1. Company Statement
GlobalMed Technologies Inc. was incorporated in the State of Florida on April 9th, 2002 for the purpose of manufacturing and distributing a patented state of the art Ultraviolet Light Blood Irradiation System for the treatment of HIV/AIDS.
After two decades of the HIV/AIDS pandemic, an estimated eight out of nine people with the detectable HIV virus have developed resistance to at least one drug in the HIV/AIDS medicine cabinet, i.e. the retrovirals, and from 20 to 60% of infected patients have exhausted drugs in at least two of the three classes of HIV medicines currently in use.(Annex # 1)
19050209550Western & Central Europe760 000[600 000 1.1 million]Middle East&North Africa380 000[270 000 500 000]Sub-Saharan Africa22.5 million[20.9 24.3 million]Eastern Europe & Central Asia1.6 million [1.2 2.1 million]South & South-East Asia4.0 million[3.3 5.1 million]Oceania75 000[53 000 120 000]North America1.3 million[480 000 1.9 million]Latin America1.6 million[1.4 1.9 million]East Asia800 000[620 000 960 000]Caribbean230 000[210 000 270 000]UNAIDS and CNN Special World Health, both report approximately 36,000,000 HIV afflicted people worldwide (See Annex # 2) and although hundreds of millions of dollars have been spent in search of a cure, no effective solution has been found. Retroviral medications have side effects so severe that many HIV/AIDS patients refuse to take the medication.(Annex # 3)
-184785064770Total: 33.2 (30.6 36.1) million
The HIV virus in a thirty six hour period (36 hours) can replicate itself approximately 800 million times. Of these copies 75% will find target CD4 cells and each one will in a thirty six hour period produce 800 million more copies.After 7 to 10 years, the persons infected immune system will be near total collapse.Add to this the mutations which develop during replication and we can understand why the development of a vaccine is not possible.
(Annex # 4)
4105275857255476875142875People newly infected with HIV in 2007
4010025250825Total2.7 million [2.2 3.2 million]Adults2.3 million [1.9 2.8 million]Children under 15 years370 000 [330 000 410 000]The implications are dire:A virus that once seemed on the verge of containment is beyond the reach of medications that promised to transform HIV/AIDS into a chronic but treatable condition.In the last 4 years nearly 12 million new cases of AIDS were reported.(See Annex # 5)
GlobalMed Technologies has developed an effective treatment modality for HIV/AIDS and other blood-borne diseases, utilizing ultraviolet irradiation, which is safe, efficient, and has minimal side effects.In Government Approved Clinical Trials performed in 2004 in the Dominican Republic, viral load counts in 36 subjects were reduced by 84-99% within 90 days.CD4 cell counts remained stable and life expectancy increased tenfold. (Annex # 6)
The current U.S. costs to treat an HIV/AIDS patient, with retroviral medication, ranges from $12,000 to $48,000 per year. Add to this the costs of opportunistic infection medications, hospitalization, diagnostic testing, laboratory tests, infusion therapy, home care therapy, plus all the administration costs and the yearly total for a chronic carrier is approximately $200,000 per year.(Annex # 7)
Besides the efficiency of the GMT Process there is an added benefit, we can Decrease Costs Across the Board by 75% in the first year, 80% in the second year and 90% in the third year.We can save insurance companies billions in revenue per year and offer a viable solution to the HIV/AIDS Pandemic.
5810250257175Background Orientation
The father of Phototherapy is Dr. Niels Finsen from Denmark, and who treated 300 patients who suffered from Lupus Vulgari.He obtained a 100% curative rate, and thereby was awarded the Nobel Prize in Physiology and Medicine in 1903.(See Annex # 8).
7620034290America would not enter this field of medicine until the 1920s and 1930s, when a Scientist by the name of Dr. Emmet Knott, from Seattle(See Annex 9) sought to harness the known bactericidal property of ultraviolet rays in order to treat infectious diseases of the blood.Knott built an apparatus known as the Knott Irradiator that would remove a small amount of blood from the body through an IV tube, citrate it to avoid coagulation, expose it in a small chamber to calibrated UV irradiation, and then infuse it back into the body through the same IV tube.
