel and be used as an adjunct to clinical historyand the results of other testsMarketing PlanBeta tests in several practicesCedars Sinai Medical Group-Los AngelesJackson Memorial Hospital North-MiamiInitially use VF Medical's 25 sales reps in NC and SCThought Leader seminars: 2H 2010Roll out in 2H 2010 of other states

14

Cardiac Mortality - PD2i Cardiac Analyzer(tm)

"MUSIC" Trial

MUSIC trial data set was sufficient to submit the 510(k) premarket notification for cardiacmortality MERTE SUBITA EN INSUFFICIENCIA CARDIACA (MUSIC) TrialCollaboration with the University of Rochester and the Catalan Institute of Cardiovascular Sciences inBarcelonaThe trial studied the ability of the algorithm to predict cardiac events in congestive heart failure patientsLargest heart failure population ever studied: 651 patients with congestive heart failureThe first trial to document abnormal heart rhythm as a predictor of sudden cardiac deathPatients followed for a mean of 44 months138 total deaths; 52 verified arrhythmic deathsResults show the PD2i algorithm was effective in predicting:Total mortalityCardiac mortalityHeart failure mortalityThe 510(k) will broaden the market for the PD2i Analyzer as a diagnostic tool forcardiologists in their assessment of treatment options for heart failure patients

15

Cardiac Mortality - PD2i Cardiac Analyzer(tm)

Competitive Advantages

Currently existing tools to determine patients at risk of Sudden Cardiac Death (SCD orarrhythmic death) all have significant drawbacksNon-invasive tools: ECG, ambulatory monitoring, echocardiography, cardiac stress testsAre inaccurate because (a) they are insensitive to nonlinearities in the data, (b) they assume randomvariation in the data (stochastic) and (c) the system generating the data cannot change during therecordingRequires stress testing (risky for heart patients)Invasive diagnostic tools: cardiac catheterization, electrophysiology studySame type of risks that accompany any major surgeryCambridge Heart (competitor to the PD2i Cardiac Analyzer)Requires stress testing (risky for heart patients)More expensive: use costly electrodes (physicians are not separately reimbursed)Procedure cannot be performed on patients with irregular heartbeats or taking beta blockersDevice costs ~$45,000 compared to $5,125 for the PD2i Cardiac Analyzer(tm)

16

17

Trauma - PD2i-VS(tm) (Vital Sign)Market OpportunityMilestones and Marketing PlanUSAISR Trial

Trauma - PD2i-VS(tm) (Vital Sign)

Market Opportunity

PD2i-VS to be used as a diagnostic toolTo assess the severity of injury and imminent death and to determine the need for immediate life savinginterventionMilitary sector opportunity: U.S. and foreign armed forcesCritically injured soldiersCivilian sector opportunity: triage and trauma emergency response38 million annual emergency response calls (e.g. car accidents) in the United StatesTo target hospitals, emergency service providers and critical care personnel$760 million market for the PD2i-VSVS monitoring application would provide critical care personnel with ongoing statusupdates of the patient's condition18

Trauma - PD2i-VS(tm) (Vital Sign)

Milestones

Being developed in collaboration with the United States ArmyResearch and Development Agreement signed in January 2008 Allows for emergency responders to sort victims based on need for medical treatment. US Army has presented the findings at several conferences in the United States and Europe - the PD2i-VS was presented as the most promising diagnostic tool for in-field trauma triageFDA submission for 510(k) marketing clearance expected in 2H 2010If cleared, Vicor can begin marketing the PD2i-VS for a claim of trauma triageAnticipated to be used for civilian triage and trauma emergency response and in intensive care units In addition to the triage application noted above, Vicor completed programming necessaryfor the PD2i-VS to also operate as a continuous vital sign monitorThe monitor would indicate the ongoing status of the patient's condition and alert critical carepersonnel if lifesaving intervention was requiredEmergency roomsIntensive care unitsOperating rooms

19

Trauma - PD2i-VS(tm) (Vital Sign)

USAISR Trial and Other Studies

U.S. Army Institute of Surgical Research (USAISR) TrialSupports a 510(k) submission to the FDA for a marketing claim related to diagnosing patients atimminent risk of death from trauma (trauma triage)Collaborative Research and Development Agreement in January 2008"Prediction of Injury Severity and Outcome in the Critically Ill Using the Point Correlation DimensionAlgorithm (PD2i(r))": the trial studied the ability of the algorithm in the prediction of death in traumapatientsStudy of 325 trauma patients to determine which patients would die of their injuries20 deaths: all were correctly identified by low PD2i(r) valueConventional triaging techniques had indentified only 6 of the 20 patients as requiring lifesavinginterventionPD2i-VS as a continuous vital sign monitorPlanned and ongoing studies to test the PD2i-VS as a monitoring instrumentMassachusetts General HospitalUniversity of Mississippi Medical CenterFurther studies by the USAISR

