Craniocerebral Therapeutic Hypothermia

Moscow, 2017
Galina Repina
+7 915 421 13 50
repina.galina@googlemail.com

PROBLEM IDENTIFICATION*:
Overheating, caused by brain injury/damage, leads to neuron destruction in the area of lesion
 Cardiovascular diseases are in the World
 Average level of traumatism in RF -
is diagnosed with alcoholism
 Migraine – and №3 reason for inability to work
1
* - For detailed description please refer to Appendix (Slides 13,14)
Galina Repina
+7 915 421 13 50

SOLUTION: CRANIOCEREBRAL HYPOTHERMIA – COOLING OF THE BRAIN*
«CryoTechnoMed» solution: Craniocerebral hypothermia using «THE-01» equipment
brain ТС, not body temperature
 No complications
various states of consciousness
Brain ТС < Body ТС
Current solution on the market: General Therapeutic Hypothermia (Cooling of the whole body)
 Edema in the area of lesion does not allow to reduce temperature in the core of injury
 Sedation and miorelaxation is required – additional expenses
 Danger of complications – additional expenses
2
Brain ТС > Body ТС
Galina Repina
+7 915 421 13 50

TECHNOLOGY OF CRANIOCEREBRAL HYPOTHERMIA USING «THE-01» EQUIPMENT (EXPLAINED)
3
2
5
1
4
3
Galina Repina
+7 915 421 13 50

APPLICATION EXPERIENCE*
Effect:




Purpose:
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Galina Repina
+7 915 421 13 50
* - For detailed description of reasons for, effects and experience of application of «THE-01» in hospitals in RF please refer to Appendix (Slides 19)
BRAIN ТС BEFORE AND AFTER APPLICATION OF «THE»
BrainТСofpatientafter
ischemicstroke
BeforeapplicationofTHE
BrainТСofpatientafter
ischemicstroke
AfterapplicationofTHE

COMPETITIVE ADVANTAGE*
BETTER
FUNCTIONALITY
MAXIMUM
SAFETY
COMFORT FOR
PATIENT
SUITABLE FOR CONSCIOUS
STATE, COMA, MEDICAL
ANESTHESIA
NO COMPLICATIONS AND
SIDE EFFECTS
WIDE RANGE OF
APPLICATION
LOW COST OF THE
EQUIPMENT AND
CONSUMABLES
REDUCTION EXPENSES ON
TREATMENT &
ADDITIONAL SOURCE OF
INCOME FOR HOSPITALS
MULTI-CHANNEL Т°С
REGISTRATION
(scalp, tympanic,
thermoregulation center)
INDIVIDUAL APPROACH
(LCH, GH)
ADDITIONAL
PHARMACOLOGICAL
ASSISTANCE IS NOT
REQUIRED
5
* - For detailed comparison with analogues please refer to Appendix (Slide - 20)
Galina Repina
+7 915 421 13 50

PRODUCT LINE AND TIMELINE OF DEVELOPMENT*
7 PATENTS
Month 6
Update
of DS THE-01
Month 7
Start of production
(outsourcing)
Start of preparation
for serial production
of THE-01
Month 12
THE is included into the
Standards of equipment of HC
Month 30
Pilot testing
of THE-02/02P
is complete
Month 23
Start of serial production of
THE-01
Month 36
Sales reached
$5 m USD per year
Month 21
Pilot batch
THE-02/02P
Month 18
R&D completed
THE-02/02P
Month 27
75 THE-01 are produced
6
* - For detailed characteristics of the Product line please refer to Appendix (Slides 21-25)
Start
Galina Repina
+7 915 421 13 50

