Diagnostics: Novel Approaches

Institute for Atherosclerosis ResearchSkolkovo Innovative Center, Resident

• 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

European Cardiovascular Disease Statistics 2010

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.

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

problem: no adequate methods of individual risk assessment

decision: novel highly informative markers + novel methodology

Software & Hardware Complex

Risk factors &

Biochemistry

Physician

Conclusion

UltrasoundGenetics *Genetics *

* Genetic diagnostics: principally novel markers (mutations in mitochondrial genome)

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

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

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

• 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)

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