01 Motivation

The central role of the heart muscle for the human body is not a new insight. This fact usually becomes most obvious when it comes to the consequences of dysfunctions and their frequency. More than every third US citizen suffers from at least one form of cardiovascular disease. The American Heart Association (AHA) also estimates that this figure will rise to around 44 % of the total population by 2030. This makes cardiovascular diseases the leading cause of death in the United States since 1919. Of these, coronary heart disease (CHD) is the main killer, accounting for 45% of all annual deaths [1]. In Europe, too, the heart is the organ with the most fatal disease cases. Here, CHD, also known as ischemic heart disease, is the leading cause of death with 119 deaths per 100,000 inhabitants [2].

„the one muscle that always has to work: the heart!“

When coronary heart disease shows symptoms, they usually manifest themselves in the form of chest pain. If patients take these signs of angina pectoris seriously and present themselves to their physicians, non-invasive examinations such as blood tests, echocardiography and, above all, electrocardiography (ECG) are usually carried out first, as recommended in international medical guidelines [3], [4]. In more than two thirds of these cases, the ECG is the first step in the medical diagnosis [5]. This allows a quick examination of the patient without having to expose him or her directly to radiation or invasive procedures.
Unfortunately, this „absence of side effects“ of the ECG is associated with limited diagnostic accuracy, as shown by corresponding studies: The sensitivity of electrocardiography usually fluctuates within a range of 50 ± 15%, which is why patients with chest pain are often discharged without good reason [6-12].

Another problem of CHD are asymptomatic courses. For example, it often manifests itself for the first time as a myocardial infarction or sudden cardiac death, which can cause permanent damage to the heart muscle or even death.

These numerous hurdles in the early diagnosis of CHD suggest the need for more accurate and comprehensive screening of potential risk groups. First of all, people with pre-existing cardiovascular diseases or known cases among their relatives are of course eligible for this. Other known risk factors for cardiovascular diseases include high blood pressure, obesity as well as cholesterol and blood sugar disorders. Low physical activity, a diet low in fruit and vegetables, as well as alcohol and tobacco consumption have been shown to increase the risk of these diseases [13].

Mag netocardiography (MCG) could be the alternative to these compromise procedures

To summarize: Like so many diseases, coronary heart disease can have numerous causes, such as other pre-existing conditions, even genetic, an unhealthy lifestyle or a combination of these. The most common symptom of coronary artery disease is a feeling of pain or pressure in the chest area, but it is not uncommon for it to initially progress without symptoms until it manifests itself in the form of a heart attack or sudden cardiac death. These conditions, combined with the fact that the most commonly used screening method, the ECG, has a comparatively low diagnostic accuracy, may be a possible reason why CHD is still the most common cause of death in most industrial nations,

The key to reducing these deaths may be a reliable detection and thus early treatment of the disease. Although imaging procedures such as cardiac CT or cardiac MRI have a significantly higher diagnostic information content than the ECG, they are associated with disadvantages such as exposure to radiation, contrast agents or a long examination duration and are therefore not a suitable screening solution.
Magnetocardiography (MCG) could be the alternative to these compromise procedures. It is a non-invasive procedure that offers the superior diagnostic accuracy of imaging techniques, while being faster to use and as safe to health as an ECG.

Our motivation is therefore the potential to become the new gold standard in the diagnosis of the widespread disease CHD and other cardiovascular pathologies, and our goal is the availability of an MCG in the major metropolitan areas.

to the references

02 System

During each contraction of the heart electrical currents are generated. Each of these in turn induces a magnetic field, which has field lines with a direction. With the CS-MAG X this information can be displayed in a 3D image with high temporal and spatial resolution. The decisive advantage of magnetic fields is that they penetrate the body almost unhindered. Only the combination of extremely sensitive superconductor magnetic field detectors with helium cooling system and a magnetic shielding chamber allows the cardiac magnetic field, which is several tens of poles smaller than that of the earth, to be displayed.

Software

In order to ensure that the recorded information offers reproducible and reliable diagnoses in broad clinical applications, several scoring models are currently being developed in research and visualized in our own developed software. The four most important scores are the PLP-Score, the T-Score, the VMCG and the T-Dispersion-Score. All scores are combined in the software to a total score in order to be able to derive a final diagnosis in the form of a traffic light scale.

System

CS-MAG X

In the CS-MAG X itself the patient is leaning backwards on an ergonomic couch positioned. The measuring cylinder is directed contactless towards the patient heart positioned to perform the stress measurement with a bicycle ergometer non-invasively and without any radiation exposure. During the diagnostic examination, a resting measurement is performed first. Then the patient operates the bicycle ergometer in five steps to increase the stress level. The post-stress measurement is used to check the complete loading process. The patented predecessor MCG systems being used for clinical research, for example at the University Charité in Berlin.

With the new generation CS-MAG X, the sensitivity of the measuring system has been further improved and at the same time the susceptibility to interference reduced. With the new design of the patient couch and the software, the user-friendliness of the system has also been improved for everyone involved.

