1. MCG INVESTOR PITCH RAFFI EDIT 12-16-2016-1

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The Computational Electrophysiology Singularity THE MULTIFUNCTION CARDIOGRAM™ (MCG™) MCG™

Transcript of 1. MCG INVESTOR PITCH RAFFI EDIT 12-16-2016-1

The Computational Electrophysiology Singularity

THE MULTIFUNCTION CARDIOGRAM™

(MCG™)

MCG™

MULTIFUNCTION CARDIOGRAM (MCG) – A DIAGNOSTIC REVOLUTION VIA COMPUTATIONAL SYSTEMS BIOLOGY

Low CostAmazing Accuracy Unmatched SpeedObjective &

Quantitative Non-Invasive

Clear Market Differentiation

Cutting Edge Computational Electrophysiology

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Empirically Data Driven

3Confidential - Do Not DistributeDr. Joseph Shen • August 2015

What differentiate MCG from all the other imaging tools? Anatomy vs. Function

ACS Types MCG Current

Type 1 95 to 100% 0 to 30%

Type 2 95 to 100% 0 to 30%

Type 3 89-100% 50 to 90%

Type 4 80 to 100% 0%

MI Type 3

MI Type 4

MI Type 2

MI Type 1

How

Cur

rent

Car

diac

Tes

ts M

easu

re U

pHow Do We Compare?

Two major meta-analysis of ~ 1,000,000 people undergoing angiographyshowed ~60% false positive rate of combined use of CTA, EKG, Nuclear and Echo Stress

How

Cur

rent

Car

diac

Tes

ts M

easu

re U

pHow Do We Compare?

Two major meta-analysis of ~ 1,000,000 people undergoing angiographyshowed ~60% false positive rate of combined use of CTA, EKG, Nuclear and Echo Stress

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1.Safavi KC,

Confidential - Do Not DistributeDr. Joseph Shen • December 2016

Critical Issues to Remember

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Misdiagnosis = Tremendous Waste and Injures to the Public ($750B with $210B repeated testing) This is another reason why we urgently need a better diagnostic tool - (5)

Studies Population Source Result Date os Discovery

MCG Data-Mining ~100,000 IJMS; 2009

(1) 40% yield before 1990

Patel, et al; 398,978ACC

database NEJM (2)

38% yield 2010

Medscape ~600,000 JAMA; 2014 (3) 40% yield 2014

Anders

Eklund. et al

20 years literature

review

fMRI failed (4)

70% False Positive 2016

1. Strobeck JE et al. Comparison of a two-lead, computerized, resting ECG signal analysis device, the MultiFunction-CardioGrams or MCG (a.k.a. 3DMP), to quantitative coronary angiography for the detection of relevant coronary Artery stenosis (>70%) - A Meta-analysis of all published trials performed and analyzed in the US. International Journal of Medical Sciences 2009; 6:143-155.

2. Patel MR et al. Low diagnostic yield of elective coronary angiography. N Eng J Med 2010;362:886-95.

3. Dharmarajan K, Venkatesh AK, et al. Hospital variation in the use of noninvasive cardiac imaging and its association with downstream testing, interventions, and outcomes. JAMA Intern Med 2014; DOI:10.1001. Jama. Intern. med..2013.14407

4. Anders Eklund. et al Cluster failure: Why fMRI inferences for spatial extent have inflated false-positive rates www.pnas.org/cgi/doi/10.1073/pnas1602413113

5. IOM Report: Estimated $750B Wasted Annually In Health Care System http://khn.org/morning-breakout/iom-report/

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We are medical device and services company.

THE MAJOR GLOBAL MARKETS AND HEART DISEASE

Source: World Health Organization

Global annual cardiovascular disease deaths (17.327 million)

Americas: 1.94 million

Europe: 4.58 million

East Med.: 1.19 million

Africa: 1.25 million

SE Asia: 3.62 million

West Pacific: 4.74 million

Region / Country Annual CVD Deaths

Annual Market (USD)

China 3.87M $20.8 Billion

West Pacific (less China)

1.38M $7.40 Billion

India 2.71M $14.56 Billion

SE Asia (less India) 1.45M $7.78 Billion

Europe (incl. Russian Federation)

4.23M $22.74 Billion

Americas (less USA) 1.30M $8.28 Billion

Total (less USA) 14.94M $81.53 BillionThese include emergency markets only, and do not include other application areas (internal medicine, etc.)

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CHALLENGES OVERCOME

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INTELLECTUAL PROPERTY AND LICENSING FLOW

Innovation, Intellectual Property, Clinical Trials, R&D

$4.1Bn Annual Market

$81.5Bn Annual Market

The United States has 23.5 million patient acute chest pain emergency room visits each year. Cardiovascular disease is estimated to cost the US $1 trillion by 2030, and kills 17 million people each year globally (AHA 2015; 800K in the US).

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STRONG MOMENTUM IN USA, JAPAN, KOREA, AND IN OTHER ASIAN COUNTRIES

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•After Premier Heart Japan was established in 2010 in Tokyo, the MCG has enjoyed early and enthusiastic adoption in Japan. Japanese hospitals were some of the first to implement MCG.

• MCG systems are in 100+ hospitals and clinics across China, Japan, Korea, Nepal, Myanmar, Indonesia, the Philippines, and India, with several thousand MCG tests performed each month.

• Clinical trials to validate the MCG’s high accuracy, as well as to expand its clinical use, are being conducted in Japan, Korea, and other Asian Pacific countries in addition to the current US trials.

http://PremierHeart.jp

• Toray is the MCG’s primary Japanese marketing partner. We are finalizing a ten year technology agreement with Toray to develop the next generation of Atrial Fibrillation technology.

Pediatrics

Cardiology

Anesthesiology

Neurology

Oncology

EMERGENCY MEDICINE IS THE MOST IMMEDIATE MARKET… ... BUT ONLY THE TIP OF THE ICEBERG

Neonatal and specialty care

Intervention, surgery and specialty care

Pre-operative heart strain assessment

Stroke and neurocardiology diagnosis

Chemotherapy tolerance

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These medical applications represent revenue above and beyond our market estimates for MCG.

Screening and ongoing general carePrimary Care and Internal Medicine

Trauma care and severity assessmentFirst Responders Military or Civilian

Obstetrics and Gynecology Screening and ongoing general care for Women

THE CONVERGENCE OF TIMING AND OPPORTUNITY

• Mankind’s #1 killer.

• Decades of ineffectual, expensive, invasive, harmful, and obsolete technology.

• A tremendous and untapped global market.

Poised for Revolution

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THE SEARCH ENGINE OF YOUR HEART

THE MULTIFUNCTION CARDIOGRAM™

(MCG™)