INTELLECTUAL PROPERTY
REGISTRATION DOCUMENTS AND CERTIFICATES
No Name Document Status Author
1 Hypothermia applicator
RF Patent no. 74563
dd. 15.02.2008
valid
Usyshkin I.M.
Shevelev O.A.
2 Device for human body local cooling/heading
RF Patent no. 94149
dd. 20.03.2010
valid
Usyshkin I.M.
Shevelev O.A.
3 Device for human scalp and brain cord cooling
RF Patent no. 96762
dd. 20.08.2010
valid
Usyshkin I.M.
Shevelev O.A.
4
Heat exchanger for human body local cooling
systems
RF Patent no. 97504
dd.10.09.2010
valid
Galkin I.I., Agishev S.A.,
Kostenko A.Yu., Rostovtsev V.I., Chernetsov V.A.,
Usyshkin I.M., Shevelev O.A.
5 Device for human body local cooling
RF Patent (industrial model) no.
83369 dd.16.10.2012
valid
Usyshkin I.M.
Shevelev O.A.
6 Device for therapeutic hypothermia induction
RF Patent no. 126262,
2013
valid Shevelev O.A.
7 Device for correction of cerebral hyperthermia
RF Patent no. 2615283
04.04.2017
valid
Shevelev O.A., Balaboshko N.G.,
Gapeev U.A., Syrchenko N.V., Rostovcev V.I.
 Registration certificate
 Certificate of compliance
 Performance specifications
 Engineering documentation.
 Application methodology.
7
Galina Repina
+7 915 421 13 50

MARKET*
Total therapeutic hypothermia market(RF):
16 197 clinics
32 559 «THE»
$0,77 billion USD
EXPORT POTENTIAL
RF MARKET IS INCREDIBLY PROMISING
Country
Market volume
thousand units m $USD
USA,
Canada, EU, Japan
275 000 6 132
Kazakhstan 3 464 78
Belorussia 9 427 218
China 277 286 6 183
India 253 263 5 645
Resuscitation and
intensive care units
7 973 clinics
19 727 units
$474,8 million
49%
Ambulance
1 800 stations
2 880 units
$50,8 million
11%
Childbirth
1 992 clinics
6 600 units
$165,6 million
13%
Psychiatric care
3 418 clinics
3 418 units
$70,5 million
21%
Sport
204 clinics
204 units
$3,7 million
1%
Sanatoriums
810 clinics
810 units
$17,7 million
5%
8
* - Only priority market (Emergency medicine), for additional application of «THE» please refer to Appendix (Slide-26)
Galina Repina
+7 915 421 13 50

STAGE OF IMPLEMENTATION








9
Galina Repina
+7 915 421 13 50

PROJECT SUPPORT
 Major specialists of the Russian Ministry of Healthcare
(anesthesiology/resuscitation, sport medicine, neonatology).
 Anesthetist-in-Chief of Ministry of Healthcare of RF, M.D. Professor
Molchanov I.V.
 Chairman of anesthesiology-reanimation association and of the Central
Federal region. Laureate of USSR Government award, M.D. Professor
Butrov A.V.
 Director of Moscow Scientific-Research Institute of emergency pediatric
and traumatic surgery, M.D. Professor Roshal L.M.
 Sport medicine Specialist-in-Chief of Ministry of Healthcare, Polyaev B.A.
 Chief physician of Hospital No.1, (Volynskaya hospital), Boyarincev V.V.
 Chief physician of clinical hospital No.64, Sharapova О.V.
 Rector of Scientific-Research Institute of sports medicine, Bleer A.N.
10
Galina Repina
+7 915 421 13 50

TEAM*
Leader/Director of the Project
 Developer of therapeutic hypothermia method and equipment
 M.D. Professor. 3 monographs, 240 published articles
 Supervised 3 PhD and 9 MSc
 Over 20 years of experience in production of medical equipment business management
Key specialist/clinician.
 Developer of therapeutic hypothermia method and it's clinical application in emergency care
 M.D. Professor. Over 300 published articles, 20 textbooks and methodical manuals
 Laureate of USSR Government award
 Chairman of anesthesiology-reanimation association and of the Central Federal region. Member of European
anesthesiology and resuscitation communities and parenteral and enteric nutrition
Key Specialist/Marketing/Management
 5 years of experience as Project Manager
 MSc Management/Marketing CASS Business School, City University, London, UK
PARTICIPANTS
GALINA REPINA
ANDREY BUTROV
 Project company: «CryoTechnoMed» (Moscow)
 Co-investor/Partner: OJSC «Izhevsk Mechanical Factory» («Kalashnikov Group», «ROSTECH»)
 Partner: «Agency of Strategic Initiatives»
 Partner: Innovation Fund «Skolkovo»
OLEG SHEVELEV
11
* - For Project Support and Team contacts please refer to Appendix (Slides-29-30)
Galina Repina
+7 915 421 13 50

