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Moscow, 2014 NEW MEDICAL TECHNOLOGIES OF RUSSIAN FEDERATION MEDICAL APPARATUS "NADEZHDA" "KNOW - HOW " PRODUCT

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Moscow, 2014

NEW MEDICAL TECHNOLOGIES OF RUSSIAN FEDERATION

MEDICAL APPARATUS

"NADEZHDA"

"KNOW - HOW " PRODUCT

Apparatus of the remote electromagnetic high

freguency radiation of low level with

automatic control system

for the use complex cancer patients care

“Nadezhda”

NAME:

General view of the medical apparatus “Nadezhda”

Pic.1General view of the closed

apparatus Pic.3 General view of the

open apparatus

Pic.3 General view of the upper

surface of the apparatus

Generators – 9 pieces; Bandwidth from 100 to 1300 MHz, second and third harmonics of basic nine frequencies; Modulation mode – frequency, modulation from 0 up to 200 MHz; Power of each generator at a load of 50 ohm at fundamental harmonic – 10 ± 5 mW; Total energy-flux rate – 4 : 6 mkW/sm²; Power and frequency of power supply – 220V, 50Hz; Power intake not more than 30 VA; Protection class against electric-shock hazard – II type B; Time between failure not less than - 1500 hours; Time of the continuous working not less than - 8 hours; Service life not less than - 10 years; Overall dimensions not more than - 460x410x120 mm; Weight not more than - 8 kg.

Specifications:

Medical apparatus “Nadezhda” is dedicated for complex cancer diseases care.

Principle of therapeutic modalityThe curative effect is achieved by the biomolecular differential absorption of

high frequency electromagnetic radiation, that leads to the change of its energetic state and in the following doesn’t permit these molecules to take a full part in the process of proliferation of cells

Method of achievement of curative effectThe patient is effected by the spectrum of high frequency electromagnetic radiation of low level, formed by nine discretely elected in predetermined combinations frequencies of radio range (100-1300 MHz), with the use of second and third harmonics of basic frequencies, with the energy flux-rate of less than 10 mkW/sm² and directive changing frequency modulation in the range of 0-200 Hz.

Development prospectsPrognosis for the perspective are based on the unique theory, created by Fund “Nadezhda”, which is found to the creation of medical apparatus “Nadezhda”. The apparatus is perspective with regard to the extension of the possibilities of its use for the cure of other types of diseases, as AIDS and tuberculosis, after the realization of additional clinical trials and the modification of cure technique.

Application of the apparatus

Before starting the cure it’s necessary to defuse the static tension from the patient.

The patient should be wearing the cotton clothes.The patient should be in a handling radius of the

apparatus in a distance of not less than 1m and not more than 5m from the apparatus. The distance of the patient from the apparatus depends on the power of radiation of the apparatus and the tumor’s occurrence depth.

In case of a group therapy the conditions of the patients’ positioning should answer the principle of the most power absorption of each patient. For that the patients should be in a distance of 0,5m from each other.

The significant factor of the patients’ positioning is the absence of other objects or patients on the way of the signal from the apparatus to the patient.

The duration of the radiation effect depends on the general condition of the patient, disease pattern, readings for the use of the apparatus and is 50-180 minutes in a session. Sessions should follow each other every 24 hours or in 24 hours.

Average total time of effect for a course of treatment: 12-24 hours.

Average total time for the whole course shouldn’t exceed 40 hours.

Note: Medical apparatus “Nadezhda” can be applied

autonomously or together with the existing traditional cure methods.

Application conditions

1,0 – 5 м

0,5 м

0,5 м

0,5 м

Counter-indications:Counter-indications for the cure process for the patient can be pregnancy, thrombembolia, presence of implanted stimulators.

The cover of the apparatus – the unique aerial-radiator

The use of the unique technique and apparatusin curing cancer diseases guarantees:

=Radiation at the

frequencies of radio range with the power

flux density of not less than 10 mkW/sm².

Besides, in case of the combined cure method the application of the apparatus ensures the abovementioned results, and also to reduce the applied dose of the radiation therapy, to reduce negative effects of radial and chemotherapy

and to get the radiomodifying effect in case of radial therapy.

tumor growth retardation;

localization of generalized processes;

reduction of pain syndrome 1-2

stages;

improvement of immunological status;

reduction of inflammatory processes

and forming of the favorable situation

for the acceleration of the process of

angenesis;

forming of the sedation;

Principal pluses of the apparatus

the cure is realized in a noncontact and noninvasive way;

provides the cure for a group of patients;

selectively effects only cancer cells of the tumor and focuses of metastasis regardless

of its location and is secure for the normal cells of the organism;

doesn’t have side negative influence on the patient and operational staff, that is in the

zone of action of the apparatus;

doesn’t have home and foreign analogues;

is competitive and economical, low costs;

minor expenses for cure;

performed in the movable variant, compactness and convenience permit to use it at

any moment, at any place, without special equipped placing;

is perspective in the expansion of the possibilities of its use (cure).

The medical apparatus “Nadezhda” passed the following clinical trials:

1996-1998: Clinical trials of the breadboards of the apparatus on mice with transplanted tumor.

