NNLX Strategic Positioning
I wanted to highlight what I consider some of the most important points from several sources that indicate quite clearly the Company is moving along well. The sources include NanoLogix’s recent Press Release but I have added a little analysis to some of the points as well as noted a few additional opportunities for significant gains for NanoLogix, its technology and its investors. Taken together they build a strong case for significant progress. I am just going to “mix and match” below and will begin by “bulleting” the most important.
• UNITAID, based in Geneva, Switzerland and hosted by the World Health Organization (WHO), on Friday published their Tuberculosis diagnostics technology and market landscape – 3rd edition. NanoLogix's sandwiched-membrane BNP rapid testing technology for tuberculosis is cited [favorably] on pages 17 and 37 of the report.
• “UNITAID is a global health initiative in great part financed by a solidarity levy on airline tickets. Established in 2006 by the governments of Brazil, Chile, France, Norway and the United Kingdom, it provides sustainable funding in order to tackle inefficiencies in markets for medicines, diagnostics and prevention for HIV/AIDS, Malaria and Tuberculosis in developing countries.”
• This is the second year that NanoLogix has been mentioned in the UNITAID annual report. This means the global medical community is aware of the Company’s technology and that once proved “in the field” it is likely to have strong supporters in that community. The combination of the long life and extreme durability of the NNLX tech fit perfectly into the needs of the medical contexts with which the WHO and its affiliates are most intensely interested.
• NanoLogix anticipates having their BNP technology included in TB studies in Africa and Australia in 2015. These actions are critical to achieving the support of WHO and other UN-type organizations focused on providing services in areas that do not have ready access to Western-type high tech medical care and facilities.
• NanoLogix's TB detection technology is well suited to the needs of medical personnel in remote areas, with rapid detection of TB bacteria in as little as 5 days available in a kit with extended shelf life and robust packaging. The capabilities of the NNLX technology actually are considerably beyond this as the Battelle research demonstrates. There is nothing even close on the most relevant parameters related to point-of-treatment and diagnosis in the conditions found in most countries representing the bulk of the world’s population. The sensitivity, speed and durability under arduous conditions of the kind existing in many of the WHO situations puts the NanoLogix diagnostic kit ahead of all others.
• The BNP technology is patent pending in the United States, China, India and Brazil and has received patents in Japan and Russia in 2014 and notice of allowance of patent in the European Union in 2014, with the EU patent issuance expected in October 2014.
• NanoLogix is also pleased to announce that they have received a purchase order from The Ohio State University for provision of laboratory supplies to at least two departments on the Columbus campus. The purchase order term runs from 9/17/14 through 6/30/15. NanoLogix made their first delivery of product on 25 September.
• The Ohio State University joins the growing list of educational institutions ordering NanoLogix products. These include the University of Colorado-Boulder, Massachusetts Institute of Technology (MA), Worcester Polytechnic Institute (MA), and Cardiff University, (Wales, UK). The Company anticipates many more to come.
• NanoLogix has sold product to Abbott Labs,
• To personal care companies,
• To food processing companies,
• To soil testing companies,
• To the US EPA, as well as
• To other purchasers who currently cannot be named due to contractual agreements.
• The diversity of the listed purchasers represented in the list immediately above demonstrates the great potential of the NNLX technology in a range of important niche markets. The ability to design a durable packaged diagnostic kit for the specific needs of a particular type of end-user opens up an entirely new marketing strategy in which a user can trust that they have a rapid, non-degraded and accurate diagnostic tool at hand. This allows the preventive testing of the users’ unique products and processes by use of a reliable and high quality kit.
BARDA
• NanoLogix executives are scheduled to meet with BARDA—the Biomedical Advanced Research and Development Authority of the United States government.
• “The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.”
• BARDA is under the authority of the U.S. Department of Health and Human Services (HHS) in the Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes the includes the Division of CBRN Countermeasures.
• The “Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures (MCMs) develops and procures the CBRN MCMs required by the U.S. Department of Health and Human Services (HHS) to mitigate the adverse health effects arising from public health emergencies. CBRN accomplishes this by supporting advanced research and development of MCMs against CBRN threats and establishing stockpiles of vaccines, drugs and diagnostics against these threats. Ultimately, these medical countermeasures are used to help the Nation prepare to respond to and recover from public health emergencies.