CONTACTS
Project Leader/Director: Oleg Shevelev (Professor, M.D.)
 Telephone: +7 916 532 61 41
 E-mail: shevelev_o@mail.ru
Science and research manager: Andrei Butrov (Professor, M.D.)
 Telephone: +7 969 123 03 28
 E-mail: Abutrov@mail.ru
Marketing and sales : Galina Repina
 Telephone: +7 915 421 13 50
 E-mail: repina.galina@googlemail.com
Project site: www.cryotechnomed.com
12
Galina Repina
+7 915 421 13 50

APPENDIX
Slide Slide number
Problem identification: 14-15
Reasons for application of cerebral hypothermia 16
Effect of craniocerebral hypothermia and «THE» application 17
Clinical application of «The-01» in hospitals 18
Comparison with competition 19
Product line 20
Technology – Temperature monitoring 21
Technology - «SHF-radio thermometry» 22
Hypothermia – additional areas of application 23
13
Galina Repina
+7 915 421 13 50

PROBLEM IDENTIFICATION:
14
 Up to 3.7 million cases of newly detected cardiovascular diseases are revealed annually in the Russian Federation, including:
 more than 1 000 000 coronary heart diseases;
 about 450 000 people suffer an stroke
 In 2013-2014 the mortality due to cardiovascular diseases in the RF equals to about 56% of overall death rate, which is 970 000 people per
annum.
 Traumatism:
 Traumas are 3rd cause of death (among men above 40 years old – 1-st cause)
 Average level of traumatism in RF - 12% of population per year
 Skull traumas (from overall number of traumas): 34% - on average; 91% - after car accidents
 In RF 2013 more than 204 thousand road traffic accidents were registered, where:
 from 258 thousand people were injured,
 27 thousand people died.
 Traumatism specifications after car accidents:
 30-40% of overall deaths from traumas.
 Mortality after car accident is 12 times higher
 Morbidity after car accident is 6 times higher
 Economic loss – 2,5% GDP (5,5 billion rubles)
Name USA Germany France Russia
Number of dead for 100 car accidents 1,9 2,5 6,4 20,4
Number of dead for 100 victims of car
accidents
1,2 1,9 4,3 15,8
Number of vehicles per individual 0,65 0,46 0,53 0,18
Galina Repina
+7 915 421 13 50

PROBLEM IDENTIFICATION:
15
 Addiction medicine (relieving the alcohol withdrawal syndrome and application during remission):
 RF FDCS: drug consumption market (2014) – (regular and episode consumption).
 Every month in RF 5000 people die as a result of drug consumption.
 Number of drug addicts under medical supervision in RF (2013) — 630 000 people.
 Sport medicine (rehabilitation after sport trauma intense exercises):
 Sport skull trauma is considerable part of sport traumatism (18% - 232,6 thousand people). It is most common in martial arts and
contact/technical sports.
 Hypothermia can be used after intense exercises – martial arts (box, wrestling and others), athletics (medium, long distance running, sport
walking), skiing, football, hockey.
 Neurology (migraines):
 Migraine is number 1 among neurological diseases and number 3 reason for prevalence of inability to work.
 10-12% of RF population or 3,5 million men and 10,5 million women suffer from migraines.
 Early losses associated with migraine (direct and indirect expenditure) are equal to €111 billion.
 Arthrology (rheumatoid arthritis)
 Cases in RF (2014 г.) - 28 842.
 Prevalence of the disease - 0,61% of RF adult population - 891 thousand people.
 $8,4 billion US dollars is spent yearly. Indirect losses equal to - $11 billion per year.
Galina Repina
+7 915 421 13 50

