KardioPal by Heartpal

Heart attacks are the leading cause of death in the world – Every sixth death is caused by a heart attack. The time that elapses from the recognition of symptoms to medical intervention is crucial for saving a patient’s life. More than half of the patients fail to reach medical assistance for 4 hours after their first symptoms appear – which is too late to prevent a heart attack and makes avoiding a fatal outcome severely difficult. KardioPal shortens that time. And saves lives. KardioPal is a device which helps you record your own ECG and immediately forward it to your cardiologist.

The KardioPal technology is fully functional at this moment. KardioPal is a smartphone-based diagnostic platform with a personal handheld ECG device providing the patient with timely diagnostic information in case of a heart attack. The current technology level corresponds to TRL 7: Demonstration system operating in an operational environment at a pre-commercial scale. It comprises a prototype series of handheld ECG devices, android smartphone application (signal acquisition, preliminary signal quality analysis in real-time, communication with server, GUI), server application (communication with android smartphone, signal quality analysis, reconstruction of 12-lead ECG, communication with diagnostic center, patients and calls databases) and diagnostic center application (communication with server, GUI, signal display, patients and calls databases display). The basic approach of the technology – reconstruction of full 12-lead ECG signal based on hand-held device 3 lead recording and patient’s individual transformation matrix has been validated in 4 clinical studies. The current smartphone-based technology has been validated in a clinical study (2018-2019) involving 40 patients in two hospitals (Belgrade, Serbia), showing excellent performance. The next step is the CE mark certification, taking about nine months to obtain.

Envisaged end users are patients or people with Coronary Heart Disease (CHD). Primary KardioPal users are people with diagnosed Coronary Heart Disease (CHD). These are people that have experienced “this kind” of chest pain and are highly motivated about it. In addition, there are people that are aware of having risk factors for CHD, like elevated blood pressure, high cholesterol, or diabetes.
The KardioPal technology helps the patient with timely diagnostic information in case of a heart attack. Since the product meets a specific clinical need, the main market segmentation reduces to patient groups: patients with diagnosed CHD, patients with risk factors for CHD (elevated blood pressure, high cholesterol, diabetes, smoking..), as well as healthy people concerned about their health (“worried well”).
Only in Europe, there are 30 million people with CHD diagnosed and almost a double more with one of the risk factors that lead to heart attack which accounts to 36% of all deaths. KardioPal sells portable ECG device they can carry anywhere. Devices are sold to hospitals that provide the service. In the future, the technology could be part of mobile phones and sold directly to manufacturers.
The product creates a new market category: an ultra-portable device that can detect heart attack without cables. So far portable ECG devices had cables and were larger (impossible to carry in the pocket), the measurement was less convenient (undressing and laying down required) and process longer (5-10 minutes instead of 30 seconds).

Compared to existing product categories, KardioPal belongs to ECG equipment and more precisely mobile cardiac telemetry systems. The market is enormous and grows rapidly:

• The global ECG market size was valued at USD 5.12 billion in 2018 and is estimated to grow at compound annual growth rate (CAGR) of 6% to reach USD 7.6 billion by 20252.
• The Europe mobile cardiac telemetry systems market is expected to reach US$ 478 Mn in 2027 from US$ 167 Mn in 2018 with CAGR of 13.0%3.

HEARTPAL TECH has developed KardioPal: a proprietary, smartphone-based diagnostic platform with a personal handheld ECG device. It is a handheld, anytime, anywhere cardiac diagnostic device providing the patient with timely diagnostic information in case of a heart attack.
Symptoms of cardiovascular disease (CVD) usually appear suddenly and unexpectedly, and often rapidly degenerate into a life-threatening emergency. Patient’s reaction time to these symptoms can make a critical difference to the ultimate medical outcome. Hence, an always available, personal device for detecting all major cardiac conditions would be a significant advance in timely treatment of CVD - the global leading cause of death. To address this important unmet need, we have developed a highly innovative, smartphone-based cardiac diagnostic mHealth technology that is easy to use, individualized (individually calibrated for each user), and diagnostically accurate.
Patients record and transmit their cardiac electrical signals by simply pressing the KardioPal device against their chest. No wires, no ECG machine and no technician are required. Despite its simplicity, the KardioPal technology can accurately monitor a broad range of cardiac conditions, including acute and chronic Coronary Heart Disease (CHD). For these conditions, and specifically for AMI (Acute Myocardial Infarction - heart attack), no convenient, user friendly and accurate outpatient monitoring device currently exists.

