Business Summary
Health-E-Nose is an innovative gas sensing technology which aims to use human breath as a diagnostic tool. Our breath is rich in information, containing hundreds of compounds which can provide insight about our health, but there has never been a good technology for using breath as a diagnostic tool at a population level. However, by using a combination of computational chemistry and big data techniques, we are designing handheld gas sensing arrays, better known as electronic noses, which can quickly analyze breath for biomarkers indicative of lung cancer, the single deadliest cancer worldwide. By providing screening during routine doctors’ visits, we can increase screening rates and catch lung cancer early, improving treatment outcomes and saving on treatment costs. As the technology matures, we will expand our platform to screen for other diseases with known breath biomarkers, such as kidney and liver disease. Overall, the goal of Health-E-Nose is to build a low-cost, portable, and non-invasive medical device which makes healthcare more accessible, less expensive, and improves patient outcomes.
Check out our introductory video below!
Customer Problem
Lung cancer is the single deadliest cancer in the United States, responsible for around 150,000 deaths per year (25% of all cancer deaths), more than colon, breast, and prostate cancers combined. It amounts to $14B in national healthcare costs ($180B worldwide), and an additional $36B in lost productivity each year. Unfortunately, symptoms rarely appear until late-stage disease and screening rates are extraordinarily low, with only 5% of the high-risk population receiving their annual screening. Consequently, lung cancer is rarely detected until it is in the late stage, when survival rates are lowest, around 7%. When diagnosed at earlier stages, survival rates can be anywhere from 50% to 90%. The current screening method, low-dose helical computed tomography (LDCT), is also of limited utility, preventing only 3 lung cancer deaths for every 1000 people screened, while causing 356 false alarms (94.5% false positive rate).
Technology & Intellectual Property
Health-E-Nose is a handheld gas sensing array, known as an electronic nose, which can be used as a point- of-care screening device for the detection of biomarkers in breath which signify lung cancer. The device consists of three main components: single-use peripherals for the collection of breath samples, hardware for measuring the breath sample, and software for analyzing the results. Primary care physicians (PCPs) can use this device during routine visits to quickly screen patients with a high-risk of developing lung cancer. With a negative result, the doctor can confidently decide not to pursue additional screening, and with a positive result, they can prioritize additional screenings such as an LDCT and biopsies.
The technology behind Health-E-Nose is a new class of gas-adsorbing materials called metal-organic frameworks (MOFs). Thousands of MOFs have been identified, and we firmly believe that the right combination of MOFs for most gas sensing applications already exists, and that the true challenge is in identifying this combination of MOFs and developing the corresponding analysis. To address this, we use various computational chemistry and big data techniques to accelerate the selection of sensing materials in ways that would never be possible experimentally. As the technology matures, we can use these same techniques to expand beyond lung cancer and begin targeting breath-based detection of liver disease, kidney disease, and many metabolic diseases, all of which have known breath biomarkers.
We have published several scientific papers about this technology and have been awarded one provisional patent (WO 2018/140696 A1). We are also in the process of preparing two more scientific papers, and an additional patent application.
Target Market / Market Analysis
Globally, the 2021 lung cancer screening market was valued at $2.8B and is expected to grow to $4.85B in 2028, with a compound annual growth rate (CAGR) of 8.1%.In the United States, annual screening is recommended for patients between the ages of 50-80 with at least a 20 pack-year smoking history, corresponding to a high-risk patient population of 14.5M adults. However, between the 94.5% false positive rate and relatively high radiative dose, many PCPs forgo lung cancer screening to focus on more immediate health issues. By offering doctors a safer and more reliable breath-based screening alternative, we can increase screening rates and early detection of lung cancer, resulting in is increased survival rates and reduced treatment costs of $22K per patient, equivalent to $3.3B in savings nationally each year.
Furthermore, there is a precedent for this shift in the approach to cancer screenings. Until recently, colorectal cancers were screened for with a colonoscopy, but doctors have begun using non-invasive stool tests, such as Cologuard by Exact Sciences, currently valued at $10.5B. Similar to Health-E-Nose, negative results help doctors to decide not to recommend a colonoscopy, but patients are expected to continue screening with Cologuard. Positive results, on the other hand, require a follow-up colonoscopy to confirm the diagnosis, just as a positive result with Health-E-Nose should be followed up with an LDCT scan. Additionally, because of the non- invasive nature of Cologuard, screening rates for colon cancer have increased with its introduction to the market. We view Health-E-Nose as the lung cancer screening analogue to Cologuard, with Cologuard demonstrating the enormous market potential for our device.
Marketing & Regulatory Strategy
Like Cologuard, our goal is to sell our devices directly to PCPs. There are approximately 210,000 PCPs in the United States, each responsible for anywhere from 500 to 2500 patients. We plan to start sales by targeting PCPs in internal medicine, geriatrics, and with high Medicare populations, as they serve a larger portion of high-risk patients. We want to use a combination of direct sales lines, which gives us flexibility in our pricing, and partnerships with distributors, who can increase our market reach and streamline the purchasing process, thus lowering customer acquisition costs. Furthermore, we intend to partner with local health systems, such as the University of Pittsburgh Medical Center (UPMC), during the research and development stages to establish a network of key relationships early.
By capturing a health system the size of UPMC, which employs around 1,500 PCPs (1⁄3 in geriatrics or internal medicine) each with 1,500 patients (1 in 10 high-risk), we would be screening 75,000 patients per year for an initial serviceable market of $15M (revenue of $30K / PCP).
Currently, no device would be deemed substantially equivalent to Health-E-Nose and thus we plan to apply for FDA approval as a Class II De Novo device. Prior to applying, we will utilize the FDA’s pre-submission process to help prepare a successful application. For FDA approval, we will need both clinical and non-clinical data. To simplify reimbursement for providers, Health-E-Nose will need to obtain a new CPT code.
Competitors & Competitive Advantage
Aside from the existing screening method of LDCT, there are very few direct competitors, and most are startups themselves. Our closest competitor is Cypath Lung of bioAffinity Technologies, which uses sputum (phlegm) as a sample type, however sample collection is difficult and takes place over a three-day period. There is also the Breath Biopsy of Owlstone Medical, a breath collection device which is shipped to a facility and analyzed by gas-chromatography mass-spectrometry, an expensive and low-throughput form of analysis. Health-E-Nose, on the other hand is a rapid, point-of-care, breath-based screening tool which can be used to screen a large number of patients quickly and easily.
Founders & Management Team
The Health-E-Nose team is lead by Brian Day, a PhD candidates in chemical engineering at the University of Pittsburgh. Our primary advisors are Dr. Christopher Wilmer, and tenured professor at the University of Pittsburgh, and co-founder of NuMat Technologies, which uses MOFs for gas storage and separations, and Kelly Collier, an entrepreneur-in-residence at the University of Pittsburgh’s Big Idea Center, who is the former founder of an exited medical device startup company and former corporate innovator at UPMC‘s corporate VC and innovation group.
We have won numerous business plan competitions in the past, including the Pitt Innovation Challenge (PInCh), the Big Idea Blitz, the Big Idea Blast, the Randall Family Big Idea Competition, the Pittsburgh Data and Management Alliance Competition, and TiE Pittsburgh. We recently finished participating in the University of Pittsburgh’s Innovation Institute’s Forge Program, an accelerator for student entrepreneurship, and will be joining Pitt Venture First Gear program this Summer.