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One more thing with regard to the patent. Once the issue fee is paid, they should be given an actual patent number at which point I would expect a PR with those details (and hopefully more).
Go to the uspto pair site and search application 14256694
Saudi Arabia FRA approval
NanoLogix is very pleased to announce that today we have been informed by Faisal Alharthi, CEO of the Nasaem AlJazira Co., that the Saudi Arabia FDA (SFDA) has approved our products for import to and use in The Kingdom of Saudi Arabia. This approval came after many months of extensive testing of our products in Saudi Arabia and diligent pursuit of the approval by the Nasaem AlJazira Co. The process required a large expenditure on the part of the Nasaem AlJazira Co., multiple trips to the United States, and multiple trips by NanoLogix management to Washington DC for required approvals from the US Department of State and the Embassy of the Kingdom of Saudi Arabia.
I would think they will wait until the issue fee has been paid and a patent number has been applied. Most companies do this so that thy can say "patent #Xxxxxxx has been issued..." And to make sure everything goes smoothly until then.
I made a breakdown of all the different EL plates listed for sale on the website. On many of them I have added to the description of the plates as provided by Nanologix to better describe their uses or limitations. I am hoping this will be useful to some who see it.
Tryptic Soy Agar
Application: For the isolation and cultivation of a variety of fastidious and non-fastidious microorganisms. TSA is also used for total plate counts and for maintaining stock cultures.
Red Blood Agar
Application: For the isolation and cultivation of a variety of fastidious microorganisms, to detect hemolytic activity, and to perform CAMP tests (identification of Group B ß-streptococci).
Nematode Growth Media
Application: For use in cultivating Nematodes. In particular Caenorhabditis elegans.
Currently an international consortium of laboratories are collaborating on a project to sequence the entire 100,000,000 bases of DNA of the C. elegans genome.
Chocolate Agar
Application: For the isolation and cultivation of fastidious microorganisms, primarily Neisseria (e.g. N. meningitidis and N. gonorrhoeae) species from clinical samples.
LB Lennox Agar
Application: For the growth of recombinant Escherichia coli, and for culturing enteric bacteria and facultative organisms.
LB Miller Agar
Application: For the growth of recombinant Escherichia coli, and for culturing enteric bacteria and facultative organisms.
LB Miller Agar(LBM0.1X) (Less Tryptone, Yeast and NaCl than the one above)
Application: For the growth of recombinant Escherichia coli, and for culturing enteric bacteria and facultative organisms.
Note: What is the difference between LB Miller and LB Lennox broths?
The LB Miller Broth and LB Lennox Broth contain higher and lower sodium chloride levels respectively. There are minimal differences between the two formulations in most molecular biology studies with commonly used E.coli strains. Different bacteria strains may require different salt concentrations. The low salt formula is more often used in salt-sensitive antibiotic selections. The LB broth used in most labs is LB Miller broth which contains 10 grams NaCl per liter of medium.
Middlebrook 7H10 Agar
Application: For the isolation and cultivation of Mycobacterium species, predominately for Mycobacterium tuberculosis. It has been reported that the 7H10 medium tends to grow fewer contaminants than the egg-based media commonly used for the cultivation of mycobacteria.
Tryptic Soy Agar-Kanamycin (TSAKAN20)
Application: For the isolation of various strains that are Kanamycin resistant, or for strains that contain plasmids that may confer Kanamycin (a common antibiotic) resistance. Kanamycin has been used to treat infections caused by Gram-negative bacteria including E. coli, Proteus spp., Serratia marcescens, and Klebsiella pneumoniae.
Tryptic Soy Agar-Kanamycin Plates (TSAKAN50) (Larger quantity of Kanamycin than TSAKAN20)
Application: For the isolation of various strains that are Kanamycin resistant, or for strains that contain plasmids that may confer Kanamycin resistance.
Tryptic Soy Agar-Carbenicillin Plates (TSACARB50)
Application: Carbenicillin (antibiotic) is an analog of Ampicillin (a form of penicillin). For the isolation of various strains that are Ampicillin resistant, or for strains that contain plasmids that may confer Ampicillin resistance. Can be used for detection of Pseudomonas aeruginosa, a sometimes fatal bacterial infection in animals (including humans).
Tryptic Soy Agar-Carbenicillin Plates (TSACARB100) (same as TSACARB50 with more Carbenicillin)
TSA-Kanamycin-Ampicillin Plates
Application: For use with ampicillin and kanamycin resistant strains and strains harboring plasmids. Similar use to those listed previously.
Tryptic Soy Agar-Ampicillin Plates
Application: For the cultivation of Escherichia coli and various antibiotic resistant bacteria. It is also sometimes used for the treatment of urinary tract infections, meningitis, and salmonella infections, but resistance to ampicillin is increasingly common among the bacteria responsible for these infections.
Tryptic Soy Agar-BioNanoPore
Application: For the detection of a variety of fastidious and non-fastidious microorganisms. Can be used with aerobic or anaerobic microorganisms. In the BNP form!
Polymyxin-Lysozyme-EDTA-Thallous acetate
Application: PLET Agar is the best selective medium for the isolation and cultivation of Bacillus anthracis (anthrax) from environmental samples, animal products, and clinical specimens.
