Modern Approaches to Heart Disease Detection - Carl H. Rosner, CardioMag Imaging, Inc.
Modern Approaches to Heart Disease Detection pp Medical Device Presentation Carl H. Rosner November 2012 CardioMag Has Developed A Key to Prevention and Avoidance of Heart Attacks CONFIDENTIAL/PROPRIETARY NOTICE: This presentation contains p p p proprietary information of CardioMag Imaging, Inc. It is for use only as directed by y g g g, y y CardioMag, and may not be used for any other purpose or disclosed to others or reproduced, in whole or in part, without CardioMag’s prior written authorization. Statements presented in this presentation which are not historical fact are forward looking statements which involve various important assumptions, risk, uncertainties and other factors set forth herein, including but not limited to, obtaining additional FDA clearance, market acceptance, insurance companies reimbursement policies on particular diagnostic applications and the growth of customer acceptance. Given these uncertainties, readers of this presentation are cautioned not to place any undue reliance on such forward looking statements. The Company disclaims any obligation to update any such forward looking statements in this document to reflect future events or developments.
OVERVIEW of Presentation• Causes of Heart Disease• Progress Over Past Decade• Heart Disease in America• List of Cardiology Societies• More Statistics• Approach to Patient Evaluation/Treatment• Ideal Solution to Avoid Heart Attacks and Possibly Other Procedures• IT IS HERE! - MagnetoCardioGraphy (MCG)• Existing Technologies• MCG Equipment View• Test Information• Economic Benefits• Clinical Results• Publications• Suitable for Testing Everybody, Especially Women, Athletes and Children• Conclusion
GENERAL AGREEMENT: Causes of Heart Disease (CVD)I. KEY PROBLEM – As People Age – Their Heart AgesII. FAMILY HERITAGE – Plus Individual Characteristics and Behavior - High Blood Pressure - High Cholesterol - Diabetes - Obesity - Physical Inactivity / OR too much - Poor Diet - Excessive Alcohol Use - Smoking - Inadequate Sleep
INTRODUCTIONENORMOUS PROGRESS OVER PAST DECADE IN: Exciting New Technologies Continually Being Pursued• Evaluating Heart Disease Non-Invasively Non Invasively• Treating Heart Disease with Pharmaceuticals• Treatments of Heart Disease with Invasive Procedures• Opening Clogged Arteries with Stents• By-Pass Operations – Replacing Arteries• Replacements of Entire HeartsYET1. Almost 1 Million Americans per year have Heart Attacks or Stroke – of whom almost 500,000 DIE.1.1 Cardiologists know that about 90 Percent of Heart Attacks are Preventable!!2. What Needs To Be Done to Accomplish Such A Goal?
Heart Disease in America – The EpidemicThe Hidden Epidemic: Heart Disease in America“Heart disease is the number one killer in America and one of the nation’s greatest health challenges for both men and women. More than half of all people who die of heart disease succumb suddenly without warning - and the other half have the disease lurking in their body for many years before it strikes. “Phillip, 44, worked out played golf, and died suddenly of a massive heart attack.Pat,Pat 57, did ’t know she h d hi h bl d pressure and di b t – until th lled t h h t attack. didn’t k h had high blood d diabetes til they d to her heart tt kRobin, 42, knew that an inherited form of high cholesterol put her at risk, but her first of multiple heartattacks caught her by surprise.
