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[Type text]                                                                                1 June 2009Ms. K. Sujatha RaoSe...
[Type text]• The only alternative before India which is already home to one of the highest number of  HIV+ve and AIDS rela...
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[Type text]                Executive Summary              The SMART Solution                 INDIA needs                  ...
[Type text]                                       It’s a game of                                     Death & Disaster     ...
[Type text]    The war against THE KILLER TWINS-- HIV & HCV— cannot be won with the hands tied                     behind ...
[Type text]•   According to WHO more than double i.e. as against 5.1 million Indians suffering from    HIV, around 12 mill...
[Type text]•   Early diagnosis can reduce the risk of blood-borne infections among individuals who    take drugs or engage...
[Type text]              The SMART Solution                      v                 INDIA needs                            ...
[Type text]SMARTubeTM being introduced for the first time in India – is a simple, yet revolutionarybreakthrough in medical...
[Type text]Background:Window Period or the Latent Period— when even +ve appears –veIf a person tests negative for HIV or H...
[Type text]This is where SmartubeTM – based on a simple technology called Stimmunology helps out bystimulating the in-vitr...
[Type text]Q . What is SMARTubeTM ?A. The name SMARTubeTM being introduced for the first time in India – is derived from: ...
[Type text]Q . Why is something like SMARTubeTM the SMART solution to India’s needs?A. One of main purpose behind any dign...
[Type text]              •   Given the trend that only less than 1 % population of India get themseleves                  ...
[Type text]Q. What can be the various uses and applications of SMARTube in India?A. SMARTube can have uses and application...
[Type text]This phenomenon that came to prominence in the mid ’90s when people tested anddiagnosed as ’sero-negative’, wen...
[Type text]Q. What is the technological background behind SMARTubeTM and how is ito be used?A: SMARTube enables antibody p...
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[Type text]Q. How does the detection process using SMARTubeTM compare with regards to some ofthe other known methods ?A. T...
[Type text]Q. Why SMART? What is so smart about SMARTube?A. Well this is because the HIV virus itself is a smart virus, ju...
[Type text]So it gives a false sense of security to the HIV/HCV virus by convincing it to grow as there areno immune syste...
[Type text]   •   Indirect draw – using heparin wash tubes or syringes and later transferring it in the       laboratory i...
[Type text]Q. Does SMARTube substantiate any International quality control and productionstandards?A. SMARTube is manufact...
[Type text]Q. Has SMARTube been clinically tried? If so what were the results?A. SMARTube has been tested in controlled cl...
[Type text]       HCV               •       653 individuals tested.               •       389 Seropositive.               ...
[Type text]       2.     Low risk populations were screened using the SMARTube™:       HIV              •       Over 1,500...
[Type text]   •   Increase in antibody levels in low seropositives (and new ones)   •   Safer blood transfusion – detectio...
[Type text]The Team Composition is as follows:       Name              Designation                   Brief BackgroundDr Na...
[Type text]Dr. Tamar Jehuda- Founder and CTO,      With in-depth experience in immunology,Cohen             SMARTube Bio  ...
[Type text]Case Study # 1 : Diagnosis by default-- Jacob Johnes – a US marine never thought he couldcontract HIV, despite ...
[Type text]The nurse explained that such a result does not mean that she is not infected for sure, asshe could have been i...
[Type text]Case Study 3: If we only knew! Katub had her fifth child less than a year after sheimmigrated to Israel. Upon a...
[Type text]Case study 4: Building a new relationship -- Seth and Diane decided to move in togetherand formalize their rela...
[Type text]              ROAD MAP TO SMART BENEFITS                                           35
[Type text]              ROAD MAP TO SMART BENEFITS                                           36
[Type text]              ROAD MAP TO SMART BENEFITS                                           37
[Type text]              ROAD MAP TO SMART BENEFITS                                           38
[Type text]              ROAD MAP TO SMART BENEFITS                                           39
[Type text]              ROAD MAP TO SMART BENEFITS                                           40
[Type text]              ROAD MAP TO SMART BENEFITS                                           41
[Type text]              ROAD MAP TO SMART BENEFITS                                           42
[Type text]Follow Up Questions / Clarifications:Finally, please do not hesitate to contact us with whatevertechnical or pr...
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Nacco proposal with cover letter

  1. 1. [Type text] 0
  2. 2. [Type text] 1 June 2009Ms. K. Sujatha RaoSecretary & DG, NACCONew DelhiDear Ms Rao,It gives me a great pleasure to announce that we are introducing for the first time in IndiaStimulating Maximal Antibody Response Tube – SMARTubeTM—a new scientificinnovation that may revolutionize HIV & HCV detection and help in saving millions oflives. It is based Stimmunology-- a breakthrough technology which targets the hiddenantibodies by stimulating specific humeral immune response and overcoming the immunesuppressants of the body. SMARTubeTM is like an early warning radar system for thedetection and diagnosis of HIV and/or HCV infections – in the early stages of the diseasewhen most tests cannot diagnose it on the basis of antibodies produced in the infected blood.As a cost effective method SMARTubeTM may increase the SENSITIVITY and SPECIFICITYof other known HIV & HCV detection devises—with very little additional training or costinput. Using SMARTube™ may enable earlier, better and complete detection of HIV/HCV justa week after exposure. Besides detection of all the patients who are diagnosed in theconventional testing – this may also enable detection of additional patients who are actuallyinfected, but otherwise remained undetected at that testing time.SMARTube™ has been clinically tried on over 10,000 patients/individuals in China, USA,South Africa, Mexico, Israel and Kenya and has been awarded-- CE Mark—the regulatorystamp of approval for use in the whole of Europe (the EU countries) and is being used in thehospitals, blood banks and laboratories across Germany, Russian Federation, SouthAfrica, Israel, Romania, Nigeria, and Turkey wherever blood requires to be tested for HIVand/or HCV. SMARTubeTM can detect both HIV and HCV.All this makes SMARTubeTM – the smart and the ultimate weapon of choice to attackand fight against the killer twins – HIV & HCV-- both of whom are smart and lethalinvaders – and masters in the art of camouflage, deception and hidden combat aftersilently crippling the defenders – inside the human body.• It’s a world wide trend that many HIV infected -- medically undiagnosed people are walking the on streets blissfully unaware of their HIV+ve status. They are like potential Human Time Bombs that can explode any moment causing irreparable damage by actually infecting 100 s of other innocent and unsuspecting people• Given the trend that only less than 1 % population of India get themselves tested for HIV-HCV even once in the lifetime and worst still up to 27 % HIV infected people remain undiagnosed… Can India be left to the mercy of these killer twins- HIV & HCV?• It is not a just medical but human rights issue related to the right to live and stay away from any accidental HIV contamination 1
