1 Supersensitive magnetocardiographic system for early recognition, precise diagnostics and monitoring of heart diseases 12.10.2006 Kiev Dr.Volodymyr Sosnytskyy.

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Supersensitive magnetocardiographic system for early recognition, precise diagnostics and

monitoring of heart diseases

12.10.2006

Kiev

Dr.Volodymyr Sosnytskyy

+38(044)5013072

[email protected]

Kiev Medical Group, Ltd.

Kiev

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Proprietary information statement

• The technology material presented in this talk is available for licensing or joint product development.

• None of the slides contain any confidential or proprietary information which would prevent patenting the technology.

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Problem Description & Market Need

- Ischemic heart disease is the leading cause of death in Western countries.

- The early noninvasive diagnosis of ischemia is one of the major clinical problems that could benefit from the additional information provided by MCG.

- MCG can identify propensity to ventricular arrhythmias, in heart diseases , independently of other clinical variables.

- Contactless MCG can be ideal for research and development of new drugs and for experimental evaluation of gene therapy.

- The vicious circle: lack of clinical equipment -> clinician skepticism ( lack of experience) -> lack of evidence-based clinical benefit -> no real market -> lack of investment -> lack of development of clinical equipment.

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Brief technology description

• MCG is the measurement of magnetic fields emitted by the human heart from small currents by electrically active cells of the heart muscle.

• MCG is a completely noninvasive method that permits the registration of cardiac electrical activity at multiple site in a plane above the chest cage without the need for electrodes.

• MCG is both a method to record cardiac signals and to provide 3D functional imaging of cardiac electrophysiology.

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Map of magnetic field distribution on Tapex

Averaged MCG 36-channels

Map of current density distribution on Tapex

Normal MCGNormal MCG

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Advantages• MCG is modern imaging and quantitative analysis technique for detection

abnormal difference in electrophysiological cardiac phenomena

• Magnetocardiography (MCG) is a noninvasive and risk-free technique for contactless surface mapping of the magnetic fields generated by the electrical activity of the heart.

• This SQUID-based MCG system has a high potential for health care, especially because it could be used in hospital environments without expensive and inflexible magnetic shielded rooms.

• Recent availability of budget-price multichannel minisystems for unshielded MCG.

• MCG has been accepted as a clinical tool.

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Experimental results

MCG – Animal Studies

PHANTOM AND SOURCE MODELING

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MCG 84.6 %

Sensitivity Specificity

- 90 -

- 80 -

- 70 -

- 60 -

- 50 -

- 40 -

- 30 -

- 20 -

- 10 -ECG at rest

Exercise-ECG

Holter monitoring

Stress-EchoCG

PET

Stress Scintigraphy

ECG at rest

Exercise-ECG

Holter monitoring

Stress-EchoCG

PET

Stress Scintigraphy

MCG 90.5 %

Sensitivity & Specificity of MCG in CAD with normal ECG

Clinical Trials (CAD with normal ECG vs. Controls)

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Stage of development

• System is ready for application• Clinical Trials: detection of myocardial ischemia

and arrhythmogenic risk assessment

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Targeted Market Segment

• MCG can be used for noninvasive diagnosis of cardiac events related to :

- coronary artery disease (CAD),

- safety of all medical drugs with respect to the drugs potential to cause heart arrhythmia,

- early detection of graft rejection after cardiac transplantation,

- pathophysiological role and therapeutic potential of stem cells .

Introduction of MCG diagnostics into routine clinical practice can improve patient outcomes, decrease mortality and risks, increase comfort and significantly reduce cost of health care.

The cost of commercially available few-channel systems for unshielded MCG range between 200,000 and 500,000 US$

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Competition

• More expensive or invasive methods:

- Stress-echocardiography, - Single photon emission computed tomography (SPECT) - Coronary angiography

The cost of the equipment for MCG differs widely as function of approach prefered.

Small unshielded systems can now be operated by nurses or research technicians

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Competitive Matrix

Important product or technology characteristics

Kiev Medical

Group, Ltd.Cardio Mag Imaging Inc.

Cryoton Co.Ltd

Cost-effectiveness

-------------------------

automated

high

complitely

low

semi

middle

semi

The evaporation rate

L/day

1,7 2,5 2 - 3

Solution of the Inverse problem

(Software)

modern old modern

Costs

( X 1000 ) 200-300 > 300-500 > 300

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Opportunities

We look forward on international collaboration for :

• clinical trials

• joint product development

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Contact information

Dr.Volodymyr Sosnytskyy+38(044)5013072

[email protected] Kiev Medical Group, Ltd.

Kiev