MacConkey Agar
Application: For the selective and differential isolation of gram-negative bacilli by lactose fermentation. Designed to selectively isolate Gram-negative and enteric bacilli (normally found in the intestinal tract) bacteria and differentiate them for lactose fermentation.
So you admit that you don't inder the basic technology behind the products and you argue they aren't capable of generating money based on them.
Unbelievable.
Grab a bio textbook and compare to what else is out there. You might be surprised what you see.
Any "logical person" would realize exactly what is going on here and ignore every post on this site or any other message board where the same type of comments pop up.
A logical person would also put some weight in the technology rather than mere equations that anybody can plug numbers into to get the results they want.
I don't think that anybody here has ever suggested that the company should be making $1m a month at this point so the idea that somehow they are failing due to that is absurd. Any impartial observer would be able to see this. Only those seeking out negative opinions would take these boards seriously.
Do you have an opinion on the n-assay for example? I do not think I have ever seen you comment on it and that could be a major part of the company's sales model soon.
I did not say anything about the value of the company being tied to the bid/ask. I was just pointing out that on most days the spread is much larger with a bid below the current price. Today the bid kept creeping up so there was at least one buyer out there who is interested.
Also, any new investors out there will clearly see that these message boards are a mess and not put any stock in them either way.
Mission accomplished!
Easy there. It is just an observation about the action today. No need to slip in barbs about "educated investors". I am sure if somebody was to say that to you it would be deleted as a personal attack. I will allow it though.
The bid is stil at the current price which is much better than the usual day.
It looks like the bid is actually moving up today to meet the ask instead of the other way around. Hopefully if people realize this they will raise their asks accordingly and we might see a little positive momentum for a bit
Apologies. That was the bnp patent. The n-assay application is pending with relatively minor rejections that will hopefully be overcome this month. THAT is the one with 18+ years left.
Also, with regard to the n-assay patent, this is from another board:
Update on patent application 13/350127.
As I previously noted here just a few days ago, the application above had received a non-final rejection with most of the claims allowed and a few dependent claims rejected under 35 usc 112. For those not familiar with the process, those rejections are made with regard to legal issues and essentially formatting rather than the actual invention.
As expected, they have filed an amendment to clear that up which can now be seen in uspto pair.
What this means is that assuming the amendments are ok (they simply deleted the subject matter in question, so they should be) we should be able to expect an allowance shortly.
This is the bnp patent that uses aptamers to cut down on detection time I believe. Very important to the company in my opinion.
This is correct. And their most important application right now (n-assay) which has yet to be allowed will hopefully have 18+ years on it once it is issued.
Most of their parents have well over 10 years left which is plenty of time. They just need to make that time count
You stated that
"It's already been predicted, immediately after the financials were released, that the company would go on a massive PR campaign in order to offer "great news" in hopes of persuading investors to ignore the fact that the company is operating itself extremely poorly and the future is looking bleak."
This is what YOU said on another MB. And now you are using it as a "fact" here to further your own opinion that "the future is looking bleak."
In my opinion, even with the shape of the company currently, these developments are nothing but good for it. Would I like to see more revs? Of course, but that will have to come with time, and myself and many others think that will be sooner than later.
Also, sending an email to people who are on their mailing list is not a "massive PR campaign" now matter how you define it.
Please explain where you get this information. Otherwise it is merely speculation on your part.
Sometimes, good news comes all at once. Nanologix cannot tell the EU when to issue a patent.
The EU is a major market and considering that the only patents that really matter are the US, Japan, Germany and the EU, I would say this is good news.
That is one man's OPINION which in my opinion is wrong since absolutely no companies are valued solely on a couple quarters of financials.
If all that was involved is plugging numbers into 3 equations, then the market would be pretty boring.
Borrowing from another poster elsewhere, looking at just the N-assay potential:
A rough analysis of the economic potential of the NanoLogix N-Assay technology is offered at the end of this post. The result is astounding and involves only the assumption that this technology can capture a 20 percent share of the US Group B Strep test market. The additional implications for the bacteriological test and treatment markets for Sepsis, Enterococcus, Gonorrhea, MRSA and several other infectious diseases expand the potential of the NanoLogix N-Assay test panels into revenue dimensions you can envision yourself. I have attempted to make the assumptions underlying the projections explicit but feel free to clarify or challenge aspects that you think need bolstering or that are wrong.
In the first two sections of the post rather than requiring the reader to go back to review prior posts I am trying to provide a sense of the truly advanced diagnostic technology the N-Assay represents based on research reports from Drs. Sebastian and John Faro. NanoLogix is incredibly fortunate to have been able to work with the testing and development of its “game changing” technology with two of the most highly regarded medical professionals in the area of women’s gynecological health and infectious diseases including Group B Strep, Sepsis and several others with critical needs for rapid diagnosis.
Part of the analysis highlights the seriousness of several bacterial diseases and infections in terms of their scale and severity of consequences. The numbers are high and of course this relates to the commercial and medical potential of the N-Assay system. Another key point is that rapidity of initial diagnostic results and greatly reduced period for determining the most effective type and dose of antibiotics to be administered patients. This gives the N-Assay a very significant advantage over existing diagnostic systems that in the case of Group B Strep means with the N-Assay GBS the complete diagnosis can be done in as little as 6.5 hours while with existing methods it generally takes three to five days.