  3. 3. [Type text]• The only alternative before India which is already home to one of the highest number of HIV+ve and AIDS related orphans in the world – is to detect and segregate the carriers of the deadly killer twin diseases – HIV & HCV before its too late.• Eliminating false –ves may be the only way to realistically combat HIV-HCV menace• Early and confirmed diagnosis of HIV/HCV – even before antibodies in the blood can be taken as evidence – may prove to be a turning point for better management of the infection besides U-turn towards damage control and possible recovery.SMARTube™ Benefits include: • Enables early detection than any other existing methods, within days of exposure • Simple, effective, affordable and reliable- Saves lives and suffering • Requires no changes to the existing testing procedures • Increases Sensitivity and Specificity • Cost effective – Saves: Money, Time, ResourcesSMARTubeTM has the potential to transform the lives of millions of faceless men,women and children of India – the so-called Aam Admi—both in terms of activecontributors as well as passive sufferers of the disease; housewives, pregnant women,new born babies, corporate employees and all the high risk HIV+ve categories like sexworkers, gays, IDUs and truck drivers besides having a positive impact on the Defenseand Paramilitary forces, Blood banks, blood transfusion sector and the hospital/healthcare sectors.From the Indian perspective SMARTubeTM may prove to be extremely useful in sectors likeHIV testing centers, Clinics and laboratories, Diagnostics (hospitals, labs), Epidemiology(governments, health organizations), Research (vaccine design & therapeutics). Plasmaindustry, Health & Life insurance companies, Defense & Police forces – Pre-recruitmentscreening as well as in-service monitoring, Individuals & Corporate– Government & privatesector employees, Foreign tourists, healthcare workers, Pregnant women, IDUs, MSMs andSex workersAs a pre-condition for granting import license – the Drug Controller of India’s office requires arecommendation from NACCO about the usefulness of SMARTubeTM.We seek NACCO’s all-out support and guidance not only in terms of a favorablerecommendation but also in terms of fast track clearance and approvals to bring thistechnology to India and ultimately strengthen NACCO’s efforts in this direction.Assuring you of our best cooperation at all times.For Society for Medicare(Neeraj Mahajan)Secretary 2
  4. 4. [Type text] 3
  5. 5. [Type text] Executive Summary The SMART Solution INDIA needs 4
  6. 6. [Type text] It’s a game of Death & Disaster which THE KILLER TWINS want us to Lose… INDIA cannot be left at the mercy of HIV/AIDS – HCV Close to anywhere between 2.4 – 5.7 million HIV+ve people & 165,000 reported AIDS cases 4,000,000 Men, 1,600,000 Women & 1,20,000 children -- already living with HIV In addition to this, Hepatitis C virus (HCV) accounts for one-fourth of all cases of chronic liver disease causing 1.5 -2 million deaths in Indian Homes.DANGER 1: Some 550,000 HIV patients have already developed AIDS and another 300,000 ayear will develop AIDS over the next 15-20 yearsDANGER 2: At least 600 new HIV infections in India every hour. Close to 21,000 childrengetting newly infected & 30,000 HIV+ve babies being born every yearDANGER 3: As per World Bank estimates India already has 2 million children – the largestnumber AIDS orphans in the world-- expected to double in next five years.DANGER 4: HCV or hepatitis C is known as "silent killer". Deaths from HCVare expected totriple in the next 10-20 years. The death toll is likely to surpass that of AIDS and couldreach more than a million by 2020.DANGER 5: About 18 million people in India — most of whom do not know they areinfected, are estimated to be infected with HCV. A quarter of them are likely to developchronic liver disease in the next 10 to 15 years. Prevention – is the only Cure against HIV/ AIDS & HCV!! 5
  7. 7. [Type text] The war against THE KILLER TWINS-- HIV & HCV— cannot be won with the hands tied behind the back… INDIA needs SMART WEAPONS.• Both HCV and HIV are silent killers --almost symptom-less blood-borne diseases, caused by RNA viruses. Both – are smart virus which manage to evade the body’s defense mechanism and cause irreprable damage internally—till its too late. Till date -- there is no complete cure or vaccine for both HIV & HCV which replicate at an alarming rate, once inside the body —producing anywhere between 10 billion (in case of HIV virus each) to about 10 trillion new viral particles each day (HCV virus). The issue is how to attack and fight against these smart and lethal invaders – who are masters in the art of camoflage, deception and hidden combat after silently crippling the defenders – inside the human body.• As many as half of all people with HIV are likely to be coinfected with HCV which is four times more prevalent and ten times more infectious than HIV, which causes AIDS.• Also despite the World Health Organization’s alarming projection that HCV already infects approximately 180 million people worldwide— India is so far yet to declare a “High Alert” against the killer HCV-- on its prevantive Health radar screen—like HIV/AIDs. The issue is how do we fight against a disease we know little about?• Roughly 14 % of HIV+ves in India are children below 14 years—unable to protect themselves.• According to the Center for Disease Control (CDC) more than 25% of HIV+ve people in USA are unaware of their HIV status. Healthy in appearance and feeling fine-- they do not receive proper care and unknowingly pass the HIV virus to others.• The trend worldwide, including India is that many people are blissfully unaware of their HIV- HCV + ve status and continue infect others while leading normal lives simply because– They do not have any visible or apparent symptoms of HIV/AIDS - HCV They never felt the need to get tested It is not a fashionable for people to get HIV – HCV tests done, even once a lifetime Stigma attached with going for a HIV test (what will people say!), unless unavoidableAbove all, only less than 1 % population of India get themseleves tested for HIV-HCV evenonce in the lifetime and worst still upto 27 % HIV infected people remain undiagnosed… 6
