The ELECTRO INTERSTITIAL SCANNER Technical File

SYSTEM PRESENTATIONIntroduction:Bioelectric impedance measurements (BIM) represents a wide range of old and new non-invasivetechnologies and methods where a very small electric current is applied to the body via one or moresurface electrode and the resultant current passing through the body is detected at other surfaceelectrodes placed elsewhere on the body. A drop in voltage occurs as the current encounters impedance orresistance inherent in the fluids and tissues it passes through as it courses through the variousphysiological “compartments” of the body.1-3These compartments include the bloodstream, the intracellular space, the lymphatic system, the interstitialspace, and others.4,5 This drop in voltage provides indirect information about the physical and chemicalproperties of the compartment(s) that the current passed through.

Alternating Current Bioelectric Impedance Methods:The most familiar form of BIM uses an alternating current (A.C.) system. There are dozens of readilyavailable commercial and custom-built A.C. BIMs ystems differing widely in design and complexity.6 Mostsystems are used to indirectly estimate the fat content of the body by measuring total body water.7,8These systems typically employ A.C. electricity with a wide range of currents, frequencies, and voltage. Theamount of electricity delivered to the body is usually imperceptible and far below the level that would causecellular or tissue damage.9,10 Studies of A.C. BIM systems operating at 50 MHz or higher, haverevealedthat these high frequency A.C. electric currents flow non-selectivelyt hrough both intracellular andextracellular spaces11 (see image below), and thus provide relatively non-specific information regardingthe physical properties and chemical composition of total body water.

Bioelectric Impedance Analysis in Cardiology and Oncology (technical note follows)Direct Current Bioelectric Impedance Methods:

Unlike A.C. bioelectric impedance, the electric current produced by D.C.bioelectric impedance methodsspecifically passes through the interstitial fluid compartment 23 (see image below). The interstitial fluidcompartment represents approximately 16% of the body’s total water.24-26 Interstitial fluid isextracellularwater and solutes surrounding cells, but outside of the bloodstream and lymphatic system.Interstitial fluid forms the microscopic interface between cells and capillaries. Interstitial fluid differs fromwhole blood by the absence of redblood cells, and it differs from blood plasma in that there are far fewerproteins.Any substance passing between cells and the bloodstream must traverse theinterstitial space. These substances include oxygen, carbon dioxide, glucose, as well as thousands of othercompounds.27,28 The interstitial fluid’s role as ametabolic conduit and its proximity to the collectiveintracellular space of nearbycells suggests that the chemical composition of the interstitial fluid mayreflectthe physiology (or pathophysiology) of nearby cells.29-31 Since D.C. electric current primarily passesthrough the interstitial fluid, ithas been proposed that an abnormality in the chemical composition of theinterstitial fluid could be detected with an adequately sensitive D.C. BIM device.

D.C. Bioelectric Impedance Device : EIS SystemThe EIS system is the only commercially available BIM system utilizing direct current (D.C.)technology.(patent N°06/09878)The device uses a PC to control, coordinate, and direct a specific pre-programmed sequence of brief,barely perceptible D.C. current pulses (microampere strength) through an array of 6 symmetrically placedsurface electrodes: left and right forehead, left and right hands (palms), and left and right feet (soles). This6-electrode array forms 22 electrode pairs, or “volumes” .The D.C. current passes through the interstitial space in the body and voltage is measured at the other 6electrodes. The change in voltage/impedance between the anode and cathode reflects some aspect of thephysical and chemical properties of the interstitial fluid space. The spatial array of the electrodes alsoprovides some degree of anatomical localization.

The Pre-Programmed Sequence of Electrode Pairs

Impedance in cardiology and oncologyMore sophisticated A.C. BIM technology has been recently developed and can provide clinically importantinformation, above and beyond the fat and water composition of the body.There are now 2 commercial A.C. BIM devices (12),(13)the BioZ and the TEBCO approved by the FDA as diagnostic aids to complement existing imaging andelectrophysiological tests in cardiology. These “impedance cardiography” devices measure changes inthoracic electrical impedance as a function of changes in thoracic aortic blood volume and pressure thatoccur with each heartbeat. The impedance data is fed to a computer where empirically derived algorithmsare used to calculate a range of cardiovascular functional indices, including cardiac output, stroke volume,contractility, systemic vascular resistance, and thoracic fluid content.(12),(13)The values for the cardiac indices determined by the BioZ and TEBCO devices closely match thosedetermined with long-established methods, such as cardiac catheterization. Unlike the more invasivetesting, impedance cardiography is especially suited to serial measurements. The improved validity andreliability of contemporary impedance cardiography14 methods and now 3rd party payor reimbursement15for the procedure has led to rapid growth. By 2004, more than 5,000 BioZ units were in clinical use world-wide, and annual sales have grown by 25-35% since 2002.(16)The FDA approved a separate BIM device in 1999 as a diagnostic aid (17) and complement tomammography and MRI, for the detection of early breast cancer.The T-Scan 2000ED (18) (Mirabel Medical, Inc.) uses an A.C. current of < 5 mAmps (mA) at 200 Hz toperform BIM. The current is introduced into the body through a metal cylinder held in the hand contralateral

to the breast being examined. Several impedance measurements are performed via a handheld detectionelectrode placed at specified locations on the breast(17).The original research describing the impedance properties of breast cancer dates back to 1926.19However, in the past decade, rapid technological improvements have led to FDA approval and theincorporation of BIM testing for breast cancer screening in many centers worldwide.(20)In a recent clinical study of this BIM device21, 29 breast cancers were identified in a cohort of more than

years old, the sensitivity and specificity of the T-Scan 2000ED were 50% and 90%, respectively. Although asensitivity of 50% seems at first sight to be low, the BIM testing appears to be capable of identifying tumorstoo small or otherwise undetectable by mammography and MRI. A separate study also indicates that BIMappears to be more sensitive at detecting small tumors (< 10 mm) than large ones (> 10 mm).(22)An analysis of the data submitted to the FDA for the 1997-99 approval process, suggests that the best useof BIM is as an adjunct to mammography. When BIM is combined with mammography, the sensitivity oftesting increased from ~80% to ~90%, and the specificity increased from 55% to 77%.18 BIM +mammography has been projected to provide a 99% negative predictive value, i.e. there is a 99%probability of no breast cancer if the combined testing results are negative.(18)

EIS POSITIONNING

Specifications of the deviceType of deviceThe system EIS is a programmable electro medical system (PEMS) including

· Hardware device including black box, 6 tactile electrodes and cables

· Software installed on a computerConnected by a cable installed between USB ports of the computer and the device. Indications for use Thereare 3 types of indications for use:

· the EIS System is a non-invasive bio impedance analyzer used for measurement of actual height,actual weight and estimated body composition and lifestyle. The applicable age range is 10 to 80years old for sedentary subjects. For sportive subjects, the applicable range is 16 to 60 years.

· the system can be programmed to compute various physiologic or blood flow parameters and withinthe clinical context aid to regulate target supplementary examinations. The applicable age range is5 to 80 years old.

· EIS system is used for the therapeutic follow up. The applicable age range is 5 to 80 years oldPurpose and function of the device The hardware will have as a function to record the intensity of bodyvolumes (volumes ranging between the 2 electrodes passive and activates) following the sending of animposed tension of 1.28V on an electrode.This intensity will be transmitted via port USB of the computer to software.The software will have as a function to treat this intensity:

· In resistance and conductivity

· To make the calculation of fat mass, Total water body (TWB) and lean mass.

· To model the human body and to locate the organs

· To allot a value of conductivity to various organs

· To establish the link between conductivity and certain physiologic parameters

· To establish with a statistic program (Statistica version 7.0) an analysis of probability of thefunctional risk of the patient according to the international classification of WHO

Intended UseDevice claims or performance

· Analyzer body composition

· Compute various physiologic parameters in certain organs

· Statistical analysis of the functional risk of the various body systems

· To control the effectiveness of the treatments managed to cure or attenuate an organic dysfunctionor a disease

Cost of the examination :The frontal electrodes are disposable and cost about 1$ per examination. This examination is performed inthe doctor's office or the functional department of a hospital or clinic. The price will take into account theprice of frontal electrodes, amortization of the purchase of equipment and the moderate fees charged bythe physician producing the interpretation and report.

Latrogenic undesirable side effects :No iatrogenic side effects or adverse reactions are known to date

Contraindications :Contra indications are impossibilities in taking the measurement or in interpretation.General contra indications

· dermatological lesions in contact with the electrodes or excessive perspiration

· pacemakers

· People unable to be held upright or seated

· Metal pins or prostheses on the level of the extremities or the joints

· Pregnant women after the 6th month

· An absence of one or more limbs.

· The site of the system : the ground in synthetic material and a relative humidity < 30% can preventmeasurement. The system is sensitive to the important electromagnetic discharges owing to the factthat it measures very low current.

·

Supplementary contraindication for analyzer body composition :· Fever

· Drugs

· Strong alcohol or stimulants (amphetamines) 12 hours before the examination

· Diarrhoea

· Intense physical activity 8 hours before the examination

· Oedema

CLINICALS TESTS RESULTS

Before the realization of the clinical tests, collections of bases of patients presenting of specific affections were carriedout in 2 french hospitals : Gustave Roussy Institute and St Louis hospital.

· At the Gustave Roussy institute (follow), under the scientific control of the associated Professor M.ALIMIDavid, the measurements of patients (37 patients) having undergone patients with a cancer treatment between6 and 24 months and presenting all of neuropathy, allowed to establish a first EIS profile.

· At the St Louis hospital (follow), under the scientific control of Dr. Tritto Giuseppe,in Andrology department,the recordings of males patients (64 patients) having erection disorders, also made it possible to establish aspecific EIS profile.

It should be noted that these collections of patients was not followed of biostastitic interpretation,and no conclusion was brought at the end of the recording.However, these bases of patients having all of the established diagnoses and follow-ups in hospital, allowed usinitially, to understand that EIS graphics were specific certain affections, and to be able to carry out clinical metaanalysis and tests on a more important group of patients presenting of the affections perfectly diagnosed in hospital.These clinical tests were carried out according to international standards.