Cardiovascular diseases (CVDs) are the number one cause of death globally: more people die from CVDs than from any other cause (31% of global deaths). In the most urgent situation in cardiology - heart attack (Acute Myocardial Infarction, AMI), it is crucial to recognize symptoms and respond immediately. AMI survival rate dramatically depends on symptom-to-treatment time. The preferred AMI treatment is a reperfusion technique called PCI. The sooner reperfusion occurs, the more likely the patient will have good results. The application of PCI during the last 20 years has led to impressive reduction in AMI mortality. Unfortunately, its full potential has not been realized - many patients do not reach hospital in time to benefit. Studies show that only 1 in 5 patients reach hospital within 1 hour from the onset of symptoms - the period when benefits from reperfusion therapy are maximal.
Several sources of delay inhibit the early application of reperfusion. In the delay from the onset of AMI symptoms to reperfusion, the period from symptoms onset to the patient's action to seek treatment (going to the hospital or calling an ambulance) is the longest component of the delay and contributes with 60% to 70% to the total symptom-to-treatment time.
The conventional ECG is a standard of care in cardiology and lies at the center of the decision pathway in AMI diagnosis. Accordingly, motivation to find an efficient way to obtain patient’s ECG during AMI symptoms is a possibility for substantial reduction of the total symptom-to-treatment time.
KardioPal addresses the problem of early and correct detection of AMI, having the ability to provide real-time diagnostics: inform the patient to seek medical help in case of AMI or provide relief in case of non-alarming symptoms.

The cardiovascular handheld diagnostic ECG devices market is growing rapidly. Numerous producers and devices/services with a variety of features are accessible at reasonable prices. There are two groups of devices, both with strengths and weaknesses:
a) One lead devices: The majority of handheld ECG devices record only one ECG lead, such as Apple Watch, AliveCor, WIWE2 and ECG check. These devices typically use integrated electrodes - no cables, but can only be used to detect arrhythmia (irregular heartbeats), and cannot be used for AMI detection where full 12-lead ECG is necessary. Since KardioPal mainly targets AMI, 1-lead devices do not represent direct competition.
b) Devices with cables: These devices deliver conventional 12-lead ECG by attaching either cable electrodes (Aerotel’s HeartView, CardioSecur), or specially designed electrode belts (Shahal’s Smartheart). They are supposed to be precisely positioned on the patient’s body. Both ways (using several cables) are unpractical/uncomfortable, especially for a patient potentially agitated due to AMI.
The crucial advantage of KardioPal over the competitors is the use of integrated electrodes - no cables (as in group a), and delivering conventional 12-lead ECG (as in group b). Therefore, KardioPal clearly outperforms the competition, by offering to users a life-saving device that is exceptionally easy to use.
The most serious competitor seems to be CardioSecur, using only 4 electrodes/cables for the ECG recording.
Competition pricing:
• Arrhythmia only devices:
o Apple Watch: $529/device
o AliveCor: $99/device; $19/physician’s interpretation, $9/technician’s interpretation
o WIWE: €380/device
• 12-lead delivering devices:
o Shahal (US): $500/device, $20/month subscription;
o Shahal (Israel): $56/month subscription (including device), $9/consultation;
CardioSecur: €199/device, €19/month subscription, €1.40/electrode package.

KardioPal is an easy-to-use, reliable and always accessible device for patients or people with Coronary Heart Disease (CHD), providing them real-time information on the type and severity of symptoms if these occur. An effective outpatient ECG device for detecting AMI must offer a standard 12L ECG signal containing all relevant clinical information. The KardioPal technology prototype already meets this stringent and important standard using a device with only four integrated electrodes - without using cables. Patients record and transmit their ECG by simply pressing a handheld device against their chest.
The crucial advantage of KardioPal over the competitors is the use of integrated electrodes - no cables, and delivering conventional 12-lead ECG. Therefore, KardioPal clearly outperforms the competition, by offering users a life-saving device that is exceptionally easy to use.
At present, there is no competitor with a comprehensive, user-friendly cardiac mHealth solution for addressing AMI detection outside the medical office.
Among all other existing Hearth attack + Arrhythmia detection devices in the market, Kardiopal is the only one that has no wires/cables, no undressing needed, no ECG machine and no technician are required.

The initial revenue model for KardioPal is consumer/patient subscription based. There are about 30M individuals with IHD (Ischemic Heart Disease, a condition causing AMI) in Europe. Based on that and at a conservative subscription rate of €10/month, the total available market for KardioPal services in Europe is estimated to be €3.6B.
The potential market in Serbia counts around 365,000 people (patients diagnosed with IHD). With a conservative assumption of 2.5% potential users as early buyers, the Company should quickly become profitable (~ €1.1 million annual revenue at €10/month).