  8. 8. [Type text]• According to WHO more than double i.e. as against 5.1 million Indians suffering from HIV, around 12 million have HCV. And about 30 per cent of HIV +ve are co-infected with HCV. HIV - HCV co-infection can be extremely complicated with more severe side effects and repercussions during treatment.• Hepatitis has become a leading cause of death, perhaps the No. # 1 cause of death, in HIV today. Since HIV can accelerate the progression of HCV, it is important not to delay the diagnosis of HCV and the assessment of the stage of liver disease.• One thing that both HIV & HCV share in common is the window period i.e. the early stage of the infection when none of the available tests can detect their presence. The incubation period of HCV infection is 2-26 weeks i.e., the symptoms may take this much time to appear after a person has been infected. It may take as long as 5-10 years for an infected person to develop chronic liver disease after exposure to the virus.• The financial cost of HIV and HCV treatment is beyond the means of the average citizens. The bottom line is that if infected people are treated and treated early, the epidemic will prove far less costly in terms of lives, quality of life, and healthcare costs.• Early detection can often mean a more successful chance at treatment if the situation is right for one to begin the complex drug regimen.• Early detection of HCV can significantly lower healthcare costs by preventing high-risk practices and decreasing virus transmission.• Early detection of HIV – HCV is also helpful as treatment options and outcomes may be vary depending on the stage of infection• Early diagnosis and management may limit the fatality and the spread of the illness. Early treatment can restore immune response against HCV and help eliminate the virus rapidly.• According to a new study published in the Journal of Virology, Canadian researchers have shown that patients, who receive early treatment for Hepatitis C virus (HCV) within the first months following an infection, develop a rapid poly-functional immune response against HCV similar to when infection is eradicated spontaneously. Researchers from University of Montreal have observed that success rates among those treated early after infection are significantly higher— around 90 percent. 7
  9. 9. [Type text]• Early diagnosis can reduce the risk of blood-borne infections among individuals who take drugs or engage in high-risk behaviors putting themselves and others at risk for contracting or transmitting hepatitis C (HCV), hepatitis B (HBV), tuberculosis (TB), as well as sexually transmitted diseases, like syphilis, chlamydia, trichomoniasis, gonorrhea, and genital herpes. IDUs are also susceptible to skin infections at the site of injection as well as bacterial and viral infections, which can lead to serious health problems.• Early detection can prevent further transmission of HIV/HCV from mother to child• Newly infected individuals have a very high viral load— which in other words means that people are highly infectious at a time when they may still be unaware they have HIV• IN CONCLUSION: besides helping in timely intervention and effective management of the HIV & HCV, their early detection is highly desirous from the following points of view: National & International Interest– savings in economic and healthcare costs HIV +ve / HCV +ve Individuals: As a result of early detection, counseling and treatment can start early Better chances of success in terms of treatment, better and more options Lesser chances of side effects and complications Other Individuals: Lesser chances of unknowingly getting the infection from an infected person Lesser chances of mother to child transmission Lesser chances of acquiring the infections due to exposure to unsafe blood in hospitals and organ transplantation centers Safer blood transfusion High Risk Categories: Early detection of disease in every HIV/HCV positive individual may prevent further transmission of the diseases in at least 10 other Injection Drug Abusers & Addicts Hemophiliacs / Thalassemia patients Blood Donors Armed Forces & Para Military force personnel-who share barracks, razors Female Sex workers and Men having sex with men 8
  10. 10. [Type text] The SMART Solution v INDIA needs 9
  11. 11. [Type text]SMARTubeTM being introduced for the first time in India – is a simple, yet revolutionarybreakthrough in medical technology for early warning and detection of HIV & HCV infectionsin human beings, months before any other known test or diagnostic method.Stimulating Maximal Antibody Response Tube – SMARTube™ will revolutionize HIV & HCVdetection by enabling one of the earliest and complete detection of HIV/HCV just a weekafter exposure. SMARTube™ not only enables the detection of all the patients who arediagnosed in the conventional testing - but also enables detection in additional patients thatare infected, but otherwise would have gone undetected at that testing time. As a costeffective method that increases the SENSITIVITY and SPECIFICITY of other known HIV & HCVdetection devises—with very little additional training or cost input, it will help in savingmillions of lives.SMARTube™ is manufactured under strict ISO 9001:2000 and ISO 13485:2003 regulationsand the highest global Quality Control, R&D and professional standards. SMARTube™ hasbeen awarded-- CE Mark—the regulatory stamp of approval in the whole of Europe (the EUcountries) and is certified for public and individual use in Germany, Russian Federation,South Africa, Israel, Romania, Nigeria, and Turkey. It is being used in these countries inhospitals, diagnostic labs, blood banks, health or life insurance uses—anywhere bloodsamples need to be tested for HIV.SMARTube™ has been tested in controlled clinical trials on over 10,000 patients/individualsin several countries like China, Israel, Kenya, Mexico, Romania and South Africa. Most ofthese clinical trials and tests were done by reputed government agencies, blood banks,reference laboratories, academic and professional bodies. 10
  12. 12. [Type text]Background:Window Period or the Latent Period— when even +ve appears –veIf a person tests negative for HIV or HCV – it doesn’t mean that he/she is not infected. Onthe contrary he/she might be in the most contagious stage of the infection. Such a personcould well infect as many as 50 -100 others before actually testing positive – months later.This is due to the “Window Period”.To understand how this window period affects us… we have to first understand how ourbody responds to infections and virus attacks … The Human body is made up of about a 100million cells. Just one teaspoon of blood contains about 25 billion red blood cells. Theimmune system is the bodys main line defender against infection and illness. It recognizesthe bodys cells and tries to get rid of anything unfamiliar. It destroys parasites and germs -bacteria and viruses.In case of most infections, the immune system sees the foreign invaders and startsproducing antibodies. Usually it takes 5-7 days for the antibodies to develop. Antibodieshelp out in detecting infection before the liver or lungs are affected. However, in case of HIVand HCV--it could take weeks or up to many months before any antibodies are detected inthe blood.The only reliable way to tell whether someone has HIV is through blood tests, which candetect the infection. Most of the HIV –HCV detction tests available today detect theantibodies in the blood instead of the virus itself. In case of both HIV and HCV it can takeweeks or months after infection before antibodies against are detected. This infected yetserum-negative period is called the “window period”-- or the most deceptive phase wheneven HIV – HCV infected people will be considered non-infected simply because they havenot yet produced or developed detectable levels of antibodies in their blood.As long as there are no antibodies, these patients are diagnosed as non-infected. This iscalled the window period - the time between infection and the detection of antibodies. It isa major cause for concern among the health authorities, professionals, blood banks, vaccineand drug developers all over the world, as many infected individuals test negative for HIV orHCV antibodies, and are thus misdiagnosed. Shortening the window period actually holdsthe key to saving millions of lives, billions of dollars, untold human resources, suffering, anddeaths. 11