• Leading Medical Countermeasures Advanced Research and Development. The Pandemic All-Hazards Preparedness Act (PAHPA) of 2006 established BARDA as the lead agency in HHS for MCM development. This legislation provided BARDA with authorities and funding that enable more flexible contracting to support advanced research and development of MCMs.
• The Division of CBRN MCMs uses the authorities granted under PAHPA to enhance the overall MCM portfolio of CBRN candidate products and is now managing a portfolio of over 60 contracts and grants for the development of these countermeasures. The CBRN investments include funding for the advanced research and development of anthrax vaccines and therapeutics; smallpox vaccines and antivirals; broad spectrum antimicrobials; biodosimetry/diagnostics; radiological/nuclear countermeasures; and countermeasures to a variety of chemical threats.
• As part of a comprehensive strategy, the CBRN division is not only developing pipelines of products for each of these health threat but has also begun support for multi-use MCMs that may be used for a variety of other health threats (e.g. community acquired pneumonia) while providing a source of effective countermeasures in the event of a public health emergency response.
• Stockpiling Lifesaving MCMs. The Division of CBRN MCMs is responsible for developing and establishing stockpiles of lifesaving vaccines, drugs, and diagnostics against CBRN threats.”
The New $900,000,000, the N-Assay, and a $20 million Prize Competition
As indicated below, a just-released report to the President and the President’s endorsement of a $900,000,000 program to attack the serious problem of rapidly increasing antibiotic resistance involving bacterial infections such as MRSA and others of the kind for which NanoLogix and the research team of Sebastian and Jonathan Faro opens up additional extremely important opportunities for NanoLogix. If you take the time to review the analysis of Dr. Sebastian Faro’s BioOhio presentation I posted weeks ago (link at top of message board) and watch the presentation through the link on the NanoLogix website you will understand that the N-Assay technology is perfectly suited to respond to the Presidential initiative. The announced program also includes a competition for a $20,000,000 prize for the most effective technology. I would anticipate that a collaborative effort on the part of NanoLogix, the Battelle Institute and the Faro’s based on use and adaptation of the N-Assay panel would be a leading competitor for such a prize. As Dr. Faro indicated the system already is effective for rapid detection of MRSA and other infectious bacteria. This looks like a perfect opportunity for NanoLogix to team up with highly respected researchers who are also quite well-connected with US governmental agencies and their processes.
• Report to the President on Combating Antibiotic Resistance
www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_carb_report_sept2014.pdf
• From the Wall Street Journal, Obama Orders Plan Against Antibiotic Resistance, Sept. 18, 2014. “The White House unveiled new measures on Thursday to try to preserve the effectiveness of infection-fighting drugs as strains of bacteria become increasingly resistant to the existing arsenal of antibiotics.” WSJ
• “The moves signal a growing concern over drug-resistant infections, which are linked to two million illnesses and 23,000 deaths in the U.S. each year, according to the Centers for Disease Control and Prevention. Some infections are almost entirely untreatable because the appropriate antibiotics have been rendered powerless.” WSJ
• “The new national strategy announced Thursday calls for specific steps to prevent the spread of the drug-resistant bacteria and to accelerate the research and development of new antibiotics by 2020.” WSJ
• “The rollout of the measures coincides with the release of a report by PCAST that reiterates that bacteria are growing resistant to antibiotics in large part because the drugs are being used too frequently in humans and also perhaps in animals raised for food. As much as 50% of all antibiotics prescribed for U.S. patients are either unnecessary or not optimally prescribed, according to the CDC. "This brewing problem has become a crisis," the PCAST report warns. The report calls for the government to spend $900 million to track and research antibiotic resistance and to promote the appropriate use of existing drugs, among other initiatives.” WSJ
Tuberculosis Threats in the US
• “The official visa application process administered by the U.S. Department of State for legal immigrants contains a thorough medical screening process. The Immigration and Nationality Act created medical eligibility requirements that include a review of an applicant's medical history, a physical exam, chest x-ray and blood test. Applicants must admit to and show treatment for conditions such as tuberculosis, mental illness and drug abuse as well as prove they are vaccinated for multiple diseases including mumps and polio. An inability to do so jeopardizes an application and legal entry into the United States.”1
• One perhaps legitimately fearful on-line report warns: “The hordes of illegal immigrant minors entering the U.S. are bringing serious diseases—including swine flu, dengue fever, possibly Ebola virus and tuberculosis—that present a danger to the American public as well as the Border Patrol agents forced to care for the kids, according to a U.S. Congressman who is also medical doctor.”