BOTKIN HOSPITAL (Moscow Russia) 2003

· Site of investigation : S.P Botkin Hospital recorded with the service of the department of the public health ofthe townof Moscow (Russia) Number registration 1037739085900Adresse : 125284, Moscow 2-Botkinski pr, No. 5

· Sponsor : LD TechnologyRepresentative person of LD Technology : Sergei Medvedev

· Clinical Protocol of investigations TC 01 and contract of 13.09.2003 Coordinating clinical investigator :Professor Alexeev V.G deputy to the dean of the hospital

· Monitor: Doctor Markelova E.A and Doctor Kuznetsova L.V

· Ethic committee : Name of the doctors and qualifications :

2. Fedorova N.V., Professor of neurology3. TanhilevichV.M., Head of the intensive care unit in cardiology4. Mirochnichenko N.A., Head of the ORL department

7. Ivanova V.L, Head of the haematology department

After the ethical committee agreement on 22.10.2003 in the procedure of respect of the declaration of HelsinkiThe tests proceeded during the time of the 1.11.2003 to the 1.09.2004.

· N° of recording of the clinical tests: TC01

· Title of the study : Clinical tests on the EIS system: To establish reference algorithms by application ofmathematical laws of inverse problems

Clinical protocol Final Report (follow)

MARFINO CENTER

· Site of investigation: Medicine scientific center of rehabilitation MARFINO (Russia)

· Sponsor : MASTER MEDIA represented by M.Sergei Medvedev Clinical investigator coordinator: Dr.Rasnikin S.M., medical doctor and manager of the scientific program of the center. Monitor : Dr. Marasanov.Medical doctor

· Ethical committee :1. Dr. Rasnikin2. Dr. Marasanov

· Clinical Protocol TM01 and contract of 12.06.2004After the ethical committee agreement on 22.06.2004 in the procedure of respect of the declaration of HelsinkiThe tests proceeded during the time of the 7 07. 2004 to the 20.08.2004.

· Title of the study : COMPARATIVE STUDY OF THERAPY FOLLOW-UP USING THECONVENTIONAL METHODS AND EIS SYSTEM

· Reference of tests N° TM01.

Clinical protocol (follow)Final report (follow)

BOTKIN HOSPITAL (Moscow Russia) 2006

· Site of investigation: S.P Botkin Hospital recorded with the service of the department of the public health ofthe town of Moscow (Russia) Number registration 1037739085900Adresse: 125284, Moscow 2-Botkinski pr, No. 5

· Sponsor: LD Technology Representative person of LD Technology : Sergei Medvedev

· Clinical Protocol of investigations TC 02 and contract of 25.02.2006

· Coordinating clinical investigator : Professor Alexeev V.G deputy to the dean of the hospital Monitor :Doctor Kuznetsova L.V

· Ethic committee: Name of the doctors and qualifications :

2. Fedorova N.V., Professor of neurology3. TanhilevichV.M., Head of the intensive care unit in cardiology4. Mirochnichenko N.A., Head of the ORL department

7. Ivanova V.L, Head of the haematology department

9. Nikitina G.Y., Deputy to the dean of the hospital, Head of infectious and sanitary diseases and epidemics

· After the ethical committee agreement on 19.05.2006 in the procedure of respect of the declaration of HelsinkiThe tests proceeded during the time of the 20 May 2006 to 2 September 2006

· N° of recording of the clinical tests : TC02

· Title of the study: EVALUATION OF A SYSTEM OF ELECTRODIAGNOSIS (EIS) : AID FOR MEDICALDIAGNOSIS AND THERAPEUTIC MONITORING

Clinical protocol (follow)Final report (follow)

Pre study in Gustave Roussy InstituteCLINICAL PRE STUDY:REPORT OF THE PRE STUDY IN GUSTAVE ROUSSY INSTITUTE USING THE EIS SYSTEM

Site of investigation :GUSTAVE ROUSSY INSTITUTE (IGR)Clinical investigator and monitor :DR Alimi DavidSponsor :L.D représenté par M.Maarek AlbertAgreement of scientific commitee the22th of May 2002 : Doctors Missana, Janot et E. Pichard LeandriSummaryA group of 39 patients who had undergone chemotherapy treatment was seen at Gustave Roussy Institute(IGR) in France, in order to investigate the specificity of a graph called the Electrosomatogram (ESG)generated by the EIS device. After statistical study of the base by the STATISTICA program, version 6.0, itappeared that the ESG graph presented a level of sensitivity of 100% (IC calculated at 95%) compared tothe reference base and a level of specificity of 89% (IC calculated at 95%).The focus of this pre-study is three-fold; it enables the system to consider clinical investigations on variouspathologies, to determine the possibility of being a marker of these and calculates the number of patientsnecessary to such clinical investigations.Key words: Anticancer treatments- EIS device. ESG Graph - sensitivity of 100% (IC calculated to 95%) and aspecificity of 89% (IC calculated to 95%) - determination of the number of patients for clinical investigations

Justification of the pre-studyCancer and its treatment launch a polymorphic and simultaneous attack on the organism, in all itscompartments. There is no single system, whether chemical, hormonal, nervous, metabolic,electrophysiological or physical that withstands cancer and its treatment.Cancer involves a reduction in both intracellular and extracellular oxygen, also mitotic genetic processes bytotally disorganizing them and confining them to a relatively rapid exhaustion.The entire homeostasis of the organism is disrupted. The mechanisms of memory intra and extra cellularfind themselves totally destabilized. This has, as a consequence, the progressive alteration ofbioconductivities, a reduction of oxygen, pH imbalance and tissular aggregation.Since the EIS device was going towards evaluating these parameters, interest was seen in the recording ofspecific clinical data specific to this pathology and its treatment. L.D placed the device at the disposal of theIGR in order to carry out these recordings.

Tested hypotheses•For the recorded subjects does the ESG graph offer the possibility of being a marker of patients havingundergone chemotherapy and visiting the pain clinic of the IGR?•Is the number of patients sufficient for a statistical analysis in order to calculate a level of specificity for theESG graph?

Presentation of the EISThe principle of the EIS is the measurement of the conductivity of the intercellular (interstitial) liquid locallyand in vivo by application of the method of bioelectric impedance with specificity, using a D.C. current.This measurement is carried out using 6 electrodes:-2 on the forehead; -2 on the hands; -2 on the feetFrom these 6 electrodes, 22 tissue volumes are measured and are recorded in a graph. The graphicdisplay of the conductivity values of 22 volumes is called an electrosomatogram, ESG.

The originator of the system provided the following document: Recordings were carried out on a populationof more than 1000 presumably healthy subjects. An ESG reference graph was thus obtained, which canestimate the level of sensitivity on the reference graph.(below)

Exclusion of subjectsThe following were grounds for exclusion:• Dermatological lesions in contact with the electrodes or excessive perspiration• Pacemaker bearers• Patients unable to be held upright or seated• Metal pins or prostheses in the lower limbs or joints• Pregnant women after the 6th month - the presence of the fetus might distort interpretation• Absence of one or more limbs• Patients with therapeutic pumps• Patients currently undergoing chemotherapy or radiation, or closer than 1 month post-surgery• Patients refusing to sign the enlightened consent• Patients with mental or behavioural problems

Recording ConditionsSite of investigationThe recordings took place at the Center for Research and Treatment of Pain for Children and Adults at theIGR, Villejuif, France.Agreement of the Scientific Committee of the IGRDr. David Alimi, Associate in Research and Consultations at the IGR, cares for patients each week andruns the protocols for this clinical research. Following a medical conference, he spoke to interestedcolleagues about the scientific bases and principles of the EIS system and on its total safety for bothpersonnel and patients.He received a device to undertake these recordings during a period of nine months beginning May 2002 onthe formal condition that there would be no interference with current or future treatments.Inclusion of patientsThe patients attending the hospital were addressed either by their attending practitioner, or by otherpersonnel, including medical and surgical. All the pathologies treated were oncological in nature, eitherbenign or malignant. The sample of the patients was recruited from among all patients.All types of cancerous localizations, primitive and secondary, were represented in the registered patients.The registered pathologies were of various types including epithelial (carcinoma), mesodermal (sarcomas),cutaneous (epithelioma) or visceral (deep cancers.)Recording took place as often as possible in the clinical environment, during treatment and..?Care was taken not to disturb the smooth running of the clinic. All patients had the common point of havingundergone chemotherapy (eventually accompanied by a surgery and/or radiation) for between one yearand four. All the patients were seen for post-treatment pain (neuropathy).

Enlightened Consent:After having clearly heard the reasons on the harmlessness of the study and the interest of suchcollections, their free and enlightened assent was obtained.Period of the study and number of patientsRegistrations were accepted from May 2002 to January 2003. 39 patients (12 male and 27 female) wereable to participate.MonitorDr. David Alimi carried out personally all registrations during his office hours.ConfidentialityBecause of the professional secrecy and data confidentiality, all the identities of the patients were keptanonymous and numbered by date of passage of the examination. Only clinical and therapeutic data werementioned for each patient.ResultsThe statistical study of graph ESG carried out with statistical program STATISTICA version 6.0.

This graph represents the statistical study: A level of sensitivity of 100% compared to the reference graphof a base of healthy subjects and a level of specificity of 89% (IC calculated to 95%). In the Appendix areresults and the register in Excel form, as well as the calculation of the various studies.

ConclusionThis conclusion engages only the sponsor of this pre-study with a group of patients. The ESG graphaccording to results obtained by the statistical program is specific for patients having undergonechemotherapy and visiting the pain clinic of the IGR. The number of patients (39) seems sufficient todetermine levels of specificity and sensitivity. However, only clinical investigations carried out according toan established protocol and dealing with various pathologies will be able to answer the possibilities of theEIS device.Of particular interest is the question of the sensitivity of the test compared to other pathologies andinvolving larger groups of subjects, both healthy and not.