  13. 13. [Type text]This is where SmartubeTM – based on a simple technology called Stimmunology helps out bystimulating the in-vitro antibody production in the blood sample, prior to testing for HIV(and/or HCV). SMARTube™ HIV & HCV, enables the detection of HIV and HCV infections(during the window period) by overcoming, in vitro, the specific immune suppressionexerted by the virus. The process involves placing 1ml of blood sample inside theSMARTube™ for a 3-5 day incubation period, leading to the formation of HIV and/or HCVantibodies in detectable levels in all those infected, including those in the window period.SMARTube™ Benefits include: • Enables early detection of HIV & HCV– within days of exposure • Simple, affordable and reliable • Requires no changes to the existing testing procedure • Saves lives and suffering • Proven effective • Cost effective – Saves: Money, Time, Resource • Increases sensitivity & specificity 12
  14. 14. [Type text]Q . What is SMARTubeTM ?A. The name SMARTubeTM being introduced for the first time in India – is derived from: S –timulating, M-aximal A-ntibody R-esponse T-ubeIt is a simple, yet revolutionary breakthrough inmedical technology for early warning anddetection of HIV & HCV infections in humanbeings, months before any other known test ordiagnostic method.Q . What is its Unique Selling Proposition - USP ?A. The main USPs of SMARTubeTM are as under:1. It simulates the production and growth of a higher level antibodies in the blood sample—upto a level that can be easily detected by the dignostic tests.2. False negetive becomes positive: The same tests which had otherwise given a false negetive report – can now give a confirmed positive result3. Earliest possible detection of HIV-HCV within days of the infection.4. Eliminate chances of a false positive results- SMARTubeTM could prove to be a medical blessing in terms of eliminating the possibility of doubt and reduce the incidence of false positive result in some of the existing tests.5. Reduces the period of uncertianity-- You don’t have to wait for weeks or months for the body to produce antibodies in the due, natural course.6. Increases the Specificity and Sentivity of the existing tests7. No additional cost for add-on test-lab infrastructure or training of technicians. 13
  15. 15. [Type text]Q . Why is something like SMARTubeTM the SMART solution to India’s needs?A. One of main purpose behind any dignostic test – is to act like an early warning radarsystem to detect the presence of invading germs and virus before they can cause irreparebledamage to the human body.However despite advancement of technology, one problem with most aviation radars is thatthey cannot detect low flying, light aircraft. Likewise most HIV/HCV diagnostic tests candetect only the antibodies produced against the infections and not the actual virus… This isa major problem as during the window period –or the deceptive dark period just after a newinfection—many infected individuals could go undetected due to false negetive test resultsdue to low or inadequqte antibodies produced in the human body.Even in case of a normal viral infection it takes 5-7 days for the antibodies to develop afterthe infection. In case of both HIV or HCV it could take weeks or many months before anyantibodies could be found in the blood.Using the radar terminology-- SMARTubeTM is like an early warning radar system for thedetection and diagnosis of HIV and/or HCV infections – in the early stages of the diseasewhen most tests cannot diagnose it on the basis of antibodies produced in the infectedblood.SMARTubeTM is a scientifically engineered -- medicalboon– which makes it possible to detect an HIV carriereven during the so-called window or latent period of theinfection.All this makes SMARTubeTM – the smart and the ultimate weapon to attackand fight against the killer twins – HIV & HCV both of whom are smart andlethal invaders – and masters in the art of camoflage, deception and hiddencombat after silently crippling the defenders – inside the human body.Putting things in perspective— • It’s a world wide trend that many HIV infected though medically undiagnosed people are actually walking the on streets blissfully unaware of their HIV+ve status. They are like potential Human Time Bombs that can explode any moment causing irreparable damage by actually infecting 100s of other innocent and unsuspecting people 14
  16. 16. [Type text] • Given the trend that only less than 1 % population of India get themseleves tested for HIV-HCV even once in the lifetime and worst still upto 27 % HIV infected people remain undiagnosed… Can India be left to the mercy of these Zombies !! • It is not a just medical but human rights issue very much akin to the right to live and stay away from any accidental HIV contamination • The only alternative before India which is already the home to one of the highest number of HIV+ve people and one of the highest number of AIDS related orphans in the world – is to detect and segregate the carriers of the deadly killer twin diseases – HIV & HCV before its too late. • Ignorance is not bliss—Eliminating the false –ves as well as false +ves -- is the only way to realistically combat the HIV-HCV menance • Early and confirmed diagnosis of the HIV/HCV careers – well before the antibodies in their blood can be taken as evidence – may actually prove to be a turning point in their lives leading to a better management of their infection besides the U-turn towards the road to damage control and possible recovery.In this sense-- SMARTubeTM is +vely the solution India needs…Q. Medically which are the sectors where the use of SMARTubeTM could prove to be ablessing in disguise?A. SMARTube could prove to be extremely useful in Hospitals, laboratories, research centresand the blood banks where everyday hundreds of new donors come to donate blood. Noneof them is carrying a sign board on their faces – that they are HIV+ve. And if its been just 2-3 days before they have been infected by say visiting a prostitute or injectable drug abuse –none of the existing test would be able to confirm the presence of virus in their blood. Thisis where SMARTube can help. Besides this SMARTubeTM could prove to be really useful inthe Army, Airforce, Navy and other central and state police forces as well as largecorporates both in terms of pre-recruitment screening and periodic in-service monitoring ofthe HIV status. 15
