IN THIS REPORT...
  • Healthcare crisis looming
  • Roughly 10,000 Baby Boomers turning 65 every day
  • Medtech company starts trading tomorrow
  • The future of disease detection?
Special Report - First Featured Company of 2016 
 
Dear member,


Developing new drugs can take many years for regulatory approval, and huge budgets to complete. However, medical devices, in many cases, can gain regulatory approval and be brought to market much faster and cheaper.


Med Device Online reported in August that, "The U.S. Food and Drug Administration (FDA) claims it has approved medical devices markedly faster in the last five years than in the preceding decade."


With Baby Boomers expected to retire in droves over the next two decades, by necessity, the healthcare industry is now evolving faster than ever with technological breakthroughs and early detection methods that have the potential to save countless lives and the industry, governments and health insurers billions of dollars. This presents an immediate opportunity for investors in the healthcare sector.



RACE AGAINST TIME

Until recently, it can be argued the practice of medicine and healthcare in general has lagged behind other industries, such as tech or energy, when it comes to new product development and 'breakthroughs'; but, this is changing rapidly as researchers, doctors and governments from around the world embrace technology and push the limits of diagnosis and early detection methods to save lives, reduce healthcare costs and improve treatment options. The shift in focus to medical tech is a direct result of a looming economic threat we have all heard so much about: The demographic cliff.

"As members of the baby boom generation get older and reach retirement age, they present an increasing challenge and opportunity for health care."


Approximately 20% of the United States' population will hit 65, also known as retirement age, between 2011 and 2029, according to census data.


The Pew Research Center reported that from now until 2029, roughly 10,000 Baby Boomers will turn 65 every day... 


This will put tremendous strain on the healthcare system. Left unchecked, it will negatively and directly impact taxes, economic competitiveness, and GDP. To lessen the blow, government and academia are attempting to get in front of this potential fiscal disaster by putting an emphasis on medical tech research and development as it not only can save lives, but billions in hospitalization costs nationwide.


In mid-January, the non-partisan Congressional Budget Office announced that it expects the Obama Administration to run a $544 billion budget deficit in 2016. That's an increase of approximately $105 billion year over year...


Among the main culprits for the increased deficit spending are Social Security and Medicaid.


The Hill reported that the cost of Medicaid and Social Security will rise an incredible $168 billion year over year! The publication also stated that "Spending on federal health programs alone - including Medicare, Medicaid and subsidies from the Affordable Care Act - will increase 11 percent compared to 2015 levels."
Saving Lives and Potentially Preventing Insolvency

In a 2014 Health Care Industry Report, Ernst and Young stated:

"A new tide is rolling in to transform how care is delivered and paid for, rewarding those who improve patient outcomes and do so at lower costs."


The advancement of technologies in healthcare are beginning to pop up all around us. It is now one of the most aggressive, exciting and well-funded sectors in the world. The push from startups and massive corporations alike to improve the health of millions can create extremely lucrative buyouts for investors to take advantage of. And the resiliency of the healthcare industry is perhaps unmatched due to its ability to garner capital from governments and non-governmental organizations (NGOs) alike. Recession or not, there is always an appetite for disruptive medical technologies that can potentially save lives and improve the quality of life, especially today as the Baby Boomer generation embarks on retirement...


Improving patient outcomes, and saving substantial amounts on healthcare costs, can be attained through making the diagnosis process more convenient (non-invasive) and improving early detection. Doctors have recognized this for years. And we've identified it as an area now ripe with investment opportunities.


Richard A. Yost Ph.D.
In our quest to find and invest in a unique, early stage medtech company operating in this space, we learned of a technology co-invented by a highly-respected Ph.D., Richard Yost, at the University of Florida. Dr. Yost's research has involved over 100 graduate students funded by over $40 million in research grants. The research has led to over 160 publications and 16 patents to-date. Over $30 billion worth of instruments have been sold based on these patents.

"centers around three aspects of analytical mass spectrometry, instrumentation, fundamentals, and applications."
image: University of Florida Albert Murphree statue  

This development stage technology that immediately grabbed our attention is now being funded by our new featured company, which begins trading on the Canadian Securities Exchange tomorrow. Hence the timing of this report...

 
Our new Featured Company has the option to acquire US Patent 8,237,118. This patent covers the aforementioned patented technology entitled "Partial Ovoidal FAIMS Electrode." And Dr. Yost is our new Featured Company's Scientific Advisor . 


With this technology, the company aims to develop a prototype which demonstrates how it may positively impact the medical industry through non-intrusive early stage screening, which could lead to notable advances in early detection.