Pre study in St Louis Hospital (France)Clinical Pre-StudyReport on using the EIS System with hospital patients

Site of the pre-study: Hopital St. Louis, France

Clinical Investigator: Professor Giuseppe TrittoProfessor associated with the Urology Department at the Hopital St. Louis, in France; Department Head of Andrology

SponsorL.D represented by Mr. Albert Maarek

MonitorMr. Albert Maarek

SummaryA group of 37 male patients with erection disorders (ED) was seen at the Hopital St. Louis (France) by the UrologyDepartment and more precisely, in the Andrology Department (Headed by PR G Tritto), in order to test the specificityof a graph called the Electrosomatogram (ESG) generated by a device called the EIS. After statistical study of thebase (STATISTICA version 6.0), it appeared that the ESG graph had a sensitivity of 95% (IC calculated to 95%)compared to the reference index provided by the originator of the system, with a specificity of 78% (IC calculated to95%). The focus of this pre-study is two-fold; on the one hand, it enables the system to consider clinical investigationson various pathologies, to determine the possibility of being a marker of these, and on the other hand, of calculatingthe number of patients necessary to such clinical investigations.

Key words: Andrology- EIS device. ESG Graph - sensitivity of 95% (IC calculated to 95%) and a spe-cificity of 78% (IC calculated to 95%) - determination of the number of patients for clinical investiga-tionsIntroductionSince the appearance of the drug Sildénafil (Viagra), more men have been seeing doctors for disorders of erection,and are speaking more openly of this condition. However, the origin of this problem is multifaceted and treatment doesnot lead inevitably to use of Sildenafil, which is contraindicated for many people with cardiovascular conditions.

This is why the EIS device was used in the Andrology Department of the Hopital St Louis, in order to start a clinicalinvestigation specific to ED on patients without another diagnosed pathology or treatment.L.D placed the device at the disposal of the Hopital St Louis in order to carry out these recordings.

Assumptions tested• For the recorded population who visited the Andrology Department at the Hopital St Louis does the ESG graph offerthe possibility of being a marker of patients with ED?• Is the number of patients sufficient for a statistical analysis in order to calculate a level of specificity and of sensitivitycompared to a base of healthy subjects?

Presentation of the EISThe principle of the EIS is the measurement of the conductivity of the intercellular (interstitial) liquid locally and in vivoby application of the method of bioelectric impedance with specificity, using a D.C. current.This measurement is carried out using 6 electrodes:-2 on the forehead-2 on the hands-2 on the feetFrom these 6 electrodes, 22 tissue volumes are measured and are recorded in a graph. The graphic display of theconductivity values of 22 volumes is called an electrosomatogram, ESG.The originator of the system provided the following document: Recordings were carried out on a population of morethan 1000 presumably healthy subjects. An ESG reference graph was thus obtained, which can estimate the level ofsensitivity. (below)

Exclusion of subjectsThe following were grounds for exclusion:•Dermatological lesions in contact with the electrodes or excessive perspiration•Pacemaker bearers•People unable to be held upright or seated•Metal pins or prostheses in the lower limbs or joints

•Pregnant women after the 6th month - the presence of the fetus might distort interpretation•Absence of one or more limbs•Patients under specific treatments (hypertensive, anticoagulants) or presenting a pathology able to have an influenceon erection

Study ConditionsSite of investigationThe recordings took place in the Andrology Department at the Hopital St Louis between January and April 2005.

Inclusion of patientsThe patients attending the hospital were addressed either by their attending practitioner, or by one of the variouspersonnel at the Hopital St Louis. All the patients presented with chronic ED. The sample of the patients was recruitedfrom all patients. Recordings took place each time in the course of consultations.

Enlightened ConsentAfter having clearly heard the reasons on the harmlessness of the study and the interest of suchcollections, their free and enlightened assent was obtained.Period of the collection and number of patients37 male patients presented to participate in the examination. They were of variable age between 17 and 65years. All these patients consulted for ED.MonitorThe recordings took place at the Hopital St. Louis in the Department of Urology in the presence of PRTritto. Measurements were taken by Mr. Albert Maarek.ConfidentialityBecause of the professional secrecy and data confidentiality, all the identities of the patients were keptanonymous and numbered by date of passage of the examination.ResultsThe statistical study of ESG graph carried out with statistical program STATISTICA version 6.0.

This graph represents the statistical study: A sensitivity of 95% (IC calculated to 95 %) compared to thereference graph of a base of healthy subjects and a specificity of 78% (IC calculated to 95%). In theAppendix are results and the register in Excel form, as well as the calculation of the various studies.ConclusionThis conclusion engages only the sponsor of this pre-study with a group of ED patients.The ESG Graph is based on the results obtained by the statistical program specific to a base of healthypatients. The number of patients (37) seems sufficient to determine levels of specificity and sensitivity.However, only clinical investigations carried out according to an established protocol and dealing withvarious pathologies will be able to answer the possibilities of the DDFAO/EIS device. Of particular interestis the question of the level of sensitivity of the test compared to other pathologies and involving largergroups of subjects, both healthy and with ED.

CLINICAL PROTOCOL BOTKIN HOSPITAL 2003

Summary:Objectives of the studyPrincipal objective1. Modelization of the human body by assigning a conductivity value at the level of different organs.

2. Research of the interstitial electrical markers of certain pathologies.

Secondary objectives1. Prescription of targeted supplementary exams

2. Therapeutic follow-up

Criteria of principal judgment1. To be a marker of pathology ,the algorithms should present specificity and sensitivity levels of 80% (confidence interval calculated at 95 %.)

2. the algorithms of localization should present specificity and sensitivity levels of 80% (confidence interval calculated at95 %.)

Hypotheses will be tested1. The ESG measured from EIS system can be the marker of certain pathologies. In this case we must define the pathologies and thecorresponding organ in order to adjust the localization by inverse problems.

2. The ESG measured from EIS system is not a trustworthy marker for any pathology and in this case the statistical placement of organs inmodelization cannot be validated.

Experimental plan1 SubjectsHealthy volunteers from the personnel at the Botkin Hospital and their family members.Patients presenting at the hospital, following diagnosis by conventional means were authorized to participate in the study

Number of subjects foreseen

Approximately 500

Source of recruitment

Hospital personnel and family membersPatients presenting at the Botkin Hospital

2 Criteria of clinical inclusion•Inclusion was done on the medical record after conventional diagnosis and without treatment (except particular cases: type I diabetes andpatients having had a recent heart attack)

•Patients had to present an isolated affection

•Patients could not present a contraindication to the EIS examination

•Subjects were between 20 and 75 years

•Subjects had to sign the enlightened consent form based on the principles of the Declaration of Helsinki.

3 Criteria of non-inclusion3.1 Concerning antecedents

Treatment leaving sequelae such as chemotherapy or deep surgery

3.2 Concerning the duration of the study

•Patients without an illness or in treatment (except the particular cases cited above) were dismissed as well as those with a contraindication to theexamination.•Patients presented an important deviation from the prevalence of the illness.•Patients with difficulty in the associated pathologies, for example, hypertension, atherosclerosis and diabetes. These patients were not included.•Patients presenting neurological illnesses who were unable to sign the enlightened consent form.•Patients who, in the opinion of the investigator could not be included in the study

Experimental protocol

1 Type of studyControlled

2 Organization of the studyThe experimental plan consisted of

1. Establishing a reference graph with a group of 40 healthy subjects2. Regroup the patients by pathology and create 19 groups•Hypertension•Angina, Transient ischemic cardiac accident•Recent heart attack•Arrhythmia•Circulatory troubles – phlebitis and varices of lower limbs•Cancer•Chronic bronchitis and asthma•COPD•Type I Diabetes•Type II Diabetes•Hypothyroidism•Gastritis•Peptic ulcer•Spasmodic colitis•Pancreatitis•Alimentary hepatitis•Viral hepatitis•Cerebral circulatory troubles and neurological maladies•DepressionThe selection of patients in each group was undertaken by diagnoses issued by conventional means, with theanamnesis perfectly complete.Each patient was registered three times by the designated monitor.Measured variables•Values of the ESG graph

FINAL REPORT OF CLINICAL INVESTIGATION IN BOTKIN HOSPITAL 2003(SUMMARY)

Final Report of the Clinical Trial of December 27, 2004These clinical trials were run during the period November 1, 2003 to September 1, 2004 in the Departmentof Functional Medicine at the S.P. Botkin Hospital.Hypotheses tested1. The EIS can be a marker of certain pathologies. In this case we must define the pathologies and thecorresponding organ in order to adjust the localization through inverse problems.2. The EIS is not a reliable marker for any pathology and in this case the statistical localization of organs inmodelization cannot be validated.Number of patients in the 20 groups in the study1.Healthy persons: 41 persons2.Hypertension: 54 patients3.Antherosclerosis: 31 patients4.Recent heart attack (within one month): 21 patients5.Arrhythmia: 25 patients6.Circulatory problems, thrombophlebitis, lower limb varices: 26 patients7.Cancer, all types: 35 patients8.Chronic bronchitis, asthma: 28 patients9.COPD: 25 patients10.Diabetes I: 27 patients

11.Diabetes II:30 patients12.Hypothyroidism: 25 patients13.Gastritis: 35 patients14.Peptic ulcer: 39 patients15.Spasmodic colitis: 26 patients16.Pancreatitis: 26 patients17.Hepatitis, alimentary: 24 patients18.Hepatitis, viral: 23 patients19.Cerebral circulatory disorders, neurological maladies: 20 patients20.Depression: 28 patients

Results by illnessHealthy persons: 41Ci, the graph of the 41 persons and the average of the reference graph of healthy persons. This graphpresents a specificity of over 93%. Three persons presented a too important deviation.N and A: 1, 3, 9, 10, 16, 18 < -20 and > -502, 4, 15, 17 >0 and < - 20

Hypertension: 54 patientsThe statistical program determined two graphs and so this group was divided into two subgroups with 46patients. Eight patients who presented too important deviations could not be incorporated.Subgroup 1: 28 patientsAge >40 + Na (2+15) >= 20Aa (2+4+15+17) >= 20) + 9 or 10 >-20Graph type 1

Subgroup 2: 18 patientsAge >40 + Na (6+13+19) > 20) + 1Aa normal values +Aa (6> 20 +13> 20 +19> 20) + (Hdi) + not TrueGraph type 2

In terms of statistical values, the results of the 2 subgroups present a specificity of 85% calculated accordingto a confidence interval of 95%.