KardioPal generates revenue from 3 sources:
1) Sale of device
The retail price of 300 EUR is in line with existing competitor devices (which are larger to carry, include cables and require more time to measure and undressing). Retail partner (e.g. pharmacy chain) would keep 30% as margin in line with existing industry standards. We estimate we can reach production price of 60 EUR relatively quickly. This would allow us to reach 50% gross margin => 300 EUR (price) – 90 EUR (30% retail margin) – 60 EUR (production) = 150 EUR (margin)
2) Subscription
Customers pay a monthly subscription of 30 EUR and get 24/7 access to call center with cardio specialists. We share revenue with hospital that runs call center 50-50 so they keep 15 EUR per patient. On the other side, our entire 15 EUR, become gross margin as server costs and technical maintenance costs become negligible with the higher number of patients/doctors.
Our price is significantly cheaper than competitors ($561). We go after mass adoption as we count on our costs per patient accelerating down with economies of scale.
3) Sale of user data
The data we will collect is very valuable not only for patients themselves but also for scientists, producers of ECG devices as well as for pharma companies.
Our technology is to a great extent ready (CE mark certification to be obtained): pocket handheld ECG device, Bluetooth-connected to a smartphone, a smartphone application, and a data processing central server. Commercialization will come in two steps:
1) Pilot launch with a medical partner/hospital with 150 patients (Q3 2021)
Before the pilot study, we have to scale up the software infrastructure, produce the first larger batch of devices and finalize an agreement with the medical partner/hospital. Based on the discussions so far we expect to rent them for 20 EUR per device or 3000 EUR in the first month. Pilot study will serve to get feedback on our service and to test infrastructure in real conditions on limited number of devices before going live.
2) Launch after receiving CE Mark (Q4 2021)
Upon receiving CE Mark, we can start selling in Serbia with a single partner that we will offer 12-month exclusivity. We are giving exclusivity in exchange for advance payment for additional devices as well as a significant marketing campaign. In Serbia, we are already talking with decision-makers with the 4 most desired partners. Working on expansion to EU countries will start right after the pilot study. Concrete results abroad and the first signed contract we expect in Q4 2021.
If we take conservative COGS=Device price in the beginning, break-even analysis boils down to subscription services on call center per country basis. Minimal capacity call center requires 4 FTE doctors which including other expenditures account to 9150 EUR per month in Serbia. With 15 EUR monthly margin, break-even comes at 615 customers. Long term profitability that covers operational expenditures as well as further R&D and 20% EBITDA would start at 3000 customers although both potential and our ambition are higher in Serbia alone and especially in EU market which is our focus in mid-term.
Profit margin is increasing both in devices sale and in monthly subscriptions. Device margin increases as early on due to small quantities we have artificially high per-device production cost. As for the ongoing call center service, we will see over time not only higher utilization due to optimal doctors/patients ratio but also more efficient processes due to division of labor between doctors and other medical staff. Additionally, in long run, we plan to get CE Mark and FDA approval to automatize fully some of the decisions to algorithms so that speaking with doctors remains only a premium service.

Currently testing 4 different approaches :
1. Mass market
-Device distribution to customers via retailers e.g. Amazon
-Independent cardiologists provide service using our white label software
2.Through Medical Partners
-Selling devices and SaaS to medical partners, who provide the service to patients (run the call centre and distribute devices)
3.Through Payors
-Selling devices to patients through payors (health insurers)
-Execution of services through payors’ medical partner
4. Standalone
-Operating our own call center, employing cardiologists
-Selling devices to patients via our website, mobile app sales via app stores

Money will be spent on the completion of the certification process, production of devices and commercialization of the product.

It will be addressed in the process of negotiation

Timing, milestones and results :
1) Low patients enrollment rate in the clinical study
3) Extension of period for obtaining CE mark certificate.
Partners:
1) Inability of medical institution to participate in a clinical trial
Budgetary issues:
1) Additional funds needed to get the CE mark certificate.
Market risks:
1) Slow expansion due to local m-health legislation in each individual market
2) EU Patients reluctant to pay out-of-pocket for medical services
3) KardioPal reminds people of something they would rather forget

Participated in the programs organized by Innovation Fund of Republic of Serbia

Balkan Venture Forum 2014/ first prize in life sciences competition

KardioPal platform has been protected by two patents filed in 2019 (Serbian and international/PCT filings for both patents):
Device housing: specific device construction optimized for maximal ECG signal quality, also solving the problem of electrode wearing.
Signal processing: specific signal conditioning approach enabling high diagnostic accuracy.