• “This has created a “severe and dangerous” crisis, says the Georgia lawmaker, Phil Gingrey. Most of the Unaccompanied Alien Children (UAC) are coming from Central America and they’re importing infectious diseases considered to be largely eradicated in this country. Additionally, many of the migrants lack basic vaccinations such as those to prevent chicken pox or measles, leaving America’s young children and the elderly particularly susceptible, Gingrey reveals.” July 8, 2014.
• Sept. 2, 2014. “Federal law subjects legal immigrants to a medical screening process (and even has health safety rules covering the importation of animals). These rules are not being applied to illegal immigrant children.
• The federal government is, largely clandestinely, sending these children to various U.S. locations and ordering local school districts to allow them to enroll in the public schools.
• Project 21 members note any health impact resulting from these federal policies will have a disparate health impact on black children, who are disproportionately likely to attend public schools and also disproportionately likely to live in the public school districts to which the federal government is sending the illegal aliens.”
• A July 30 memo to Homeland Security Secretary Jeh Johnson from DHS Inspector General John Roth about the oversight of "unaccompanied alien children" and children traveling with families found that "[m]any UAC and family units require treatment for communicable diseases, including respiratory illnesses, tuberculosis, chicken pox and scabies."2 The report further notes that Border Patrol agents at the Del Rio, Texas facility said they contracted scabies, lice and chicken pox, with at least two officers reporting their children also contracted chicken pox. Agents at other facilities reported exposure to tuberculosis.3 “
I wanted to highlight what I consider some of the most important points from several sources that indicate quite clearly the Company is moving along well. The sources include NanoLogix’s recent Press Release but I have added a little analysis to some of the points as well as noted a few additional opportunities for significant gains for NanoLogix, its technology and its investors. Taken together they build a strong case for significant progress. I am just going to “mix and match” below and will begin by “bulleting” the most important.
• UNITAID, based in Geneva, Switzerland and hosted by the World Health Organization (WHO), on Friday published their Tuberculosis diagnostics technology and market landscape – 3rd edition. NanoLogix's sandwiched-membrane BNP rapid testing technology for tuberculosis is cited [favorably] on pages 17 and 37 of the report.
• “UNITAID is a global health initiative in great part financed by a solidarity levy on airline tickets. Established in 2006 by the governments of Brazil, Chile, France, Norway and the United Kingdom, it provides sustainable funding in order to tackle inefficiencies in markets for medicines, diagnostics and prevention for HIV/AIDS, Malaria and Tuberculosis in developing countries.”
• This is the second year that NanoLogix has been mentioned in the UNITAID annual report. This means the global medical community is aware of the Company’s technology and that once proved “in the field” it is likely to have strong supporters in that community. The combination of the long life and extreme durability of the NNLX tech fit perfectly into the needs of the medical contexts with which the WHO and its affiliates are most intensely interested.
• NanoLogix anticipates having their BNP technology included in TB studies in Africa and Australia in 2015. These actions are critical to achieving the support of WHO and other UN-type organizations focused on providing services in areas that do not have ready access to Western-type high tech medical care and facilities.
• NanoLogix's TB detection technology is well suited to the needs of medical personnel in remote areas, with rapid detection of TB bacteria in as little as 5 days available in a kit with extended shelf life and robust packaging. The capabilities of the NNLX technology actually are considerably beyond this as the Battelle research demonstrates. There is nothing even close on the most relevant parameters related to point-of-treatment and diagnosis in the conditions found in most countries representing the bulk of the world’s population. The sensitivity, speed and durability under arduous conditions of the kind existing in many of the WHO situations puts the NanoLogix diagnostic kit ahead of all others.