Angina: 31 patientsThe statistical program determined two graphs and so this group was divided into two subgroups with 28

patients. Three patients who presented too important deviations could not be incorporated.Subgroup 1: 16 patients

Age > 50 + 1Aa value (+) or (+) (+) + Aa 6>20 +13>20+19>20 + (Hdi) + not True

Subgroup 2: 12 patientsAge > 50 + Aa (value (+) or (+) (+) or (2+15)> +20) + (6<- 16 + 13 < - 16 +19 < - 16)

In terms of statistical values, the results of the 2 subgroups present a specificity of 91% calculated accordingto a confidence interval of 95%.

Recent heart attack: 21 patientsThe statistical program determined one graph. Two patients who presented too important deviations could

not be incorporated.Age > 40 Na: (2+15) > 20 + (6+13+19)> +40

Aa 1Aa > Value (+) + (2+15) > 20 + (6>20+13>20+19>20)+ (4+17)<0

In terms of statistical values, the results of this group present a specificity of 90% calculated according to aconfidence interval of 95%. Arrhythmia: 25 patientsThe statistical program determined one graph. Four patients who presented too important deviations couldnot be incorporatedAge >40+ 1Aa value (+) or (+) (+) + (6+13+19) > 20 +2>20

In terms of statistical values, the results of this group present a specificity of 84% calculated according to aconfidence interval of 95%. Circulatory problems, thrombophlebitis, lower limb varices: 26 patientsThe statistical program determined one graph. Six patients who presented too important deviations could notbe incorporated.Aa abs (7+5+20+22) > 20 or (Aa abs (6+13+19) > 20) or (9or 10>20)) + Aa abs (6+19+8+21+13+14) > 20

In terms of statistical values, the results of this group present a specificity of 77% calculated according to aconfidence interval of 95%. Cancer, all types, untreated: 35 patients

The statistical program determined one graph. Nineteen patients who presented too important deviationscould not be incorporated.

Age >351Aa value (-) or (-) (-) + Na (11+12) <- 20 + Aa 9+10 <-60+ Aa (2+ 4+ 15+ 17) <20

In terms of statistical values, the results of this group present a specificity of 46% calculated according to aconfidence interval of 95%.COPD: 25 patientsThe statistical program determined two graphs and so this group was divided into two subgroups with 22patients. Seven patients who presented too important deviations could not be incorporated.Subgroup 1: 10 patientsNa (2> +20+ 4> +20+15> +20+17> +20)Aa (2+4+15+17) > Na (2+4+15+17)

Subgroup 2: 12 patientsAge > 50 + Aa (value (+) or (+) (+) or (2+15)> +20) + (6<- 10 and >-16 + 13 6<- 10 and >-16 +19 6<- 10and >-16)

In terms of statistical values, the results of the 2 subgroups present a specificity of 72% calculated accordingto a confidence interval of 95%. Diabetes I: 27 patientsThe statistical program determined one graph. Two patients who presented too important deviations couldnot be incorporated.Na (Mdi) < -20 1Aa – 1Na < -10 + Aa (5+6+20+21) < -20 + ((5) < -20 or (6) < -20) + ((21) < -20 or (20) <-20)) + (13+14) <-20 + ((2+4+15+17) > -20) + (9 or 10) >0

In terms of statistical values, the results of this group present a specificity of 93% calculated according to aconfidence interval of 95%.Diabetes II: 30 patientsThe statistical program determined two graphs and so this group was divided into two subgroups with 26patients. Four patients who presented too important deviations could not be incorporated.Subgroup 1: 15 patientsAge > 40 + IMC > or=22Na (6+5+20+21) > 20 + 1Aa norm + Aa (6+5+20+21) > 20 + Aa (6+5+20+21) < Abs Na (6+5+20+21)

Subgroup 2: 11 patientsNa (Hdi) > 201Aa Value (+) (+) + (2+4+15+17) > 20 + (7 < 15 or 12<15 or 22 <15)

In terms of statistical values, the results of the 2 subgroups present a specificity of 87% calculated accordingto a confidence interval of 95%. Hypothyroidism: 25 patientsThe statistical program determined one graph. Two patients who presented too important deviations couldnot be incorporated.1Aa < 1Na + (11< -5 + 12< - 5) + (2+4+15+17) < -20

In terms of statistical values, the results of this group present a specificity of 92% calculated according to aconfidence interval of 95%. Gastritis: 35 patientsThe statistical program determined one graph. Six patients who presented too important deviations could notbe incorporated.Abs Aa ((5+6+11+19+20)>20 and > Na ((5+6+11+19+20)) or(Na (6+8+19+21) > 20 + Aa: ((6+8+19+21) > 20))

In terms of statistical values, the results of this group present a specificity of 83% calculated according to aconfidence interval of 95%. Peptic ulcer: 39 patientsThe statistical program determined one graph. Nine patients who presented too important deviations couldnot be incorporated.(Na abs (5+6+11+19+20) <= 20 or Na abs (Mdi) <= 20) +Aa ((Mdi > +20 or(6>+20 +19>+20)) + ((9+10) < -50)

In terms of statistical values, the results of this group present a specificity of 77% calculated according to aconfidence interval of 95%. Spasmodic colitis: 26 patientsThe statistical program determined one graph. Four patients who presented too important deviations couldnot be incorporated.Aa: ((6+8+19+22) > 20) and> Na (6+8+19+22)

In terms of statistical values, the results of this group present a specificity of 85% calculated according to aconfidence interval of 95%. Pancreatitis: 26 patientsThe statistical program determined one graph. Six patients who presented too important deviations could notbe incorporated.Na (Hdi) > 201Aa Value (+) (+) + (2+4+15+17) > 20 + (5 < 15 or 11<15 or 20 <15)

In terms of statistical values, the results of this group present a specificity of 77% calculated according to aconfidence interval of 95%. Hepatitis, viral, ABC: 23 patientsThe statistical program determined one graph. Two patients who presented too important deviations couldnot be incorporated. The program was unable to differentiate the different groups of viral hepatitis.Na (Hdi) > +20 + Aa (Hdi) > + 20 + Aa (2+4+15+17) < - 20 + (9+10) < -60

In terms of statistical values, the results of this group present a specificity of 91% calculated according to aconfidence interval of 95% Cerebral circulatory disorders, neurological maladies: 20 patientsThe statistical program determined one graph. Six patients who presented too important deviations could notbe incorporated.Age > 60 + IMC < 22AaHdi + (9+10) < -80 or Hdi -++ (9+10) > + 30 + Aa (9+10) > Na (9+10)

In terms of statistical values, the results of this group present a specificity of 70% calculated according to aconfidence interval of 95%. Depression: 28 patientsAll subjects were diagnosed with unipolar depression. The statistical program determined one graph. Sevenpatients who presented too important deviations could not be incorporated.Aa (9+10) < -75) + 1+2+3+4+15+16+17+18) < -60

In terms of statistical values, the results of this group present a specificity of 75% calculated according to aconfidence interval of 95%.Discussion / Conclusions / Commentaries

Concerning the specificity of the ESG graphs:With all the confidence intervals being calculated at 95%, the results were ranked from the highest specificity to thelowest in the following way:1. Endocrine illnessesDiabetes I: 93%Diabetes II: 87%Hypothyroidism: 92%2. Cardiovascular illnessesHypertension: 85%Angina: 91%Heart attack: 90%Arrhythmia: 84%Circulatory problems: 84%

3. Digestive illnessesGastritis: 83%Duodenal ulcer: 77%Spasmodic colitis: 85%Pancreatitis: 77%Hepatitis, alimentary: 87%Hepatitis, viral ABC: 91%4. Neurological illnessesCerebral circulatory disorders, neurological maladies: 70%Depression: 75%5. Respiratory illnessesChronic bronchitis and asthma: 72%COPD: 72%6. Cancer: 46%Concerning the level of sensitivity:Compared to the reference group of healthy persons, the level of sensitivity is very high, in the order of 98%, howeverwhen observing the graphs of different illnesses, it seems that certain different illnesses present similar graphs:Pancreatitis and subgroup 2 Diabetes II and Hepatitis, alimentary.Hypothyroidism, cancer and depressionAngina and COPDThis substantially diminishes the sensitivity level of these illnesses.With all the confidence intervals being calculated at 95%, the results of the statistical program are ranked from thehighest sensitivity level to the lowest in the following:Diabetes I: 98%Hepatitis, viral ABC: 96%Hypertension: 95%Heart attack: 93%Chronic bronchitis and asthma: 84%Cerebral circulatory disorders, neurological maladies: 83%Circulatory problems: 83%Spasmodic colitis: 81%Arrhythmia: 81%Depression: 76%Gastritis: 76%Duodenal ulcer: 76%Hypothyroidism: 72%Angina: 71%Diabetes II: 70%Pancreatitis: 70%Hepatitis, alimentary: 70%COPD: 57%Cancers: 30%Thus, from these results, concerning the previous hypotheses:1. The ESG can be the marker of certain pathologiesThe ESG can be the marker of the following pathologies:Diabetes I (under insulin treatment)Hepatitis, viralHypertensionHeart attack, recentChronic bronchitis and asthmaCerebral circulatory disorders, neurological maladiesCirculatory problemsSpasmodic colitisArrhythmia2. The ESG is not a reliable marker for a pathology.The ESG cannot be the marker for the following pathologies:

DepressionGastritisDuodenal ulcerHypothyroidismAnginaDiabetes IIPancreatitisHepatitis, alimentaryCOPDCancersNew hypothesis:It is certain that the ESG cannot be retained as a marker for cancers and for COPD.Concerning cancers, statistical results from the collection of patients at Gustave Roussy, showing a remarkablespecificity and sensitivity after chemotherapy, the ESG might be interesting in post-treatment rather than inscreening?.Concerning diabetes II, alimentary hepatitis and pancreatitis, because of its high specificity, the ESG might beinteresting in the prescription of targeted complementary examinations.Concerning angina, duodenal ulcer, gastritis and hypothyroidism, again, because of its high specificity, the ESG mightbe interesting in the prescription of targeted complementary examinations.Concerning depression, the ESG might provide assistance to the symptomatic diagnosis, if the complementary thyroidand cancer examinations turn out negative.Results from localization of organs in the modelization program by inverse problems:Because of the obtained results in specificity and sensibility of the algorithms, it is possible to localize the followingorgans more precisely and separately:LiverCardiac baroreceptorLeft cardiac ventricleCardiac musclebronchiCerebral vesselsLower limb vesselsColonsTo regroup, the following organs:Pancreas, stomach, duodenumFrontal lobes and thyroidLungs and cardiac coronariesHowever, direct methods can distinguish the frontal lobes (volumes 9 and 10) and thyroid (volumes 11 and 12).Other organs pose more problems, especially at the level of the digestive system, the differentiation is delicate.Concerning the distinction between lungs and coronaries, direct verification is delicate and differentiation can befacilitated by the conductivity of the left ventricle which is specific.