Given the inherent conservatism of the medical field and the power and dominance of large companies in the market an extremely important development that is expected to rapidly increase demand for the NanoLogix N-Assay panels is that the Centers for Medicare and Medicaid will start withholding payment for certain Hospital Acquired Infections (HAIs). The Center for Disease Control states: “People getting medical care can catch serious infections called healthcare-associated infections (HAIs). Right now the CDC is focused on orthopedic and bariatric procedures for which infections develop but they will probably increase the denial of payment program to include caesarian and other gynecological services. This development is something that will generate considerably greater incentives for hospitals, HMOs and doctors to take significant steps to ensure the prevention of infections as well as the early detection and effective antibiotic intervention. The idea is to nip the infectious bacteria “in the bud” when it is most susceptible to focused treatment at the point before it develops into a serious (and non-reimbursable) event. The rapidity and accuracy of the N-Assay technology is precisely what is needed for this purpose.
An equally important fact that will drive the demand for the N-Assay panels is that for OB/GYNs the N-Assay is very important because they are the second most sued group of doctors in the US behind only neurosurgeons. This makes GBS screening very important due to neonatal morbidity and mortality. Even if those problems do not immediately manifest, the “down the line” consequences of untreated GBS during pregnancy involve a wide range of health problems as the child develops. A birth that seems normal can turn into a “horror story” for parents who find a developing set of severe and debilitating problems affecting their child. One of the first places they look will be the hospital, doctor and associated processes. Estimates suggest the average cost of treating a GBS-infected infant in a Neonatal Intensive Care Unit (NICU) is $30,100. But in Sebastian Faro’s judgment and based on his experience he estimates the cost is around $100,000. Plus most of the exposed children have significant problems with health over their lifetime.
The information below offers a sense of the great competitive advantages of the N-Assay, the potential numbers of uses and needs in the areas of Group B Strep, sepsis, Enterococcus (VRE), MRSA, Gonorrhea and several other areas of infectious bacteria that the Faros’ work has shown can all be successfully tested by means of the N-Assay panels. As indicated, I offered a “rough cut” of the earnings potential of the N-Assay diagnostic panels just in the US system and just with the Group B Strep infection. This is what I consider a conservative projection that assumes a 20% market capture for GBS diagnosis. Although I didn’t project anything for the other types of infections I listed them below the GBS analysis and may begin to put numbers on the categories and do some projections. But with the GBS N-Assay panels alone it is obvious that NanoLogix has incredible earnings and profit potential. In any event, have fun reading.
• Dr. Faro and his son Dr. Jonathan Faro are internationally respected experts on women’s reproductive health and have conducted research for more than three years with the NanoLogix, Inc. technologies, including a highly successful clinical test involving 356 women in the 35-37 week period of gestation at which the Center for Disease Control (CDC) urges testing for Group B Strep.
• They have expanded their research to include the NanoLogix N-Assay multi-well technology (N-Assay) and applied that technology not only to the area of Group B Strep (GBS) but have expanded the method to include the detection of other infectious diseases and conditions including sepsis, enterococcus, c. albicans, MRSA, c. difficile, and gonorrhea.
• This process includes the design of specific diagnostic “panels” (the N-Assay system with 96 individual “wells” on the panel)—each capable of being set to identify different bacteria. The N-Assay panels are of great importance in relation to sepsis and neonatal diagnosis for G BS and other concerns. The N-Assay multi-well panels significantly expand the utility of the methodology because the multi-wells allow an array of different types of infection to be evaluated simultaneously rather than sequentially.
• There is no other methodology that can come close to matching the N-Assay technology on a significant range of diagnostic qualities detailed in 2013 by the Infectious Disease Society of America. The Society stated that what was needed in order for a physician to have a positive impact on a patient’s care was a diagnostic test that produced reliable results in an hour. The reliability of the test and its functional utility in a variety of important settings depended on the results being:
• Accurate
? Composed of heat stable reagents
• Having an extended shelf life
• Was portable
• Low cost relative to other methods
• Suitable for diagnosis of a broad range of clinical samples
• Required minimal technical skills
• Was rapid
• Sensitive
• Specific for each disease for which it was being used
• Provided on-demand individual testing rather than being delayed for large batched pools in order to reduce expense.
• The N-Assay not only provides almost immediate (as low as thirty minutes) initial identification of potential problems with infection but also reduces the subsequent incubation period to only six hours during which antibiotic sensitivity and potential effectiveness in a patient’s treatment are accurately evaluated. This compares to the three to five days time requirement involved in the use of current technology for GBS. The rapid detection of antibiotic sensitivity allows the specific use of the most effective antibiotic to treat the infection. This is a vital step forward in terms of reducing the overuse of multiple antibiotics by medical professionals that has increasingly been resulting in antibiotic resistance for a number of the most widespread infectious diseases. Obviously it is also a major benefit to patient treatment and well-being.
