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PRHB - New Video Format August 2010
Pure H2O Bio Technologies, Inc.
New Video Format
August 2010
Market Opportunity – Treatment of Emerging Water-Borne Disease Pathogens
Over the past 20-years, increasing demands for pure drinking water by hospitals, clinics, nursing homes, residential consumers as well as recreational, educational, military, and commercial facilities have generated the need for water treatment technology that can disinfect organisms that are refractory to conventional water treatment and filtration. 286 million people in the US receive their water from public drinking water systems. In 2007, the EPA determined that over 51,252 or 32.9% of the drinking water systems in the US reported at least one health-based standard, monitoring and reporting, or other violation. Moreover, there is an additional need for the 5,747 registered hospitals in the US to provide safe drinking water in the heath care delivery setting. International opportunities are also another market sector particularly in developing countries. Pure Water Bio-Technologies intends to leverage its novel Silver TTO™ disinfection technology to produce water treatment systems that effectively treat chlorine-resistant water-borne pathogens such as Cryptosporidium and related enteric bacteria. The proprietary Silver TTO™ technology has the potential to disrupt the existing water treatment market in commercial, institutional as well as residential market sectors.
Silver-TTO™ Water Disinfection of Resistant Cryptosporidium
Crytosporidiosis – Disease Epidemiology
Infection by C. parvum has been reported in six continents and identified in patients aged 3 days to 95 years old ( Flanigan and Soave, 1993) and results in the gastro-intestinal disorder known as Crytosporidiosis. Transmission is usually fecal-oral, often through water contaminated by mammalian livestock. Persons most likely to be infected by Cryptosporidium are:
infants and younger children in day-care centers
those whose drinking water is unfiltered and untreated
those who have oral contact with feces of an infected individual
patients in a nosocomial (hospital patients) or healthcare setting with other infected patients or health-care employees
veterinarians who come in contact with farm animals
immunocomprised individuals such as those with AIDS, undergoing irradiation or chemotherapy
Consumers of water continue to express concerns over their water quality in response to several driving factors: (1) a growing population and industrial concentration in urban areas which place increased demand on existing water treatment facilities, (2) reoccurring outbreaks of chlorine-resistant water-borne pathogens, and (3) the potential impact of water-borne parasites that are refractory to conventional chlorine water-treatment particularly to immune-compromised patient cohorts. The 1993 outbreak of Cryptosporidiosis in Milwaukee, WI and the 1998 outbreak of Coliform (E. coli) bacteria in Atlanta, GA, (4) and in 2000 the Cryptosporidium outbreak in the Northwest UK are prime examples. In FY2004, the EPA reported that were 159,796 public drinking water systems in the United States (Factoids: Drinking Water and Ground Water Statistics for 2004) and 9,099 of these systems reported violations of TCR/T (Total Coliform Rule/Turbidity) that affected an estimated 11,382,966 people.
Images
Photomicrograph of Crpytosporidium.
Immunofluorescence image of Cryptosporidium parvum oocysts
Courtesy of H. D. A. Lindquist, U.S. EPA
Transmission Electron Micrograph of E. coli O157:H7 Bacterium
Courtesy of E. H. White – Centers for Disease Control & Prevention
Images:
Silver-TTO™ molecule, flowing rivers, ocean waves, glass filling with water.
Hospital and IV administration, high-tech lab fluid handling.
Cryptosporidium Cell Wall Structure and the Basis of Resistance
Cryptosporidium oocysts have also been shown to be resistant to all halogen compound treatments, including chlorine, iodine, bromine and fluorine, since they are designed to treat microorganisms in their vegetative state and not the oocyst stage of the parasite life cycle. Within the membrane-enclosed oocyst large amylopectin carbohydrate granules (0.1-0.3 micron) can be found besides as well as a large lipid bodies and a crystalline protein inclusion.
Specifically, classic disinfectants have been shown to have little effect on the carbohydrate component of the oocyst cell wall. Oocyst cell wall proteins can also contribute to resistance. In the past decade, the retail market has seen the introduction of iodine-based carbon resins for residential water treatment at the point-of-use. These systems merely entrap microorganisms and provide no disinfection capability to Cryptosporidium parvum oocysts..
Pure H20 Bio-Technologies (PRHB) has developed proprietary Silver-TTO™ point-of-entry and point of-use systems which can effectively disinfect chlorine-resistant organisms such as Cryptosprodium oocysts and water-borne bacteria.
Existing Water Treatment Limitations
Water treatment facilities, although operated correctly and remove the vast majority of microbial contaminants, can be breached by some recently emerging pathogens, as evidenced by the large number of waterborne disease outbreaks. This has created considerable concern for response to several driving factors:
¦ A dramatic increase in the number of cases of waterborne diseases caused by newly emerging pathogens
¦ The need for added protection against potential bio-terrorism
¦ Public awareness of waterborne outbreaks, e.g., the well-known outbreaks of cryptosporidiosis in Milwaukee, 1993, in Las Vegas, 1992-1994, and Lancashire, UK , 2002. There were 7,212 cases of cryptosporidiosis; 17,256 cases of giardiasis; 2,368 cases of E. coli 0175:H7; 9,877 cases of hepatitis; and 1,952 cases of legionellosis during 2005, proving that the threat of outbreaks still exists.
¦ Growing population and industrial concentration in urban areas
¦ Population demographics - cancer and other immune-compromised population cohorts.
¦ The Centers for Disease Control and Prevention have estimated that there are on the order of 940,000 cases of waterborne enteric (intestinal) disease in the USA annually (GFL & Associates, 1993).
Existing hyper-chlorine disinfection and carbon filter-based water treatment systems appear to have limits that suggest a need for improved potable water supplies in military installations or remote locations, residences, hospitals, nursing homes, day-care centers, commercial facilities, recreational facilities, cruise ships and hotels..
Presently, ozone and ultraviolet water treatment procedures are approved by the USEPA for disinfection of Cryptosporidium oocysts, however, there are practical problems associated with their use to deliver pure and safe drinking water. Ozone is very expensive to use as noted in the Southern California Water District study (G.Quist, I.C. Felkner and R. DeLeon. Evaluation of a Real-Time Online Monitoring Method for Cryptosporidium. J. AWWA, USA 2004, pp 1-103.) Ozone is readily absorbed by particulate organic matter, so that it's disinfectant capacity can be significantly reduced in turbid source water. In addition, water treated with ozone can become re-contaminated at or before the point of entry or point of use because ozone decays to oxygen leaving no residual disinfection capacity and requiring further augmentation by other disinfectants such as chlorine products, which are not effective against Cryptosporidium oocysts.
Ultraviolet light has a limited penetration capacity and does not work well except in very shallow water streams. It also does not leave a residual protection for water at the point of entry or point of use and penetration is blocked by turbidity, as is ozone. In addition, it is mutagenic so that resistant forms of microbes can be created when killing is not complete.
Although halogens such as iodine, chlorine, and fluorine can be very effective in killing pathogenic bacteria, our intended use of Silver TTO™ disinfectant is far superior for overall removal and/or killing of the newly emerging pathogenic strains
Unmet Need – Effective Water Disinfection
As a result of the current unmet market need to successfully disinfect Cryptosporidium parvum oocysts in drinking water, Pure H20 Bio-Technologies, Inc. intends to introduce its proprietary combination water purification systems, using its Silver TTO™ disinfection agent. It will be used in combination with absolute 1-micron porosity activated-carbon filter elements facilitating the removal of the Silver TTOTM along with other organic and metallic contaminants. This means that water pure enough to supply hospital needs as well as private homes is generated. These system components have been evaluated by independent U.S. environmental labs and demonstrate antimicrobial activity against E. coli and Cryptosporidium oocysts. These results were first produced in a bench-level disinfectant study and were reproduced successfully in the complete automated disinfectant delivery system. This means that the technology has been successfully converted to a product that has the potential for serving hospitals and private individual systems. It should be especially important when the municipal water gets contaminated at or before the point of entry or point of use, e.g., under a "boil water" directive from the city water management. The Silver TTOTM kills not only bacteria and viruses, but also Cryptosporidium oocysts (emerging pathogenic threat organism in water). The system can regulate the amount of Silver TTOTM present in the final water so that a low residual is present (use in private homes) or can remove it entirely when it is designated for hospital use where sensitive individuals could otherwise be at risk. It is not mutagenic, and can remain as a residual disinfectant at the point of entry or point of use. The PRHB Silver TTO™ technology can now be viewed as very competitive and a significant improvement over all current water treatment products from a business development perspective.