CLINICAL PROTOCOL marfino center 2004Summary: 05.12.2004JustificationFollowing the clinical investigation carried out at the Botkin Hospital from November 2003 to September 2004, with anaim of validating of the EIS system as a marker of certain pathologies, it would be interesting to determinated by thisstudy the validity of its claims:Claim 1: Statistical risks analysisClaim 2: Estimate of the values of the ionogrammeClaim 3: Calculation of the percentage of the body fat mass

OBJECTIVE OF STUDYPrincipal objective

Evaluation of the claims of EIS system were compared to the conventional means or other medical device.(predicatedevice)

Criterion of main judgement

The results of the examination given to the level of the program were compared to results from conventional exams orpredicate device to indicate the statistical percentage of correlation and the confidence interval.•Between the results of the statistical functional risk analysis of EIS program and the real risk of the patientestablished by the conventional exams. At least the correspondence must be 80% with the confidence intervalcalculated at 95%•Between the estimate of the values of ionogramme EIS and the results obtained by the laboratory tests. At least thecorrespondence must be 80% with the confidence interval calculated at 95%•Between the results of percentage of the fat mass EIS and the results obtained according to the device: AVITA BF 1BODY ANALYZER. The difference of value can not exceed 5%

Hypotheses:

EIS can be validated in its claim 1And /or EIS can be validated in its claim 2And /or EIS can be validated in its claim 3EIS can not be validated in its claim 1, 2, and 3

EXPERIMENTAL PLANNumber of subjectsGroup 1Concerning the claims 1 and 2/30 patientsGroup 2Concerning the claim 3/50 healthly subjects (25 men and 25 women)

Criteria of clinical inclusionGroup 1Inclusion is done on the medical folder and after diagnostic by the conventional exams:Group 2patients healthy

Groups 1 and 2Patient without treatment and without contra indication to EIS system.

Criteria of no inclusion:Concerning the antecedentsGroup 1Patients have important treatment in antecedents such as a chemotherapy or deep surgery.

Concerning the period of the studyThe patients with treatment during this period.

Experimental Protocol:

Type of studyControlled study

Organization of the study:

Conventional exams :

- The anamnesis retained the main risk and the associated risks- Blood tests at capillary level:Calcaemia/Magnesaemia/Natraemia/KaliaemiaPredicate device:

The percentage of the fat mass using AVITA BF system.

These examinations will be carried out at the beginning of the cure and at the end of the cure.

Recording using EIS system.The recordings will be carried out at the beginning of cure, then at one week and at the end of the cure.•The evaluation of the system for the statistical risk analysis will be the EIS software results and the real risk of thepatient established by the conventional examinations.•The evaluation of the values of the ionogramme will be the correlation between estimates value of the EIS software(scale +30/-30) and the results of the laboratory tests.•The evaluation of the calculation of the percent of the fat mass will be the correlation between results of EIS softwareand the results of the predicate device AVITA BF 1 BODY ANALYZER

MEASURED VARIABLESThe EIS software statistical estimatation of the risk according to classification I, II, III, IV.The main risk being risk I.The EIS software estimation of the values of the ionogramme on a scale +30/-30 with reference values between +10/-10.The EIS software estimatation in percent of the fat mass.

Strategy of analysis of the data

Assumptions 1:With regard to claim 1, we will immediately have the results of the EIS software by calculating risks I compared to thediagnosed risks with conventional examinations.Assumptions 2:With regard to claim 2:A statistical program (STATISTICA version 7.0) will analyze the correlation between the scale +30/-30 of EIS softwareand the laboratory tests.Assumptions 3:With regard to claim 3:A statistical program (STATISTICA version 7.0) will analyze the correlation between the results of EIS software andthe predicate devive.

FINAL REPORTS CLINICAL INVESTIGATION MARFINO CENTER(SUMMARY)

COMPARATIVE STUDY OF THERAPY FOLLOW-UP USING THE CONVENTIONAL METHODSAND EIS SYSTEMFINAL REPORTAccording to the clinical protocol of investigation (PICMFN)06.12.2004Center of investigationMEDICAL SCIENTIFIC CENTER OF REHABILITATION MARFINO

Correspondence of the values of the blood tests ionogramme and EIS iongramme estimation (scale +30/-30 withthe norms between +10/-10)

Correspondence of the values of the body composition using AVITA BF 1 BODY FAT ANALYZER system and EISsystem

Conclusions

Concerning the claim 1 of EIS system , it appears that in 33 patients of group 1, the program indicates the main risk ofthe patient to 75% accuracy.The criterion of validation of this claim 1 being fixed at 80% with a confidence interval at 95%. Thus, this claim 1 isnot validated and must be the subject of clinical investigation presenting a more significant number of patients , or tomodify the validating criterions.The assumption1 is rejectedConcerning the claim 2 of EIS system , it appears that in 33 patients of group 1, the statistical program (STATISTICAversion 7.0) have analysing the correlation between the scale 30/-30 of EIS software and the laboratory tests and thecorrespondence is 89% with a confidence interval at 95%The assumption 2 is validated.Concerning the claim 3 of EIS system, it appears clearly that on the 58 patientsof group 2, the EIS software gives results in conformity (standard deviations < to 5% with a confidence interval at95%) to the AVITA BF1 device .The assumption 3 is validated.

CLINICAL PROTOCOL BOTKIN HOSPITAL 2006Summary:25 February 2006

Justification, ObjectivesFollowing the clinical trials undertaken at the Botkin Hospital between November 2003 and September2004, with the goal of validating the EIS system as a marker of certain pathologies, it became interesting todemonstrate by the undertaking of this clinical trial the validity of its revendications or claims :1.Statistical functional risks offering an aid to medical diagnosis and the prescription of targetedsupplementary examinations.2.Controlling the efficacy of treatments given to cure or attenuate an organic dysfunction or an illness.Judgment criteriaThe results of the examination given to the level of the program were compared to results fromconventional exams as much at the diagnostic level as at the therapeutic follow-up. The validationmodalities are described below.Expected results and possible implicationsIn cases where the clinical tests would be validated in EIS claims, it would offer a screening of certainpathologies and a rapid therapeutic follow-up, easy for in-office use, which permits prescription ofsupplementary, targeted tests and of creating a low cost therapeutic follow-up.Justification of the studyPresentation of the problemThe first clinical validation tests raised many questions from the point of view of the installed programincorporating numerous algorithms. In effect, the tests of 2003 led to the creation of the system as itcurrently exists but what is it about its claims?In addition, the clinical trial performed in 2003 at the Botkin Hospital concluded that the EIS could not bethe marker of the following pathologies due to a lack of sensitivity of the ESG graph:•Depression•Hypothyroidism•AtherosclerosisAnd that from the point of view of localization of organs on the proposed modeling by the EIS system thetrial referred to the difficulty of distinction between the following organs:•Frontal lobes and thyroid•Lungs and heart?This current study proposes to focus on the pathologies and organs described above.

Data from the literatureData was available from the results of bio-electro impedance (6), (6), (20), also derived from interstitial fluidphysiology (27), (28) and from the final report of clinical trials done at the Botkin Hospital in 2003.Justification of the study considering current knowledgeThe physiology of interstitial fluid is still poorly known due to conditions of sampling. The electrical measurein vivo might bring new elements to the level of our internal environment and cells activity , similar to bloodtests, might be markers of certain pathologies.Modelization of the human body which allows rapid visualization of the interstitial conductivity at the level ofdifferent organs will bring new elements to the level of organic function and therapeutic follow-up.Objective of the studyPrincipal objectiveEvaluation of the claims of the EIS systemCriteria of principal judgmentThe results of the examination given by the program were compared to results from conventional exams asmuch at the diagnostic level as at the therapeutic follow-up.Validation of claim1: Statistical functional risks offering assistance to medical diagnosis and the prescriptionof targeted supplementary examinations.It is estimated at the level of four diagnostic pathologies done by conventional means and results of the riskanalysis done by the EIS program. We consider that only risks I and II would be returned with a positiveresult. A minimum of 80% (with an interval of confidence calculated at 95%) would be a proof of validation.Validation of claim 2: To control the efficacy of treatments administered to cure or attenuate an organicdysfunction or an illness.It is estimated at the level of administered treatments of the same four pathologies in follow-up byconventional examinations and the values of different volumes of ESG graph or the value of the organ onthe modelization in intensity (µA): statistical curves of ESG values will be compared to laboratory tests or tomeasurement by other medical devices or to the symptomatology.Hypotheses that will be testedThe EIS system can be validated in claim 1The EIS system can be validated in claim 2The EIS system can be validated in claim 1 and 2The EIS system cannot be validated in claims 1 and 2Experimental planSubjectsWe will not have a group of healthy subjects but will use the results obtained from the trial in 2003 whichestablished a reference graph for the ESG, i.e., a healthy group of 40 persons.Patients presenting at the hospital after being diagnosed by conventional means would be authorized toparticipate in the study.Number of subjectsApproximately 200Source of recruitmentPatients presenting themselves at the Botkin Hospital and not receiving any treatmentClinical inclusion criteria• Inclusion can be made on the medical file after diagnosis by conventional means and without treatmentand presenting one of the following pathologies:• Thyroid hypofunction• Hypertension• Atherosclerosis• Depression• Patients should present one isolated illness.• Patients should not present a contraindication to the EIS system• Subjects’ age would be between 20 and 75 years