GENERAL AGREEMENT: Reduce Heart Disease (CVD)III. Cardiologists’ Approach Today (Generally) - Check Blood Pressure once a year - Check Weight - Measure EKG Diagram – 12 Leads - Admonish patient to observe healthy life styles - Recommend Daily Dose of Aspirin - Prescribe – if Necessary – Cholesterol lowering drugs - Prescribe – if Necessary – Blood Pressure lowering drugs - If indicators are serious – proceed to invasive procedures such as CT, Nuclear Stress Tests, Angiography or moreIV.IV Newer Methods (Work in Progress) - Functional MRI - Meditation - Stem Cells Plus Others
CARDIOLOGY AND CARDIOVASCULAR PROFESSIONAL SOCIETIES AND ASSOCIATIONS• The American Heart Association• American College of Cardiology• Heart Failure Society of America (HFSA)• American Society of Echocardiography (ASE)• Alliance of Cardiovascular Professionals (ACVP)• American College of Chest Physicians (ACCP)• Society f I S i t of Invasive Cardiovascular P f i C di l Professionals (SICP) i l• American Association of Heart Failure Nurses (AAHFN)• Cardiovascular Credentialing International (CCI)• American Society of Nuclear Cardiology (ASNC)• National Heart, Lung and Blood Institute• WomenHeart• World Heart Federation• The National Heart Forum• Cardia Arrhythmias Research and Education Foundation (CARE)• Children’s Heart Association
Existing Technology LimitationsThe quick tests (EKG, blood tests)• lack accuracy – delayed results y y Indications of a heart attack include sweating, anxiety and chest painsThe expensive tests (SPECT, MRI, CT)• Take too long - Cells DIE if MI• Require specialists to perform• Not usually available 24/7• S Some also i l involve i j ti of l injection f radioactive chemicals• Some involve very heavy doses of x-rays or Gamma rays
MORE STATISTICS1. The U.S. spends about $300 Billion on Heart Disease Annually! y2. Twice as many women than men die from Heart Attacks.3. The initial test for Heart Disease is the over 100 year old EKG (which is about 40 – 50 percent accurate).4. Heart Dysfunction often leads to Stroke.5. Many more men and women die from Heart Disease than from Cancer.
MAGNETOCARDIOGRAPHY (MCG) EXPLAINED New Approach To Heart Health TestingMagnetoCardioGraphy is the continuous recording of the magnetic fields created by cardiac electric activity.MCG sensors do not contact the patient who can remain dressed.MCG is entirely non-invasive with no injections or radiation required.Test results for existence or absence of Cardiac Dysfunction are displayed within 15 minutes from beginning of procedure.
INITIAL VALUE PROPOSITION11.2 million chest pain visits to the Emergency Room each year 7 million admissions 4.2 million discharged 4,900,000 no ACS* 700,000 MI 210,000 missed MI† Billions of $ in excess costs >1 in 9 will die in 30 days MCG can save MCG can save a life $5000 per patient every thirty minutes *Acute Coronary Syndrome †Myocardial Infarction
SYSTEM PARAMETERS NEEDED TO REDUCE HEART DISEASE• Organize Prevention Program (Develop Compensation)• Early Detection of Cardiac Dysfunction• Early Treatment (Still Relatively Inexpensive)• Regular Monitoring of Functional Cardiac Changes• Patient Can Remain Dressed• Test Procedure Less Than 10 – 15 Minutes• Results Available in Real-Time Immediately Thereafter• Equipment Can be Operated by Nurse/Technician• Test Totally Safe – No Injections or Radiation• Test Over 90 Percent Accurate• Test Recordings In Visual Color Format• Remotely Readable• FDA Approved – Needs Recognition By Medical Societies• Insurance Needs to Pay For Tests• Periodic Tests d Early Treatment A id H t Att k P i di T t and E l T t t Avoid Heart Attacks
The CardioMag MCG System* * FDA Cleared •No radiation No •No biohazards •No injections •24x7 operation •Patient at rest •15 minute test •Quantitative results Q tit ti lt CLEEARED
CardioMag’s New Cardiac Diagnostic Technology Offers Major Benefits To:• PATIENTS – No Radiation, Non-Invasive Test• CARDIOLOGISTS – Earn More Money• HOSPITALS – Increased Incomes• INVESTORS – High Return on Investment g• INSURANCE CO’S – Reduced Expenses/Costs 10 Minute Test is Safe Results are Immediate Safe, 5th Year Goal – Population Screening: Early Detection of Heart Disease
Company Information• CardioMag Imaging Inc. formed in 1999; Delaware Incorporation• 2004 – FDA Clearance, CE mark in Europe for MCG Clearance• 2005 – Med. Device Reg. in China, Russia• 2005 – Raised $ 7,200,000 (Net) – London / AIM Exchange• 2006 – Left AIM Exchange – No Realistic Benefits• 2007 - Audited Statements Available Since 2001• 2008 - Marketable Systems Available For Installation• 2012 - More Patents – US and Internationally CardioMag Has: 12,000,000 Shares Outstanding Approx. Approx 120 shareholders $23 Million Tax Loss CarryForward CardioMag is inviting a limited number of sophisticated investors to join the Company’s shareholders.
