What is Atherosclerosis?
Visionary Health Services (VHS) aims to detect early-stage atherosclerosis in the cardiac region. Atherosclerosis is the build-up of plaque (fat substances) in your arteries. At a low level of plaque, there are no symptoms or ill-effects. Late-stage atherosclerosis is the precursor to most cardiovascular diseases (CVDs) such as heart attacks or strokes which are often deadly. Quite often, there is no visual symptoms before a cardiovascular event. Thus, patients that could have undergone lifestyle changes or statin therapy and avoided death didn’t because of a lack of knowledge of their condition. (NHS, 2019) (NHLBI, 2022) (NHLBI, What Is Coronary Heart Disease?, 2022) (Cheong, 2020)
Image: https://www.physio-pedia.com/Atherosclerosis
Heart Disease in Serbia
Serbia has one of the highest rates of CVDs in Europe: 448 out of every 100,000 Serbians die of CVDs per year (Jankovic et al, 2022). Ischemic Heart Disease is the most common CVD in Serbia which is almost exclusively caused by atherosclerosis. They are also are the biggest cause of years lived with disability (excluding depression) and the biggest cause of working days lost in Serbia. Approximately 42% of adults will have some level of atherosclerosis, with 5.2% of those having significant obstruction and 2% with severe atherosclerosis (MediLexicon International, 2022). Atherosclerosis rates in Serbia are presumed to be even higher than the global average due to lifestyle choices (for example high levels of smoking) but also due to systemic problems, like insufficient access to diagnosis and lack of trust in the public health system. This means there are over 800,000 people with atherosclerosis in Serbia.
In addition to the lives lost, the high levels of heart disease in Serbia also has a significant economic burden. The total costs of CVD in 2009 for the Serbian government was € 400 million, with hospitalization, surgery & diagnosis accounting for 60.13% (Lakic et al., 2014). Lower hospitalization rates has the biggest impact on direct CVD costs in Serbia. In addition, it is estimated that half a million working days are lost per year in Serbia due to CVDs. CVD related disabilities in Serbia cost approximately € 11 – 11.6 million in productivity per year. The economic burden of years of life lost due to CVD is estimated to be € 102 – 104 million (Lakic et al., 2014). The total CVD costs per year in Serbia is € 514 million.
Healthcare Problems in Serbia
Trust
During research it was noted that there is a lack of trust tin public institutions in which where exacerbated when talking about health.
Access
Over 44% of the Serbian population is rural and most do not travel beyond their area of comport to access healthcare services.
Continuity
Through the combination of lack of access and trust, continuous healthcare is very difficult in Serbia which is particularly important in treating heart disease.
Serbian Market Sizing & Analysis
The population of Serbia is 6.8 million people. It has an increasingly aging population with 41% of its population over the age of 50 which is the best age to start getting your heart scanned in order ro prevent atherosclerosis from developing into CVD. This means that there are 2.8 million people in Serbia who need to be scanned every 5-10 years. Each scan would take under 30 minutes for the whole appointment, which means that each scanner has the capacity to do 16 scans per day, 96 per week (6 day work work) or 4,992 per year.
Since patients only need to be scanned every 5-10 years, each scanning machine could serve 37,440 Serbian patients (assuming 7.5 years between scans). Using these numbers and the population of each Serbian province we have concluded that 55 machines could cover 73% of the population. To view the region coverage, capacity and placement of these scanners please click here. Most of the population we are not covering are located in Belgrade where CT scanners and access to healthcare is better and VHS would have a lower impact.
How do we detect it?
As the build-up of plaque progresses, calcification starts to occur:
Since calcium is denser than anything else in the cardiac region, these spots of calcified plaque are easily seen on a CT scan:
Since calcium is denser than anything else in the cardiac region, these spots of calcified plaque are easily seen on a CT scan:
Atherosclerosis is the only cause of artery calcification, which makes the diagnosis capabilities of this scan (known as Coronary Artery Calcium scanning or CAC scanning) excellent. (Devarashetty, 2021) (Greenland, 2018). The Agatson score is used to quantify the amount of calcification present in a patient. It gives a single number based on the density and number of calcium deposits on every slice of the scan. The results are a clear and internationally accepted risk stratification that includes concise guidelines for lifestyle modification, statin therapy or surgery. The diagnostic given is much better than those obtained in classical risk analysis. (Neves, 2017) (Cheong, 2020). A score of zero (no calcification present) is a good indication of excellent cardiovascular health, predicting an almost zero chance of having a cardiovascular event in the next five to ten years. A patient is diagnosed with atherosclerosis starting at 100 and considered high risk above 300.
Using POSICS-2 to reinvent CAC scanning.
While this technique boasts amazing results, it is not widely used largely because of the costs and inconvenience of getting CAC scans.
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To detect small pearls of calcium, with an area of the order of 1mm^2, slices with a width of about 3mm are used (Neves, 2017). In order to keep radiation exposure to a minimum (ideally under 1mSv (Blum, 2013) (Cheong, 2020), while looking for such small features, high slice count CT scanners are needed. The more modern machines, normally reserved for cardiac scans and other advanced imaging techniques, use 256 slices. These scanners are extremely expensive and out of the question for all but the biggest hospitals. Thus, conducting extensive CAC screening faces an impossible dilemma: either subject a large portion of the population to a much higher radiation dose than needed by using widely available cheaper scanners. Or completely saturate the few CT machines available and leave other urgent procedures unattended or undiagnosed.