Ground: - extract from the protocol № 2 of 03.10.1996 of the Committee on new techniques of the Ministry of

Health of Russian Federation.

Place of realization:

Medical Radiological Research Centre Russian Academy of Medical Sciences, city of Obninsk;

1998-1999: Clinical trials of the breadboards of the apparatus on patients with cancer diseases.

Ground: - extract from the protocol №3 of 04.07.1998 of the Committee on new techniques of the Ministry of

Health of Russian Federation.

Place of realization:

Medical Radiological Research Centre Russian Academy of Medical Sciences, city of Obninsk;

Municipal Clinical Hospital of the city of Mytishy, Moscow Region;

Moscow Research Cancer Institution in the name of P.A. Gertsen and 11th Municipal Hospital (MNIOI) in

the name of P.A. Gertsen.

1999-2001: Clinical trials of the development types of the apparatus on patients with cancer diseases.

Ground: - extract from the protocol №3 of 04.07.1998 of the Committee on new techniques of the Ministry of

Health of Russian Federation.

Place of realization:

Medical Radiological Research Centre Russian Academy of Medical Sciences, city of Obninsk;

Russian Scientific Centre of Radiology and Nuclear Medicine of the Ministry of Health of Russian Federation;

Moscow Research Cancer Institution in the name of P.A. Gertsen.

The medical apparatus “Nadezhda” after successful realized clinical trials is recommended by Ministry of Health of Russian Federation to the use in

medicine practices and in series production.Grounds for the use – availability of the full package of permissive

documents:

extract from the protocol №3 of 05.07.2001 of the Committee on new techniques of the

Ministry of Health of Russian Federation on the use of the apparatus in the medical

practices;

Registration Certificate FSR 2012/13159 of 14.03.2012;

Certificate of Conformity 6563062 №ROSS RU.IMO2.B12699 of 15.04.2005;

Sanitation-and-epidemiological conclusion № 77.99.28.944.D.003230.06.05 of

10.06.2005;

Certificate for a trademark № 282671 of 22.04.2005;

Permit of State Committee on Radiofrequencies “On frequencies allocation” № 04-03-

05-024 of 06.12.2004.

Patent status of the deviceRussiaPatent received for the device for № 2155084 of 27.08.2000

Patent received for the device for № 2209642 of 10.08.2003

UkrainePatent received for the device for № 7491of 15.12.2005

IsraelPatent received for the device for № 141105 of 11.07.2006

GermanyPatent received for the device for № 202 21 025.1 of 27.10.2004

Experimental sectionFor the purpose of the efficiency of the apparatus of the apparatus for the cure of newgrowths

took place trials on male-mice of the line C57B1/6 in the age of 3,5 months with the intorted tumor of lungs Lewis (strain LLC). The results were treated by the methods of variation statistics and are shown in the table:

Conclusion: the influence of the apparatus retards the growth of the tumor and its metastasis approximately to 20-25%.

From the materials of realized clinical trials Estimate of efficiency of the influence of the apparatus

Group Volume of the

tumor at the 12th

day, sm³ Volume of the

tumor at the 21st

day, sm³ Mass of the

tumor at the 21st

day, sm³ Number of

metastases in

lungs, M - m

Control 0,7 ÷ 0,2 5,7 ÷ 0,4 5,5 ÷ 0,4 22,7 ÷ 2,2

Influence of the

apparatus 0,8 ÷ 0,2 4,3 ÷ 0,2 4,2 ÷ 0,3 17,7 ÷ 1,9

From the materials of realized clinical trials Estimate of efficiency of the influence of the apparatus

№ Neoplasm form Number ofpatients

Including

Age interval Mail Female

1 Carcinoma of uterus 14 - 14 65-73

2 Large intestine cancer 9 4 5 65-66

3 Carcinoma of uterine cervix 10 - 10 42-62

4 Carcinoma of uterine tube 4 - 4 48-58

5 Ovarian carcinoma 12 - 12 38-59

6 Vulva carcinoma 5 - 5 31-75

7 Breast cancer 45 - 45 32-54

8 Thyroid gland cancer 10 - 10 38-57

9 Chronic lymphatic leukemia 3 - 3 58-65

10 Chronic myeloleukemia 3 3 - 65-72

11 lymphosarcoma 8 8 - 37-63

12 Lymphogranulematosis 6 4 2 22-46

13 Rectal cancer 13 11 2 43-67

14 Carcinoma of nasopharynx 1 1 - 44

15 Esophadus cancer 22 20 2 44-72

16 Carcinoma of liver 5 4 1 69-71

18 Сarcinoma of lung 25 17 8 40-69

19 Сarcinoma of stomach 15 5 10 41-68

20 Carcinoma of oral cavity 2 2 - 49-54

From the materials of realized clinical trials Estimate of efficiency of the influence of the apparatus