• The N-Assay provides an unbatched, low cost, simple to use test. This is important from both a cost and diagnostic perspective because current cost considerations dictate that labs delay sample testing until they have a substantial batch of different requests. This occurs in order to reduce the cost to the lab of tests due to the expense of existing technologies. The N-Assay offers an immediate, better, and less expensive individualized test which avoids potentially harmful delays in diagnosis and patient treatment.
• The N-Assay technology is a “game changer” across a range of distinct and dangerous conditions of bacterial infections.
• The N-Assay test represents the future direction of bacterial medical diagnosis and the ability to deliver more effective treatment through targeted and precise antibiotic infusion. An important consequence of improved patient treatment is the avoidance of unnecessary and generic antibiotic treatments that may not help the patient, may have negative health effects and is likely to result in more rapid development of antibiotic insensitivity.
• There is a serious and growing problem of rampant antibiotic (AB) resistance caused by now almost automatic large scale generic infusion of antibiotic treatments that make up the treatment protocols in situations where a bacterial infection is diagnosed.
• The rise in AB-resistant strains makes it essential that antibiotic overuse is avoided because a result of overuse and imprecisely targeted AB applications is the rapid growth in resistance by microbes that adapt to medicines to the point of rendering them ineffective.
• Many doctors use antibiotics like they were “turning on a faucet”. (Presentation of Dr. Sebastian Faro at BioOhio)
• The problem entirely independent of the issue of AB resistance is that these are not simply benign substances but quite dangerous drugs that can have important impacts on patients.
• Current tests are simply not good enough to satisfy the Infectious Disease Society of America’s criteria. They are also ill-suited to help deal with the array of emerging challenges related to infectious diseases.
Commercial Implications of the N-Assay/BNF Technology
I. The “Numbers Game”:
1. There are at least 6,000,000 pregnancies annually in the US with 4,058,000 live births and 1,995,840 losses from various causes. This includes 1,200,000 abortions, 600,000 miscarriages, 64,000 ectopic pregnancies and 26,000 stillbirths. CDC 7/8/2014.
2. 14.5% of women experience one or more pregnancy complications, 7.7% deliver prematurely, 5.1% have low birth weight and 7.6% have inadequate prenatal care. CDC 7/8/14.
3. The Center for Disease Control (CDC) now recommends universal screening at 35-37 weeks of gestation. The screen is to determine the existence and degree of colonization of GBS due to the morbidity and mortality potential from the infection. The GBS infection in women beyond “regular” child bearing years (mid to late thirties included) represent a high morbidity and mortality potential further exacerbated by such other conditions as diabetes, HIV and other infectious conditions. More mature patients are therefore at greater risk and require screening to ensure that surgical outcomes will be improved.
4. Group B Strep Potential—US Premature Births: Another issue of significant medical concern is that ten percent (10%) of women deliver prematurely and this increases the morbidity and mortality (M & M) potential for the newly born infant due to their immune systems not being fully developed. GBS “M & M” is a particular problem in the very young and very old. For women who go into preterm labor there is a significant risk of the premature rupturing of membranes. These women are placed on an antibiotic mix but up to 60% of E-coli strains are resistant to ampicillin. The # 1 source of neonatal infection is E-coli.
5. The Alan Guttmacher Institute estimates there are 6.7 million US pregnancies annually and 208 million worldwide with 185 million of those pregnancies in the developing world. The AGI indicates 358,000 women die from pregnancy related complications with the vast majority of those in the developing world. The US leads developed countries in terms of the worst maternal mortality rate.
6. The World Health Organization (WHO) concludes: “The high number of maternal deaths in some areas of the world reflects inequities in access to health services, and highlights the gap between rich and poor. More than half of these deaths occur in sub-Saharan Africa and almost one third occur in South Asia.”
7. “The maternal mortality ratio in developing countries in 2013 is 230 per 100 000 live births versus 16 per 100 000 live births in developed countries. There are large disparities between countries, with few countries having extremely high maternal mortality ratios around 1000 per 100 000 live births. There are also large disparities within countries, between women with high and low income and between women living in rural and urban areas.” WHO.
8. “Improving maternal health is one of WHO’s key priorities. WHO is working to reduce maternal mortality by providing evidence-based clinical and programmatic guidance, setting global standards, and providing technical support to Member States. In addition, WHO advocates for more affordable and effective treatments, designs training materials and guidelines for health workers, and supports countries to implement policies and programmes and monitor progress. During the United Nations MDG summit in September 2010, UN Secretary-General Ban Ki-moon launched a Global strategy for women's and children's health, aimed at saving the lives of more than 16 million women and children over the next 4 years. WHO is working with partners towards this goal.”
9. Enterococcus (VRE) is one of the serious infections with which the N-Assay is able to provide very rapid detection. VRE affects 2,000,000 people annually. Estimates are that 23,000 people die from the infection each year. The CDC has classified VRE as a serious threat. It is a major threat in hospital acquired cases of VRE.
10. C. difficile causes diarrhea linked to 14,000 American deaths each year. Many others suffer from the infection. The N-Assay panel is also designed to detect C. dificile. Those most at risk are people, especially older adults, who take antibiotics and also get medical care.”