• The BNP technology is patent pending in the United States, China, India and Brazil and has received patents in Japan and Russia in 2014 and notice of allowance of patent in the European Union in 2014, with the EU patent issuance expected in October 2014.
• NanoLogix is also pleased to announce that they have received a purchase order from The Ohio State University for provision of laboratory supplies to at least two departments on the Columbus campus. The purchase order term runs from 9/17/14 through 6/30/15. NanoLogix made their first delivery of product on 25 September.
• The Ohio State University joins the growing list of educational institutions ordering NanoLogix products. These include the University of Colorado-Boulder, Massachusetts Institute of Technology (MA), Worcester Polytechnic Institute (MA), and Cardiff University, (Wales, UK). The Company anticipates many more to come.
• NanoLogix has sold product to Abbott Labs,
• To personal care companies,
• To food processing companies,
• To soil testing companies,
• To the US EPA, as well as
• To other purchasers who currently cannot be named due to contractual agreements.
• The diversity of the listed purchasers represented in the list immediately above demonstrates the great potential of the NNLX technology in a range of important niche markets. The ability to design a durable packaged diagnostic kit for the specific needs of a particular type of end-user opens up an entirely new marketing strategy in which a user can trust that they have a rapid, non-degraded and accurate diagnostic tool at hand. This allows the preventive testing of the users’ unique products and processes by use of a reliable and high quality kit.
BARDA
• NanoLogix executives are scheduled to meet with BARDA—the Biomedical Advanced Research and Development Authority of the United States government.
• “The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.”
• BARDA is under the authority of the U.S. Department of Health and Human Services (HHS) in the Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes the includes the Division of CBRN Countermeasures.
• The “Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures (MCMs) develops and procures the CBRN MCMs required by the U.S. Department of Health and Human Services (HHS) to mitigate the adverse health effects arising from public health emergencies. CBRN accomplishes this by supporting advanced research and development of MCMs against CBRN threats and establishing stockpiles of vaccines, drugs and diagnostics against these threats. Ultimately, these medical countermeasures are used to help the Nation prepare to respond to and recover from public health emergencies.
• Leading Medical Countermeasures Advanced Research and Development. The Pandemic All-Hazards Preparedness Act (PAHPA) of 2006 established BARDA as the lead agency in HHS for MCM development. This legislation provided BARDA with authorities and funding that enable more flexible contracting to support advanced research and development of MCMs.
• The Division of CBRN MCMs uses the authorities granted under PAHPA to enhance the overall MCM portfolio of CBRN candidate products and is now managing a portfolio of over 60 contracts and grants for the development of these countermeasures. The CBRN investments include funding for the advanced research and development of anthrax vaccines and therapeutics; smallpox vaccines and antivirals; broad spectrum antimicrobials; biodosimetry/diagnostics; radiological/nuclear countermeasures; and countermeasures to a variety of chemical threats.
• As part of a comprehensive strategy, the CBRN division is not only developing pipelines of products for each of these health threat but has also begun support for multi-use MCMs that may be used for a variety of other health threats (e.g. community acquired pneumonia) while providing a source of effective countermeasures in the event of a public health emergency response.
• Stockpiling Lifesaving MCMs. The Division of CBRN MCMs is responsible for developing and establishing stockpiles of lifesaving vaccines, drugs, and diagnostics against CBRN threats.”
The New $900,000,000, the N-Assay, and a $20 million Prize Competition
As indicated below, a just-released report to the President and the President’s endorsement of a $900,000,000 program to attack the serious problem of rapidly increasing antibiotic resistance involving bacterial infections such as MRSA and others of the kind for which NanoLogix and the research team of Sebastian and Jonathan Faro opens up additional extremely important opportunities for NanoLogix. If you take the time to review the analysis of Dr. Sebastian Faro’s BioOhio presentation I posted weeks ago (link at top of message board) and watch the presentation through the link on the NanoLogix website you will understand that the N-Assay technology is perfectly suited to respond to the Presidential initiative. The announced program also includes a competition for a $20,000,000 prize for the most effective technology. I would anticipate that a collaborative effort on the part of NanoLogix, the Battelle Institute and the Faro’s based on use and adaptation of the N-Assay panel would be a leading competitor for such a prize. As Dr. Faro indicated the system already is effective for rapid detection of MRSA and other infectious bacteria. This looks like a perfect opportunity for NanoLogix to team up with highly respected researchers who are also quite well-connected with US governmental agencies and their processes.