The MCG Measurement Preparation • Remove metallic items • Connect 3 ECG leads • Rough positioning • Fine positioning using laser pointer • Lower sensors • Lock bed oc
Heart disease = fingerprint in MCG Example: Colour magnetic field maps during repolarization Normal 100% LCX 3 vessel disease Normal := homogeneous, stable, correct orientation Abnormal := inhomogeneous, dynamic, wrong orientation
Economic Benefits to Hospitals / Clinics•Scanner th S throughput up to 5000 per year ( <15 min / patient t t ) h t t 15 i ti t test – Just $300 per test yields $1,500,000 revenue•Improved worker productivity (less lost time out of office)e) p p y( ) )•Catch disease earlier while amenable to aggressive medical therapy•Faster turnover of beds (avoid ER overcrowding) Faster overcrowding), more efficient use of resources• Capture more DRG value – Avoid multiple diagnostic procedures g•Increase Cathlab Volume, especially with patients needing intervention•Keep lower risk cardiology patients from being sent to another hospital•Avoid litigation (inadvertent discharge of patient with MI)
Published Clinical Results - Example Park et al*: “The high predictive values of the admission MCG could make it possible to more accurately and in a very early stage select [ACS] patients who should proceed quickly to invasive coronary angiography.” Sensitivity y 95.1 % Specificity 92.8 % PPV 97.8 % NPV 84.8 84 8 % No. of Patients 185Published in : A.N.E. 10(3):1–12, April 2005*Jai-Wun Park, Peter M. Hill, Namsik Chung, Paul G. Hugenholtz, and Friedrich JungHoyerswerda Hospital, Germany; Johns Hopkins University; Yonsei University, Seoul, Korea; Erasmus University,Rotterdam, The Netherlands; Institute for Heart - and Circulation Research, Hoyerswerda, Germany; University ofSaarland, Homburg/Saar, Germany
Publications/Talks are Increasing• Magnetocardiography study on ventricular depolarization-current pattern in patients with brugada syndrome and complete right-bundle branch blocks [Pacing Clin. EP]• Comparison of magnetocardiography and electrocardiography: a study of automatic measurement of dispersion of ventricular repolarization [Europace]• QRS duration in high-resolution methods and standard ECG in risk assessment after first and recurrent myocardial infarctions [Pacing Clin. EP]• Magnetocardiographic assessment of healed myocardial infarction [ANE]• Three-dimensional recovery time dispersion map by 64-channel magnetocardiography may demonstrate the location of a myocardial injury and heterogeneity of repolarization [Int Jrl CV Imaging]• Magnetocardiography changes in coronary artery disease patients with normal or unspecialized resting electrocardiogram [Chinese Jrl of CV Disease]• Magnetocardiographic diagnosis for myocardial ischemia and arrhythmias [Clin Disease Science]• Increased intra-QRS fragmentation in magnetocardiography as a predictor of arrhythmic events and intra QRS mortality in patients with cardiac dysfunction after myocardial infarction [Jrl CV EP]• Magnetocardiographic markers of functional hemodynamic overloading of the right atrium [Aviakosm Ekolog Med ]• Identification of patients with coronary artery disease using magnetocardiographic signal analysis [Biomed Tech]• Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain [Cardiology]• Electrical space-time abnormalities of ventricular depolarization in patients with Brugada syndrome and patients with complete right-bundle branch blocks studied by magnetocardiography [Pacing Clin. EP]
Athletes Advised to Take Heart TestsScreening could be an entry requirement for competitionsAthletes should be screened for heart conditions before taking part in sporting competitions, a coroner has said. Columbia Football to Participate in Heart Screening Program Screening and treatment are necessary to meet the i i th rising problem of obesity in th U it d bl f b it i the United States, the task force said …
A SOLUTION FOR 21ST CENTURYCARDIOLOGISTS ‘SEE’ HEART FUNCTIONS
CONCLUSION• Magnetocardiography (MCG): a sophisticated new technology that provides rapid, unique and valuable information about early signs of heart disease in a safe and Radiation-Free Patient and Physician Radiation Free environment. – The technique relies on analyzing magnetic fields generated by the heart s heart’s electrical activity and quantitatively measuring dynamic behavior of ventricular repolarization. – Using this information a physician can determine the earliest of risk that a patient might have coronary artery disease and -- for some patients -- the relative risk of sudden cardiac death.• MCG Complements and adds to Existing Technology• MCG creates a New Market Space in large Cap-Ex Area of Cardiac Diagnostics to favorably impact HealthCare Costs, saving $ Billions.
Thank You13 British American Blvd. Latham, NY 12110 L th 518-381-1000 www.cardiomag.com