• Subjects had to sign the enlightened consent form based on the principles of the Declaration of HelsinkiCriteria of non-inclusionConcerning antecedentsTreatment leaving sequelae such as chemotherapy or deep surgeryConcerning the duration of the study• Patients without an illness or in treatment (except the particular cases cited above) were dismissed aswell as those with a contraindication to the examination.• Also, those who presented an important deviation from the prevalence of the illness• Those with difficulty in the associated pathologies, for example, hypertension, atherosclerosis anddiabetes. These patients were not incuded.• Subjects presenting neurological illnesses who were unable to sign the enlightened consent form• Patients , according to the investigator, could not be included in the studyExperimental protocolType of study

ControlledOrganization of the studyFour pathologies previously diagnosed by conventional examinations will be registered by the system:• Thyroid hypofunction• Hypertension• Atherosclerosis• DepressionSubjects will be registered three times consecutively. Total time of the examination = 8 minutesPatients will receive no treatment at their first registration. A specific treatment for pathologies will be put inplace after the first registration. Therapeutic follow-up for patients will be provided by the EIS system andby conventional methods every 15 days. Evaluation of the system concerning the assistance to medicaldiagnosis and the prescription of targeted complementary examinations was established based on theindication of risk and the indication of the supplementary examinations recommended by the program’sinstructions.Evaluation of the therapeutic follow-up is a function of the correlation between the ESG measures and thesupplementary examinations on one hand, and between the functioning of organs and the organic goal oftreatment, on the other.Measured variablesThe statistical scale of functional risk proposed by the program: Risk I, II, III, IV. Risk I is the highest.The values of the ESG graph or the value of the organ on the modelization in intensity (µA).

Strategy of analyzing the dataConcerning assumption 1 we can immediately access the results with the EIS program by calculating risks Iand II with connection to the diagnosed pathology.Concerning assumption II:According to pathology the analysis of data will be different.Hypothyroidism: A curve of average values of intensity of the thyroid on the modelization in function of thechanged dosage every 15 days. This will be compared to the curve of average values from the laboratoryTSH test.Hypertension:Following placement of a beta-blocker, a curve of average values (noted every 15 days) of intensity of ESGvalues 2, 4, 15, 17 (corresponding to catecholamines based on tests from 2003) will be compared to thecurve.Atherosclerosis:Following placement of an anticoagulant treatment: a curve of average values (noted every 15 days) ofESG volumes 6, 13 and 19 (corresponding to blood circulation at the level of the left ventricle, according totests from 2003) will be compared to the curve of average values (noted every 15 days) from the laboratoryprothrombine test.

Depression:Following placement of an IRSS treatment: A curve of average values (noted every 15 days) of ESGvolumes 9 and 10 (corresponding to frontal lobes, according to the tests of 2003) will be evaluated infunction the symptomatology of the depression.

FINAL REPORT OF CLINICAL INVESTIGATIONS 2006 BOTKIN HOSPITAL(SUMMARY)

Final Report of September 15, 2006

Number of patients in the groups of the studyGroup 1: Thyroid hypofunction: 52 patientsGroup 2: Hypertension: 57 patients. This group was divided into 2 based on prescribed treatments. Group 2A(37 patients) and Group 2B (20 patients)Group 3: Atherosclerosis: 49 patientsGroup 4: Depression: 57 patientsTreatments provided for the groups of patientsGroup 1: Thyroid treatmentGroup 2A: Beta blockersGroup 2B: IEC (Inhibitors of enzyme conversion)Group 3: AnticoagulantGroup 4: AntidepressantsResults of the tests concerning the aid to the medical diagnosisThe program EIS analyses the measurement and proposes an statistical functional risks analysis classified between R0 and R IV (R IV is the higher risk)Hypothyroidism :Results of the examination as regards the risk of hypothyroidismR 0 : 2R I : 4R II : 3R III : 5R IV : 38Hypertension :Results of the examination as regards the risk of hypertensionR 0: 1R I: 5R II: 7R III: 12R IV: 32Coronary atheroma :Results of the examination as regards the risk of atheromaR 0: 5R I: 0R II: 3R III: 8R IV : 33Depression :Results of the examination as regards the risk of major depression unipolarR 0: 7R I: 0R II: 3R III: 22R IV : 25

Measurement of the risks as a function of the disease

the monitoring of the following treatments applied to the disorders

· Thyroid treatment

· Beta blocking agents

· CEI (conversing enzyme inhibitors)

· Anticoagulants

· Anti-depressants

Results of the tests concerning the therapeutic monitoringThe following results represent the means of the variations for all patients presenting the same disease.1. Monitoring of the thyroid hormone treatmentMean (for 52 patients) of the variations in the EIS values on the thyroid as a function of the dose of thyroid treatment:Fig. 2Visit 1 : 100 µg doseVisit 2 : 120 µg doseVisit 3 : 150 µg doseVisit 4 : 100 µg doseMean (for 52 patients) of the thyroid values expressed in scale -100/+100 on the EIS programBefore treatment : -40Visit 1: -10Visit 2: 0Visit 3: 20Visit 4: -5Mean of the thyroid values expressed in scale -100/+100 on the EIS program

Mean (for 52 patients) of the variations in the TSH values established according to the laboratory tests.Before treatment: 7Visit 1: 6Visit 2 : 3Visit 3 : 0Visit 4 : 2Mean of the variations in the TSH values established according to the laboratory tests

2. Monitoring of the hypotensive treatmentsa) Treatment with beta adrenergic blocking agentsMean (for 37 patients) of the variations in the EIS values for the mean of the EIS volumes 2+4+15+17 as a function ofthe beta adrenergic blocking agent treatment.Before treatment: 40Visit 1: -15Visit 2: -27Visit 3: -40Visit 4: -20Mean of the EIS volumes 2+4+15+17 as a function of the beta blocking agent treatment

Mean (for 37 patients) of the variations in the blood pressure values during the beta adrenergic blocking agenttreatment:Before treatment: 105/115Visit 1: ./ 95Visit 2: ./ 90Visit 3: ./ 80Visit 4: ./ 85

b) Treatment by conversion enzyme inhibitor (CEI)Mean (for 20 patients) of the variations in EIS values for the mean of the EIS volumes 6+8+19+21 as a function of theCEI treatment (sartan): Fig. 6Before treatment : 37Visit 1 : -12Visit 2 : -22Visit 3 : -37Visit 4 : -31

Mean (for 20 patients) of the variations in the blood pressure values during the CEI treatment: Fig. 7Before treatment : 120/ 120Visit 1 : ./ 115Visit 2 : ./ 95Visit 3 : ./ 80Visit 4: ./ 90

3. Monitoring of the patients receiving anticoagulantsMean (for 49 patients) of the variation of EIS values for the mean of the EIS volumes 6+13+19 (series 1: heartcirculation) and volumes 9+10 (series 2: brain circulation) as a function of the dose of anticoagulant treatment: Fig. 8Before treatment: 6+13+19: 23 9+10: 50Visit 1 : 6+13+19 : -25 9+10 : -30Visit 2 : 6+13+19 : - 30 9+10 : -45Visit 3 : 6+13+19 : -30 9+10 : - 60Visit 4 : 6+13+19 : -27 9+10 : - 60

4. Monitoring of patients receiving anti-depressants (IRSN)Mean (for 57 patients) of the variations of EIS values for the mean of the EIS volumes of volumes 9+10 as a functionof the anti-depressant treatment.Fig. 9Before treatment: -60Visit 1: -60Visit 2: -67Visit 3: -30Visit 4: -20

Discussion and conclusion

In view of the results obtained at the level of risk analysis by the EIS, interest is found as an aid to medical diagnosisand prescription of targeted supplementary examinations. In effect, the system indicates the supplementary exams forrisks I and II and from this point of view the results are remarkable. The examination can be recommended for:Thyroid at 79.4% (confidence interval calculated at 95%)Hypertension at 80.3% (confidence interval calculated at 95%)Atherosclerosis at 91.9% (confidence interval calculated at 95%).Depression at 90.5% (confidence interval calculated at 95%).

The strong point of the system is the therapeutic follow-up with its non-invasive character and the cost of theexamination.The system is quite sensitive and brings about modifications of parameters of targeted organs induced by differenttreatments permitting an adjustment of dosages and visualization of the efficacy of treatment as well as side effects. Interms of performance and security, considering the total absence of side effects, the performance is remarkable.

INTERPRETATION

The program was carried out the interpretation of the results is simplest possible. The analysis programdeals with the algorithms calculated by inverses problems resulting from the clinical tests, and thebiochemical results in order to present the results in form of synthesed images and the organs to youaccording to a specific chromatology corresponding to certain measured functional criteria to which you

have access.

Physiological significance of the colors (later)An risk analysis per system and the biochemical results in the form of graphs are also proposed to you.Algorithms conventions (later)However, certain requirements are to be respected in order to use your system as well as possible :1.The results obtained by the examination are not used imperatively to confirm the diagnosis of structure(imagery) or blood (laboratory tests) established by other examinations.Instead they bring functional and complementary new elements to the interstitial level. Each medicalexamination has its specificities ; the EIS as a whole analyzes the function of the organs via the interstitialfluid with its specificities and information which one can extract from this examination.Just like laboratory tests, the interpretation of the EIS thus requires that one has knowledge of adequatereferences and a list of variables which can modify the results.