Laboratory System Studies
The disinfection of E. coli and Cryptosporidium parvum oocysts using the Pure H20 Water Purification System was performed by Clancy Environmental Consultants in St. Alban, VT in 2008 to demonstrate the effectiveness of the Silver TTO™ technology. It meets the challenge posed in a major AWWA publication (P. Rochelle and J. Clancy 'The Evolution of Microbiology in the Drinking Water Industry' J. AWWA, March 2006, pp 163-191) that enumerates newly emerging pathogen threats to safe drinking water. After successfully demonstrating the ability of Silver-TTOTM to kill E. coli and Cryptosporidium oocysts in a bench level study, an automated delivery system (patent pending) was designed and used to test the the efficacy of silverTTOTM for killing of high concentrations of E. coli and Cryptosporidium parvum, thus producing water suitable for drinking.
E. coli disinfection tests: The Silver-TTO disinfection of water inoculated with E. coli bacteria were measured by Colony Forming Units (CFU/mL) with mEndo media at 2 and 10 minute intervals using the PRHB water purification system.
Disinfection of E. coli bacteria by PRHB Silver-TTO™.
E. Coli Sample
Silver-TTO™
Contact Time
Average
E. coli CFU/mL
Log10 E. coli
Inactivation
0 min
1.1 x 105
0
2 min
1.1 x 104
1.1
10 min
< 1
> 5.0
*< 0.5 mg/L of dissolved silver Conclusions:
Low Silver-TTO concentrations will reduce the concentration of E. coli bacteria by greater than a factor of 5 log 10 in compliance with current US EPA's regulations.
Combination of AC-carbon filtration and Silver TTO™ disinfection is a functional system design for water purification.
In the next series of studies, samples of PRHB Silver-TTO™ purified water was incubated with human HCT-8 ileocecal adenocarcinoma or colon cells. They were subsequently stained for IgG-FITC labeled antibody for intracellular reproductive stages of Cryptosporidium parvum oocysts, and scored for infectivity.
Disinfection of Cryptosporidum Oocysts by PRHB Silver-TTO™ over 60 minutes.
Crytosporidium parvum Oocyts Sample ID
Cryptosporidium Oocysts per Innoculum
Average Percentage
Infectious Post-Treatment by Immunofluorescence
Oocyst Stock Culture
9.4 x 102
5.2 %
Heat-Shock Control
1.0 x 104
0.0 %
Process Control
8.6 x 102
4.0 %
Silver TTO™ – Test A*
1.2 x 103
< 0.08 %
Silver TTO™ – Test B*
1.3 x 103
< 0.08 %
Silver TTO™ – Test C*
1.2 x 103
< 0.08%
Silver-TTO Log Disinfection of Cryptosporidium parvum oocysts.
< 0.5 mg/L dissolved silver
Conclusions:
* Low Silver-TTO (less than 0.5 mg/L) can effectively reduce the infectivity of Cryptosporidium oocysts.
* Combination of AC-carbon filtration and Silver TTOTM disinfection is a functional system design for water purification.
PHBT Silver TTO™ Systems
The current point-of-use and point-of-entry systems are primarily based on carbon or fiber filters that merely entrap, but do not disinfect drinking water. The Pure H2O technology system combines use of absolute micron carbon pre- and post-filters with controlled release of oxygenated tetrasilver-tetraoxide (TTO) to treat waterborne pathogens and remove heavy metals and objectionable biomass. The use of TTO in the system is a great improvement over use of halogenated compounds such as chlorine, bromine and iodine because it is capable of killing the oocysts of Cryptosporidium and cysts of Giardia with an already proven ability to destroy pathogenic bacterial and viral species, including Escherichia coli and waterborne viral species specified by the US Environmental Protection Agency (US EPA). The US EPA, for treatment of swimming pools, has already approved TTO for its efficacy on microbes. Its efficacy for treatment of Cryptosporidium oocysts was successfully tested in 2008 for PRHB by a laboratory nationally recognized for its well-established expertise on Cryptosporidium as well as other pathogenic microbes. A non-provisional patent for use of TTO to disinfect Cryptosporidium oocysts has recently been submitted to the US Patent Office. The Company plans to certify the system through NSF using updated NSF/ANSI standards.
Intellectual Property
The Company’s decision to utilize new Silver TTO™ in combination with Activated-Carbon in its treatment of water is based upon known properties, including the novel Silver TTO™ capability to inhibit the proliferation of Cryptosporidium parasitic oocysts..
Pure H20 has 2 patents pending, i.e., tetrasilver tetraoxide application in the area of micro-biotechnology and mechanical engineering with the U.S. Patent & Trademark Office.
PRHB Products
The Pure H2O water purification systems include the latest Silver TTO™ disinfection technology designed to provide microbiologically pure and safe drinking water. Recent independent laboratory studies demonstrate the PRHB Silver TTO™ technology disinfection of resistant Crytosporidium oocysts. Pure H2O Bio-Technologies, Inc. has designed this product to purify water at point-of-entry (POE) and point-of-use (POU) to remove: chlorine, lead and organic chemicals, chloramines, and unpleasant tastes and odors. This reliable potable water system combines the proven unique benefits of absolute AC and absorption removal of offending contaminants with microbiological disease control and prevention.
Model 7000 Hospital Water Purification Unit
The Model 7000 Hospital Water Disinfection Unit incorporates the leading Pure H20 granular activated carbon water purification technology for applications in healthcare facilities. The Pure H20 Model 7000 SilverTTOTM storage and dispensing process, in conjunction with Activated-Carbon, generates a near 100% disinfection rate against various disease causing waterborne microorganisms. The final water generated is pure and will not contain organic or inorganic contaminants that will be harmful to sensitive patients, such as those undergoing kidney dialysis or those who are seriously immunocompromised (e.g., radiation or chemotherapy treated patients).
Independent Testing
Performance evaluations of the PRHB Silver TTO™ disinfection system were conducted under established protocols at Clancy Environmental Consultants, Inc. (CEC) which is an independent environmental testing laboratory based in the United States. CEC is a USEPA-approved laboratory for Cryptosporidium and E. coli analysis for the EPA Long Term 2 Enhanced Surface Water Treatment Rule and provides laboratory services to federal agencies and private sector clients through contracts with the U.S. General Services Administration (GSA) and corporate entities. The CEC laboratory is certified in Vermont and is NELAC (National Environmental Laboratory Accreditation Conference) accredited for microbiological analysis of drinking water. Independent validation of silverTTOTM and dissolved silver concentrations on these studies were conducted by Genapure, Inc. (formerly US Biosystems, Boca Raton, FL)
Product
The Pure H20 Bio-Technology potable water disinfection system utilizes a non-heat reliant, power independent method known to kill Cryptosporidium, which has been found in municipal water supplies and recreational facilities. As a result, the PHBT systems are designed with a technology combination of Silver TTO™ and absolute micron porosity GAC or similar final finish absorbent provide an additional level of protection for both residential and commercial / institutional applications.
Pure H2O Bio-Technologies has refined the traditional drinking water purification processes by utilizing Silver TTO™ disinfection systems, thereby achieving a purity unequalled in the water purification and bottled water markets. The Company offers four different structural point-of-entry (POE) & point-of-use (POU) disinfection / purification systems designed to meet various market and client preferences.
PHBT Silver TTO™ Models (images)
PHBT 75: Under-the-Counter System
PHBT 4000 & 3000: Residential and Commercial Systems
PHBT 7000: Hospital and Medical System
Competitive Landscape
Existing carbon-based iodine resin water treatment systems were initially certified without the use of live Cryptosporidum oocysts. These ion-exchange systems appear to have limited value or performance in disinfecting water. They temporarily entrap curtain organisms that may pass through the AC blocks during certain stages of the Cryptosporidium or bacteria life cycle. Ozone and UV treatment systems have shortfalls that were previously explained and involve cost, penetration, and lack of residual disinfectant protection. The SilverTTOTM system at present is not intended to replace existing municipal water treatment systems, but for use at the point-of-entry and point-of-use.
Pathway to Market Launch
The ability to launch a new drinking water purification system onto the market requires certification of both the system and manufacturing facility by NSF International in Ann Arbor, MI. NSF is a non-profit, non-governmental organization that is recognized as an authority in product certification and risk-management that is focused on food, water, indoor-air and other environmental standards and independent assessment services that serves manufacturers in over 80 countries. This independent NSF certification of the PRHB Silver TTO™ water purification system and manufacturing facilities will require additional funds for approximately “6” months.