REASONS FOR APPLICATION OF CEREBRAL HYPOTHERMIA
Reason / Nosology/Condition Mechanism targeted by hypothermia
Intellectual overload, emotional stress.
Increase in metabolism activity of neurons during physiological
excitement.
Increase of the temperature of the body during intense physical
exercises professional sport, army).
Malfunction of convection heat removal.
Fever in case of inflammatory diseases and neurogenic fever (central
nervous system disfunction).
Malfunction of convection mechanism.
Emotional distress, epilepsy, parkinsonism, convulsions. Metabolism during hyper-synchronized activity of neurons.
Psychoactive medicine treatment, drugs and alcohol intake. Metabolism during excitement.
Migraine, «steal» syndrome, ischemic stroke.
Vessel cerebral dysfunction with identification of hypo-perfusion foci
and activation of free radical processes.
After total termination of blood flow and cardio-pulmonary
reanimation.
Acute disorders of brain blood flow, brain failure.
Cerebral hypoxia, ischemia and reperfusion, neurogenic
inflammation, excitotoxicity, lipid peroxidation.
Neurotrauma – all types of skull injury including car accidents, sport
medicine and neurosurgeries.
Excitotoxicity, neurogenic inflammation, lipid peroxidation.
16
Galina Repina
+7 915 421 13 50

EFFECT OF CRANIOCEREBRAL HYPOTHERMIA AND «THE» APPLICATION
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17
Galina Repina
+7 915 421 13 50

CLINICAL APPLICATION OF «THE-01» IN HOSPITALS
NO. HEALTH CARE FACILITIES QTY FOCUS
1 Neurosurgical Institute named after L.A.Polenov, St-Petersburg 1 Patients after neurosurgical repair of arterial aneurysms rupture
2
Peoples' Friendship University of Russia, Anesthesiology and Emergency Department,
clinical site of city clinical hospital No.64, Moscow
2 Patients after cardio-pulmonary resuscitation, with acute ischemic stroke
3
Moscow Scientific-Research Institute of emergency pediatric and traumatic surgery,
Emergency Department
1 Children’s craniocerebral injury
4 Scientific-Research Institute of Surgery named after Vishnevsky 1 Patients after cardio-pulmonary resuscitation
5 Hospital No.1, Department of Presidential Affairs (Volynskaya hospital), Moscow 1 Patients with acute ischemic stroke
6 Moscow arthrology center 1
Patients with rheumatoid arthritis and degenerative-dystrophic diseases of
large-size joints
7 Scientific-Research Institute of sports medicine 1 Orthopedic traumas, athletic craniocerebral injuries
8
Nizhnevartovsk Central Regional Hospital, Emergency Department of
Psychoneurological dispensary
1
Patients after cardio-pulmonary resuscitation,
neuro-intoxications,
intractable fever,
abstinence syndrome
9
Yaroslavl Central Clinical Hospital, Emergency Department of Psychoneurological
dispensary
2
10 Saransk Regional Psychoneurological dispensary, Emergency Department 1
11 Central Clinical Hospital in Kursk city, Emergency Department 1
Patients after cardio-pulmonary resuscitation, with acute ischemic stroke12 First-aid station in Ufa city 1
13 Regional Clinical Hospital No.2 in Tyumen city, Emergency Department 2
14 1st Regional Clinical Hospital (Izhevsk), Emergency Department 1 Patients after cardio-pulmonary resuscitation
Total: 17
18
Galina Repina
+7 915 421 13 50

COMPARISON WITH COMPETITION
Analogues Stage Price million RUB Method Functionality Safety Mobility
«THE-02» Development
1,6
(consumables 0,01)
Craniocerebral hypothermia
Mild general hypothermia
Different states of consciousness
Sedation, artificial ventilation (AV) and
mio-relaxation is not needed
SHF registration of brain ТС.
Automated thermoregulation (ТС in 4
areas of the body).
No complications,
automated feedback.
No
«THE-02P» Development
1,6
(consumables 0,01)
mio-relaxation is not needed
Automated thermoregulation (ТС in 4
areas of the body).
No complications,
automated feedback. Yes
«HCU 40» On the market 4,288 General hypothermia
mio-relaxation is needed.
Only one channel of temperature
registration.
Complications
associated with general
hypothermia.
No
«Arctic-Sun 5000» On the market 4,002 General hypothermia No
«3T Heater-
Cooler System»
On the market 3,757 General hypothermia No
«Blanketrol-III» On the market 3,757 General hypothermia No
CoolCard 3000 On the market
2,127
(consumables 0,076)
General hypothermia
Invasive
No
The RhinoChill® On the market
0,691
(consumables 0,131)
Intranasal
Yes
19
Galina Repina
+7 915 421 13 50

