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9 Companies Pioneering Breath Diagnostics

Scent has been used in medical diagnosis since the dawn of medicine. In ancient Greece, practitioners like Galen used all five senses to determine patients’ health, going as far as to smell their breath or faeces, or even to taste their sweat or urine. Inexplicably, these methods fell out of favor until 1989, when a British journal called “The Lancet” published the first report of a dog sniffing out cancer. Dogs were a natural first step in recognizing the importance of smells because they have 220 million smell receptors, whereas humans only have 5 million. Training dogs and using them for precise diagnoses still poses challenges, but these findings pointed researchers in a new direction: they started looking at molecules contained in the breath.

Our breath contains Volatile Organic Compounds (VOCs) which, according to Wikipedia, are “organic chemicals that have a high vapor pressure at ordinary room temperature caused by a low boiling point”.  The ratio of these substances in our breath is unique to each of us, and with the proper analysis, can provide us with red flags about certain illnesses. The analysis is done by using mass spectrometry, a process that ionizes molecules in a compound (basically it gives them charge) and separates them by passing these ions through electric or magnetic fields. Differences in the weight-to-charge ratio of different particles means they will be deflected on different paths by these fields, allowing for the detection of very small amounts of particles in compounds such as breath.

Going back to our earlier example of man’s best friend smelling cancer, we can change the dog’s nose to a mass spectrometer and the dog’s brain to some AI algorithms. Then we have breath diagnostics, which are non-invasive and quick alternatives in diagnosing illnesses like cancer, diabetes, liver disease, or heart failure. A look a 9 companies playing in the breath diagnostics space.

Founded in 2014, Prospect, Kentucky startup Breath Diagnostics has received a $25,000 grant to develop a breath diagnostic device for lung cancer. The company claims that their OneBreath test provides better accuracy than current radiographic technologies detecting lung cancer in 93.6% of cases and distinguishing benign from malignant tumors 77% of the time. Testing is easy. Patients breathe a liter of air into a plastic bag which is then hooked up to a vacuum pump and analyzed with mass spectrometry.

Source: Gust.com

Pre-clinical trials have been completed and Breath Diagnostics is currently looking for seed funding of $2.2 million for design and development, independent clinical validation studies, and application for FDA approval. Just because you have a great idea or product doesn’t mean investors will be knocking down your door to fund it.

 

Founded in 2005 by a group from the University of Cambridge, Owlstone is a profitable company selling “Field Asymmetric Ion Mobility Spectrometry (FAIMS)” which could also be described as “chemical detection on a chip” and is presently being sold to military and industrial customers worldwide.

In 2016, they spun off Owlstone Medical to develop and commercialize FAIMS technology in medical diagnostic applications with $31.5 million in funding taken in so far. The below diagram shows how their “Breath Biopsy” technology might replace single drop blood tests like the one Ms. Holmes was developing:With a full suite of tools for VOC analysis, an internal analytics team to outsource VOC research to, and a strong clinical trial pipeline, Owlstone Medical is getting close to bringing their  breath diagnostics tools to market and researchers can already place an order on the website. Their latest funding round led by Aviva Ventures this month netted the company $15 million which they will use to commercialize their Breath Biopsy tools globally.

New Jersey startup Menssana Research has raised undisclosed funding to develop a breath sample collection method that can be combined with quick off-site analysis for instantaneous results. Their BreathLink system requires a person to breathe into an instrument that measures their VOCs for two minutes. Information is encrypted and uploaded through a cloud application to a central laboratory, then analyzed with proprietary algorithms. Results are sent back to the point-of-care within minutes. Their “breathtaking technology” identifies breast cancer, abnormal mammograms, and pulmonary tuberculosis.

Evaluation to obtain FDA approval is currently underway with multi-center blinded studies funded by a $2 million grant from the National Cancer Institute. Menssana already offers an FDA cleared heart transplant rejection test to doctors, and recently created a “Breath Bag” as well that allows the collection of samples outside clinical environments.

Founded in 2015, Spanish startup Fossil Ion Tech received undisclosed funding to develop their iteration of a mass spectrometer. The SUPER SESI (short for Secondary Electro-Spray Ionization) produces a cloud of ions that charge vapor molecules upon contact. The procedure is done at high temperature to allow for better detection of low volatility species which carry greater biological significance (not all VOCs stay in gas phase at room temperature). Looks like they have a whole slew of products you can blow into:This technology uses lower energy levels, which results in high ionization efficiency, better precision and instantaneous results. The SUPER SESI product suite uses 11 patented technologies and comes with a proprietary analytical software called Ariadne. Products are available for laboratories and research institutes upon filing out an application and plunking down some cold hard cash.