Images:
Lab video elements from NSF or other stock video.
Financial Needs
· Silver-TTO engineering specifications list and Certification
· Manufacturing Facility Certification
· Beta Model Manufacturing.
· IP fillings.
Investment Opportunity
In the event voice mail box is full, please write to
Mr. Joseph P. Doxey, President at his E-mail address:
JDoxeyintl@comcast.net
or contact him directly at telephone number (561) 271.4777:
Contact Information
Mailing Address
Pure H20 Bio-Technologies, Inc.
370 W Camino Gardens Blvd Suite 332
Boca Raton, FL 33432
Telephone
Phone: 561.347.2771
Fax: 561.218.6169
Management Team
Joseph P. Doxey – Chairman, President & CEO
Dennis P. Boudreaux, P.E. - Director and COO
C. Eric Jones, Ph.D. - Director and Corporate Communication
Todd D. Stong, Ph.D, P.E - Technical Advisor
Cecil Felkner, Ph.D. - Consulting Microbiologist, Biochemist, & Toxicologist
EdwardC.West,P.E.-TechnicalConsultant
MichaelSember,V.P.-SalesandMarketing
MissionStatement
Pure H20 Bio-Technologies, Inc. (Pure H20) is an emerging, publicly traded (OTC-BB Pink Symbol PRHB), Florida based corporation that designs, develops, manufactures and markets potable water disinfection systems for residential and commercial applications. Potential uses include water treatment for whole house (under the counter), medical point-of-use, and well watersystems.
PRHB - Special Report T.V. Q & A's
PURE H20 BIO-TECHNOLOGIES, INC.
Company Information and Questionnaire by Special Report T.V.
________________________________________________________________________
Name of Company: Pure H20 Bio-Technologies, Inc.
Pure H2O Bio-Technologies, Inc. (OTC-BB Pink symbol: PRHB) is a company dedicated to development and production of point-of-use, or secondary water treatment systems for hospitals, small communities, and individual water treatment systems.
The company develops unique treatment and purification systems which consists of a disinfectant to kill pathogenic microbial species that may have by passed the primary/municipal water treatment system and a filtration system to remove chemical contaminants and reduce or eliminate the disinfectant to yield highly purified and safe water.
The disinfectants offered include a unique silver molecular device, activated tetrasilver tetraoxide (TTO), which is a very broad spectrum disinfectant or iodine, which is more limited, but effective against many common bacterial and viral species. TTO is effective against many halogen-resistant (e.g., chlorine, fluoride, bromide, and iodine) microbes such as Cryptosporidium parvum (whose oocysts are not readily inactivated/destroyed) and likewise Giardia lamblia cysts, which also resist halogen treatments, as well as Legionella, some E. coli pathogenic species, fungi, algae, and some viruses that lack the normally present protein/fat layered coats.
We approach developing a business that first determines what problems exist that are not already controlled and by investigating what approaches have been unsuccessful or partially successful. We, therefore, avoid re-inventing what others have developed and/or do not solve the problem(s). Then, we determine whether there is a real need and a substantial market for any products that we develop to market.
We are especially knowledgeable about problems with drinking water and the microbes that are currently problematic because our consulting microbiology advisor, particularly, I. Cecil Felkner, has done extensive project work with the US EPA Office of Water, American Waterworks Association, and the Water Environment Research Foundation. The target includes emerging threats from pathogenic microbes that are currently not even being controlled by state-of- the-art water treatment systems.
Our techniques to develop and improve disinfectants are unique because they start with an in depth investigation of the target microbes. This begins by gaining knowledge about their molecular and physiological makeup. For example, the Cryptosporidium oocyst has unique properties that make it resistant to penetration by the commonly used disinfectants. The endospores of some bacterial species are highly resistant to heat, chemical, and irradiation treatment because of a unique chemical within the spore wall.
We have learned from experience, that penetration through the oocysts and endospore walls provides a mechanism for the disinfectant to render the organism non-viable. Penetration can be facilitated through the knowledge of how the wall is constructed and what sorts of elements, molecules or sub-particles are likely to pass this barrier. Chemical bonding and the production of certain ionic particles have been employed successfully.
Questionnaire by Special Report T.V.
Jay Crosby, Executive Producer
Please discuss the Top Ten Reasons that differentiates your company from its competitors or otherwise sets you apart in the marketplace. Why should someone consider investing in your company? How is what Pure H20 Bio-Technologies developed better than what your competitors offer?
Answer: The current point-of-use and point-of-entry systems are primarily based on carbon or fiber filters that merely entrap, but do not disinfect drinking water. It provides disinfection of ordinary and resistant pathogens not killed by halogens and then removes metals, pesticides, toxins, organic material and the disinfectant (entirely or to a desired level), producing only pure water that is safe even for sensitive individuals. It is also economical to use.
PHBT Silver TTO™ Systems
The Pure H2O Bio-Technologies’ system combines use of absolute micron carbon pre- and post-filters with controlled release of oxygenated tetrasilver-tetraoxide (TTO) to treat waterborne pathogens and remove heavy metals and objectionable biomass. The use of TTO in the system is a great improvement over use of halogenated compounds such as chlorine, bromine and iodine because it is capable of killing the oocysts of Cryptosporidium and cysts of Giardia with an already proven ability to destroy pathogenic bacterial and viral species, including Escherichia coli and waterborne viral species specified by the US Environmental Protection Agency (US EPA). The US EPA, for treatment of swimming pools, has already approved TTO for its efficacy on microbes. Its efficacy for treatment of Cryptosporidium oocysts was recently tested successfully for PHBT by a laboratory nationally recognized for its well-established expertise on Cryptosporidium as well as other pathogenic microbes. A non-provisional patent for use of TTO to disinfect Cryptosporidium oocysts has recently been submitted to the US Patent Office. The Company plans to certify the system through NSF using updated NSF/ANSI standards.
The US EPA has set a non The US EPA has set a non-enforceable limit or standard in water for silver at 0.10 mg/L. However, individual states may set their own limits. As a result, Pure H20 Bio-Technologies, Inc., is designing post-treatment units for residential, institutional, and commercial applications that will include a silver absorbent such as silicon dioxide to reduce residual silver for additional safety in its water disinfection system design.
References
R. Pedahzur, et al. The efficacy of long-lasting residual drinking water disinfectants based on hydrogen peroxide and silver, Water Science & Technology 42(1-2): 293-298, 2000.
R. Pedahzur, et al. Silver and hydrogen peroxide as potential drinking water disinfectants: their bactericidal effects and possible modes of action. Water Science & Technology 35 (11-12: 87-93, 1997.
J. B. Rose. Environmental ecology of Crytosporidium and public health implications. Annual Review of Public Health 18: 135-161, 1997.
CEC. Consulting and Microbiology Laboratory Services. Disinfection of Cryptosporidium parvum Oocysts with Tetrasilver Tetraoxide for Pure H20 Bio-Technologies, Inc., 2006.-enforceable limit or standard in water for silver at 0.10 mg/L. However, individual states may set their own limits. As a result, Pure H20 Bio-Technologies is designing post-treatment units for residential, institutional, and commercial applications that will include a silver absorbent such as silicon dioxide to reduce residual silver for additional safety in its water disinfection system design.
Cryptosporidium oocyst has unique properties that make it resistant to penetration by the commonly used disinfectants. The endospores of some bacterial species are highly resistant to heat, chemical, and irradiation treatment because of a unique chemical within the spore wall.
1. Explain how we can all understand the potential threat to water systems around the world now. What are some of the most common ways that water is being infected these days? What kinds of threats to the water system are posed by terrorists? What are the threats posed by man-made and natural disasters? What kind of problem is water contamination in developing countries?