20

21

Business Model / EconomicsVicorPhysician

Vicor's Business Model

"Printer, Printer Cartridge" Business ModelRevenue from the sale of the device (~$5,125)Recurring fee ($40) for each test performedExpected to be the catalyst for growth as installed unitbase increasesVicor bills the physician monthly for the number of testsperformedHigh margin productsEstimated product margin of 30%Estimated test margin of 70%22 Sample Economics Vicor Number: Tests Per Day 3 Analyzers 500 Annual Tests 375,000 Dollars: Product Revenue $2,562,500 Test Revenue $15,000,000 Total Revenue $17,562,500 Profit $11,268,750

Physician's Economics

Reimbursement to healthcare providers by third partyinsurersThere are currently 60 ICD-9 diagnosis codes availablefor reimbursement by Medicare, Medicaid and privateinsurersReimbursement to physicians will likely be ~$160 pertestIncentive for Physician UseLow up-front investmentPer test revenue (Vicor and Physician)Physician break-even in less than a month (after 51tests performed)23 Sample Economics Physician Number: Tests Per Day 3 Analyzers 1 Annual Tests 750 Dollars: Up-front investment $5,125 Revenue $160 / test Gross Profit $100 / test Total Annual Gross Profit $75,000

(1) Estimated gross profit per test after payment toVicor, technician's time and disposables.

24

ManagementScientific Advisory BoardInvestment Highlights

Management

Highly experienced management team has track record with public and high-growthcompanies as well as discovery and commercialization of products.David Fater - President and CEOOver 13 years experience as a senior executive with 3 public healthcare companiesSpent 24 years as a senior international partner with Ernst & YoungDr. Jerry Anchin, Ph.D. - VP of Product Development25 year's accumulated experience in the biotechnology diagnostic and medical device sectorActively involved in immunology, molecular biology, and drug discoveryHolds patents for 14 immunoassay and drug discovery platforms and an additional 16 patents pendingDr. Richard M. Cohen, Ph.D. - Chief Operating Officer30 year's experience in worldwide operations and sourcing for manufacturing companiesCOO of four health care companies, including two medical device companies25

Management

Dr. Daniel N. Weiss, M.D.,F.A.C.C. - Chief Medical OfficerExtensive experience as a practicing cardiologist and electrophysiologistPartner of Florida Arrhythmia Consultants. Director of the Jim Moran Heart and Vascular Center since1994Consultant to Medtronics, St. Jude Medical, and GuidantDr. James Skinner, Ph.D. - VP of Research and ScienceExtensive experience as a scientist and manager of large research and development projectsProfessor of Medicine at Baylor College of Medicine. Recipient of many research grantsPrincipal investigator of a program that operated 5 laboratories and 3 core facilitiesVicor is in the process of searching for an SVP of Sales & Marketing. Candidates in consideration are currently heading up sales efforts at major medical device companies.26

Scientific Advisory Board

Vicor has assembled a Scientific Advisory Board consisting of medical doctors and otherprofessionals with experience in relevant scientific and medical fields. The advisory boardprovides thought-leader guidance to management regarding science, research and productdevelopment.Mark E. Josephson, M.D.Chief of Cardiology at Beth Israel Deaconness Medical CenterAuthor of "Clinical Cardiac Electrophysiology"Scientific Advisor to over 20 companiesHein J. J. Wellens, M.D.Professor & Chairman of Department of Cardiology Academisch Ziekenhuis MaastrichtDirector of Interuniversity Cardiology Institute of the NetherlandsRichard M. Luceri, M.D., F.A.C.C. Director Interventional Arrhythmia Center, Holy Cross HospitalClinical investigator in MADIT II TrialClinical investigator & Principal Author SCD-HeFT TrialJules Mitchel, Ph.D., MBAFounder and President/CEO Target Health Inc. NYC

27

Scientific Advisory Board

Robert G. Hauser, M.D., F.A.C.C., FHRSSenior Consulting Cardiologist - Minneapolis Heart InstituteChairman Cardiovascular Services Division at Abbott Northwestern HospitalChief Executive Officer of Cardiac Pacemakers, Inc -acquired by Guidant Jonathan Kaplan, M.D., M.P.H.Medical Director of Fidelis Care in New YorkFormer Medical Director for Excellus Blue Cross Blue ShieldDavid ChazanovitzFormer CEO of Cambridge Heart, Inc.Edward F. Lundy, M.D., Ph.D. Chief of Cardiothoracic Surgery at Good Samaritan HospitalPh.D. in Physiology with focus on altered-state physiologies (hibernation)

28

Investment Highlights

Life Saving TechnologySubstantial Unmet Medical Need in Risk StratificationIn the Process of Entering Three Large MarketsHigh Margin, High Operating Profit ProductsAttractive Business Model: "Printer, Printer Cartridge" Model with Recurring Test RevenueHighly Experienced Management TeamWorld-Class Scientific Advisory Board

29

Thank You.

Vicor Technologies, Inc.