11. Sepsis infections represent an enormous volume of dangerous afflictions for which an N-Assay panel has been developed. Sepsis causes millions of deaths globally each year. Sepsis is becoming more prevalent because of antibiotic resistance plus it is very dangerous as a complication for patients. The severity of the sepsis “crisis” is highlighted by Anne-Marie Botek, “Sepsis: The Common Cause of Death You've Never Heard Of”, http://www.agingcare.com/Articles/sepsis-dead...153239.htm. She observes: “Caused by the immune system's over response to an infection, sepsis (also referred to as blood poisoning) is the most common cause of death in hospitalized patients in the United States. … If left too long, sepsis can escalate into a fatal condition, called septic shock, which is marked by extensive tissue damage and organ failure…. Anyone can get sepsis at any age. It can start off as a practically anything—a bug bite, a blister, a sinus infection—and escalate to extreme proportions in a matter of hours…. Despite the fact that it kills nearly 200,000 people in the U.S. every year, only about one-third of Americans have ever heard of sepsis.”
12. “The Surviving Sepsis Campaign (SSC) estimates that the incidence of sepsis is 3 per 1,000 worldwide. It is estimated that there are over 30,000 cases of severe sepsis in the UK every year. There is a steady rise in the number of patients with sepsis. Worldwide there are over 18 million cases per year. Because of its high mortality, sepsis is a leading cause of death. In the developing world, sepsis accounts for 60 to 70% of deaths per year. It kills over 6 million new-borns and children each year and there are over 100,000 cases of maternal sepsis. Each hour around 36 people die of sepsis and over 1.16 million people are affected annually in the US.” See, Dr. Ananya Mandal, “What is Sepsis?” http://www.news-medical.net/health/What-is-Sepsis.aspx.
13. The N-Assay Sepsis panel is very important because the sepsis infection may take several days to fully manifest. With hospitals and insurance providers establishing requirements that lead to quick discharges and short term stays for patients a patient may be released and then have to come back in several days later as fever, diarrhea and other serious effects increasingly set in. As reimbursement for Hospital Acquired Infections becomes more limited this raises not only a serious issue in patient care but a looming financial dilemma for doctors and hospitals.
14. Jim Kling, “C. difficile Infections Rising, deaths Leveling Off”, Medscape Medical News, 9/12/2013. “Rates of Clostridium difficile infection (CDI) nearly doubled in a decade in US hospitals, results of a new survey show. The diarrhea-causing bacteria, which often occur as a complication of treatment with antibiotics, affected about 2.2 million people during a 10-year period…. The median age of the 2.2 million hospitalized patients with CDI was 75 years (interquartile range, 61 - 83)…. The median hospital stay overall was 8 days (range, 4 - 14), but it was shorter for patients with a primary diagnosis of CDI than for patients with a secondary diagnosis….The mortality rate peaked in 2003, at 8.7%, and hit its lowest in 2009, at 5.6%. The overall mortality rate for the study period was 7.1%, but it was lower for patients with a primary diagnosis of CDI than for patients with a secondary diagnosis… he increased incidence is a concern. "The study gives clinicians and researchers an idea of the burden of disease in our hospitals, which can help to push forward implementation of prevention initiatives and public policies that can help reduce the incidence of these infections. There's more work to be done on prevention," said Dr. Daniels.”
15. There are 800,000 new cases of gonorrhea annually in the US and 246,000 of them are drug resistant. The cost of treating “primary” gonorrhea is over $250,000. Gonorrhea infections run at a rate of over 800,000 per year and early detection and rapid intervention with the most effective and targeted treatment protocols is vital, as is informing affected individuals about the condition to avoid further spread. Gonorrhea is an immediate public threat the CDC has indicated requires “urgent and aggressive” action.
16. MRSA is estimated to result in 20,000 deaths each year and this is only the “tip of the iceberg” in terms of the number of people who need to be tested for the infection. MRSA infections, particularly outside of health care facilities, are much more common than government statistics suggest. They sicken hundreds of thousands of Americans each year in various ways, from minor skin boils to deadly pneumonia, claiming upward of 20,000 lives. The inability to detect or track cases is confounding efforts by public health officials to develop prevention strategies and keep the bacteria from threatening vast new swaths of the population. ” http://www.usatoday.com/story/news/nation/201...s/3991833/.
17. “Methicillin-resistant Staphylococcus aureus (MRSA) bacteria are resistant to all beta-lactam antibiotics such as methicillin, penicillin, oxacillin, and amoxicillin. A MRSA infection can be fatal, and is sometimes called the "Super Bug."… According to the CDC, an estimated 10,800 deaths in the U.S. each year are caused by staph; 5,500 of which are linked to MRSA. … According to JAMA [2005], an estimated 94,360 cases of MRSA infection are reported in the U.S…. According to JAMA [2005], MRSA is responsible for an estimated 18,650 deaths in the U.S.” CNN Library, “MRSA Fast Facts”, June 14, 2014.
18. The antibiotic susceptibility testing capability is one of the most important aspects of what the methodology provides. The other pathogens with which the test has been adapted to this point include 1. c. albicans, 2. MRSA, 3. enterococcus, and neisserial gonorrhoae. The work involves the creation of specific testing panels that focus on some of the most prevalent and dangerous bacterial infections. These include a “Sepsis” panel, a “Prenatal” panel, and several others.