Answer # 1. (a)Agencies such as the US EPA, World Health Organization, State and Local Health Departments alert the public through television, newspapers, and various journals/magazines. The American Waterworks Association (AWWA) gathers and distributes information to municipalities and even publishes major articles such as that by Paul Rochelle and Jennifer Clancy (J.AWWA 98:3, March 2006, pp163-191) which gives the history of water microbiology and which also talks about past and emerging threats to our drinking water systems. (b) Terrorists would not likely attack the municipal treatment facilities, but the distribution points and points of use (e.g. hospital or community sites). (c) Hurricanes, tornadoes, floods, run-off from chemicals and fecal material and the like can breach the system through breaks in pipes from water distribution and or sewage that can enter the water distribution sites. It should be noted that these are more likely to occur than terrorist activity. (d) Water contamination is severe in developing countries due to lack of treatment facilities and even cost, e.g. in India there was a recent report that stated the people did not use treated water due to cost and were using water that had rats, feces, etc. even though there was clean water available.
According to the US EPA’s summary “Water On Tap – what you need to know, OCT 2003,” some individuals may be more vulnerable to contaminants than others. People that are receiving chemotherapy or living with immune compromised conditions, the elderly, pregnant women and their unborn children can be at risk for infective agents. The potential for health problems from microbial organisms of waterborne disease has been attributed to bacteria, viruses, and parasites such as Gardia and Cryptosporidium. These incidents of biological contamination most likely originated from animal waste material. In the period of 1999-2000, the EPA indicates that there were 39 reported disease outbreaks in drinking water and some were associated with public drinking water supplies. One of the more well-known incidents was a serious outbreak of cryptosporidiosis occurred in 1993 in Milwaukee, Wisconsin, causing more than 400,000 persons to be infected with the disease, and resulting in at least 50 deaths. This was the largest recorded outbreak of waterborne disease in United States history. The overloading or failure of water treatment facilities and/or distribution systems are reasonable sources of concern as drinking water systems are expanded, age, and are exposed to adverse weather, or subjected to other external events particularly as it relates to the buildup of biofilm on the surfaces of systems components. Another example involves the observation by WHO that V. cholerae may have been re-introduced to South America in 1991, after 100 years of absence, from the bilage and ballast of water in cargo ships. 2. What is the impact of infected water on people's health? See above and below.
Answer #2. Infected water can cause anything from severe diarrhea, dehydration, cramps, etc in healthy individuals to various levels of disability and death, depending upon which type of parasite is involved and the level of infection. We could be talking about pathogenic bacteria (Shigella, Salmonella, Escherichia coli, Vibrio cholera, Legionella, Campylobacter, etc), viruses (noro viruses, polio, rotavirus, etc.), protozoans (Cryptosporidium, Giardia, Endamoeba coli, etc) or fungi (eg, Aspergillus flavus)or actinomyces species (Mycobacterium tuberculosis, etc). Of course there are algal toxins that can be lethal as well. It should be pointed out that chlorine does not kill the cysts of Giardia or oocysts of Cryptosporidium nor various protozoans that may act as carriers of bacteria such as Legionella. There is a spreading epidemic of Cryptosporidium in swimming pools and hot tubs which was recently reported on CNN and other networks. This organism causes severe and long lasting enteric infections in normal individuals (diarrhea, cramps, dehydration, etc), but in immunocompromised individuals (chemotherapy, irradiation, HIV (AIDs), elderly, and very young) it is lethal because it infects the lungs. As is pointed out by the Rochelle/Clancy article, Cryptosporidium infection and some others are newly emerging threats that are not remedied by chlorine and state-of-the-art water treatment systems.
In particular, what is the dimension of the problem with infected water in hospitals and other health care facilities?
Answer #3: Infected or contaminated water in hospitals in hospitals and other health care facilities pose a severe threat to the patients because they are usually immunocompromised. Organisms such as Cryptosporidium parvus at doses as low as 1 (one organism) would be enough to cause an infection that would likely be lethal or E. coli, Legionella, Mycobacterium etc. would be similar. These organisms have been known to breach municipal water treatments and can even escape ordinary water filtration systems. Hospital and Health Care facilities are having very significant problems with infectious organisms. In addition, water must be free of various metals, organic materials, Pesticides, etc., for example, an individual on kidney dialysis is very sensitive to aluminum (and other metals) or otherwise could have severe damage or even death. This is why both disinfection and removal of chemical contaminants is crucial. According to the WHO publication “Emerging issues in water and infectious diseases, 2003.” Infectious, water-related diseases are a major cause of morbidity and mortality worldwide. Newly-recognized pathogens and new strains of established pathogens are being discovered that present important additional challenges to both the water and public health sectors. Between 1972 and 1999, 35 new agents of disease were discovered and many more have re-emerged. Among these are pathogens that may be transmitted by water.
Since 1970, several different species of microbial agents from human, animal, and environmental sources including water, have been identified as pathogens. Those transmitted by water include Cryptosporidium, Legionella, Eschericha coli O157, rotavirus, hepatitis E and norovirus (formerly known as Norwalk virus), as well as Helicobacter pylori (H. pylori), and drug-resistant parasites such as Plasmodium (etiological agent of malaria).
Elias J. Anaissie, et al, reported in a paper entitled “The Hospital Water Supply as a Source of Nosocomial Infections, Arch. Inter. Medicine, 2002,” that specifically P. Aeruginosa can persist in hospital water for extended periods. Other bacteria associated with waterborne nosocomial infections include species of L. pneumophilia, Aeromonas, Acinetobacter, Burkholderia, Enterobacter, Flavobacterium, other Psuedomonas, Serratia, and others. Pathogenic mycobacteria have also been isolated from hospital water supplies and can persist in water systems over several years. As a result, they too have been implicated in serious nosocomial outbreaks. Nosocomial aspergillosis continues to occur despite air filtration. Moreover, fungi can colonize water distribution systems, including those of hospitals. For example, the water system of one hospital in Houston, TX harbored Fusarium species, causing infections among its patients. Other opportunistic molds, including Aspergillus species have been isolated from the same hospitals as well as two other hospitals in Little Rock, AK. Anaissie’s team also discussed outbreaks of toxoplasmosis (T. gondii) that were traced to contaminated water. Sources of contaminated water within healthcare facilities include drinking water and ice, bathing water, or medical equipment that has contacted tap water. Anaissie and his co-authors estimate that 20% of the nosocomial pneumonias are caused by P. aeruginosa. Of these, 30% are waterborne resulting in a yearly mortality rate of 1400 in the US. It is the authors’ estimation that hospital waterborne infections are frequently under diagnosed since many other pathogens, some of which are resistant, may also cause infections.
4. What is the federal government trying to do to introduce new technologies to disinfect the water supply?
Answer #4: The federal government would like to replace chlorine with a better alternative to chlorine because chlorine can produce at least 13 different carcinogenic chemicals when in contact with organic materials (eg. the chemicals called trihalomethanes), it is ineffective against many emerging pathogens such as Cryptosporidium, Giardia, and the non-enveloped viruses, noroviruses, etc. It has approved ozone and ultraviolet light for treatment but there are disadvantages to each of these. Ozone is expensive to produce (electricity) and turns to oxygen overtime, leaving no residual to protect the water, whereas ultraviolet lacks penetration ability (only disinfecting the surface layer) and in addition is mutagenic (when it doesn't kill microbes, they may be mutated to more resistant forms or their pathogenic potential may be changed); also once water is treated with UV there is no residual left to prevent reinfection or contamination. The technology which we are developing kills the critical emerging pathogens as well as those which chlorine kills, can leave a residual for protection against re-infection and does not mutate microbes, i.e., it simply destroys them.
Susan W. Putnam
Jonathan Baert Wiener
Edited by:
John D. Graham and Jonathan Baert Wiener
HARVARD UNIVERSITY PRESS
Cambridge, Massachusetts
London, England
1995
Today Americans consume over three and a half billion gallons of treated water every day. There are nearly 250,000 public water supply systems in the United States, serving everything from the smallest towns to major metropolitan centers (AWWA 1984). Ninety percent of the population receives its water through these community water systems, with the rest using private wells or other individual sources. The Environmental Protection Agency (EPA) ranks drinking water pollution as one of the top four environmental threats to health (Carpenter 1991). At the state level, drinking water contamination ranked first among twenty seven environmental health concerns of state public health officials in 1987 (Galbraith 1989), and the issue has also been included on the platforms of several recent major gubernatorial campaigns (Carpenter 1991). Internationally, where over a billion people lack clean drinking water and almost two billion lack sewage systems, waterborne microbial disease presents perhaps the world's single largest environmental health risk, afflicting more than a billion people and killing millions each year (World Bank 1992)…
Managing the Risk
Caught between the risks of cancer and microbial disease, the federal EPA has begun negotiated rulemakings, involving industry as well as community leaders, aimed at managing the risks of disinfection without undermining the control of microbial disease (EPA 1994a, 1994b). Many communities are beginning to search for "risk superior" options for obtaining clean drinking water. At the technical level, there are currently various options available to Americans for managing the port folio of drinking water risks. Chlorination as a disinfecting treatment has long been demonstrated as an effective system for achieving a substantially microbial free drinking water supply. Many of the cases of waterborne disease that do occur every year can be attributed either to breakdowns or inadequacies in the treatment system or to areas where no disinfection has been implemented (Akin, Hoff, and Lippy 1982; NAS 1987)--though some, such as cryptosporidium, may be unaffected by chlorination (EPA 1994b).