2300 NW Corporate Blvd.,Suite 123

Boca Raton, FL 33431

Phone: (877) 528-PD2i (7324)

Fax: (561) 995-2449 www.vicortech.com

31

AppendixAvailable ICD-9 Diagnostic CodesICD-9 Coding ExampleClinical Trials SummaryUSAISR Trial DetailsIntellectual Property

AVAILABLE DIAGNOSTIC CODES

(ICD-9 for test authorization)

32

INTERNAL MEDICINE278.01 Morbid Obesity279.3 Unspecified Immunity Deficiency296.80 Bipolar Disease311 Depression300.00 Anxiety307.4** Sleep Disorders530.11 GERD536.3 Gastroparesis564.1 Irritable Bowel Syndrome729.1 Fibromyalgia309.81 Post-Traumatic Stress Syndrome782.3 Edema

CARDIOLOGY401.0 - 405.99 Hypertension412 Post - MI413.9 Angina440.9 Atherosclerosis424.0 Mitral Valve Prolapse Syndrome425.4 Cardiomyopathy427.9 Cardiac Dysrhythmias428.0 Congestive Heart Failure

ENDOCRINOLOGY244.8 Acquired Hypothyroidism246.9 Thyroid Disorders256.31 Premature Menopausal Symptoms627.2 Menopausal SyndromesNEPHROLOGY402.90 Hypertensive Renal Disease586 Renal FailureDIABETES 250 - 250.8**NEUROLOGY307.01 Tension Headache314.01 ADD/ADHD332.0 Parkinsonism333.0 Shy-Drager Syndrom (Orthostatic Hypotension with Multisystem Degeneration)337.00 Idiopathic Peripheral Autonomic Neuropathy 358.1 Myasthenic Syndrome (Eaton-Lambert)337.2 Chronic Regional Pain Syndrome or RSD 458.0 Orthostatic Hypotension340 Multiple Sclerosis 458.1 Chronic Hypotension346.0 - 346.9** Migraine 742.8 Other Specified Congenital Anomalies of the Nervous System356.4 Idiopathic Progressive Polyneuropathy 780.2 Syncope and Collapse356.8 Other Specified Idiopathic Peripheral Neuropathy 780.4 Dizziness, Light-headedness and Vertigo356.9 Unspecified Peripheral Idiopathic Neuropathy 780.71 Chronic Fatigue Syndrome357.2 Polyneuropathy in Diabetes 780.0 Headache357.4 Polyneuropathy in Other Disease Classified Elsewhere 785.0 Tachycardia (Postural)

PULMONOLOGY780.5 - 780.59 Sleep Disturbances493.9 - 493.92** Asthma493.2** COPD (Asthma with Chronic Obstructive Pulmonary Disease)This example was put together to help aid you on proper reimbursement procedures. If you have any questions regarding reimbursement, please feel free to contact David Fater toll-free at 800-998-9964

ATTN: BILLING DEPARTMENT

ICD-9 CODING FOR VICOR MONITORING

33

CPT CODING EXAMPLE:STEP 1: Use proper diagnosis code(s) for patient. See reverse side for ICD-9 Coding list.*** (i.e., 250.6 Diabetes with neurological manifestations)STEP 2: CPT CODING for VICOR TESTING (95921 & 95922) 95921 & 95922 are separate and distinct procedures. On occasion, certain Coding Software requires the -59 Modifier be used to unbundle claims. Please contact David Fater with any questions or concerns. CPT CODE DESCRIPTION 2010 NATIONAL REIMBURSEMENT AVERAGE SUBMITTAL REQUEST 95921 Parasympathetic Nervous System Testing $75.59 $150 95922 Sympathetic Nervous System Testing $91.81 $150

PT CODING for 3-Lead Rhythm ECG:

During the Vicor test a 3-lead ECG is also performed. You may bill for this procedure in addition to Sympathetic and Parasympathetic testing, but you may not be paid separately if it's included in Vicor's testing.** This code is not specific to our technology. It is not reimbursed by every insurance provider; those that are reimbursing may require a 59Modifier. (Please refer to your states policies.) CPT CODE DESCRIPTION 2010 NATIONAL REIMBURSEMENT AVERAGE SUBMITTAL REQUEST 93000** Routine ECG with at least 12 leads; with interpretation and report $20.28 $25

Ongoing Clinical Trials & Market Potential

Ongoing Clinical Trials & Market Potential

34

Current trials underway at various institutions (some of which are sponsored by Vicor) includethe following:

PD2i VS(tm)

35

USAISR Study #1USE OF HEART-RATE COMPLEXITY TO DETERMINE THE NEED FOR LIFE SAVINGINTERVENTIONS IN COMBAT CASUALTIES

Abnormal HRC values exhibited in all patients Those requiring LSI's had Min PD2i values < 1 Findings suggest utility of PD2i for diagnosis of need for LSI

Intellectual Property

Intellectual Property

36

Patents issued related to the PD2i technology includes 4 U.S. patents (listed below) and 3foreign patents. Pending patent applications include numerous U.S. and foreign patents.

GRAPHIC3y03817y03817z0001.gifGRAPHIC

begin 644 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