Founded in 2015, Massachusetts startup New England Breath Technologies or NEBT has received a $25,000 grant to develop a breathalyzer that detects blood sugar levels. Diabetic patients need to check their blood sugar 4-12 times a day, which typically involves drawing a drop of blood every time from their finger. The procedure is invasive and moderately painful with adherence rates between 20-66%, which causes diabetic complications.The breathalyzer called Glucair registers the concentration of acetone in patients’ breath, which was shown to have a linear correlation with blood sugar. The two-person NEBT team has received praise from accelerator programs and the American Diabetes Association with plans to go to market in 2020. They’re not alone though, as it looks like some scientists across the pond in “Old England” are working on this as well.

Tennessee startup Cairn Diagnostics has raised undisclosed funding to create a breath test for gastroparesis. Gastroparesis is a condition in which the stomach cannot empty itself properly, affecting an estimated 1.8% of the population. According to medical research, the majority of cases remain undiagnosed impacting on the quality of life of people with this condition. Traditional scans measuring gastric emptying work with radioactive material ingested with a meal. The stomach is then scanned with a gamma camera to measure the rate of emptying of the stomach. Doesn’t sound so appetizing, does it?Cairn’s breath test works with Carbon-13 isotopes mixed into your pre-screening omelet instead of glowing plutonium rocks. As the stomach empties and the small intestine metabolizes the food, exhaled breath will contain CO2 particles made of Carbon-13 isotopes. Measuring the ratio of the exhaled 13CO2 over time and comparing it to the patient’s pre-meal value, the rate of 13CO2 excretion is calculated and the individual’s gastric emptying rate determined. Because the 13C molecule is naturally occurring and harmless, this test is much less invasive. It’s also quicker and more convenient. The test is FDA cleared and already available for MDs.

Founded in 2015, UK startup BreathDX has raised $1.2 million to develop a device measuring ammonia in the breath as an alternative to blood tests. Ammonia in the breath is a marker for a number of conditions, but most importantly for problems with the kidney. The company developed its AmBeR tests for home testing as well as clinical environments. Home testing options didn’t exist beforehand, so patients had to visit a hospital frequently to have their ammonia levels checked. Dublin City University licensed the AmBeR technology to BreathDX in August 2015 and also holds an equity stake in the company. Their funding of $1.2 million will be used to bring the device to market.

In addition to the seven startups we’ve covered so far, we also came across a few small companies that are publicly traded which may be of interest to retail investors.

Founded in 2015, Canadian company Breathtec Biomedical (CNSX:BTH) began trading on the Canadian Securities Exchange in 2016 and presently has a miniscule market cap of $10.5 million. The company is developing a test screening for cancer, diabetes, respiratory diseases and liver disease. Based on the same FAIMS technology that Owlstone Medical uses, the team has refined this method to come up with a sensitive, cheap and portable device that can be used in non-clinical environments as well, like airport border entry points.Breathtec Biomedical says “anything in your body that is eventually in the blood can be measured in your breath”. Now they just need to start selling the device and generating some revenues.

Founded in 2002, New Zealand company Syft Technologies (USX:SYF) has a market cap of $60 million and is listed on the Unlisted Securities Exchange, an obscure SME exchange in New Zealand. Their team has developed a new, advanced version of mass spectrometry called Selected Ion Flow Tube Mass Spectrometry (SIFT-MS). The technology uses “ultra-soft, precisely controlled chemical ionization” which takes highly sensitive measurements and produces analytics in real-time, much like the process of Fossil Ion Tech. It is used in the automotive, petrochemical, food processing, and medical sectors.Syft has been profitable for the past three years and is expanding with global offices in the US, Germany, and China. Clients include some big names like Samsung, LG, and Colgate-Palmolive and the team is gearing up for some M&A activity in the coming years according to an article by ShareChat which talks about plans for “selling between 500 to 1,000 of its instruments a year, generating revenue of between $125 million to $250 million, within the next five years”. That same article talks about how they’re looking at new markets like “developing a process to get rid of the ‘new car smell’, which many Asian consumers find offensive”. If you always drive a new car and you don’t have any Asian friends anymore, now you know why.

Breathing is the only automatic body function you can willfully control, and without it you would die or even worse, not be able to smoke cannabis. With advancements in mass spectrometry and molecular analysis, your breath will also become your diagnostic fingerprint, swapping out invasive methods like biopsies, blood tests, and x-ray scans. Johns Hopkins already uses breath analysis to diagnose four conditions, and as these companies mature that number is likely to grow. Maybe someday our HVAC units will become the first point of detection for diseases that afflict us.

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