  17. 17. [Type text]Q. What can be the various uses and applications of SMARTube in India?A. SMARTube can have uses and applications in many sectors like: • HIV testing centers • Clinics and laboratories • Diagnostics (hospitals, labs) • Epidemiology (governments, health organizations) • Research (vaccine design & therapeutics). • Plasma industry. • Health & Life insurance companies. • Army, Police & Police – Pre-recruitment screening • Individuals & Corporate -- Pregnant women, Healthcare workers, Foreign travelers, Sex workersQ. What are the risks involved if all the carriers of the HIV virus are not detected well intime?A. HIV and HCV carriers can be identified by detecting the antibodies against the virus intheir blood. After the HIV infection has set in, diagnosis is made using a blood test to detectantibodies to the virus or copies of the virus itself.Most HIV tests measure the antibodies produced by the body against HIV. It takes sometime for the immune system to produce enough antibodies for the antibody tests to detect.This can vary from person to person. Most people develop detectable antibodies within 2to 8 weeks (the average is 25 days). Even so, there is a chance that some individuals willtake longer to develop detectable antibodies. Therefore, if the initial HIV test wasconducted within the first 3 months of possible exposure, there is a great possibility of afalse-negative result. The length of this period varies from person to person, and dependson a wide range of factors, such as the amount of HIV present in the bloodstream, generalhealth, the presence of other illnesses, and the response to treatment. During theasymptomatic period, the virus is far from inactive. It is constantly replicating and causingdamage to the immune system.Blood donated at blood banks during the ‘window period’ test negative and hence can betransfused into unsuspecting patients – requiring urgent blood tranmission – for instancein cases of accidents, surgeries or say for instance pateients of heomophilia or thalesemia.Imagime the magnitiude of the problem if every such person requiring blood transfusionfor one reason or the other came back infected with HIV+ve virus. 16
  18. 18. [Type text]This phenomenon that came to prominence in the mid ’90s when people tested anddiagnosed as ’sero-negative’, went out and infected others. You can’t infect somebody ifyou’re not infected – that’s when the realization came that there was something wrong withthe present tests which could not diagnose everybody.Ninety-seven percent people usually develop antibodies in the first 3 months of theinfection. In some rare cases, it may take up to 6 months to develop antibodies to HIV.The only alternative is the RNA test which can detect the HIV virus directly. Even the timebetween HIV infection and RNA detection is 9–11 days. However these tests, are morecostly and used less often than antibody tests.Researches show that every unidentified carrier could infect, directly and indirectly, somefifty people a year.• In the Latent or Window period – when infected people are still serum-negative – i.e. they do not have enough anti-bodies in their blood that could be detected by any conventional tests. At this stage, they pose a greater risk to their community because: They continue infecting others without any precautions. They think they have a “certified immunity” as they engaged in high risk behavior and yet did not get infected.• Blood Banks – blood units donated by donors during the “window period” could get transfused into unsuspecting patients thus infect them.• Epidemiological studies- are incomplete, as critical information as to the true rate of new infections is missing for incidence calculations in a study population.So in conclusion we can say: • SMARTube– has opened up newer possibilities for fool-proof diagnosis of HIV or HCV • SMARTube has reduced the suspense and made it possible to take on HIV in the earliest stage of progression of the infection in the body. • SMARTube will help save millions of innocent lives by early diagnosis of high risk carriers • SMARTube– will help to eliminate doubt and reduce the incidence of false-positive results in most of the existing tests. Imagine the trauma of a person and his family members who has been falsely diagnosed as HIV+ve. 17
  19. 19. [Type text]Q. What is the technological background behind SMARTubeTM and how is ito be used?A: SMARTube enables antibody production, in a small blood sample, within days frominfection, without having to wait for the body to produce antibodies weeks or months later.The technology is the culmination of more than 12 years of work by Jehuda-Cohen, animmunologist with a PhD in immunology from the Technion - Israel Institute of Technology.The core of the technology is overcoming the specific immune suppressants of the body. It isa simple three step process.Step 1: A few drops of blood are placed into the SMARTubeTM which is like a sealed testtube with a pink coloured plasma solution inside it. This plasma solution gives a false senseof security to the invading virus to grow without bothering about suppression by the body’simmune system. In this way the it simulates an extremely fast process of antibodyproduction.Step 2: The solution inside the SMARTubeTM is allowed to incubate at 370C for 3-5 daysStep 3: The end result– even routine test by any of the existing methods can now detect asuffiecient level of antibodies of HIV+ve virus in the same the individuals still in the veryearly stages of the window period- who was earliar misdiagnosed as a false negetive. So tosay SMARTube makes it possible to reverse the false positive or negetive as the case may bemuch before any other technology today can detect the virus inside the body. 18
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  21. 21. [Type text]Q. How does the detection process using SMARTubeTM compare with regards to some ofthe other known methods ?A. This can be explained with the help of the following diagrams which clearly indicates thatSMARTubeTM allows the earliest detection of the HIV & HCV at the most affordable cost 20
  22. 22. [Type text]Q. Why SMART? What is so smart about SMARTube?A. Well this is because the HIV virus itself is a smart virus, justaround 100-150 billionths of a meter in diameter that it isabout 0.1 microns or 4 millionths of an inch in size. Unlike mostbacteria, it is much too small to be seen through an ordinarymicroscope, yet it manages to trick and evade the bodysdefenses. Once the Smart HIV virus takes hold, theimmune system can never fully get rid of it and theHIV+ve person may not even know that they areinfected and may look and feel perfectly well formany years. But deep inside the immune systembecomes weak and increasingly vulnerable to evenminor illnesses which a normal person can easily fight off.To fight such a smart virus, you really have to be SMART. Though inside the human body,the Smart HIV/HCV virus can conceal its presence for a fairly long time by inhibiting theimmune systems ability to produce antibodies from 30-90 days in case HIV or 70-180 daysin case of HCV— the proprietary plasma solution inside the SMARTube is able to seethrough this game. 21
  23. 23. [Type text]So it gives a false sense of security to the HIV/HCV virus by convincing it to grow as there areno immune system cells inside the SMARTube trying to attack it. This encourages the virusto grow and the blood sample to develop antibodies against it during the incubation phase.Once the incubation of 3-5 days is over, enough anti-bodies have been developed by theblood sample inside the SMARTube that even a routine ELISA test – which 3-5 days backgave a false negative report—can now confirm the seroconversion. Its a warfare in whichthe SMARTube technology manages to outsmart the opponent i.e. the HIV/HCV virus.SMARTube enables antibody production, in a small blood sample, within days frominfection, without having to wait for the body to produce antibodies weeks or months later.Q. What is the technological basis behind SMARTube and what is it called?A. SMARTube is based on a unique and innovative technology called Stimmunology-- a breakthrough technology that holds the key to detect hidden antibodies by stimulating specific humeral immune response. The core philosophy behind this technology is to overcome the specific immune