76200245745The FDA has approved only one Photopheresis machine in the united states, that of a company called THERAKOS, a subsidiary of Johnson & Johnson. Dr. Eldeson of THERAKOS developed a Extracorporeal Photopheresis Blood Irradiator.They were granted preliminary certification to performed clinical trial studies with HIV and Graft Host Diseases.(Annex # 10, 11).
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Studies which were performed by Columbia Universitys Photopheresis Unit in Morristown NY demonstrated that 4 of 7 patients (57%) with HIV/AIDS became SERO NEGATIVE after 5 to 19 treatments and remained so for 14 to 16 months after the termination of the study.In an extended trial several years later 17 of 19 patients became SERO NEGATIVE. (Annex # 12, 13)
This treatment modality with its long existence and proven record throughout the US and Europe could be a beneficial tool in modern medicine.If applied properly, Hemoirradiation is an answer to todays world pandemics
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Dr. Fernandez GMTs Founder, designed THE PCI-1 Hemoirradiator, along with theGMT-Disposable Kit and the GMT-Cuvette, which acts as the irradiation chamber during treatment.
76200186690It has taken Dr. Fernandez 12 years of research, development and testing to establish the correct intensity, time of exposure volume, flow rate, and process of irradiation.When applied within standards it guarantees a precise dosage of UV Irradiation that only destroys the invading organisms and leaves unharmed the surrounding tissues, blood and serous components.
Side effects are minimal and transitory. (See Annex #14)
The GMT-PCI-1;
3876675482601Measures and displays the precise time of irradiation.
2Measure, vary and display the intensity of the beam of light.
3Adjust and display the precise amount of UV dosage.
4Allow for the use and variance of a narrow or wide wave band of light.
5Measure and display the precise flow rate for any given Volume of Blood.
6Computer Interfaced with Print capabilities.
7Proprietary Software which generates detailed reports of all data acquired.
8Measures the amount and flow of blood irradiated.
9Barcode Scanneing, assures single use of GMT-Kit and Cuvette.
10Patient Prescription Memory Chip (PPMC).
11PPMC stores all patient treatment sessions and dosages.
12Controls the UV energy needed for each specific blood borne virus, fungus or bacteria.
13Internet Interfaced for downloading of clinical trials data.
17145038100The GMT-PCI-1 design will include a component that will deactivate all electronics within the machine if tampered with in any manner whatsoever.This design and safeguard feature will assist to prevent the GMT-PCI-1 from being reproduced or utilized for other purposes.
571500053530538100227330To date the company has raised three million dollars in the development and patenting of its products and process.The company requires the amount of $4 to $5 million dollars to enable it to reach its next phase in its development, which is, Phase Two Controlled Clinical Trials with 200 HIV/AIDS subjects.We are currently approved to perform said trials in the country of Colombia.We have Government, Academic Sponsorship from two universities, Laboratories, and the Government Public Hospital La Maria to carry out the trials.
FUNDING-PHASE 2 CONTROL CLINICAL TRIALS
IN 200 PEOPLE LIVING WITH HIV/AIDS.
DESCRIPTIONPROFESSIONAL PERSONNEL$356,400.00GENERAL LAB TEST FOR 200 PATIENTS$400,000.00VIRAL LOAD LAB TESTS FOR 200 PATIENTS$360,000.00GENERAL SUPPLIES$50,000.00UNIVERSITY CES RESEARCHERS$100,000.00UNIVERSITY ANTIOQUIA RESEARCHERS$100,000.00INDEPENDENT BIO ETHIC COMMITTEE$100,000.00MISCELLANEOUS$133600.00TOTAL:$1,500,000.00
FUNDING GLOBALMED TECHNOLOGIES
DESCRIPTIONPROFESSIONAL PERSONNEL$720,000.00OVERHEAD EXPENDITURES$400,000.00MARKETING-LOBBYING-CERTIFICATIONS$500,000.00VETINARY CLINICAL STUDY$250,000.00TOTAL:$1,870,000.00
FUNDING FOR LEGAL AND ADMINISTRATION
DESCRIPTION$1,000,000.00LEGAL AND ADMINISTRATION COSTS$1,000,000.00GRAND TOTAL:$4,370,000.00
POSSIBLE SCENARIO TO GENERATE FUNDS
WHILE CLINICAL STUDY IS IN PROGRESS.