Much of the risk associated with chlorine exposure may occur in extraordinary circumstances, not in routine situations. Most municipal drinking water supplies maintain chlorine levels such that the concentrations of chloroform in the systems range from 0.02 to 0.05 milligrams per liter (Wilson 1980), well below the standard of 0.10 milligrams per liter that the EPA has set as a safe level for ingestion of THMs. Trihalomethane levels can vary, however, particularly with seasonal or water quality changes. This is true especially in the summer months, when microorganisms grow more quickly and greater amounts of chlorine are added to the water supply to combat the increased microbial growth. In Washington, D.C., for example, THM levels can rise to 30 percent over the EPA limit, despite the $35 million water treatment plant that the city recently built (Carpenter 1991).
The concern over trihalomethane levels has spurred in creasing use of alternative disinfectants. For example, both the state of Kansas and the Metropolitan Water District of Southern California now use chloramination for the maintenance of a disinfection residual in their distribution systems. Ozone disinfection processes, widely used in Europe, have also been on the increase in the United States. Recent improvements in the reliability and efficiency of ozonation technology, coupled with its high efficacy against resistant protozoan cysts and viruses, have strengthened the desirability of this chlorine alternative (NAS 1987).
New options include modifications to the chlorination process to reduce chlorine by products. Particular attention has focused on reducing the level of organic precursors in the water to protect against trihalomethane production. Once THMs are formed, they are very difficult to remove, so the goal is to prevent their initial formation. One way to try to accomplish this is to pretreat the source water, with technologies such as granular activated carbon or other absorbents, to remove organic materials before the water enters the disinfection process. Another solution under investigation involves moving the chlorination step to a point in time after much of the organic material has been removed through the other treatment stages (AWWA 1984).
Again, however, these technological alternatives pose their own countervailing risks. For example, prechlorination of low quality water is important to maintaining the efficacy of the other disinfection stages. This step is essential in removing algae and other growth from the treatment machinery and equipment and ensuring their optimum function and efficiency (White 1978). Without this step, the effectiveness of the disinfection process in preventing microbial diseases may be severely compromised.
5. What do most of the other existing water filtration systems do to remove toxins from the water supply?
Answer #5: The answer is variable depending upon which types of filtration is used ,e.g., reverse osmosis removes most chemicals, including organic, metals and pesticides but does nothing to remove microbes that may have breached the treatment system; membrane filters will hold back many microbes although viruses and Cryptosporidium oocysts, etc. will breach them. Toxins may be removed by activated carbon filters/GAC as well so that toxins from "red tide" algae, aflatoxin from Aspergillus flavus, etc are eliminated or reduced. None of these systems, to our knowledge uses a disinfectant (capable of killing all known microbes) followed by filtration to remove metals, organics, toxins, etc and still retains a residual disinfectant level to prevent re-contamination. In other words, they are incomplete.
Further, during the past fifteen years, giardiasis has been
recognized as one of the most frequently occurring waterborne diseases in
the United States. The most common sources of water contamination include
improperly treated municipal sewage, infected animals, and indiscriminate
defecation by outdoorsmen. Chlorine concentrations in the 0.1 mg per liter
to 0.5 mg per liter range are largely ineffective against Giardia at the
contact times commonly employed by municipal water utilities. The long-term solution to the problem of municipal waterborne outbreaks of giardiasis will involve appropriate pretreatment combined with improvements in and more widespread use of filters in the municipal water treatment process. While both micrometer- and submicrometer-rated filters are being employed on a limited scale for personal or household use, further evaluation of the efficacy of filters distributed by different manufacturers is needed to enable individuals and public health personnel to distinguish those that are safe and effective from those that are not.
6. What technology has Pure H20 Bio-Technologies developed to disinfect water and how does it actually work?
Answer #6. The current disinfectant most widely used in municipal water treatment systems is chlorine, a member of the chemical group called halogens, i.e., chlorine, bromine, fluorine, and iodine. Chlorine has been an effective detrant for numerous enteric bacteria and viruses for years and still provides adequate protection under most circumstances. However, there are newly emerging pathogenic organisms that are resistant to chlorine treatment and have breached state-of-the-art water treatment using chlorine or derivatives with other treatments, including filtration. Major examples are Cryptosporidium parvum and Giardia lamblia and other related parasites, as well as some powerful viruses, etc. Tetrasilver tetraoxide, activated by a chemical oxidizer has been tested as a disinfectant against organisms such as Cryptosporidium oocysts and Escherichia coli. The Cryptosporidium oocyst is a resistant form which contains the infectious sporozoites within a structure that is highly resistant to penetration by most chemical treatments, especially, the widely used halogens. Tetrasilver tetraoxide (silver TTO) is a molecular form of silver that exists as a crystal which contains both trivalent and monovalent silver (ordinary silver is an element whereas silverTTO is a molecular device, hence tetravalent). This semiconductor operates by transferring electrons from its 2 (two) monovalent silver ions to the two other trivalent ions throughout the liquid media in which it is immersed. When these ions come in contact with the pathogenic organism's cell membrane, it essentially "electrocutes" the pathogen in combination with other TTO molecules whose electron paths are within the same vicinity. Present evidence shows that TTO is not mutagenic (like halogen derivatives that are carcinogenic/mutagenic) so that mutant microbes will not emerge as a by-product of treatment, i.e., it only kills microbes.
The Pure H2O water purification delivery systems include the latest Silver TTO™ disinfection technology or ultra pure diatomic Iodine for limited use applications both designed to provide microbiologically pure and safe drinking water. Recent independent laboratory studies demonstrate the PRHB Silver TTO™ technology disinfection of resistant Cryptosporidium oocysts. Iodine in its chemical treatment of water has been proven to kill or deactivate certain types of disease causing water microorganisms, including bacterial and viral etiological agents.
Correct Mechanism for TTO according to M. S. Antelman is as follows:
The semi conduction silver tetraoxide crystal Ag4O4 is a device, which operates on a molecular scale. It transfers electrons from its two monovalent silver ions to the two other trivalent ions in the crystal throughout the aqueous media in which it is immersed. Within the media, electrons are conducted along a path which when coming in contact with a pathogen, contributes to it's death because the electrons traverse the cell membrane surface (CMS) and "electrocutes" the pathogen, not only by these electron, but others following the paths emanating from the other molecular devices within the vicinity. The device (TTO) is attracted to the CMS of the pathogen by powerful covalent bonding forces caused by the affinity of silver for elements such as sulfur and nitrogen in the CMS.
References for TTO mechanism:
M.S. Antelman. Silver (II, III) Disinfectants, Soap/Cosmetics/Chemical Specialties, March 1994, pp 52-59 .
M.S. Antelman. Anti-pathogenic Multivalent Silver Molecular Semiconductors, Precious Metals Institute, 1992 pp141-149.
· Products. Iodine and silver log10 pathogen reductions.
E. coli with iodine should be >6.0 log10 reduction of the population or a reduction of 6 logs Cryptosporidium with TTO should be >1.8 log10 reduction of a Cryptosporidium oocysts population.
Pure H2O Bio-Technologies, Inc. has designed these products to purify water at point-of-entry (POE) and point-of-use (POU) to remove: chlorine, lead and organic chemicals, chloramines, unpleasant tastes and odors. These reliable potable water systems combine the proven unique benefits of absolute GAC and absorption removal of offending contaminants with microbiological disease control and prevention.
7. What pathogens does the Pure H20 Bio-Technologies system remove from the water?
Answer #7. The system kills and removes pathogenic bacteria, viruses, protozoans, and fungi. In addition it removes other contaminants such as toxins, metals, organics, pesticides, and ultimately the disinfectant unless a low residual level is required. SilverTTO is a broad spectrum disinfectant, whereas iodine is effective as a bactericidal and viral disinfectant with properties similar to halogens such as chlorine and fluorine. However, halogens, including iodine, are ineffective against bacterial endospores and the cysts or oocysts of Giardia lamblia and Cryptosporidium parvum, respectively (which as well-known human pathogens).