suppressants of the body. A few drops of blood are placed into the SMARTube and a solution inside helps the cells of the immune system to overcome the suppression and pushes them into an extremely fast process of antibody production. The end result– We can detect those individuals already infected when nobody else can - because they’re still at the very early stages of the window period-when no other technology today can detect them.Q. What does SMARTube actually contain?A. SMARTube is a pretreatment test tube that holds two ml of a pink colored proprietaryliquid solution which is sterile in nature and has a shelf life of six months when kept at 2-8oC. Before use, SMARTube is brought to room temperature and 1ml of whole blood collectedin heparin is introduced into it.Q. Does it require extraordinary laboratory apparatus; space required or specifically trainedtechnicians to conduct the test using SMARTube?A. There is no specific requirement for any special laboratory equipment except anincubator which is usually present in any diagnostic or testing laboratory. For tests usingSMARTube we also do not need any extra space in the laboratory where just one ml ofblood is required to be collected. This too any normal trained technician can collect. Theblood sample for the SMARTube can be collected in any of the following ways: • Direct draw – directly into the vacuum packed SMARTubes in the laboratory 22
  24. 24. [Type text] • Indirect draw – using heparin wash tubes or syringes and later transferring it in the laboratory into the SMARTube using sterile pipette.The blood sample thus collected by any of the above methods is transferred inside the SMARTube and incubated at 37oC in a humidified CO2 incubator for 5 days. After incubation a sample of the supernatant is removed for testing using any currently available method for HIV/HCV testing. The greatest advantage of this cutting edge technology is the flexibility and simplicity of use, enabling the collection of blood even in remote places. The blood sample thus collected can be transferred to the SMARTube even a day later, when it reaches the testing lab. Since it is a blood pre- treatment device, once the blood is treated in the SMARTube it can be tested using any HIV or HCV antibody ELISA tests. Therefore the labs do not need to change their way of diagnosing the infection, they only change the way the blood is handled prior to the tests. This makes the SMARTube very simple to use -- with great return for the money and betterdetection of infected individuals.Q. How long does it take for the test results using SMARTube?A. Usually the blood sample inside the SMARTube has to be incubated at 5% CO2 and 37oCfor 3–5 days in a humidified CO2 incubator. For the blood banks, the protocol for usingSMARTube is 3 days. Towards this end a validation and implementation protocol has beendeveloped by experts in the field.Q. Does SMARTube require any specific diagnostic platform? What will happen to theexisting and available tests?A. SMARTube does not require any specific diagnostic method to be adopted. It is a pre-testing device which does not replace or make diagnostic test redundant. It only improvesor accelerates the development of antibodies to enable early antibody detection using ELISA(or other antibody test methods). During the incubation period, in-vitro antibody productionis accelerated to such an extent that even regular tests become completely effective. HenceSMARTube only enables earlier, better and complete detection of HIV/HCV, while excludingthe chances of false negative of false positive reports. 23
  25. 25. [Type text]Q. Does SMARTube substantiate any International quality control and productionstandards?A. SMARTube is manufactured under strict ISO 9001:2000 and ISO 13485:2003 regulationsand highest globally acceptable Quality Control, R&D and professional standards. Flag Country Certificate European CE Mark-EU Union Russian Registration Federation Certificate Israel AMAR Certificate Registration South Africa Certificate Registration Romania Certificate Nigeria DOR RegistrationSMARTube has been awarded-- CE Mark—the regulatory stamp of approval forregistration and marketing as a blood collection and pre-treatment device in the whole ofEurope. It has also been permitted and certified for public and individual use in Germany,Russian Federation, South Africa, Israel, Romania and Nigeria. It is now being reviewed byFDA (USA) for use in hospitals, diagnostic labs, blood banks, health or life insurance uses—basically anywhere blood samples need to be tested for presence of HIV. Proceedings arealso on for implementation by prestigious world bodies like World Heath Organization,Family Health Initiative (FHI) and the International AIDS Vaccine Initiative (IAVI). 24
  26. 26. [Type text]Q. Has SMARTube been clinically tried? If so what were the results?A. SMARTube has been tested in controlled clinical trials on over 10,000 patients/individualsin several countries like China, Israel, Kenya, Mexico, Romania and South Africa. Most ofthese clinical trials and tests were done by reputed government agencies, blood banks,reference laboratories, academic and professional bodies.Extracts of Clinical Trials in different parts of the world :Clinical studies of the HIV&HCV SMARTube™ for HIV/HCV have been performed in • China • USA. • South Africa, • Mexico, • Israel, • Kenya Country Sample Size Trial Agency Department of Cell Biology, National Institute for Control of Pharmaceutical and China 6,000 approx Biological Products (China). Trials conducted in five different regions of China. HIV 2,000, high risk Israel HCV 300 HIV 2,000, blood units Kenya HCV 300 , blood units Mexico HIV 200 High Risk approved government agency South Africa HIV 90 High RiskChina: Clinical Trials in China were conducted, executed and reported by the Department ofCell Biology, National Institute for Control of Pharmaceutical and Biological Products. Thetrials were done in 5 different regions in China (Total samples tested: approximately 6,000). 1. Trial in high risk population (IVD) in Sichuan District: HIV • 653 individuals tested. • 149 Seropositive. • 151 Seropositive after pre-treatment in the SMARTube™. 25
  27. 27. [Type text] HCV • 653 individuals tested. • 389 Seropositive. • 391 Seropositive after pre-treatment in the SMARTube™. 2. Trials in blood banks: HIV • Beijing Blood Bank: 2000 low risk samples, no positives. • Clearance of false positives by the SMARTube™.U.S.A : Studies were performed in monkeys. naïve monkeys were infected with a very lowdose of SIV virus (the equivalent to HIV in monkeys). • 4 monkeys tested. • 4 seronegative (one week from infection). • 4 Seropositive after pre-treatment in SMARTube™ (one week- infection). All monkeys seroconverted between 1-5 months from infection.South Africa: Clinical trials were carried out in South Africa among high risk population(blood donors): HIV • 90 individuals tested. • 3 Seropositive. • 4 Seropositive after pre-treatment in the SMARTube™.Mexico : Clinical trials were carried out in Mexico, by an approved government agency. HIV • 200 Individuals tested, very high risk, multiple, current exposures. • 20 Seropositive. • 25 Seropositive after pre-treatment in the SMARTube™.Israel : Several high risk populations were screened using the SMARTube™ as a blood pre-treatment device in a number of trials (total: over 2,000 individuals). 1. Immigrants from High risk areas: HIV • 537 individuals tested. • 26 Seropositive. • 28 Seropositive after pre-treatment in the SMARTube™. HCV • 67 individuals tested. • 1 Seropositive • 4 Seropositive after pre-treatment in the SMARTube™. 26