N-Assay Market Potential in US
My main focus in this part is on the US markets for the N-Assay. This is because different economic and medical cultures produce distinct potential. Countries that operate large scale national health systems are much less price and consumer sensitive than the US market. The UK system for example is unlikely to consider significant cost savings for medical technology to be all that important because its system is a massive bureaucracy that is not very responsive to consumers and not at all concerned about investors. The same can be said for most such systems in the developed world. This does not mean that public health systems that operate through massive tax subsidies might not at some point adopt superior technology but means that the determining factor will not be price. It also means they are not competing with anyone and are largely not accountable for their shortcomings so there are few pressures directing them to take action to improve what they currently do.
A separate issue relates to the nature of entry into many developing world countries. Since most do not have highly evolved medical centers, lack significant financial resources of their own and do not operate according to US-type market forces entry into such systems almost has to depend on UN, WHO, Non-Governmental Organization (NGO) and/or charitable foundation sponsorship and networks. This means there is a need to develop relations with those organizations but the speed at which this can be done is uncertain as is the scale of the resources and earnings that can be gained from such projects. This in no way means the approaches should not be made but that the priority must be to focus sales energy on US markets with all direct resources even while working with distributors in areas that do have resources sufficient to make it feasible to market the N-Assay and other NanoLogix products.
The agreements with Saudi and Singaporean distribution companies offer examples of how this might work and solid contacts developed. Certainly using Singapore as the means to enter the Malaysian, Indonesian, Japanese and urban Indian markets for the N-Assay represents an intelligent business strategy since those countries have highly developed market segments in the medical area and significant resources. All I can say about China and Russia is that NanoLogix should act as if they do not exist due to the high probability that they would immediately pirate the technology.
1. N-Assay Group B Strep (GBS) Potential in US
There are roughly 4,000,000 live birth pregnancies annually in the US. The CDC protocols require GBS testing of pregnant women between the 35-37th weeks. In a number of instances retesting will be required after targeted treatment to determine if a treated GBS-situation has been reduced to a safe level. It is vital for doctors to anticipate possible problems in patient management and this is why the GBS screening is essential.
This is the clear leader at this point because of the Faros' research and reputations. There are more than 6 million US pregnancies annually but there is a “net” live birth volume of a little over 4 million due to abortions, miscarriages and stillbirths. So let’s work with the 4 million live birth figure for the analysis. In relation to this figure we can assume that close to 100% involve doctors and hospitals and that given the CDC figures something close to that number receive the current 3-5 day GBS tests as part of their protocol. We will also follow Dr. Sebastian Faro’s estimate that close to 25% of pregnant women are “colonized” with GBS and have to be treated. This then assumes that those 1 million women will have to be retested to determine the effectiveness of the antibiotic treatment their doctor administers.
If we go for the “best case” scenario, within a year or so every woman tested for GBS in the US ought to be evaluated by the N-Assay panel technology. That would mean there something in the vicinity of 5 million tests sold at 100% of market capture. For this analysis I am using only a 20% market capture and 1 million tests sold.
I said in a different post that the Neo-natal GBS N-Assay panel would have to be outsourced for production given the sheer size of the market being serviced and the required scale of production. Obviously this outsourced production will be done through an independent company that is not a competitor. It has to be an experienced manufacturer of advanced medical products with a demonstrated capacity and technical expertise in the medical field. This fact is obvious and if we can see it NanoLogix leadership and the Faros are fully aware of the need in order to move rapidly into the market for the panels and there should be no question that they are certain to be engaged in discussions on design and cost. Of course they would also be crazy to share that information with us so I made some assumptions I consider reasonable.
It should also be understood that from I can discern from the presentations and research reports that the panels are sophisticated and not simply petri dishes but carefully designed and “filled” instruments fashioned for specific needs and containing critical substances with the ability to attract and bond types of bacteria as a central element of the diagnostic process. My guess is that such advanced 96-well diagnostic N-Assay panels are likely (in mass production) to cost NanoLogix somewhere between $25 and $40 to produce, including the essential profit margin to the actual manufacturer. That’s just my “best guess” but it is the figure I will work with. To be conservative in the profit projections I am going to go with the upper end of the cost of outsourced production to NanoLogix, the $40 per panel assumption.
An added cost factor to NanoLogix is the cost of operating the research and management facility in Hubbard and the cost of what must inevitably be an expanding sales staff as the N-Assay sales grow. The Hubbard facility in my understanding is a very “lean” operation. It would only require a small volume of N-Assay sales to cover the costs of the core operation that looking at the staffing I am going to estimate at around $500,000 per year. As N-Assay sales develop, however, there will need to be significant growth in a highly experienced, mobile and dedicated sales force “pushing” the N-Assay aggressively. My best guess here is that the sales force two years from now will require perhaps $1.5-2.0 million annually. Anyway, I am going to use that as my assumption.