Results
Our recent disinfection results against representative bacterial and eukaryotic parasitic agents indicate that the Pure H2O system is capable of killing enteric coliforms such as Escherichia coli and the oocysts of Cryptosporidium parvum. The use of silver TTOTM rather than a halogen, such as iodine or chlorine was found to greatly increase the efficacy of the system to include bacterial endospores as well as oocysts of Cryptosporidium. Tetrasilver tertraoxide, when previously registered by EPA for treatment of swimmimg pool water had been tested successfully against viral, fungal, and bacterial waterborne pathogens. Therefore, it was chosen as a superior disinfectant for the system. This disinfectant, Silver TTO™. was successfully integrated into a automated delivery system (patent pending) and upon rigorous testing was shown to kill Cryptosporidium oocysts and E. coli just effectively as had been demonstrated in preliminary bench-level tests conducted by the Clancy Enviormental testing laboratory
Acceptance
Underlying scientific principles of Silver water treatment are well established. Silver has been used since ancient times to treat drinking water and certain infectious diseases, such as infections in the eyes of newborne infants. Tetrasilver tetraoxide, which is a molecular form of silver has been proven to be many times more effacious than elemental silver.
Product
The Pure H20 Bio-Technology potable water disinfection system utilizes a non-heat reliant, power independent method known to kill Cryptosporidium, which has been found in municipal water supplies and recreational facilities. As a result, the PRHB system is designed with a technology combination of Silver TTO™ and absolute micron porosity GAC or similar final finish absorbent provide an additional level of protection for both residential and commercial / institutional applications.
8. How much time and money has gone into developing this technology? What kinds of testing and feasibility studies have been done on your system?
Answer #8. Years of testing and design have culminated in the initial PHBT delivery system design US Patent 7,250,111 which just issued on July 31, 2007. The Company raised approximately six million dollars to date. Testing has included protozoan oocysts (e.g. Cryptosporidium) for excystation and infectivity, Disinfection of Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis. Prior studies have also been performed on various other bacteria, viruses, algae and fungi for other applications of TTO and in addition toxicology data required by EPA for registration of TTO as a pesticide product.
9. What kinds of testing does your system need to go through in order to be approved by the government? What kinds of test results have you received so far?
Answer #9: A general plan for Certification by NSF on behalf of the US Environmental Protection Agency includes testing for efficacy against Rotavirus, Polio virus, Klebsiella, and Cryptosporidium and testing for purifier operations, materials evaluation and design and construction evaluation. Our results so far show that Cryptosporidium and various bacteria that are equally or more difficult to kill are killed by silverTTO and that bacterial species are killed by iodine. Other studies that were used to register TTO as a pesticide showed that TTO is not expected to have adverse effects in humans and that viruses, bacteria, algae and fungi are killed by oxygenated TTO. Further, it should be noted that the US EPA sets allowable contamination limits, defines standards, and develops testing protocols in conjunction with NSF. The Agency does not approve or recommend individual point-of-entry or point-of-use drinking water systems. Testing for these types of systems usually done by NSF under standard protocols.
10. Explain to understand each of the potential markets for your technology. First of all, why would hospitals be interested in your technology?
Answer #10. Hospitals require pure water that is free of microbes, toxins, various metals, organic materials, and pesticides because patients are very sensitive and in a compromised state. For example, AIDS patients, elderly patients, patients receiving chemotherapy or radiation therapy would be in grave danger from Cryptosporidium infection because in those individuals, the organism enters the respiratory system and is usually lethal (healthy individuals get severe diarrhea, cramps, dehydration, etc. which lasts for several weeks). Kidney dialysis patients cannot tolerate metals such as aluminum, mercury, or other things present in ordinary tap water disinfected with chlorine or other halogens. For personal households, everything from taste to toxic substances and the threat of pathogens would be an advantage in addition; following a natural disaster such as flood, hurricane, etc. or a "boil water" order, the system would provide safe and good-tasting water. The system is capable of taking water from a contaminated source and converting it to a potable/drinking water source. Further, the reduction of opportunistic infections in the care of compromised patients is at the center of infection control in all hospitals. The PHBT would provide another layer of protection for both patients and healthcare professionals.
11. What other kinds of health care facilities would be interested in your technology and how would it benefit them?
Answer #11. Extended care facilities and outpatients centers may also find the PHBT technology of particular value to its patients and staff. The answer is always the same, i.e., pure, safe, and good tasting water. Child Care Centers, Elder Care Centers, Clinics, Physician offices, Dental offices, etc.
12. How would you expect a hospital or health care facility to pay for their system--would they buy it or lease it?
Answer # 12. Both purchase and lease options are available depending on the type and size of system. The choice would depend on the financial resources of each client institution and their individual operating objectives.
13. How would a Pure H20 Bio-Technologies system help a hospital or health care facility save money?
Answer #13. Prevention of waterborne infections is the major benefit or damage due to substances in ordinary water that would cause harm to patients. Law suits for such things as these would be enough to shut down a hospital for negligence. One should keep in mind, what is the risk operating a healthcare facility without a PHBT water purification system. The reduction of water-borne nosocomial and opportunistic infections along with a reduction in the costs associated with infection control would potentially be the most important benefits of the PHBT technology.
14. Why would a multi-family residential complex want to install your system? Would it save them money? How would this work for a cruise ship?
Answer #14. To have better tasting and safe water, especially safer for very young children and infants. Also, in case of contamination with municipal water/boil water warning, etc., there would be drinkable/potable water. Also, cheaper and better than having to get bottled water and safer than water purifiers that do not disinfect or cannot take out chlorinate resistant microbes that breach the municipal water treatment. Cruise ships could use the PHBT technology in their closed system designs in concert with onboard monitoring of potable water supplies. A cruise ship would use this as a primary drinking water source or water used to wash vegetables and used for food preparation...many incidences of food or waterborne infections have recently occurred on cruise ships. Multi-family complexes could install PHBT systems at either the point of distribution in the facility or the point-of-use. There could be savings of scale in these applications while adding a level of protection for residential water supplies.
15. Why would an individual homeowner want to install your system and how would it complement a water purification system they already have in their house? Roughly how much would a system cost for a homeowner?
Answer #15. It would be used subsequent to tap water to remove toxic substances, chlorine, any microbes that breached the treatment system/distribution system prior to or at the point of use. It should replace an existing purifier system if there is redundancy exists. The costs of the disinfection delivery systems will vary according to the application, although affordable in the range of $850 for the 4,000 gallon capacity under-the-counter system up to $4,500 for the whole house system, plus installation. Further;
The EPA publication entitled “Water Healy Series – Filtration Facts,” September 2005 states that “Americans spend billions of dollars each year on home water treatment units. According to the Water Quality Association, more than four out of 10 Americans use home water treatment unit.”
Consumers of water continue to express concerns over their water quality in response to several driving factors: (1) a growing population and industrial concentration in urban areas which place increased demand on existing water treatment facilities, (2) reoccurring outbreaks of water-borne pathogens, and (3) the potential impact of water-borne parasites that are refractory to conventional chlorine water-treatment particularly to immune-compromised patient cohorts. The 1993 outbreak of Cryptosporidiosis in Milwaukee, WI and the 1998 outbreak of Coli form (E. coli) bacteria in Atlanta, GA are prime examples. In FY2004, the EPA estimated that were 159,796 public drinking water systems in the United States (Factoids: Drinking Water and Ground Water Statistics for 2004) and 9,099 of these systems reported violations of TCR/T (Total Coli form Rule/Turbidity) that affected an estimated 11,382,966 people.
As a result of the current unmet market needs, Pure H20 Bio-Technologies, Inc. (PHBT) intends to exploit its proprietary combination water purification systems which are designed with Silver TTO™ or soluble iodine disinfection agents and are used in combination with absolute 1-micron porosity activated-carbon filter elements. Both PHBT agents have been evaluated by independent U.S. environmental labs and demonstrate antimicrobial activity against E. coli, E. faecalis, and Pseudomonas indicator bacteria (iodine) and Cryptosporidium oocysts (Silver TTO™).
16. What kinds of commercial and industrial facilities would be interested in your system? How would it help them and would it help them save money?