Potential commercialization of FAIMS could revolutionize early detection of many deadly diseases, according to the company. How so? Utilizing the technology, and through further research and development, our new Featured Company's goal is to create a handheld, non-invasive breath analysis device that can help detect certain life-threatening diseases...
 
* Additional info on FAIMS technology


Our new Featured Company is in business to help develop and commercialize this technology for the healthcare industry. Its objective is to develop a miniature FAIMS unit that can be as effective as the current technology in breath analysis. This could provide the potential for these machines to be available in a doctor's office. The company is aiming to develop and deploy a miniature FAIMS technology to detect diseases through breath analysis.



Breath Analysis - The Future of Disease Detection? 

In a popular Mashable report by Lauren Drell a few years back, professor of medicine and director of the breath analysis program at the Cleveland Clinic, Dr. Raed Dweik, stated that, 
 
"I think breath analysis is the new frontier and the future of medical testing..."

 
In a Health Day report from 2013 by Alan Mozes, Dr. Dweik explained the importance of breath analysis:

"Every individual has a breath print that differentiates them from other people, depending on what's going on in their body..."

The report continued, 

"That's what makes the new field of breath testing so promising, because it is non-intrusive, so there is no risk involved," Dweik said. "And you can do it anywhere, in a clinic, in a hospital, anywhere."



Arguably well ahead of his time, in 1992 breath testing expert and Physician Michael Phillips wrote a report titled Breath Tests in Medicine, in which he stated, "Since the time of Hippocrates, physicians have known that aroma of human breath can provide clues to diagnosis."


However, only recently has the potential of breath testing in the healthcare industry become somewhat mainstream knowledge, thanks to technological advances around the world.  


Let's go over some of the diseases which various breath testing methods may be able to help detect:

Cancer, as we all know, has become an epidemic in modern society. According to the American Cancer Society, in North America the lifetime probability of being diagnosed with an invasive cancer is approximately 43% for men and 38% for women.


Scientists from a US firm have developed a breath test kit (known as the BreathLink ™ kit) that research shows "is at least as accurate as breast X-rays routinely used in hospitals," according to the Daily Mail.


Catharine Paddock PhD, reported in a Medical News Today article from 2013 that,

"Bacteria that cause lung infections like tuberculosis (TB) release volatile organic compounds that end up in exhaled breath. Now scientists have identified the unique "chemical fingerprints" given off by different bacteria in the lungs in a way that potentially allows for the diagnosis of such lung infections via a quick and simple breath test."


Diabetes is one of the most widespread diseases in the world, impacting 382 million patients globally. By 2035, that number is expected to rise to 592 million.
source: http://www.ncbi.nlm.nih.gov/pubmed/24630390


In respect to breath testing, diabetes is characterized by elevated breath acetone levels. Researchers can use this biomarker as a possible screening tool.


Editor-in-Chief Martin Denholm of Wall Street Daily reported in late-January of 2015:

Gus Hancock, Emeritus Professor of Chemistry at Oxford University, explains: "It's been known for thousands of years that people have noticed the sweet smell of the breath of people suffering from diabetes. The sweet smell is this particular ketone that's given out - acetone."


King 5 in Washington State reported on progress being made by researchers in the field of breath analysis in October of 2014:

"Diagnosing disease can mean blood tests, body scans, and waiting weeks for results. But soon, it may be as simple as just breathing in and breathing out."
  
 
Click to watch King 5 video
image source: King 5 screen capture 


We've just scratched the surface of what various researchers, companies and doctors have been recently working on in the burgeoning medical niche of breath testing and analysis. That's a 10,000 feet view on the industry so you'll understand why it's of great interest to us as investors. Just imagine if there was a non-invasive method to test for certain cancers, lung diseases or even diabetes from analyzing one's breath. That's the blue sky potential...



Begins Trading Tomorrow...
Our new, and first of 2016, Featured Company is Breathtec Biomedical (BTH:CSE), a small-cap medtech firm aiming to propel development and commercialization of breath analysis screening technologies. The company begins trading for the first time ever on the Canadian Securities Exchange tomorrow under the symbol "BTH".

 
Breathtec Biomedical is working with the Head of the Analytical Chemistry Division at the University of Florida, Dr. Rick Yost. He is the Scientific Advisor to Breathtec Biomedical.


Dr. Yost has supervised the research of over 100 graduate students, with funding totaling over $40M from a wide range of sources (including NIH, NSF, NASA, DoD, DHS and USDA). The fact that Dr. Yost is well-versed in receiving grants from some of the largest associations in the United States was a key reason for our decision to select and invest in Breathtec Biomedical at such an early stage.