With these figures in mind I am going to assume that the full cost of the N-Assay panel to NanoLogix is going to be in the vicinity of $75 per panel for the first 100,000 sold, $65 per panel for the next 500,000 sold, $50 per panel for the 500,000-1 million panel sales and $40 per panel after that. The latter figure might even be lower due to volume discounts based on larger production. Since the N-Assay has significant cost advantages (including labor savings) over current technologies and those technologies in my understanding are quite expensive to the point they require the assembly of larger test sample batches before actual testing in an effort to reduce costs per tests I am going to assume that NanoLogix is going to price its N-Assay at $200 per panel. This price could (and probably will) go down for individual volume purchasers.
Based on these assumptions we come up with revenue figures such as the following and not assuming total market dominance for the N-Assay. Of course there will not be total market dominance but let’s see what the best case is for NanoLogix.
100,000 panels sold @ $200/panel: Gross revenue is $20 million, cost of production $4 million, operating costs $2.5 million. Net revenue is $13.5 million @ 100,000 panels sold.
400,000 additional panels sold @ $200/panel: Added gross revenue is $80 million, cost of production is $16 million, additional operating costs $0 million because the initial 100,000 sales cover all those expenses. Net revenue on added 400,000 panels sold is $64 million.
500,000 additional panels sold @ $200/panel: Added gross revenue is $100 million, cost of production is $20 million, operating costs $0. Net revenue on 500,000 added GBS panels sold is $80 million.
In this scenario involving capturing only 20 % of the US Group B Strep (GBS) market of 5 million tests annually, the total gross revenues are $200 million, production and operating costs $42.5 million and net revenues $157.5 million.
Other Bacteriological Infections Diagnosable by the N-Assay Technology
2. N-Assay MRSA Potential in US : Significant potential to help rapidly diagnose and treat a potentially fatal disease that according to the Journal of the American Medical Association (JAMA) saw an estimated 94,360 cases of MRSA infection in 2005 and an estimated 18,650 deaths in the U.S.
3. N-Assay Sepsis Potential in US : Huge potential and area of N-Assay concentration. It could be larger than GBS. One researcher laments that Despite the fact that it kills nearly 200,000 people in the U.S. every year, only about one-third of Americans have ever heard of sepsis.”
4. N-Assay Enterococcus (VRE) Potential in US : Significant potential in human infection diagnosis and treatment and even in the area of veterinary medical diagnosis of VRE. Estimates are that 2 million people are infected annually and 23,000 die each year from VRE.
5. N-Assay C. albicans Potential in US
6. N-Assay C. dificile Potential in US
7. N-Assay Gonorrhea Potential in US : Gonorrhea infections run at a rate of over 800,000 per year and early detection and rapid intervention with the most effective and targeted treatment protocols is vital, as is informing affected individuals about the condition to avoid further spread. Gonorrhea is an immediate public threat the CDC has indicated requires “urgent and aggressive” action.
NanoLogix receives official grant of BNP patent from the EU
NanoLogix has received notification of BNP patent grant from the European Union. Grant date was 11/26/2014. This is a welcome addition to the NanoLogix patent portfolio, providing intellectual property protection in the EU for the first time for any NanoLogix product. Interested shareholders should note the length of time from date of application to date of patent grant. Over 6-1/2 years of legal and financial resources went into this achievement. The company thanks Gwen Acker Wood, PhD, JD, of ACKER WOOD Intellectual Property Law, LLC, for her outstanding work on this and other patents pending and granted.
EUROPEAN PATENT GRANT CERTIFICATE _____________________________________________________________
Applicant Nanologix, Inc. Application Date 24 March 2008 Grant No 2134857 Grant Date 26 November 2014 Expiry Date 24 March 2028 (If renewed as set out below) Title Detection and identification of microorganisms on transparent permeable membranes Priority Application(s) United States of America Application No. 60/896321 filed on 22nd March 2007 Renewal Fees Due Annually in each designated state in March
Very low volume today. Seems odd.
Interesting. A new vape store just opened there last summer that seems to be doing a decent amount of business. I wonder if it's from them. Vapor solutions
NanoLogix Updates Financial information
NanoLogix is pleased to furnish updated financial information through Q1 2014. Q2 & Q3 to be released in December.
http://nanologix.com/about/financials.html
Update on N-Assay (V) for rapid virus detection
At a minimum, the press release has been covered with stories in the Washington Post Innovation blog, The Warren Tribune Chronicle, Warren, Ohio; The YoungstownCBS/Fox/ABC/NBC Youngstown, Ohio affiliated television stations; NBC/Pittsburgh, Fox/Tampa television.
As a result, NanoLogix N-Assay (V) is currently being evaluated by pharmaceutical companies for use as a simple rapid diagnostic tool for viruses for use in remote locations in close proximity to outbreak events. Nanologix this week signed two Mutual Confidentiality Agreements with US corporations interested in their technology.
Given the key word "Confidentiality", further information will be released when and if dictated by events.
Its not the petri (BNP) that they would use. It is the N-Assay, an ELISA multiwell assay
More local news coverage:
http://www.wfmj.com/story/26809334/hubbard-company-hopes-product-could-detect-viruses
A Hubbard company is reconfiguring a testing product to detect viruses,like Ebola, quickly.
Nanologix officials said the diagnostic test kit would cut detection time from three days to as soon as 30 minutes.
The kits have been widely used for bacterial tests, but are now being changed to detect viruses.
Bret Barnhizer, CEO of Nanologix anticipates they could be able to detect the virus before you show symptoms.