№ Neoplasm form Number ofpatients

Including

Age interval Mail Female

21 Carcinoma of pancreas 3 2 1 66-73

22 Carcinoma of larynx 5 4 1 55-79

23 Carcinoma of blind gut 2 - 2 51-63

24 Carcinoma of sigmoid gut 2 - 2 44-51

25 Carcinoma of prostate gland 27 27 - 32-89

26 Gallbladder carcinoma 1 - 1 64

27 Melanoma 4 1 3 45-58

28 Chondrosarcoma 1 1 - 42

29 Esophadus cancer 4 1 3 54-64

30 Carcinoma of jaw 5 1 4 41-75

31 Kidney cancer 5 2 3 42-73

32 Soft tissues sarcoma 1 1 - 36

33 Carcinoma of piriform sinus 2 2 - 41-42

34 Spinal column affection wothout primary lesion 2 - 2 65-75

35 Carcinoma of tongue 4 3 1 41-57

36 Carcinoma of urinary bladder 3 2 1 54-64

37 Swelling of a brain 1 - 1 39

38 Glioblastoma 2 2 52-76

39 Neuroblastoma 1 1 - 45

Total : 290 127 163 22-89

From the materials of realized clinical trials Estimate of efficiency of the influence of the apparatus

For the purpose of the efficiency of the apparatus of the apparatus for the

cure of the patients with cancer diseases the two groups were formed in random

order. One of them, Group (I), incurred the real influence of the apparatus, and for the

other, Group (II), the placebo effect. The trials were carried out by the double

randomized method. All the patients had the expressed, characterized by the disease

development: chronic pain syndrome, reduction of the degree of freedom in case of

physical activity, reduced performances of hemotogenic activity, etc. The character

of the disease is that it is impossible to recommend surgical methods, and the cure

by conservative methods (radial and chemotherapy) resulted to be ineffective, or the

efficiency was less than 20%.

The patients with clinical symptoms were estimated by antitumoral, wound

healing, anesthetic and immunomodulatory effects, forming of the sedation,

localization of generalized processes.

From the materials of realized clinical trials Estimate of efficiency of the influence of the apparatus

The estimate of the efficiency of the therapeutical influence of the apparatus was held on the objective and subjective characteristics.

The laboratory-instrumental research on the dynamics of the objective condition of the patient was realized by: ultrasonic investigation, X-ray diagram, tomographic image, general blood test, the analysis of biochemical and electrolytic composition of blood before the start of the cure, at the 14th and 28th days at the moment of the beginning of the cure.

The dynamics of the performances of the immunological blood test of the patients with radiation complications was examined.

The estimate of pains of the patients with pain syndromes was realized, by the approved methods of World Health Organization (visual-analog scale and scale of verbal estimates in grades).

All the patients were estimated on physical activity on the common scale of the estimate of the general condition Karnovsky and the scale of physical scale, approved by World Health Organization.

From the materials of realized clinical trials Estimate of efficiency of the influence of the apparatus

Total info on the patients with cancer diseases, which took part in clinical trials of the apparatus “Nadezhda”.

№ Name of the institution Number of patients Male Female Age interval

1. Medical Radiological Research Centre Russian Academy of Medical Sciences, city of Obninsk. 89 28 61 22-78 years

2. Moscow Research Cancer Institution in the name of P.A. Gertsen 50 32 18 31-77 years

3. Russian Scientific Centre of Radiology and Nuclear Medicine 58 30 28 28-89 years

4. Municipal Clinical Hospital of the city of Mytishy, Moscow Region 40 17 23 22-79 years

5. 11th Municipal Hospital (MNIOI) in the name of P.A. Gertsen. 53 20 33 36-76 years

In total: 290 127 163 22-89 years

From the materials of realized clinical trials Total clinical estimate of efficiency of the influence of the apparatus

In the clinical trials took part 290 patients.The balance of frequencies of objective and subjective effects in the basic group (I) placebo group (II) is shown in the tables:

Objective effect after the therapeutic influence of the apparatus

Subjective effect after the therapeutic influence of the apparatus

Group

Effect

Without

effect Progressing Full regression

(100%CR) Partial

regression

(>50%PR) Process

stabilization I (197) 1.1% (2) 27.4% (54) 37.5% (74) 0 34.0% (67)

II (93) 0 0 0 58,0% (54) 42.0% (39)

Group

Effect Without

effect Progressing To reduce of the pain

syndrome

Improvement of immunological of

paramoters

Improvement of gualite of

life

I (197) 58.7% (115) 67,9% (134) 55,4% (109) 0 34.0% (67)

II (93) 0 0 0 58,0% (54) 42.0% (39)

Efficiency of the influence of the apparatus

Along with the previously agreed in course of the cure by the therapeutic effects we succeeded in:

o to increase the immunologic status and antitumoral organism resistance;

o to reduce the tolerance of the new growths to the influence of the radiation cure methods;

o to reduce the risk of the complications development in case of chemotherapy;

o to localize the generalized forms of the complications development;

o to improve the life quality of the patients with the inveterate forms of cancer diseases of different

localization and anatomic forms, that is: to reduce the intensity of the pain syndrome; to improve the physical activity; to improve the quality and to increase the duration of nocturnal sleep.

Moscow, 2014

For notes

Moscow, 2014

For notes

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