Furthermore, Dr. Yost's research has led to over 160 papers and 16 patents. Over $30 billion worth of instruments have been sold based on these patents.


Before outlining the University of Florida patent U.S. 8,237,118 entitled "Partial Ovoidal FAIMS Electrode," which Breathtec Biomedical holds an option to acquire (option details on SEDAR in Breathtec's Final long form prospectus dated January 28, 2016), along with the planned prototype development, it is important to note that the company's President is Mr. Kal Malhi.


Kal Malhi, President and Director of Breathtec Biomedical
Some of our long-time readers may remember Mr. Malhi as he is a co-founder and President of Cannabix Technologies (CSE:BLO), a company we introduced in July of 2014. Cannabix is developing a prototype marijuana breathalyzer device. It has received press coverage from Huffington Post Canada, VICE News, Yahoo News, The Globe and Mail, Time Magazine, and many other networks. Its shares didn't perform too badly either; as more investors learned about the technology its stock provided early investors with a significant profit taking opportunity. We introduced it to our readers in July of 2014 when it had last traded at $0.26. By February, 2015, approximately 8-months later, it hit an all-time high of $0.77...


Below is a stock chart for Cannabix Technologies which began trading on the CSE shortly before our introduction:

Chart source: Canadian Securities Exchange
   

Cannabix Technologies was a client of ours. We were shareholders in the company and profited from our investment. Breathtec Biomedical is a client of ours; and, as was the case with Cannabix when we launched coverage, we own shares of Breathtec which we intend to sell for a profit. Like Cannabix, Breathtec will also trade on the Canadian Securities Exchange starting on Monday.



Breathtec Biomedical - The Opportunity

Breathtec Biomedical is aiming to deliver a non-invasive, alternative diagnostic screening aid for various conditions such as certain cancers, alzheimer's, parkinson's, liver disease, kidney failure, diabetes, asthma and tuberculosis.

 
Breath Analysis - The Future of Disease Detection 
Click image above to watch Breathtec's corporate video explaining precisely what the company is pursuing and its legacy goal.
 


As mentioned above, Breathtec holds an option to acquire key University of Florida patent U.S. 8,237,118 co-invented by Dr. Yost entitled "Partial Ovoidal FAIMS Electrode."


According to Breathtec, FAIMS is a mass spectrometry technique that exploits differences in ion mobility at very high electric fields, to separate ions in the millisecond timescale of someone's breath after liquid chromatography separation and prior to introduction to a mass spectrometer.


"Eventual commercialization of FAIMS could revolutionize early detection of many deadly diseases." 
 
 

 
Click image above to watch FOX 35 interview with Dr. Yost about the related technology



The Technology, Patent and Planned Prototype

FAIMS stands for Field Asymmetric Ion Mobility Spectrometry (FAIMS).


The FAIMS device is like a coin sorter, but instead of separating coins,
ions are filtered via electric fields.


Once molecules in the breath are filtered they can be identified. Because of the ion filter - only molecules of interest are allowed to be detected.


" FAIMS technology allows for miniaturization of breath testing devices and will enable development of non-invasive clinical screening."   
               - Breathtec

image source: Breathtec Biomedical corporate presentation
 
 
Biomarkers can help identify diseases by uncovering molecular signatures and or markers in the blood which can be measured via breath.

    ·    There exists a blood-breath interface in the lungs called alveoli.
    ·    Molecules diffuse out of blood and into breath.


Breathtec Biomedical is aiming to deliver a non-invasive, alternative diagnostic screening aid for various conditions including certain cancers, alzheimer's, parkinson's, liver disease, kidney failure, diabetes, asthma and tuberculosis.


Breathtec states in its corporate presentation that, "These diseases (and more) all produce distinctive signatures in the breath which can be distinguished using our innovative technology."



Understanding the Blood-Air Barrier 
 
     

The blood-air barrier (alveolar-capillary barrier or membrane) exists in the gas exchanging region of the lungs. Michael T. Costanzo, Ph.D., Chief Executive Officer of Breathtec Biomedical, states in his CEO message that:

"Our goal is to deliver a device that can be commercialized as a highly effective rapid screening tool for identifying early stage disease bio-markers as well as offering quick and painless means to monitor certain diseases to ensure treatment efficacy on an ongoing basis. We envision a future where a trip to the doctor's office could determine early signs of breast and lung cancers, alzheimer's and parkinson's, tuberculosis, diabetes, liver disease and more, all with just a single breath sample. And it's worth noting that results can be made available in moments instead of days."