  28. 28. [Type text] 2. Low risk populations were screened using the SMARTube™: HIV • Over 1,500 individuals tested – no positives. HCV • Over 600 individuals tested – no positives.Kenya : Clinical trials were carried out in Kenya. 1. Screening of high risk population: HIV • 555 individuals tested. • 28 Seropositive. • 42 Seropositive after pre-treatment in the SMARTube™. 2. Additional trials conducted in the blood bank in Kenya for complete detection of HIV infected blood units: HIV Adults: • 513 individuals tested. • 45 Seropositive. • 66 Seropositive after pre-treatment in the SMARTube™. Youth: • 332 individuals tested. • 12 Seropositive. • 22 Seropositive after pre-treatment in the SMARTube™. HCV • Over 300 individuals tested. • 13 Seropositive. • 14 Seropositive after pre-treatment in the SMARTube™. 3. A study was conducted on pregnant women: HIV • 40 Seronegative women tested. • 8 out of the 40 Seronegative women, were positive after pre- treatment in the SMARTube™.Based on these clinical trials the following observations were recorded: • After pre-treatment with SMARTube: 1.4% to 40.0% additional positives • All seropositives are positive after SMARTube • Increase in specificity • No adverse affect on specificity • 30% to-95% reduction in false positive rate 27
  29. 29. [Type text] • Increase in antibody levels in low seropositives (and new ones) • Safer blood transfusion – detection of infected blood units missed by current serology • More efficient detection. • Less repeat testing, less blood units lost • Saving in terms of time & money– with improvement in performance. • Better indication of incidence rates-- rate of new cases versus prevalence (rate of positives, total).Q. What are SMARTubes plans for India?A. Initially SMARTube test kits will be imported into India, later as the demand grows,SMARTube will be manufactured in India for the domestic market as well as exports toneighboring countries in the region.Q. How much are tests using SMARTube likely to cost in India?A. It is still too early to predict the final costs, which would depend on many factors likequantities to be imported, infrastructure, logistics and operational costs. A fair idea of theactual cost could only be worked out after the final codal formalities of registration andimport license as completed—still we estimate the cost to consumer should be around Rs1000 per test – which is very reasonable considering the fact without SMARTube it takes –atleast 2-3 different types of tests – which consume much more time and money topositively diagnose or rule out HIV in India, today.Q. Who are the people behind importing SMARTube technology into India?A. The vision and moving spirit behind SMARTube operations and import into India – is DrNarendra.K. Gupta – a Indian born US & Canadian citizen who is President of the Society forMedicare as well founder President & CEO of the Eternal Health & Wellness Foundation(USA). 28
  30. 30. [Type text]The Team Composition is as follows: Name Designation Brief BackgroundDr Narendra K. President – Society Medical Director & CEO, Diabetes &Gupta for Medicare Hypertension Center, Duluth, GA, MD, FRCP(C) Founder President & CEO, Eternal Health Member: Vascular Biology working Group & Wellness University of Gainesville, Florida. Foundation (USA) Principal Investigator: Multiple Trials on Diabetes, Hypertension and cardiovascular diseases. Clinical Associate Professor of Medicine, Medical College of Ohio, Toledo Research Grant: Merck & Co., Novartis Pharmaceuticals, and Takeda Consultant Nephrologist - Regina General Hospital, Canada America’s Top Physician— 2007 Award by the Consumer Council of AmericaYisrael Serok – Founder and CEO, Yisrael Serok has over 20 years experience in SMARTube Bio managing small and large scale operations, both in Israel and other parts of the world. With a world-wide and established network of government and strategic relations, he is on the Board of Directors of several companies with investment portfolio in a variety of projects. 29
  31. 31. [Type text]Dr. Tamar Jehuda- Founder and CTO, With in-depth experience in immunology,Cohen SMARTube Bio diagnostics and AIDS, Dr. Jehuda-Cohen is the inventor of Stimmunology technology. She holds over 10 patents, has authored over 30 publications, and more than 100 abstracts— many of them as presentations at international conferences. Dr. Tamar is currently serving as a consultant for the Family Health Initiative (FHI), funded by the UNAIDS. Dr Tamar holds Ph.D in Immunology and cell Differentiation from the Technion Medical school, Haifa Israel and completed post doctoral studies at Emery University in Atlanta, home of U.S Centers for Disease Control and Prevention.Neeraj Mahajan Secretary, Society A media professional with over 20 years for Medicare and experience, proven competence and Country Head consistency in Print, Electronic, Web or New (India), Eternal media as well as Corporate Communications, Health & Wellness PR, Image building and Perception Foundation (USA) Management. He has held various assignments in print and electronic media from staff reporter to Editor (Print) & Producer-Director (TV). He specializes in image building and has conceptualized and executed various propaganda, counter-propaganda and Perception Management and psychological operations for the Indian Army in counter- insurgency areas in J&K and North East. Rakshak video magazine– produced and directed by him was recognized as the official medium for audio-visual communications of Indian Army. 30
  32. 32. [Type text]Case Study # 1 : Diagnosis by default-- Jacob Johnes – a US marine never thought he couldcontract HIV, despite risky behavior… A routine HIV test confirmed him as sero-negetive tilla doctor who had heard of Smartube decided to test again. It took 48 hours for the HIVantibodies to develop in vetro and Jones was declared HIV +ve… Imagine how many peoplehe could have infectedCase Study 2: A baby saved: Mayama was 22 when she came to the antenatal clinic. Thiswas her third pregnancy, yet her first visit to that clinic. She has come because her friendtold her that she could save her baby if would go there. She was five months pregnant, andthe nurse explained the risks of transmitting HIV to the un-born baby, and that there wasmedicine that could save the baby form getting AIDS. Mayama was tested for HIV, using arapid test, which was negative. 31
