This document discusses developing novel diagnostic approaches for atherosclerosis risk assessment. It outlines an institute's credentials and research in this area. The institute aims to create more accurate diagnostic kits and hardware/software using new genetic markers and methodology. This approach could increase sensitivity, specificity, and accuracy of risk assessment 1.4 to 1.9 times compared to current methods. The product aims to identify risk cases 4 to 6 times more frequently than competitors, at a lower price. The document requests investor funding of $4.8 million to develop the product and conduct validation studies.

1. Diagnostics: Novel Approaches
Institute for Atherosclerosis Research
Skolkovo Innovative Center, Resident

2. • activity in business and innovations since 1992
• 37 trademarks, licenses, certificates
• 4 DSc, 9 PhDs
• +700 publications, 8 patents, 15 patent applications
• 25 government-funded studies and projects
• 57 contracted studies

3. European Cardiovascular Disease Statistics 2010

4. Cardiologist
Conclusion
-high risk
- medium risk
- low risk
Biochemistry
cholesterol,
HDL cholesterol,
LDL cholesterol,
triglycerides
Current approach
Risk Factors
age,
gender,
hypertesion,
smoking,
diabetes,
etc.

5. International Task Force for Prevention of Coronary Heart Disease 2007
risk of infarction or cardiovascular death
3%
low
15%
intermediate
32%
high
8% population
---------------------
15% population
---------------------
77% population
37% infarctions
---------------------
33% infarctions
---------------------
30% infarctions

6. problem:
no adequate methods of individual risk assessment
decision:
novel highly informative markers + novel methodology

7. Software & Hardware Complex
Risk factors &
Biochemistry
Physician
Conclusion
UltrasoundGenetics *Genetics *
* Genetic diagnostics: principally novel markers (mutations in mitochondrial genome)

8. current
approach
our decision our is better
Sensitivity ~65% ~90% ~1,4-fold
Specificity ~60% ~85% ~1,4-fold
Accuracy ~60% ~85% ~1,4-fold
Resolution ~40% ~75% ~1,9-fold

9. Company result of diagnostics * price
Progenika
(Spain/USA)
reveal 1 case in 300-500 examinations $500
deCODE Genetics
(USA)
reveal 1 case in 40-70 examinations $500
Our decision reveal 1 case in 4-6 examinations $200
* real incidence of predisposal to atherosclerosis, 1 case in 3-4 persons

10. 01.2007 09.2012 12.2015
basic research
clinical and epidemiologic
studies
laboratory samples
prototype
verification studies
product development activities
$1.23M
~$9.7M
product optimization

11. • investments in the project ~$4.8M
• investor’s participation in the form of a contribution to share capital and/or
contribution to the property
• sale of shares when the estimated volume of sales and/or capitalization
level is achieved
• exclusive license (for profiled investor)

12. EXECUTIVE SUMMARY
problem: no adequate methods of individual risk assessment
decision: novel highly informative markers + novel methodology
product: diagnostic kits + hardware & software complex for data interpretation
competitive advantages: no direct analogues, innovative methodology, IP as
EU patent and patent applications, unbeaten diagnostic value; quantitative
estimates
market size: up to 50M potential end users in Russia; obvious perspectives
for global markets