2.Modeling represents the organs as well as their function and the interstitial fluid which traverses them.This noninvasive and fast examination, evaluated within the clinical context, makes it possible to themedical user to have a functional assessment and not a exhautive medical diagnosis. The EIS establishesan organic functional evaluation making it possible to visualize therapeutic control and to analyze thestatiscical functional risk.if pathology does not affect the measured organs or the total organ in its functionality, the device does notdetect it, contrary to imagery systems. This is why examination by EIG is a screening examination, and anegative examination does not mean that the patient does not present pathologies, but simply that thefunctionality of the organ in its globality is respected.False positives / False negatives (later)The optimal use of tests is not based only on comparing a result with reference values (later) but also requires adefinition of physiological limits. These cover 95% of healthy subjects. Test interpretation therefore requiresavailable adequate references and lists of variables which can modify the resultsVariation factors (later)The physiological limits of decision making fluctuate with the objectives :

· Diagnosis made Patient follow up Diseases concerned

· Possible therapies

· PrevalencesThey are therefore based on current scientific and medical knowledge...

3.Reproduction and stability of results The body functions are being undulatory, the fundamental principles ofphysiology (later), can apply perfectly to EIS examination and make it possible to understand themodifications being able to occur during successive recordings or at several hours of interval. Thesevariations also apply to the laboratory tests.These variations depend on :reflects the inaccuracy of the method used :this is estimated by analysing the test several times.Intraindividual variation (later) is estimated by repeating the examination on the same person.

Interindividual variation (later) is estimated by using the mean values for several people and is influencedby variables such as age and gender.Specificity and sensitivity (later)

Help for interpretation : At the beginning, we can help you for the interpretation according to the clinicalcontext It is possible to send us by e-mail your recordings by the import-export options from EIS program .Of same we will answer all your questions by email or phone.

Physiological significance of the colors

The colors of the modeling images have made from the conductivity : See Chromatology in EIS design

The first digit of the second measurement (1A1) reflect the mitochondrial activity

Cells mitochondrial activity :

This activity is given by 1A1 ( algorithms conventions ) (later)1A1 value (+) (+) : Strongly increase activity1A1 valeur (+) : Increase activity

1A1 value (-) : decrease activity1A1 valeur (-) (-): Strongly decrease activity

YELLOW COLORpositives values +20 à +60

Organic imagesTissue in alkalosis : pH increasedVO2: increasedOrgan fonction increasedBlood volume and blood pressure increasedBlood flow decreasedInflammation and edema

Brain imagesTissue in alkalosis : pH increasedVO2: increasedNeuronal excitability increasedBlood pressure increasedBlood flow decreasedMemoiry disorders

Heart imagesTissue in alkalosis : pH increasedVO2: increasedOrgan fonction increasedMuscular contraction increasedBlood pressure increased and possibility of ischemiaBlood flow decreasedCoronary : atherosclerosisNeuro vegetative system imagesIncreased imbalance sympathic systemVertebras imagesDeformation and vertebral blocking with a possibility of cartilage compressionSegmental innervation imagesNeuromuscular excitability increased

RED COLORValues +60 à+100Organic imagesTissue in alkalosis : pH increasedVO2: increasedVolemia and blood pressure increased : possibility of thrombosis of infections or necrosisBlood flow decreasedAttack of the cells membranes Ischemia

Brain imagesTissue in alkalosis : pH increasedVO2: increasedNeural excitability strongly increasedBlood pressure increasedBlood flow:decreasedIschemia

Heart imagesTissue in alkalosis : pH increasedVO2: increasedOrgan function decreasedMuscular contraction increasedBlood pressure increased and ischemia

Nneuro vegetative systemStrongly increased imbalance sympathic systemVertebras imagesDeformation and vertebral blocking with a possibility of cartilage compressionSegmental innervation imagesNeuromuscular excitability increased and pain

BLUE COLORNegatives values -20 à - 60

Organic imagesTissue in acidosis : pH decreasedHypoxyaOrgan function decreasedblood pressure decreased/ vasodiltationBlood flow increasedChronic inflammation

Brain imagesTissue in acidosis : pH decreasedHypoxyaNeural excitability decreasedBlood pressure decreasedBlood flow increased

Heart imagesTissue in acidosis : pH decreasedOrgan function decreasedMuscular contraction decreasedBlood pressure decreasedBlood flow increased

Neuro vegetative system imagesincreased imbalance parasympathic systemVertebras imagesBone density decreasedSegmentary innervation imagesNeuromuscular excitability decreased

DARK BLUE COLORNegatives values - 60 à -100Organic imagesTissue in acidosis : pH decreasedHypoxyaOrgan function decreasedVolemia and/ or blood pressure decreasedAttack of cells membranesDégenerative zone

Brain imagesTissue in acidosis : pH decreasedHypoxyaNeural excitability strongly decreasedBlood pressure decreasedBlood flow increasedDégenerative zone

Heart imagesTissue in acidosis : pH decreasedHypoxyaMuscular contraction decreasedBlood pressure decreased : possibility of hemtome , veinious or lymphatic disordersBlood flow increased

Neuro vegetative system imagesincreased imbalance parasympathic system

Vertebras imagesBone density decreasedSegmentary innervation imagesNeuromuscular excitability decreased: somesthesia troubles

ALGORITHMS CONVENTION

Abs: absolute value ( ) = Average MidleN = averages of all the volumes Na MidleA= averages of all the volumes Aa(5+6+7+8+19+20+21+22) = Mdi Abs 5> 20 + Abs 6> 20 + Abs 7> 20 + Abs 8> 20 + Abs 19> 20 + Abs 20> 20 +

Abs value of the higher volume + Abs value of the lower volume Dispersion: 1Aa- Average Abs Na 1Aa - 1er digitAa1Na - 1er digit Nadv = 1Aa - 1Na;Value of mitochondrial activity depend from dv

· If dv > 7 and < 10 value (+)

· If dv > 10 value (+) (+)

· If dv < - 7 and > - 10 value (-)

· If dv < - 10 value (-) (-)

False POSITIVE AND False NEGATIVE

The false positive and false negative are applicable only for the patients without treatment.If a patient takes a regular treatment the device indication of use is not diagnosis but therapeutic follow up.Thus , the following data concern the patient without treatment.

Source data :1. Item 1 : The site of investigation of device EIS is the interstitial liquid :Because it is in direct contact with the cellular metabolism, the interstitial liquid is from its physiology (27) (28) muchmore sensitive to dysfunctions than :

· Blood examinations (because of buffering)

· Imagery systems which investigate all tissues.2.Item 2 :Taking into account the limited number of electrodes (6 ), the device indicates the function of the globality ofthe organ , contrary to the imagery systems which can explore each cm2 of tissue of each organ.

3.Item 3 :The statistical results on the clinical tests and approximately 300 EIS systems in use for 3 years (currently more than2400 examinations/working day) : According to the data transmitted by the clinical tests and the users :

· false negative approximately 15 %

· false positive approximately 14 %

False Positive :From item 1 :A greater sensitivity to the dysfunctions, the false positive represents statistically according to clinical tests 14 % ofmeasurements.From item 3 :This disadvantage will involve approximately 14 % of ineffectual supplementary examinations, but 86 % of positiveexaminations.

False Negative :From item 2 :Globality function of the organs.False negatives are slightly more important and account statistically for 15% of measurements. Indeed if pathologydoes not affect the total organ in its functionality, the device does not detect it, contrary to imagery systems. This iswhy EIS examination is a screening examination, and a negative examination does not mean that the patient does notpresent pathology, but simply that the functionality of the organ in its globality is respected. This is also why only thephysician can carry out the interpretation according to the clinical context and current medical knowledge.

Variation factors

The parameters of the examination (determination of item 0 of the EIS) are variable according to the age, the sex and BMI. These factors of variations are taking in charge by the software .

Above, other factors of variations that you must known for make the interpretation of the results.

Physiological principles of human body

1. physiological functional DeltaHuman body functions, like all the regulated system according to assigned values subjected to perturbingfactors or releases, regulating centers are stimulated by the sensors and are able to inhibiting effects on thesystem .In this loop of regulation, a assigned value, relativelyconstant, can in a more or less important way undergoundulatory variations. This regulation is adapting with the assigned value and not with the disturbing factor,thus, is elaborate regulation or servoregulation.Thus, when lthe body is heathly, with this mechanism,there is maintenance the assigned value in timeaccording to an oscillation of tolerable values which we will call: functional delta or reference value.

2. Dysfonction due to a disturbing factor importantWhen the system of regulation is subjected to an important disturbing factor, the regulation can be donein 2 ways :

· Fast and complete re-establishment of the assigned value : subjet healthy in compensation· Slow regulation and incomplete, there is fluctuations and an unstable regulation with maintenance of

the assigned value : it is the dysfunction

3. Change of the value assignedDysfonction and lesion In this case.The slow and incomplete regulation make fluctuations and an unstable regulation will change the assignedvalue, we are in lesional.

Intraindividual variationReliability of the EIS (ElectroInterstitial Scan) by Richard T. Clement MD When the first EKG and X-ray wereintroduced by their inventors; we may wonder at the reaction and questions of our colleagues the first time they casteyes upon such devices. Hope and skepticism were probably part of their initial reaction; that is a normal response. I

had the same skepticism when I first saw the EIS.The EIS is an electro medical device that allows screening and pre-diagnosis of functional disturbances.

1. EIS measurementThe measurement consists of the registration of data from 6 non invasive electrodes (forehead, hands and feet) in atwo minute process where the body is submitted to a low intensity voltage, 1.28 V.This process results in two series of 22 measurements and integration by computer analysis.The EIS has been used in Europe and many other countries in the world for the past 4 years.Functional analysis is variable and changes of temperature, meals, exercise, as well as some medications may affectthe data. In order to assess the reliability of the measurement, two experiments were performed.2. EIS evaluationA) I examined myself RC using two different programs(English and Spanish version) provided by LD Technology version 7.74 Fx1 and installed in two different computers.The measurements were performed at a ten minute interval with no therapeutic intervention between themeasurements.17.27 and 17.37 hours.Computer used: Hp Pavillon zd8000 (LD Technology English program 7.74 Fx1)Computer used: Compact Presario 2100 (LD Technology Spanish program 7.74 Fx1)The second exam was transferred into the English program.