"If there's a means to detect something that they've been exposed to it early on, then that can stop someone from getting on a plane. It can cause the health authorities, where ever, that may be in Europe, Asia or Africa to isolate that person and check the people around them," said Barnhizer.
Nanologix is now seeking a corporate partner to help get the testing to the next step of analysis, which is necessary to get it cleared to go to mass market.
Any video coverage is good even if it is just a local news story. Nice to see them actually using the n-assay (I assume).
Also, tomorrow is their meeting with the Gov't. Hopefully they are going to have time to talk about this new possibility with Ebola.
From the PR released today (can be found on the nanologix website):
The Ohio State University
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. In addition, NanoLogix has sold product to Abbott Labs, personal care companies, food processing companies, soil testing companies, the US EPA, and others who currently cannot be named due to contractual agreements. Mr. Hank Lewis, VP for Sales and Marketing and Michelle Durkin, Laboratory and New Products Director have interacted with multiple groups to achieve a number of these sales.
Read more: http://www.digitaljournal.com/pr/2219359#ixzz3EjJ8BTDR
The Ohio State University issues Purchase Order to NanoLogix
NanoLogix is very pleased to announce that The Ohio State University has issued a Purchase Order (PO) to NanoLogix Incorporated to supply the University with the following:
Gel culture media
Cell culture supplements
Biochemical reagents
Cell preservation/growth supplies
This PO runs from September 17, 2014 to June 30, 2015 and is a blanket Purchase Order for lab supplies.
NASA
NanoLogix is pleased to announce that this week the company has supplied product to the National Aeronautics and Space Administration (NASA). Additional information will be released as available and permitted.
Can somebody explain to the board who Mitch Felder (other than the old CEO) and how he came to be replaced.
Ideally without personal attacks, just the facts. His name keeps popping up lately and I have little info on his time with Nanologix. Would he really be disgruntled?
I was saying if you were part of a pump and dump then you missed out when the dump occurred. You would not still be here if that was your plan. Im on your/NNLX side here.
If you were part of a pump and dump then you really screwed up the "dump" part of it.
Hopefully from here on out we just get the numbers without any pumping
The site was registered back in January but only went online on the 24th or 25th. I cant remember which. It seems that the image with contact information is only a placeholder so hopefully it will show more later.
Website for IVD Tech Private Ltd.
ivd-tech.com
Basic landing page registered in singapore with contact information. Very new website, not much info.
Map shows it being about 1/4 mile from Singapore General Hospital where one James Sim is an associate consultant in microbiology.
Interesting.
Any only 1 of those James Sims is anywhere close to the biotech world.
"Since LinkedIn hasn't exactly caught on like Facebook has, It's more intelligent to assume this amount represents a small fraction of how many people go by that name and live in Singapore."
Yeah, only 70% of the country's workforce and students are on it.
http://techcrunch.com/2013/04/29/linkedin-reaches-1m-users-in-singapore-or-20-of-the-countrys-population/
I think this is the same James Sim.
Is this the same James Sim you think?
http://www.sgh.com.sg/about-us/newsroom/News-Articles-Reports/Pages/working-bacteria.aspx
http://www.ncbi.nlm.nih.gov/pubmed/23277175
Can somebody please explain to me why we are arguing over a single post that somebody who no longer seems to exist made 6 months ago like it is a fact?
For those who are unfamiliar, this goes back to a single post on another message board that somebody made probably in August. The poster stated that the share price would be $2 by this year and that a dividend would be coming soon. None of this was likely, and the comments were probably made just to get under the skin of those who not fans of the company and would then spend months trying to prove it wrong.
Looks like it worked.
My advice is to forget about a dividend, its obvious that it is not coming, whether legal or not, and go back to discussing the actual merits of the company like the new production and increasing product line.
Also, its $900,000 from a single contract. That would be the starting point with additional sales above that. Some people seem to think that the 900k is the only money, which is wrong.
As I posted elsewhere, I Just noticed that the last BNP documents added 1/20 show it as tested on E.coli, Salmonella and Staphylococcus aureus. Three food borne illnesses. Along with the recent news about a grocery chain I would think it is is pretty safe to say there is a good chance that that is where this batch was headed.
There would also be a benefit for a corporation to use BNP to test for things like e.coli even if it was not a USDA approved test since it would potentially prevent a recall that would be detected later by the additional USDA tests.
Re-read the PR. Its the truth. "...they are working with Nasaem-Aljazira, a Saudi Arabian company headquartered in Riyadh, to establish exclusive distribution and/or manufacturing of NanoLogix products in Saudi Arabia and the Arabian Gulf region, also known as the Gulf Cooperation Council (GCC) area."
You are trying to twist words to make it look bad, but it says right above that they are working with them. Even if they are a middle man it is the truth. If I sell you an old Ford Festiva, you are dealing with me, not Ford.
"There is no proof that the company has increased production other than hearsay"
I would think that the PR put out indicates there is production taking place that was previously undisclosed.
While these might not be signs of a huge increase in sales and money, they are surely not signs of bankruptcy as has been thrown around from time to time.
Most companies do not increase production and capability when they are hurting or winding down operations.