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Dr. G.B. John Mancini,

MD, FRCPC, FACC (Cardiologist)

Director, Cardiovascular Imaging Research Care Laboratory 123 Anywhere Street Vancouver, British Columbia V6T 0I8

PreVu速 Handheld Spectrophotometer


Introducing A New Clinical Tool To Assist With Coronary Artery Disease Risk Assessment

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The World’s First and Only Non-Invasive Skin Cholesterol Test

PREVU ® HANDHELD SPECTROPHOTOMETER AND POC TEST REAGENT KIT

PreVu® Point of Care Test Benefits

COMPLETELY NON-INVASIVE Utilizes safe reagents

NO BIOHAZARDOUS MATERIALS Protection not required for test operators

CONDUCTED ON THE PALM Patient observes test on the hand

REQUIRES NO OVERNIGHT FASTING Test accurately at any time

ABSOLUTELY PAINLESS No discomfort whatsoever

NO NEEDLE PRICK OR BLOOD DRAW The skin is not punctured

WWW.PREVU.COM

TAKES LESS THAN 5 MINUTES Convenient, rapid and streamlined IMMEDIATE TEST SCORE No waiting for lab results

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Foreword Dear Colleagues: As you are aware, coronary artery disease (CAD) is one of the leading causes of death in Canada and a highly difficult condition to detect. Evaluation for CAD should ideally begin in a clinical environment where adults would undergo formal risk assessment, including blood cholesterol testing and global risk assessment, under the direction of a healthcare provider. However, many remain unassessed or avoid blood testing entirely. This can result in a potentially dangerous lack of awareness of the significant risk a person may be living with for a coronary event. Consequently, the earlier identification of individuals at risk in the general population, who could benefit from more intensive primary prevention measures to guard against a first event, is of primary concern. The PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test is a Canadian developed, non-invasive risk assessment technology designed to measure epidermal sterol, or skin cholesterol – an emerging new biomarker in the early risk assessment of CAD. The skin contains 11%, by weight, of total body cholesterol1 and is derived from epithelial steroidogenesis and specific uptake from circulation. Elevated skin cholesterol levels have been shown in clinical studies to be strongly associated with significant CAD as measured by treadmill stress testing2 and coronary angiography3, as well as measured by testing for coronary calcium4, carotid artery thickening5 and carotid artery plaque6. I was involved in early research in this area published in the American Journal of Cardiology in 2002 where skin cholesterol showed significant and positive correlations with systolic blood pressure, LDL-C and the Framingham CAD risk calculation model. We also found that skin cholesterol correlated significantly with inflammatory markers, particularly ICAM-1*.

The following presentation briefly outlines the: • • • • • •

science and technology behind the PreVu POC Test test utility and applications testing procedure step-by-step mechanism of action interpretation of results and correlated CAD risk ratios summary of key clinical references

The PreVu® POC Test does not diagnose the presence or absence of CAD, but has been shown to be effective in helping to identify individuals from the general population who may be at higher, hidden risk for CAD by possessing elevated levels of skin cholesterol. Sincerely,

Dr. G.B. John Mancini, MD, FRCPC, FACC (Cardiologist)

Director, CIRCL - Cardiovascular Imaging Research Care Laboratory Department of Medicine, The University of British Columbia Chair, PreVu Medical Advisory Board *Mancini J, Chan S, Frochlich J, et al. Association of skin cholesterol content, measured by a non-invasive method, with markers of inflammation and Framingham risk prediction. Am J Cardiol 2002;89:1313-16

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How the prevu® POC test Works An adhesive foam pad with 3 wells is placed on the palm of the hand by a test operator. Through the application of safe reagents into the wells in sequence, which react with the cholesterol on the surface of the skin, a color change is achieved. The color hue is then measured by the PreVu Handheld Spectrophotometer, which is a sophisticated optical reading instrument that also guides the test operator step-by-step through the procedure. The degree of the color hue is proportional to the amount of bound skin cholesterol on the surface of the skin. The quantitative hue reading generated by the PreVu spectrophotometer places the patient on a scale showing their risk of CAD based on the clinical data for the biomarker. A color hue reading of 110 or higher may mean an increased risk of CAD.

Prevu® POC test utility and applications The PreVu® POC Test can quickly identify individuals with hidden, higher levels of risk of CAD by testing their skin cholesterol levels non-invasively and without blood draw, discomfort or fasting. It is ideal for delivery in community healthcare settings, including neighborhood pharmacies, select medical offices and cardiovascular screening clinics, where in 5 minutes an individual can receive a ‘preview’ of their possible risk of CAD. Then, if warranted, they can start down the path towards formal global risk evaluation, primary prevention and ongoing monitoring of all their relevant risks under their healthcare provider’s direction and guidance.

PreVu® Poc Test Step-By-Step Step 1: Clean Palm; Apply Foam Pad

Step 2: Add Detector Reagent

Step 3: Add Positive Control Reagent

Step 4: Blot Excess Reagents

Step 5: Add Indicator Reagent

Step 6: Read Degree of Color Hue

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PreVu® POC Test Mechanism of Action

This image shows the Mechanism of Action by which the Detector reagent - copolymer of Digitonin conjugated with Horseradish Peroxidaise (HRP) - binds with the cholesterol of the skin and then interacts with the Indicator reagent Tetramethylbenzidine (TMB) to produce a color change, which is then read and quantified by the PreVu Handheld Spectrophotometer.