Answer #16. Any commercial or industrial facility that processes food or provides bottled water. It would help them by ensuring water lacked harmful chemicals, pesticides, toxins, toxicants, toxic metals, or microbes. It would save them money by ensuring safety of their products and preventing accidental health problems that could lead to costly law suits, etc. The operators of commercial facilities and industrial facilities would be interested in protecting not only their valued employees and customers with PHBT technology, but they may also want to guard their sensitive parts and products against the deleterious effects of microbial contamination which could be found in process water.
17. What kinds of applications are there for your systems in the military? How does it improve on what the military already has and how would it help the military save money?
Answer #17. The military could use this system to provide safe drinking water at installations or in the field when provided with an electrical source such as a generator. The protection against intentional or even unintentional contamination by microbes or toxic chemicals would be provided. Money savings would result from waterborne disease prevention. Desalination and revere osmosis systems can be expensive to install and operate. It may be possible to design a system for base or forward operations that utilizes the PHBT water purification technology for additional protection against microbial contaminates as well as chemical contaminates.
18. How do you plan to market your systems to end users?
Answer #18. Potentially, customers can be reached through various marketing channels, i.e. hardware store networks, internet website, and residential home contractors and developers. Units could also be leased as another option unless client wishes to own units. Of course, services and supplies would be feasible.
19. What is the size of the potential market for Pure H20 Bio-Technologies systems?
Answer # 19. The market size would be large, based on Numbers of hospitals, nursing facilities, residential users, and commercial users that deal with providing clean water or food. In addition, the technology could expand to metropolitan water sources and very large foreign market including underdeveloped countries such as India, etc. The current potable water purification market can be divided into three segments: (A) residential point-of-use or point-of-entry involving pre-manufactured systems, (B) commercial/hospital segment involves custom designed and engineered systems, (C) municipal systems which are similar to commercial systems, however, they typically involve higher flow rates and capacities. Market entry will be facilitated by the completion of the Pure H20 Bio-Technologies system(s) certification by NSF and patent / trademark filings that support the Company’s intellectual property position on soluble iodine and Silver TTO™ disinfection technology. This will position the Pure H20 opportunity for entry into the residential, commercial, and municipal sectors.
The 2005 Frost & Sullivan Research Service report entitled “North American Residential Water Treatment Equipment Markets – Investment Analysis and Growth Opportunities” concludes that the North American market will reach $2.29 billion in revenues by 2011 based on a conservative Compounded Annual Growth Rate (CAGR) of 6.5%. In a 2004 Frost & Sullivan report, the market for point-of-entry (POE) equipment was the largest sector at $526.3 million (38.4%). The firm of Helmet Kaiser Consultancy (Tubingen, Germany) estimates in their study that the world market for domestic water treatment systems could reach nearly $6.0 billion by 2010 (Domestic Water Treatment systems Worldwide 2004-2006-2010-2015).
I hereby certify that I am the Chief Executive Officer of the Company and that all information provided herein, including any and all documents submitted herewith are true and accurate and contain no misleading information.
Joseph P. Doxey, Founder, President and CEO
Pure H20 Bio-Technologies, Inc.
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Pure H20 Bio-technologies VIDEO : http://pureh20biotech.com/e107_plugins/autogallery/autogallery.php?show=Video
Pure H20 News: 10-22-2008 Yahoo News / PR
Pure H2O Bio-Technologies, Inc. Announces Pre-Certification Testing Results for Integrated Hospital Potable Water Disinfection System
LINK: http://biz.yahoo.com/bw/081022/20081022005135.html?.v=1
For more information about SilverTTOTM please visit the newly updated website for Pure H2O Bio-Technologies, Inc. at www.pureh20biotech.com.
Research and Development:
Dr. Cecil Felkner is Director of Research and Development, as well as Advisor and Consultant to Pure H2O Bio-Technologies, on waterborne pathogens and pollutants and disinfectant treatment technologies. Dr. Felkner is an experienced risk assessor/analyzer and has analyzed the potential for adverse health effects due to both chemical and biological materials.
Dr. Felkner holds a Ph.D. in Microbiology with a minor in Biochemistry, an M.A. in Bacteriology with a minor in Genetics and Biochemistry, and his B.A. in Zoology with a minor in Chemistry from the University of Texas. He has 47 years of research, teaching, and consulting experience in the fields of genetics, microbiology, toxicology, and oncology.
His principal research activities have related to rapid screening of environmental mutagens, genetic toxicology, microbial genetics, and carcinogenesis. He has held security clearances for the Department of Energy (Q-clearance), Department of Defense (Secret and Top Secret), and for the Environmental Protection Agency (Covering Confidential/Proprietary Information). For the EPA's Office of Water, he served as Technical Director and Principal Scientist on the "Comparative Health Effects Assessment of Drinking Water Treatment Technologies: Report to Congress," a document that includes comparative risks due to toxic chemicals and their by-products and the risk of infection due to pathogenic biological species. He was the lead toxicologist for the DOD involving the Gulf War potential exposures to various nerve agents.
Investment Opportunity:
Pure H2O Bio-Technologies Inc. is seeking additional financing in the form of debt/equity financing for working capital purposes in order to achieve its business plan objectives for the calendar year of 2008 and beyond. We would like to present this opportunity to the professional investment community to capitalize on a great opportunity in the world wide demand for safe, clean, disinfected water markets.
PRHB (PK)
Executive Offices: 370 West Camino Gardens Blvd., Suite 332, Boca Raton, FL 33432
Fiscal Year End: 12/31
State of Inc: FLA
Employees: 3 (7/01/2009)
Consultants: 7 (7/01/2009)
Shareholders: Approximately 2,400 (7/21/2009)
Float: 500 M (7/15/2009)
Avg. Volume: 267 M (90-Day)
Shares Outstanding: 1.5 B (7/15/2009)
Shares Authorized: 50 B (7/21/2009)
52 Wk High: $.51 (3/28/2008)
52 Wk Low: $.0001 (10/01/2009)
Market Size: 15.44 Billion
Projected Sales: FY1 $6 Million FY2 $14 Million FY3 $57 Million
Officers and Directors:
Joseph P. Doxey, Chairman, President, and CEO
Dennis P. Boudreaux, P.E., COO
C. Eric Jones, Ph.D., Executive Vice President and Director
Auditor: Eric Filkins, CPA, PA FL
Transfer Agent : Continental Stock Transfer and Trust Co. Inc. N.Y., N.Y.
Legal: The Sourlis Law Firm, Virgina K. Sourlis, ESQ, MBA, Red Bank, N.J.
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Model 7000 Hospital Water Purification Unit
The Model 7000 Hospital Water Disinfection Unit incorporates the leading Silver TTOTM disinfection with carbon filtration purification technology for applications in healthcare.
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The Pure H20 Bio-Technology potable water disinfection system utilizes a non-heat reliant, power independent method known to kill Cryptosporidium, which has been found in municipal water supplies and recreational facilities. As a result, the PRHB systems are designed with a technology combination of elemental Iodine, Silver TTOTM and absolute micron porosity GAC or similar final finish absorbent provide an additional level of protection for both residential and commercial / institutional applications. Pure H20 Bio-Technologies has refined the traditional potable water purification processes by utilizing elemental iodine and Silver TTOTM disinfection systems, thereby achieving a purity unequalled in the water purification and bottled water markets. The Company offers four different structural point-of-entry (POE) & point-of-use (POU) disinfection / purification systems designed to meet various market and client preferences.
Products:
Models PRHB 75 Over-the-Counter System: Dimensions: Two 15" x 20" Fiberglass Cabinets, includes Three 10" High
Filter Housings, 19" x 9" (3) Gallon Storage Tank, 4,000 gallon capacity, flow rate: 1 GPM (gallon per minute), calibration flow meter with visual total gallon usage.
PRHB 3000 Residential and Commercial System: Dimensions: 23" x 32" All Stainless Steel Cabinet, includes
Three 10" High Filter Housings, 19" x 9" (3) Gallon Storage Tank, 4,000 gallon capacity, flow rate: 1 GPM, calibration flow meter with visual total gallon usage, casters for easy mobility.
PRHB 4000 Residential and Commercial System: Dimensions: 32" x 32" All Stainless Steel Cabinet, includes
Three 10" High Filter Housings, 19" x 9" (3) Gallon Storage Tank, 4,000 gallon capacity, flow rate 1 GPM, calibration flow meter with visual total gallon usage, casters for easy mobility.