5318760165105667375359410GlobalMed has established relationships with various insurance companies, government institutes and private entities which have demonstrated an interest to venture into an association with the company.GMT expects with the correct lobbying and marketing strategies we can be offering our services to the different health clinics, hospitals and institutes which treat HIV/AIDS patients. Currently in Colombia and most of Latin American, people with HIV/AIDS have demonstrated a resistance rate to retroviral medication between 60 to 85%This has burden the already strain economies in these countries.If someone could offer an effective treatment and lower costs at the same time, they would capture a niche in this hemispheres health market.
28575273685The Company anticipates in its strategies that it can commence selling GMT Kits and treatments to health clinics and hospitals while we conduct our clinical trials. By performing the appropriate lobbying we can convince the insurance companies in Colombia to pay for our treatments to patients who are resistant to the medications or those which are intolerant, due to their side effects.The percentage of people that fall into this category is 43% for the intolerants and 85% of those under government assistance.The total amount of HIV/AIDS cases in Colombia range between 190,000 to 300,000.Of these approximately 85,000 are being treated with retrovirals, of which 50% or 42.500 are either intolerant or resistant to the meds.(Annex # 15)
These people have no hope since nothing works for them, but the government according to the Law 100 of the Health Code must provide medical attention and care.The amount of funds needed to keep these people alive is draining the governments throughout all of Latin America.By providing hope to a market which no pharmaceutical can get to and by lowering cost to the insurance companies and the government, our entry is but assured.GMT has done most of the legwork in this area and with the proper funding, lobbying and marketing we can expect to generate the funds below.
The following table demonstrates the potential to generate income from the sales of kits in treatments performed at various health centers while clinical trials are in progress.
POTENTIAL REVENUES
DESCRIPTION NUMBER OF PATIENTSNUMBER OF KITS PER MO.NET REVENUES FROM THE SALE KITS/MONET REVENUES FROM THE SALE KITS/YR500 X 4 KITS/mo2,000$100,000$1,200,0001,0004,000$200,000$2,400,0001,5006,000$300,000$3,600,0002,0008,000$400,000$4,800,0003,00012,000$600,000$7,200,0004,00016,000$800,000$9,600,0005,00020,000$1,000,000$12,000,00010,00040,000$2,000,000$24,000,00015,00060,000$3,000,000$36,000,00020,00080,000$4,000,000$48,000,00025,000100,000$5,000,000$60,000,000
Committing to perform the clinical trials demonstrates a good will act on our behalf and opens the door for a profitable future.Now that Johnson and Johnson has commencement their clinical trials with irradiations in HIV/AIDS patients, the possibilities are endless.By going to South America and other countries first we guarantee a rapid approval.When we look at it from a business and benefit side, 99% of our market potential is outside the US, and we dont need to perform clinical trials in the US to be approved worldwide. (Annex # 16)
The process of approval in the US by the FDA is cumbersome and moves at a snails pace, something J&J has found out the hard way.Their first clinical pilot study was performed in 1990 at Colombia University Department of Photopheresis in Morristown New Jersey.They proved beyond a shadow of doubt that this process works by taking 4 subjects to sero negative.(Annex # 17)
In 1992 they publish their second study results and 17 of 19 subjects reached sero negative.After these two studies were completed nothing is done by J&J in the field of HIV and Photopheresis until 2006, when Merck Sharpe and Dome announced that they were out of the vaccine race for HIV.They commented on the mutability of the HIV virus and how that made it impossible to develop a vaccine that could accommodate the genetically mutating changes of the virus and how fast it did so. (Annex # 18)
This has opened the door for GMT and its process.We would be the first company to perform Controlled Clinical Trials in Various countries and certify a process of treatment which fights virus, bacterias, fungus and parasites effectively and viably.
The next stage is Phase II Clinical Trials.During the ramp up phase and during the first six months of the clinical trials we will be marketing and lobbying all interested parties and other academics and government health officials to the benefits of this treatment.By the sixth month of clinical trials we should have acquired the first 500 to 1,000 patient in various clinics.These revenues would offset the revenues needed in the clinical trials.If we reach 5,000 patients we can literally pay for the development of not only Phase II but most of Phase III trials.We welcome any and all inquiries and we are prepared to attend any meeting where we may demonstrate the functionality of the PCI-1 and the GMT-Kit.