3,3’,5,5’- Tetramethylbenzidine (TMB) H3C

CH3

H2N

NH2

H3C

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CH3

Specificity based on the affinity of Digitonin for the 3b-hydroxy ring structure of cholesterol. The reporter molecule is HRP. The oxidized product of TMB has a deep blue color. The intensity of the blue color - the hue of the TMB solution - is measured directly off the hand by the PreVu Handheld Spectrophotometer.

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Interpretation of prevu® poc Test Results Elevated Skin Cholesterol Level PreVu® Score 110 or higher Elevation correlates with an increased risk of Coronary Artery Disease

Formal risk assessment is warranted, including blood cholesterol testing and global risk assessment, under the direction of a healthcare provider.

110

Borderline Skin Cholesterol Level PreVu® Score between 100 – 109

Due to test variability of approximately 10%, formal risk assessment, including blood cholesterol testing and global risk assessment under the direction of a healthcare provider, should also be considered for patients with a borderline skin cholesterol reading.

100

Normal Skin Cholesterol Level PreVu® Score below 100 Skin Cholesterol risk marker is within normal range

Further concerns about cardiovascular health pertaining to traditional risk factors such as a family history of cardiovascular disease or high blood cholesterol, being overweight, living a sedentary lifestyle or having high blood pressure, should be discussed by the patient with a healthcare provider. Note: The PreVu® POC test score does not correlate with blood cholesterol testing and is not a replacement for blood cholesterol testing.

ELEVATED SKIN CHOLESTEROL AND RISK OF CORONARY ARTERY DISEASE Individuals with elevated skin cholesterol levels as measured by the PreVu® POC Test, have been shown to haveOF a much greater risk ofCARDIOVASCULAR scoring an abnormal resultTESTS in the clinical RISK ABNORMAL WITHcardiovascular tests listed below: ELEVATED SKIN CHOLESTEROL AS MEASURED BY THE PREVU® POC TEST RISK OF ABNORMAL CLINICAL CARDIOVASCULAR TEST WITH ELEVATED SKIN CHOLESTEROL

TEST MEASURES

IF TEST RESULT ABNORMAL

2.6 times greater risk of abnormal Treadmill Stress Test2

Functional cardiovascular disease

Possible coronary artery disease

1.4 times greater risk of abnormal Coronary Angiography3

Coronary artery atherosclerosis

Blockage of coronary arteries

3.0 times greater risk of abnormal Coronary Calcium4

Calcified coronary plaque

Higher risk of future cardiac events

2.0 times greater risk of abnormal Carotid Ultrasound5 (IMT)

Carotid artery atherosclerosis

Increased risk of heart attack and stroke

3.0 times greater risk of abnormal Carotid Ultrasound6 (Plaque)

Carotid artery atherosclerosis

Increased risk of heart attack and stroke

Note: Clinical study references appear at the end of the booklet.

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Clinical References The specific clinical references made in this booklet appear below in their order of presentation: (1) (2) (3) (4) (5) (6)

Sabine, JR (1977) Cholesterol, New York: Marcel Dekkar. Zawydiwski R, Sprecher DL, Evelegh MJ, et al. A novel test for the measurement of Skin Cholesterol. Clinical Chemistry 2001;47:1302-4. Sprecher DL, Goodman SG, Kannampuzha P, et al. Skin Tissue Cholesterol (Skin Tc) is related to angiographically-defined cardiovascular disease. Atherosclerosis 2003;171:255-258. Vaidya D, Ding J, Hill JG, et al. Skin Tissue Cholesterol assay correlates with presence of coronary calcium. Atherosclerosis 2005;181:167-73. Tzou WS, Mays ME, Korcarz CE, et al. Skin Cholesterol Content Identifies Increased Carotid Intima-Media Thickness in Asymptomatic Adults. Am Heart J 2005;150:1135-39. Stein JH, Tzou WS, DeCara JM, et al. Usefulness of increased Skin Cholesterol to identify individuals at increased cardiovascular risk (from the Predictor of Advanced Subclinical Atherosclerosis Study). Am J Cardiol 2008;101:986-991.

Since 1999, there have been multiple studies, publications, scientific presentations, and abstracts and posters related to skin cholesterol and the PreVu® technology developed to measure it, that have been conducted, submitted, prepared and delivered by respected researchers from leading North American institutions in cardiovascular research including: •

University of Wisconsin, School of Medicine

The Cleveland Clinic Foundation

The Johns Hopkins School of Medicine

University of Pennsylvania, Department of Experimental Therapeutics

Much of this clinical data has been published in prestigious peer reviewed journals that include: •

The American Journal of Cardiology

The American Heart Journal

Atherosclerosis

Clinical Chemistry

Corresponding presentations have been made at some of the most important conferences and meetings in the clinical world including: •

Annual American Association of Clinical Chemistry Meeting

American Heart Association Scientific Sessions

Canadian Cardiovascular Congress

Annual Scientific Session of the American College of Cardiology

The Endocrine Society Annual Meeting

American Heart Association Conference on Arteriosclerosis, Thrombosis and Vascular Biology

For further clinical evidence please visit www.prevu.com.

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For further information on the science of skin cholesterol, the PreVu technology and the clinical applications of both in risk assessment of coronary artery disease, please visit www.prevu.com

Copyright Š 2012 by Miraculins Inc. All Rights Reserved. Unauthorized distribution, transmission or republication is strictly prohibited. PreVuŽ is a Registered Trademark of Miraculins Inc. All Rights Reserved. 2012. by

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