Towards the conclusion of his CEO message, Costanzo states:

"I think it safe to say the value of early screening could be measured in billions of dollars annually around the globe. To that end, we have already secured a key patent in this potentially high growth sector..."

Read the full CEO message here.




Breathtec's Angle & Competition at a Glance

Breathtec holds an option to acquire key University of Florida patent U.S. 8,237,118 entitled "Partial Ovoidal FAIMS Electrode." But it is important to note that the company is proactively pursuing multiple, alternative research efforts into the breath testing technology.


As explained, FAIMS is a mass spectrometry technique that exploits differences in ion mobility, at very high electric fields, to separate ions in the millisecond timescale after liquid chromatography separation and prior to introduction to a mass spectrometer.


Needless to say, Breathtec isn't the only player in this burgeoning field of breath analysis technology R&D. This is a very competitive industry with vast sums being spent on R&D.


Examples: Menssana, a private company, has been successful in advancing its own brand of breath testing technology in recent years.


Menssana's BreathLink ™ system (patent pending) is currently in clinical studies for detection of diseases including breast cancer, lung cancer, and heart transplant rejection. The company stated that "In a recent multicenter international study, the BreathLink™ breath test accurately identified patients with active pulmonary tuberculosis."



Menssana's device has not been cleared or approved for use by the FDA as of this writing and is being used for clinical investigation only.


Owlstone is another well-known company advancing breath testing technology. They may be the most popular in this field.


We asked Michael T. Costanzo, Ph.D., CEO of Breathtec Biomedical, about some of the differences between Breathtec's technology and others mentioned:

"Menssana uses a technique called GC that separates compounds of interest from the rest. However, both Owlstone and Breathtec use a different technique called FAIMS that filters out undesired compounds leaving only those we want to monitor for disease screening, and both are capable of doing so in a fraction of the time. FAIMS can be performed in seconds, whereas GC takes minutes if not hours to run a single sample. The primary difference between Owlstone and Breathtec is the innerworkings of the device itself. Firstly, Breathtec's device allows direct device validation by mass spectrometry (the gold standard when it comes to identifying and validating analyses). Simpy put, our device would be capable of running either standalone or on an MS instrument depending on the type of analysis required. This is something the Lonestar would lack as it is a standalone device that is not capable of also attaching to this MS instrument. Secondly, while Owlstone currently produces a smaller device, experiments suggest it does not prove adequate to monitor endogenous compounds for disease detection. Endogenous compound are any compound that is produced inside the body, and are the primary markers for disease. Therefore, even though Owlstone's Lonestar system can analyze a moderate range of volatile compounds found in a high concentration in the body, it has trouble distinguishing lower volatility compounds and at lower concentrations; two areas our device should be proficient at." 
                    
                         -    Michael T. Costanzo, Ph.D., CEO of Breathtec  


TIMING

Below is an excerpt from a report published last year from the Royal Society of Chemistry titled The Application of FAIMS gas analysis in medical diagnostics:

"There is an ever increasing need to develop new tools to aid in the diagnosis and monitoring of human diseases. Such tools will ultimately reduce the cost of healthcare by identifying disease states more quickly and cheaply than current practices. One method showing promise is the analysis of gas-phase biomarkers from human breath, urine, sweat and stool that reflect bodily metabolism."

Click here to read more.  



Breathtec's Stage of Development and Goals
Florida's team, led by Dr. Yost, has an initial target to produce a prototype in the form of a handheld breath testing device. Miniaturization research being conducted by Dr. Yost's team is in the advanced stages. An interim desktop device, however, could commercialize the technology, according to the company. Breathtec's goal is to develop a handheld breathalyzer for use in the detection of diseases, by providing real-time breath analysis - a lofty, and potentially game changing, goal.

source: Breathtec Biomedical
 
 
Last year, Breathtec completed two financings, raising a total of approximately $3 million. This is a company with a potentially disruptive technology in the emerging medtech industry; and it begins trading on the Canadian Securities Exchange tomorrow morning.


We are biased towards Breathtec Biomedical because they are an advertiser client and we participated in the company's most recent private placement for our own investment purposes. Please take responsibility for practicing your own thorough and independent due diligence.


What tipped the scale in us selecting Breathtec, and investing in it, were the credentials of its leadership team, specifically Dr. Richard A. Yost who serves as the company's Scientific Advisor. He is one of the inventors of the University of Florida patent U.S. 8,237,118 entitled "Partial Ovoidal FAIMS Electrode". Dr. Yost is recognized internationally as a leader in the field of analytical chemistry, particularly mass spectrometry. And the Yost Research Group is a recognized world leader and pioneer in the development of FAIMS and was the recipient of the 1993 ASMS Award for Distinguished Contribution to Mass Spectrometry for the invention and patent (along with Prof. Chris Enke) of the triple quadruple mass spectrometer.