B) I examined the same subject GL suffering from an undiagnosed chronic condition :Fatigue, anxiety, body pain and digestive symptoms and tested GL at two occasions in different locations (EIS fromLD Technology version 7.74 Fx 1) at sea level in Miami USA (February 2006) and in Bogota, Colombia (May 2006)at high altitude.- Computer used: Hp Pavillon zd8000 (LD Technology English program 7.74 Fx1)During the three months between the two EIS examinations a minimum of therapeutic intervention had been institutedand followed by the patient, GL, who had several tests performed, all of which were within normal ranges.Clinical exam without any objective signs.Biological evaluation including liver function test and serology for hepatitis (-)Serology for auto-immune conditions which were all negativeUpper GI X rays (-)Chest X ray (-)Urinalysis and stool test (both negative).

Experiment A : Patient CRHP Pavillon zd8000 05.19.2006 5.27 pm Compaq Presario 05.21.2006 1.29 pm

HP Pavillon zd8000 05.19.2006 5.27 pm Compaq Presario 05.21.2006 1.29 pm

Experiment B : Patient GL3 February 2006 Miami USA Sea Level / results down27 May 2006 Bogota Colombia High Altitude/results up

Conclusion :It appears from the first experiment that the EIS functions independent of the computer and the version used. Theprofile and data are nearly identical on two subsequent examinations without intervening treatment.The second experiment shows that patients not treated according to the recommendation of the EIS may see minimalchanges in their profile during a three month interval.It appears also that the altitude and barometric pressure have only minimal influence on the data.About the AuthorRichard T. Clement graduated with his MD from the University of Paris in 1976. He has practiced medicine in severalcountries for the past 20 years and lectured worldwide.Dr. Clement has been a consultant on Complementary Medicine for the NIH (National Institute of Health) and he is a

member of the HPCUS (Regulation of Homeopathy), a teacher of Pharmacology and Homeopathy at the ATOMSchool of Acupuncture in Fort Lauderdale, FL. Also the formulator of nutritional and homeopathic remedies forseveral companies including Heel, Arkopharma and his own companies Be Well Homeopathic and Richard ClementNutrition.EIS is Patented Device manufactured and distributed by LD Technology . www.ldteck.comDr. Clement can be contacted at richardclementmd@yahoo.com

Intraindividual variationReliability of the ESG (Electrosomatogram) by Richard T. Clement MD When the first EKG and X-ray wereintroduced by their inventors; we may wonder at the reaction and questions of our colleagues the first time they casteyes upon such devices. Hope and skepticism were probably part of their initial reaction; that is a normal response. Ihad the same skepticism when I first saw the ESG.The ESG is an electro medical device that allows screening and pre-diagnosis of functional disturbances . 1 ESGmeasurementThe measurement consists of the registration of data from 6 non invasive electrodes (forehead, hands and feet) in atwo minute process where the body is submitted to a low intensity voltage,1.28 V.This process results in two series of 22 measurements and integration by computer analysis.The ESG has been used in Europe and many other countries in the world for the past 4 years. In the USA the FDAregistration is in process. (sensitivity 89% and specificity 84%)Functional analysis is variable and changes of temperature, meals, exercise, as well as some medications may affectthe data. In order to assess the reliability of the measurement, two experiments were performed.2 ESG evaluationA) I examined myself RC using two different programs (English and Spanish version) provided by Medildwww.medild.com version 7.74 Fx1 and installed in two different computers.The measurements were performed at a ten minute interval with no therapeutic intervention between themeasurements.17.27 and 17.37 hours.Computer used: Hp Pavillon zd8000 (Medild English program 7.74 Fx1)Computer used: Compact Presario 2100 (Medild Spanish program 7.74 Fx1)The second exam was transferred into the English program.

B) I examined the same subject GL suffering from an undiagnosed chronic condition:Fatigue, anxiety, body pain and digestive symptoms and tested GL at two occasions in different locations (ESG fromMedild version 7.74 Fx 1) at sea level in Miami USA (February 2006) and in Bogota, Colombia (May 2006) at highaltitude.- Computer used: Hp Pavillon zd8000 (Medild English program 7.74 Fx1)During the three months between the two ESG examinations a minimum of therapeutic intervention had beeninstituted and followed by the patient, GL, who had several tests performed, all of which were within normal ranges.Clinical exam without any objective signs.Biological evaluation including liver function test and serology for hepatitis (-)Serology for auto-immune conditions which were all negativeUpper GI X rays (-)Chest X ray (-)Urinalysis and stool test (both negative).

Experiment A: Patient CRHP Pavillon zd8000 17.27 (5.27 pm)

Compaq Presario 17.37 (5.37 pm)

HP Pavillon zd8000 17.27 (5.27 pm)

Compaq Presario 17.37 (5.37 pm)

Experiment B: Patient GL3 February 2006 Miami USA Sea Level 27 May 2006 Bogota Colombia High Altitude

Conclusion:It appears from the first experiment that the ESG functions independent of the computer and the version used. Theprofile and data are nearly identical on two subsequent examinations without intervening treatment.The second experiment shows that patients not treated according to the recommendation of the ESG may see minimalchanges in their profile during a three month interval.It appears also that the altitude and barometric pressure have only minimal influence on the data.About the AuthorRichard T. Clement graduated with his MD from the University of Paris in 1976. He has practiced medicine inseveral countries for the past 20 years and lectured worldwide.Dr. Clement has been a consultant on Complementary Medicine for the NIH (National Institute of Health) and he is amember of the HPCUS (Regulation of Homeopathy), a teacher of Pharmacology and Homeopathy at the ATOMSchool of Acupuncture in Fort Lauderdale, FL. Also the formulator of nutritional and homeopathic remedies forseveral companies including Heel, Arkopharma and his own companies Be Well Homeopathic and Richard ClementNutrition.ESG is Patented Device manufactured and distributed by Medi L.D. www.medild.comDr. Clement can be contacted at richardclementmd@yahoo.com

RESULTS ANALYSISThe results are in accordance with the EIS system claims

· Modeling of the human body and localization of the organs· Organic functional assessment in the form of parameters based on conductivity and according to a

chromatology

· Estimate of acid-basic balance of the interstitial fluid· Control and monitoring· Statistical analysis of the functional risk and supplementary examinations· Personalized diet / micro nutrition / body composition

1. Interstitial pH and gases/ interstitial biochemistry/interstitial hormonal assessment/interstitial ionogramme2. Electroscangram/intertitial oxydative stress/interstitial neurotransmitors3. Modeling : Expert images 4. Statistical functional risk analysis / control follow up5. Aid to therapeutic decision

1: INTERSTITIAL GASES / INTERSTITIAL BIOCHIMISTRY / INTERSTITIAL IONOGRAM /INTERSTITIAL HORMONAL ASSESSMENTInterstitial biochimistry Interstitial Davenport diagram

Interstitial Ionogram Interstitial hormonal assessment

2: ELECTROSCANGRAM / INTERSTITIAL OXYDATIVE STRESS / INTERSTITIALNEUROTRANSMITTERSElectroscangram graphic (ESG) scale +100/-100 Electroscangram graphic (ESG) scale 0/+100 (absolute values)

Interstitial free radicals of oxydative stress Mains interstitial neurotransmitters

3. MODELING AND SYNTHESED IMAGESCorrespendance of colors and functionnal parameters Brain image

Vertebra image Neurovegetative system image

4. SYSTEMS ANALYSIS / RISKS ANALYSIS / THERAPEUTY FOLLOW UP

5. Assistance to Therapeutic decision

lAST DATA OF INTERSTITIAL FLUIDNo direct methods for sampling interstitial fluid are currently available. The composition of interstitial fluid, whichconstitutes the environment of the cells and is regulated by body homeostasis, has previously been measured by thesuction blister or liquid paraffin techniques or by implantation of a perforated capsule or wick. The results have varied,depending on the sampling technique and animal species investigated. (52)In one study, the ionic distribution between vascular and interstitial compartments agreed with the Donnan equilibrium(51); in others, the concentrations of sodium and potassium were higher in interstitial fluid than in plasma (51).However, the publications (51) (52) could establish the following elements:1. Interstitial fluid differs from whole blood by the absence of red blood cells, and it differs from blood plasma in thatthere are far fewer proteins (51) . The absence of haemoglobin and poor level of proteins which are the main buffersof the vascular system explains a more acid interstitial pH and more importantly, the variations in interstitial pH andblood gases (52).2. Any substance passing between cells and the bloodstream must traverse the interstitial space. These substancesinclude oxygen, carbon dioxide, glucose, as well as thousands of other compounds (27) (28).3. The volume of this sector is closely related to the containing sodium pool (52)The exchanges between the vascular sector and the interstitial fluid are complex. The distribution of the electrolyteson each side of the membrane is regulated by “the Donnan equilibrium” which explains why the sodium concentrationis more important in the plasmatic sector. (51)Since D.C. electric current only passes through the interstitial fluid, it has been proposed that an abnormality in thechemical composition of the interstitial fluid could be detected with an adequately sensitive D.C. BIM device.Correspondence of the interstitial and blood values:Reference Studies: Niels Fogh-Andersen, Burton M. Altura, Bella T. Altura, and Ole Siggaard-Andersen CLIN. CHEM.41/10, 1522-1525 (1995)Gilanyi M, Ikrenyi C, Fekete J, Ikrenyi K, Kovach AGB. Ion concentrations in subcutaneous interstitial fluid: measuredversus expected values. Am J Physiol 1988; 255:F513-9

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More informations :

http://www.md.ucl.ac.be/virtanes/ac-bs1.pdfhttp://www.acid-base.comhttp://www.nephrohus.orghttp://www.impedimed.comhttp://www.cardiodynamics.com/cdprod30.htmlhttp://www.bioanalogics.com/http://www.utc.fr/~farges/dess_tbh/98-99/Projets/Bio_Imp/BioZ.htm - 151khttp://www.biol.paisley.ac.uk/marco/Enzyme_Electrode/Chapter2/Cottrell1.htm - 5khttp://www.cermep.fr/docs/lebars/pecm2001.pdfhttp://www.butler.cc.tut.fi/~malmivuo/bem/bembook/03/03.htm.http://fr.wikipedia.org/wiki/Transform%C3%A9e_de_Fourier_rapide