  33. 33. [Type text]The nurse explained that such a result does not mean that she is not infected for sure, asshe could have been infected in the last few months, and then the test will not detect it yet.Mayama was worried. She was sure one of her regular clients on the truck route was sickwithAIDS and seeing she got pregnant… When she shared her fears with the nurse she was toldthat she could come back in 3 months or so and re-test. Mayama wanted to know. She wasworried, and she really wanted to give that baby the best chance possible. “I cannot wait for3 months; if I am infected I want to take the medicine now. In three months I will give birth,it will be too late. Plus, I cannot come back here heavy with pregnancy – everyone will talk!The nurse shrugged her shoulders. “There is nothing we can do for you now. We cannot seethe infection during the window period, when the virus is hiding and the tests are negative.Mayama started crying. The head nurse took her into her office. “There is a new way we canuse to see if you are infected, even if it happened recently. But for that we need to drawblood and send it to the laboratory in town. The results will come back next week. You willneed to come back then, and if youre positive we will give you the ART.”Mayama agreed to come back. A test tube with her blood was sent to the laboratory. Therethey treated the blood with the SMARTube™, an innovative blood pre-treatment whichcloses the window period and thus eliminates the false negative results in the early stages ofthe infection. On the fifth day, the lab sent the results back to the clinic. While negative onthe tests using the regular methods, Mayama was clearly positive after the SMARTube™was added to the testing in the laboratory. When Mayama came back, she got the resultswith tears of fear and a smile of relief. She was going to save her baby; she was going to getthe drugs to protect him from the virus that has invaded her. As she was walking out of theclinic, holding on to the medicine for both her and for the baby, when it will be born, sheturned around and ask the head nurse “How do they do it, there in the laboratory? How can see what is still hidden”. “Well” answered the nurse, “ it is as if they go behind the stage and peak into the dressing rooms, this way they know about the actors even before they get on stage”. Mayama gave birth tohealthy baby girl. 32
  34. 34. [Type text]Case Study 3: If we only knew! Katub had her fifth child less than a year after sheimmigrated to Israel. Upon arrival her whole family had their blood tested for differentthings, including HIV. Her husband was the only one that tested positive for HIV. He figuredhe must have gotten it in the camp on route to Israel. Katub was upset, but relieved forherself and the unborn baby. The baby was born slightly underweight, but pink andbeautiful. When he was six months old he had a bad cold that would not go away. Then, thedoctor said it was probably some infection in the lungs. The antibiotics did not help. Thebaby was hospitalized, but could not be saved. In the blood tests, he was found to be HIVpositive, but it was too late, he died of lung infection typical to AIDS patients.The doctors were upset “If only you would have told your doctor that you are HIV positive,you could have saved that baby. We know how to treat these type of infections, we just donot suspect it in a baby without an HIV record.” Katub was very bewildered. How could shetransmit HIV to her baby if she is not infected? Did they not tell her in the immigrationcenter that she tested negative? She told the doctors it must be a mistake. “No”, said theyoung doctor, “it is not a mistake. Unfortunately we cannot detect the HIV infection in thefirst few months. You must have gotten infected shortly before the pregnancy, this is whythe results were negative, but it was not a true negative result.A year later, in a scientific-medical conference, An immunologist presented some interestingresults with a new method which enables the detection of those infected even when stillmissed by regular testing in the first months of infection. She called the method“Stimmunology”, as it stimulates the immune system in the blood sample to “tell” us aboutthe infection “right away”. “I would like to share with you some alarming results we gotwhen studying some families with one seropositive HIV carrier. We used the Stimmunologyprocess for stimulating antibody production even in blood samples form infected individualsduring the window period. This was we can detect them using the regular diagnostic antibody tests.” On the screen appeared results showing seronegative wives who were actually infected, and their infected babies. The doctors in the audience sighed “If only we would have known”. 33
  35. 35. [Type text]Case study 4: Building a new relationship -- Seth and Diane decided to move in togetherand formalize their relationship. They both went together for HIV testing, and, to their relief,both tested negative. Because of their lifestyle, Seth’s doctor recommended to do anadditional blood test using an experimental pre-treatment of the blood in the universitylaboratory. They agreed. The following week the doctor called them in for consultation andtold then that using the experimental new technology; Seth was found to be infected withHIV. “It must be a recent encounter, in the last half a year or so” said the doctor. “But it isstill experimental, right” said Seth hopefully… Diane was silent all the way home. They havebeen together for some time now, she wanted to believe Seth that “it could not be”, yet sheinsisted that for their future they should use precaution “Just for the next few months. Thewindow period is not forever, right?” Three months later, Seth tested positive in a routinetesting.Case Study 5: Organ donor -- Sheila has been waiting for a kidney transplant for 2 years. Thephone finally rang with the news – “we have a donor”. The young motorcyclist was braindead and his family agreed to donate his organs. A battery of tests was run, including HIVand HCV antibody tests. All came negative. Additional testing was using very sensitivemolecular biology techniques to detect the virus even before the antibody tests detect theinfection. They were negative for both HIV and HCV. Sheila got the kidney, and stayed onimmunosuppressive drugs to reduce the risk of rejection of the transplanted kidney. Lessthan a year later, Sheila was diagnosed with HIV and HCV infection. The source of theinfection was the transplanted kidney. All the recipients from that donor were nowpositive for HIV and HCV. When Sheila sued the hospital the doctors testified that they haveused all known measures for testing the donor for these infectious and deadly viruses. “Buteven with the most sensitive tests, there is a window period in which we cannot detect theinfection, and this window period can take three to six months and sometimes even longer”testified the laboratory expert. “So there is nothing that could have been done?” askedSheila’s lawyer. “Well, responded the expert “there is a way to eliminate that windowperiod. It is a simple system of pre-treating the blood in a way that expresses the antibodies prior to their appearance in the body. It works like magic; it exposes those early infections we currently miss.” “So if you would have used that method, you would have been able to prevent all those terribleinfections! Why did you not use it?!”. “We do, but only experimentally, and unlinked, as ithas not yet been approved for use in our country...” responded the expert. 34
  36. 36. [Type text] ROAD MAP TO SMART BENEFITS 35
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  44. 44. [Type text]Follow Up Questions / Clarifications:Finally, please do not hesitate to contact us with whatevertechnical or practical questions or comments you might have.We would be happy to help out with whatever data, analyseand share our thoughts and ideas.For More Details Contact: 1. Dr Narendra K. Gupta President Society for Medicare. Founder President & CEO Eternal Health & Wellness Foundation (USA) Email: eternal.wellness.foundation@gmail.com 2. NEERAJ MAHAJAN Secretary Society for Medicare & Country Head (India), 3. Eternal Health & Wellness Foundation (USA) 4. Email: n2erajmahajan@gmail.com 5. Mob: 9999989066, 9818666863 43
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