By developing its prototype, Breathtec Biomedical aims to demonstrate how it can rapidly help detect, in a non-invasive (unlike blood or urine tests) and simple to analyze manner, several life threatening diseases. If a miniaturized device is successfully developed, this technology could revolutionize how patients are tested for various conditions and significantly reduce healthcare costs.


This marks the initiation of our coverage on Breathtec Biomedical. It begins trading tomorrow morning on the Canadian Securities Exchange under the symbol "BTH". We will have further updates in regards to this developing story over the coming weeks.


All the best with your investments,



Breathtec Corporate Presentation 


The Team  


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Disclosure, Risks Involved and Information on Forward Looking Statements: 
Please read carefully before proceeding.

THIS IS NOT INVESTMENT ADVICE. All statements in this report are to be checked and verified by the reader.

This report may contain technical or other inaccuracies, omissions, or typographical errors, for which Maximus Strategic Consulting Inc., owner of PinnacleDigest.com, assumes no responsibility.

In all cases, interested parties should conduct their own investigation and analysis of Breathtec Biomedical Inc., its assets and the information provided in this report.

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All statements in this report, other than statements of historical fact should be considered forward-looking statements. These statements relate to future events or future performance. Much of this report is comprised of statements of projection. Such statements or information involve substantial known and unknown risks and uncertainties, including general business, economic, competitive, political and social uncertainties; Breathtec Biomedical's ability to leverage its technology platform in the development of its lead and potential pipeline product candidates; its ability to design and conduct development activities and studies and clinical trials for its lead and potential pipeline product candidates; the potential timing and results of any such clinical trials Breathtec Biomedical may conduct; its ability to obtain regulatory approvals in order to market any planned products; its ability to achieve financial projections; and its ability to achieve milestones. Factors that could cause the Company's results to differ materially from those expressed in forward-looking statements in this report include, without limitation, the following risks: any development activities or clinical trials Breathtec Biomedical may conduct which may not produce favorable results; regulatory agencies may require that Breathtec Biomedical undertake additional or more costly studies or clinical trials than anticipated; Breathtec Biomedical may never gain regulatory approval for any of its product candidates; it may not be able to protect its intellectual property rights; the intellectual property of others and any asserted claims of infringement; general business and economic conditions may limit its ability to obtain necessary capital to carry out all of its business plans; the consequences of competitive factors in the industry in which Breathtec Biomedical operates may restrict the success of any product candidate it is able to commercialize; the company may not be able to attract or retain key personnel, and the willingness of third parties to sign agreements with Breathtec Biomedical Inc. on terms that are acceptable to management of Breathtec Biomedical Inc.

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Maximus Strategic Consulting Inc., owner of PinnacleDigest.com, has been paid CAD$50,000 plus gst to provide online advertisement coverage for Breathtec Biomedical Inc. for a pre-paid six month online marketing agreement. The company (Breathtec Biomedical Inc.) has paid for this coverage. The coverage includes, but is not limited to, the creation and distribution of reports authored by PinnacleDigest.com about Breathtec Biomedical Inc. (reports such as this one), as well as display advertisements and news distribution about the company on our website and in our newsletter. This is our first report on Breathtec Biomedical Inc. We (Maximus Strategic Consulting Inc., owner of PinnacleDigest.com) subscribed to Breathtec Biomedical's private placement. In that private placement we purchased 100,000 units of Breathtec Biomedical Inc. at a price of CAD$0.25 per unit. Each unit consists of one common share of Breathtec Biomedical Inc. and one-half of a share purchase warrant (each whole warrant, a "Warrant"). Each Warrant entitles us to purchase one share of Breathtec Biomedical Inc. on or before October 14, 2017 at an exercise price of $0.40 per share. The shares purchased in the private placement are subject to a four-month hold period expiring on February 15, 2016. We (Maximus Strategic Consulting Inc.) may buy more shares of Breathtec Biomedical Inc. following the release of this report. We (Maximus Strategic Consulting Inc.) intend to sell every share we own, as well as any shares we may purchase in the future, of Breathtec Biomedical Inc. for our own profit. All shares we (Maximus Strategic Consulting Inc.) currently own or purchase in the future of Breathtec Biomedical Inc. will be sold without notice to our subscribers. Please recognize that we benefit from price and trading volume increases in Breathtec Biomedical Inc. Please recognize that we are extremely biased when it comes to Breathtec Biomedical Inc.

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