PRODUCT LINE
Characteristics:
Original model
«THE-01»
Stationary model
«THE-02»
Portable model
«THE-02P»
Current status: Completed and registered
Weight (kg): 65
Size (mm) 940х450х520
Type of equipment: compressor
Wattage (W): 450
Cooling area: 1: cryoapplicator «helmet» 2: «helmet» + «collar» 1: «helmet»
Body TC monitoring: 3 channels
Procedure programming: No
Parameter setting: Manual
Express diagnostics: No
Mobility: No No
1 2 37 PATENTS
20
Galina Repina
+7 915 421 13 50

TECHNOLOGY – TEMPERATURE MONITORING
 «THE-01» equipment is designed to register temperature with induction temperature sensors in 3 areas of human body:
 Axial temperature,
 Tympanic temperature,
 Scalp skin temperature in the areas of heat removal.
 In the modernized «THE-01» models there is technology of non-invasive SHF radio thermometry of human brain (additional option).
Equipment allows to register temperature of the scalp skin in 18 areas and create map of cerebral heterogeneity temperature.
 In the THE-02 equipment, which is currently being designed, there is option to register temperature in various parts of the human body:
 Axial (basal) Т°С – induction thermometry (1 area of measurement);
 Tympanic (correlate of dynamics of brain Т°С) – infrared thermometry
(2 areas of measurement);
 Т°С in the area of heat removal (scalp skin) – induction thermometry
(2 areas of measurement);
 Brain Т°С (SHF- radio thermometry) - (2 - 18 areas of measurement).
 Full thermo-monitoring allows to measure and assess actual temperature balance of human organism and brain, identify if the patient is
suitable TH procedure, effectiveness of heat removal and level of induction hypothermia.
21
Galina Repina
+7 915 421 13 50

TECHNOLOGY - «SHF-RADIO THERMOMETRY»
 Non invasive SHF radio thermometry allows to measure and evaluate
level of brain temperature heterogeneity (bad prognosis predictor,
suitability of hypothermia, evaluation of effectiveness of
hypothermia).
 Measurement is carried out 4-6 cm deep from the surface of the
scalp skin (cortex of the brain), which allows to evaluate injury spot
and severity of damage (temperature of deep tissues).
 SHF-thermometry of deep tissues - high precision method, which is as
accurate as direct measurements from the brain implanted induction
thermo-sensors.
a) Registration scheme of brain temperature;
b) Temperature map of the brain after brain injury (as shown on
«THE-02» LCD monitor)
c) MRI figures of visualization of sensor location;
d) Areas of registration of scalp temperature
(Т°С mapping).
(a)
(c)
(b)
(d)
22
Galina Repina
+7 915 421 13 50

HYPOTHERMIA – ADDITIONAL AREAS OF APPLICATION
 Addiction medicine.
 Neurology.
 Rheumatology.
 Sport medicine.
 Service duration: 60 - 120 minutes.
 Quantity of the procedures in the treatment: 8 - 10
 Periodicity of procedures: daily – once in two days.
 As part of integrated therapy as the main method.
 As a subsidiary method which enhances therapy (for instance
pharmacological support).
 Licensed as a physiotherapy (service)
 Physiotherapy as part of medical healthcare in the following specialties:
 neurology,
 Orthopedic/trauma (arthrology),
 Psychiatry/narcology,
 Sport medicine.
 Recommended service parameters:
 Classification of the service:
 Hypothermia method specifications:
 Areas of application:
 Type of license:
23
Galina Repina
+7 915 421 13 50

Craniocerebral Therapeutic Hypothermia

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