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We propose a machine that, by focusing exclusively on the cardiac region, significantly simplifies the necessary mechanical construction and streamlines the user experience. By using POSICS-2 the costs are greatly reduced, both due to the possibility to use standard semiconductor fabrication procedures and by exploiting the intrinsic amplification of the APDs to simplify readout electronics while preserving the necessary sensitivity.
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By having total sensor dimensions of height of 4cm and a width of 2mm, each pixel having 0.1mm height and 1mm width, we get a scanner with 400 slices, more than enough to guarantee the necessary low dose and to detect even the smallest calcifications. We would have a dedicated 12 bit 200MHz ADC for digitizing each channel, and all the readout data would be streamed directly to processing systems on the cloud. This allows us to correct in software things like pulse pile-up before image reconstruction that would be much more difficult to do in hardware.
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In total, including all the electronics, design and development, material costs, etc… we predict our unit to cost about 30k, more than on order of magnitude cheaper than existing solutions.
As explained in our previous research, one of the systemic problems that plague healthcare in Serbia is the lack of trained professionals. Thus, if we were to significantly increase the number of scans, we would very easily reach the maximum number of scans that could be processed per day and thus simply moved the bottleneck from the scanning to the processing of the results.
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AI can be trained to automatically calculate the Agatson score using the provided images from the CT scan. This would significantly alleviate the unwanted pressure our solution would introduce into the public healthcare system (we would essentially take care of the entire diagnostic process and only leave up to the state the actual treatment).
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Significant research in this area already exists, as can be seen from the numerous research papers published on the topic (Brunner, 2010) (Martin, 2020) (Velzen, 2020) (Vonder, 2022) (Choi, 2022). This idea is thus well validated and has a sound technical foundation.
It’s not just the scan, but also who evaluates it.
The main roadblocks to a more extensive application of this automated diagnosis lie in it's legality (which we solve by having a qualified, fully out-sourced doctor validating them) as well as obtaining all the images with the same parameters (tube voltage and current, number of slices, etc...) which we solve by integrating the whole system and working only with our machines.
Impacts of Visionary Health Services
With 55 scanners across Serbia VHS could scan over 2 million patients. According to the Serbian government 53% of all deaths in Serbia are caused by CVD, which means approximately 47,000 people are dying per year from CVDs. Some studies have shown that with proper use of lifestyle changes and statin up to 90% of CVDs could be prevented (Boisclair et al., 2018). Approximately 109,500 people in Serbia have severe or significant atherosclerosis and are very likely to develop CVD in the next 5-10 years and VHS could prevent or delay many of them.
VHS would also have a significant impact on the cost of CVDs in Serbia. In 2009 Serbia spent € 16,280,000 on diagnosing coronary heart diseases, with cost of € 31.22 per diagnosis (Lakic et al., 2014). This would be approximately € 41 per diagnosis in 2022 using inflation. Doing a unit cost analysis we predict that the per diagnosis cost using VHS will be € 8.41 which is a 75% drop in unit cost.
With 73% coverage, VHS will likely lead to a costs savings of € 7 million per year for the Serbian government just in diagnosing costs. The biggest cost of CVD is hospitalization and surgery and since lifestyle changes and statin medications are significantly cheaper and more effective, we predict that VHS will also significantly reduce these costs. A 25% reduction in CVD mortality (WHO target) could result in a 9% decrease in hospitalization costs which could mean an additional savings of € 2.2 million per year for the Serbian government (Boisclair et al., 2018).
Economics
Economic burden of Cardiovascular Disease (CVD) in Serbia = 1.8% of GDP.
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Serbian GDP: $63.07 Billion.
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Therefore the current total economic burden of cardiovascular diseases in Serbia = $1.1 billion.
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Potential economic saving of 0.9% of GDP by 2045 ($567.63m) based on WHO target of 25% reduction in mortality (Adjusted for Serbian healthcare spend)
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Total Healthcare spending is 8.67% of GDP – or $4.5 Billion USD (2019) which means Government could potentially be making a saving equal to 0.55% of entire public health budget on a yearly basis ( - approx. $25M/year)
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https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS?locations=RS
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“If left to get worse, atherosclerosis can potentially lead to a number of serious conditions known as cardiovascular disease (CVD). There will not usually be any symptoms until CVD develops.”
Total Funding Ambition: Eur 7,949,000
This does not include European Medical Device Regulator (EU MDR) Approval
CAPEX: (55 Machine Rollout)
3 Yr Pilot Cost-Up
25000/Device - Materials
5000/Device - Manufacturing
1000/Device – Installation
10000 - Total Shipping
OPEX
1000/yr – Servicing
285/yr - Operator Training
50,000/yr – Awareness Campaign
24,000/yr - Web Development and Maintenance
Doctor, Pharmacist + Analyst Salaries
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52k x 4 specialist (624,000 over 3 yrs)
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32k x 20 docs (1,920,000 over 3 yrs)
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15k 55 machines (2,475,000 over 3yrs)
1000/yr - AI Diagnostics
Eur 1,375,000.
Eur 275,000.
Eur 55,000.
Eur 10,000.
Eur 165,000.
Eur 825,000.
Eur 150,000
Eur 5,019,000
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Eur 3000