• Report to the President on Combating Antibiotic Resistance
www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_carb_report_sept2014.pdf
• From the Wall Street Journal, Obama Orders Plan Against Antibiotic Resistance, Sept. 18, 2014. “The White House unveiled new measures on Thursday to try to preserve the effectiveness of infection-fighting drugs as strains of bacteria become increasingly resistant to the existing arsenal of antibiotics.” WSJ
• “The moves signal a growing concern over drug-resistant infections, which are linked to two million illnesses and 23,000 deaths in the U.S. each year, according to the Centers for Disease Control and Prevention. Some infections are almost entirely untreatable because the appropriate antibiotics have been rendered powerless.” WSJ
• “The new national strategy announced Thursday calls for specific steps to prevent the spread of the drug-resistant bacteria and to accelerate the research and development of new antibiotics by 2020.” WSJ
• “The rollout of the measures coincides with the release of a report by PCAST that reiterates that bacteria are growing resistant to antibiotics in large part because the drugs are being used too frequently in humans and also perhaps in animals raised for food. As much as 50% of all antibiotics prescribed for U.S. patients are either unnecessary or not optimally prescribed, according to the CDC. "This brewing problem has become a crisis," the PCAST report warns. The report calls for the government to spend $900 million to track and research antibiotic resistance and to promote the appropriate use of existing drugs, among other initiatives.” WSJ
Tuberculosis Threats in the US
• “The official visa application process administered by the U.S. Department of State for legal immigrants contains a thorough medical screening process. The Immigration and Nationality Act created medical eligibility requirements that include a review of an applicant's medical history, a physical exam, chest x-ray and blood test. Applicants must admit to and show treatment for conditions such as tuberculosis, mental illness and drug abuse as well as prove they are vaccinated for multiple diseases including mumps and polio. An inability to do so jeopardizes an application and legal entry into the United States.”1
• One perhaps legitimately fearful on-line report warns: “The hordes of illegal immigrant minors entering the U.S. are bringing serious diseases—including swine flu, dengue fever, possibly Ebola virus and tuberculosis—that present a danger to the American public as well as the Border Patrol agents forced to care for the kids, according to a U.S. Congressman who is also medical doctor.”
• “This has created a “severe and dangerous” crisis, says the Georgia lawmaker, Phil Gingrey. Most of the Unaccompanied Alien Children (UAC) are coming from Central America and they’re importing infectious diseases considered to be largely eradicated in this country. Additionally, many of the migrants lack basic vaccinations such as those to prevent chicken pox or measles, leaving America’s young children and the elderly particularly susceptible, Gingrey reveals.” July 8, 2014.
• Sept. 2, 2014. “Federal law subjects legal immigrants to a medical screening process (and even has health safety rules covering the importation of animals). These rules are not being applied to illegal immigrant children.
• The federal government is, largely clandestinely, sending these children to various U.S. locations and ordering local school districts to allow them to enroll in the public schools.
• Project 21 members note any health impact resulting from these federal policies will have a disparate health impact on black children, who are disproportionately likely to attend public schools and also disproportionately likely to live in the public school districts to which the federal government is sending the illegal aliens.”
• A July 30 memo to Homeland Security Secretary Jeh Johnson from DHS Inspector General John Roth about the oversight of "unaccompanied alien children" and children traveling with families found that "[m]any UAC and family units require treatment for communicable diseases, including respiratory illnesses, tuberculosis, chicken pox and scabies."2 The report further notes that Border Patrol agents at the Del Rio, Texas facility said they contracted scabies, lice and chicken pox, with at least two officers reporting their children also contracted chicken pox. Agents at other facilities reported exposure to tuberculosis.3 “