PRHB 7000 Hospital and Medical System: Dimensions: 26" x 38" All Stainless Steel Cabinet, includes Three 20"
High Filter Housings, 19" x 19" (3) Gallon Storage Tank, 9,000 gallon capacity, flow rate: 1 GPM, turbine flow meter with visual LED status indicator, casters for easy mobility.
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Management Team:
Founder of Pure H20 Bio-Technologies, Inc. was senior partner with Joseph P. Doxey & Associates, a financial consulting firm specializing in risk capital financing of high-tech, real estate and medical companies. He was manager of special projects with Palm Beach Associates & Consultant Group, a financial, consultant an international corporate finance company. He was named Who’s Who in Executive & Professionals, edition 2000-2001.
Dennis P. Boudreaux, P.E., Director / COO
Mr. Boudreaux serves as Lead Engineer for product implementation for the Florida division. Previously, he directed, supervised and managed over 50 Remedial Action Plan Implementation involving air stripping, soil vapor, insitubioremediation and thermal incineration. Formerly, President and General Manager of Oil Center Machine, Inc.
Dr. Cecil Felkner: Director of Research and Development
Dr. Felkner also is Advisor and Consultant to Pure H2O Bio-Technologies on waterborne pathogens and pollutants and disinfectant treatment technologies. Dr. Felkner is an experienced risk assessor/analyzer and has analyzed the potential for adverse health effects due to both chemical and biological materials.
Todd D. Stong PH. D.: Consulting Engineer
Dr. Stong, a West Point Graduate., was previously with Atomic Demolition’s Assembly / Installation Platoon Leader (Korea), Detachment Commander - Vietnamese city water plant construction. Technical Director, USArmy Strategic Defense Command. Assistant Professor, Graduate Business Education, Alexandria, Virginia. He received his Ph.D., Civil Engineering from the University of New Mexico.
Edward C. West, P.E.: Engineering Consultant
Colonel West is a West Point graduate. Director, Engineering and Construction Enerprise / Homestead Planning. Senior V.P., MP Faciliatators. President, Agripost, Inc. MS Civil Engineering, MIT Cambridge, MA. MBA George Washington University, Washington, D.C.
C. Eric Jones PH.D.: Director
Dr. Jones is responsible for corporate communications and planning. Previously, employed with Oak Ridge National Laboratory-Cancer Reseach Division.
Industry Classification: Bio-Technology
Pure H2O Bio-Technologies, Inc. (Pink Sheets:PRHB) has developed a unique approach to drinking water treatment, which addresses metal, pesticide, toxic chemical and pathogenic microbe water contamination. Using a team of experts on pathogenic microorganisms, toxic chemicals, and water purification engineering, the system has now completed the last stages of development and is now ready for final certification. The Company's disinfectant system has proven to kill those microorganisms that can breach state-of-the-art municipal water treatment and then removes heavy metals, pesticides and other contaminating substances. The SilverTTOTM disinfectant yields pure water that is safe enough for even the most sensitive individuals. This treatment is designed to protect even those individuals with weakened immune systems, those requiring metal-free water for kidney dialysis, and especially unable to fight infections from threat organisms such as Cryptosporidium or E. coli.
Manufacturing Location: 4251 Pat Colwell Road Blairsville, GA 30512
Country: USA
Pure H20 BioTechnologies, Inc . (“Pure H20” or “The Company”) is a publicly held company (Symbol “PRHB” Pink Sheets) specializing in product development, manufacturing, design and sale of its unique residential, commercial and hospital point-of-use potable water disinfection systems. These systems are specifically designed to work effectively against water-borne pathogens and remove heavy metals and objectionable biomasses. The Company utilizes the technological advances in micro-biotechnology to improve the safety of drinking water. Pure H20 has systematically and successfully addressed lead and other chemical and toxicological contamination, as well as waterborne diseases.
Patents:
On July 31, 2007, the Company received U.S. Patent Number 7,250,111 from the United States Patent and Trademark office, Washington, D.C. for the Company’s invention entitled, “Potable Water Delivery System with Disinfection and Residual Discharge Unit and Method.” Pure H20 Bio-Technologies, has two other patents pending in the area of microbiology and in the area of product engineering design.
Manufacturing:
The Company is currently relocationg its operations and has completed Phase I and II of its new single steel arch manufacturing facility located in Blairsville, Georgia.
Market Demand:
There is an enormous market opportunity for products that offer a combination of drinking water purification with advanced technology effectively disinfecting water from prokaryotic and eukaryotic microorganisms, neutralizing organic compounds, and removing undesirable particulates over a range of complex water constituents.
Testing Laboratories:
Clancy Environmental Consultants, St. Albans, VT
US BioSystems, a/k/a, Genapure, Florida Atlantic University Research Development Park, Boca Raton, FL
On July 15,2008, pre-certification tests were confirmed by Clancy Environmental and US BioSystems that Pure H2O’s potable water disinfection system achieved kill rates of 8 log and higher against a number of representative bacterial pathogens. Pure H2O has developed a well- defined strategy to implement its business model.
Summary:
All of this development has been made possible because of the experience and expertise of the company's management team, supported by a top-flight testing laboratory whose expertise includes in-depth experience with pathogenic microorganisms that are emerging threats to safe drinking water.
The team director, Dr. Cecil Felkner is a microbiologist, biochemist and toxicologist with considerable knowledge and hands-on experience with water treatment and monitoring solutions to problems in addition to development of patents (approved and pending) relevant to the drinking water industry. He served as principal writer/editor for the US EPA Office of Water Report to Congress for Drinking Water Treatment Technologies and was Project Manager/Lead writer for EPA office of Science & Technology/Health and Ecological Criteria Division for Water and Wastewater. The latter project included producing documents for upgrading and developing Criteria Documents on Cryptosporidium and newly emerging waterborne viruses. For the American Waterworks Association Research Foundation (AWWARF) he was co-principal investigator on a project, "Evaluation of a Real-time Online Monitoring Method for Cryptosporidium", AWWARF, Denver, CO, 2004. This online/rapid water monitoring system for microbes utilized basic and applied research that he and a physicist had co-developed. He also was Advisor/Consultant to the Water environment Research Foundation (WERF, 2006) Exploratory Team involving those risks attributed to waterborne pathogens and toxicants.
The laboratory of Clancy Environmental Consultants (CEC) performed the testing for disinfectant efficacy on organisms including Cryptosporidium (oocysts), Escherichia coli, Enterococcus faecalis and, Pseudomonas aeruginosa. The choice of this laboratory was because it has provided significant support to the US Environmental Protection Agency, AWWA and various other federal and private entities in the drinking water industry. The president of CEC was co-author of a major review article for AWWA entitled "The Evolution of Microbiology in the Drinking Water Industry", P. Rochelle and J. Clancy, J.AWWA, March, 2006.
Professional Engineers, led by Dennis P. Boudreaux, P.E. and COO and Joseph P. Doxey, CEO, developed the unique water purification units that purify water at the point-of-entry (POE) and point-of-use (POU) to remove the disinfectant, chlorine, lead, organic chemicals, biomass, chloramines, unpleasant tastes, and odors. In conjunction with granulated activated carbon filtration, the final product, i.e., pure and healthy water is released for the consumer. Potential uses include, but are not limited to water treatment for the home (under the counter), medical/hospital water, well water, multiple residential complexes, and some industrial processes requiring ultra-pure water.
Although there are other water purification systems available, which employ filtration and can remove organics, metals, etc., this system both kills the waterborne pathogens and removes virtually all water contaminants so that the only thing the consumer gets is pure and healthy water.
CEO and President of PRHB, Joseph P. Doxey reported, "We are excited about the drinking water system that we have been able to develop because it has the potential to provide an additional layer of health protection to many individuals who could otherwise be at high risk to disease and even death."
Silver TTOTM and Iodine Technology:
The Pure H20 water purification systems include the latest Silver TTOTM disinfection technology or ultra pure elemental Iodine for limited use applications both designed to provide microbiologically pure and safe drinking water. Pure H20 Bio -Technologies, Inc. has designed these products to purify water at point-of-entry (POE) and point-of-use (POU) to remove: chlorine, lead and organic chemicals, chloramines, unpleasant tastes and odors. These reliable potable water systems combine the proven unique benefits of absolute GAC and absorption removal of offending contaminants with microbiological disease control and prevention.