1

Ergonomic Seat

To make the examination as comfortable as possible for the patient, an ergonomic seat is integrated. The seat settings documentation increases the reproducibility.
2

Measuring System

The so-called Dewar contains the measuring system and is directed contactless to the patient. It is adjustable up to 45° in order to be able to react variably to each patient.
3

Ergometer

The CS-MAG X uses a bicycle ergometer to allow the patient to be stressed without the need of pharmaceutical. It is adjustable in 5 steps and can stress the patient up to 750 Watt.
System

Squid

In order to precisely display the low strength of the magnetic fields generated in the heart, the CS-MAG X uses magnetic field detectors, the so-called SQUIDS (superconducting quantum interference detector). These high-precision measuring sensors enable a contactless measurement without side effects or the use of contrast medium. Originally used in geology to detect subtle changes in the earth‘s magnetic field at the surface or to detect geological layers, the SQUIDs are now also used in medicine. Magnetocardiography makes use of this functionality. However, it is only by the use of liquid helium, which cools the SQUIDs down to near absolute zero at -269 °C, that the superconducting properties of these sensors can be achieved. The 64 SQUIDs are located in a vacuum-isolated
cryostat. Only the connection with a magnetically shielded chamber to shield interfering magnetic fields like the earth‘s magnetic field enabled a significant improvement of the quality of the results. In addition, the closed helium circuit and the integrated preparation allows a resource-saving operation of the device.

System

Shielding Chamber

The CS-MAG X is delivered and installed including the shielding chamber. The chamber is magnetically and electromagnetically shielded with a so-called Mu-metal alloy. This is important to be able to visualize the cardiac magnetic fields generated in the heart, which are several powers of ten smaller than those of the earth.

In general, the chamber is built on a wooden construction. In addition, it consists of the mentioned Mu-metal alloy, the frame structure, the inner and the outer aluminum panel.

1 Wood Construction

The wood construction reinforces the frame system and connects the individual components to form a complete system.

2 Outer Panel

The outer panel forms the outer lining of the shielding chamber. It is kept in anthracite and bmp green to emphasize the affiliation to the company.

3 Frame Structure

The frame structure forms the basic structure of the shielding chamber. It is important, for example, to maintain the weight of the rest of the structure.

4 Inner Panel

The inner panel consists of aluminum plates and forms the inner lining of the chamber. With its friendly and bright design, it offers the patient a friendly atmosphere during the examination.

5 Mu-metal Alloy

Several layers of 0.35 mm Mu-metal foil are used in the shielding chamber to make the low-frequency magnetic fields of the heart visible.

03 Work Space

Inspired by our corporate identity, the MCG practices are furnished with green, gray and anthracite accents. The warm wooden floor creates a pleasant ambience and warm atmosphere. Patients are warmly welcomed in the open reception area. As recommended by bmp, the location should be as close to the center as possible in order to guarantee accessibility by public transport. Since the MCG is a highly sensitive device, it is recommended to use it in a location with the least possible radiation exposure from streetcars or other medical equipment such as MRIs. Due to the high weight of the shielding chamber, it is also not recommended to install the chamber in a skyscraper on higher floors to keep the weight load as low as possible.

The space required for an MCG system is roughly equivalent to that of a computer tomograph. The floor plan of the chamber is 3 x 4 x 2.9 m (WxDxH). A typical MCG practice contains at least five rooms/areas: The reception, a waiting area, a changing room, the workplace for the medical staff and the MCG chamber itself. This example includes the minimum equipment with the minimum space requirement. The practice can be expanded as desired, e.g. by adding more changing rooms or more workstations.

The practice should therefore be 10 m wide and 15 m long, about 150 m². The room height should be at least 2.9 m, so that the MCG chamber can be installed without problems. The basic concept of the practice is location independent and can be set up quickly and easily due to its clean design.

04 Service

The central link between the practice operator and the customer is the corresponding app. It allows existing users to easily make bookings and view their measurement results. Above all, however, the app is also intended to make interested people aware of magnetocardiography and thereby gradually expand the customer base. This will also be supported by targeted advertising for the app. Health-conscious users who have not yet undergone an examination appreciate the app because of its personalized lifestyle tips for improving general heart health, written by medically qualified personnel. Since the app also provides articles on magnetocardiography as a completely harmless examination method, readers can be informed about the technology and familiarized with its benefits without obligation.

Login / Registration

Service | App

After the download and a short self-description of the application, first-time users can create a profile to get access to personalized functions of the app like appointment booking and viewing of measurement results.

For this purpose, either the usual registration data, such as e-mail and password, can be assigned or the convenient way of linking existing social media accounts can be chosen.

Service | App

Information

The information tab provides users with clear explanations of all aspects of magnetocardiography and heart health. Existing as well as future customers can view summary articles about the examination procedure, the measured parameters and their meaning, but also about the technology behind the CS-MAG X,

general tips for a healthy lifestyle and answers to frequently asked questions. Regular updates keep existing content up-to-date and add new topics. The result is a vivid news feed for health-conscious people.

Service | App

Booking

The location of the nearest MCG can be easily found out via the booking page.

Registered users have the additional possibility to book, pay and edit an ex-amination appointment in the location of their choice directly in the app.

Service | App

Measurements

After the examination, the measurement results of the different parameters are displayed graphically and in text form in the app. Users can recall their explanations by simply tapping on the respective score. The evaluation is completed by an individually summarized medical report. The intuitive use of symbols and colors makes any need for action apparent at first glance.

If there are still open questions, a personal follow-up discussion can be booked directly in the existing view, both on-site and digitally. If multiple examinations have already been completed, one‘s own development and thus the progress of treatments and changes in lifestyle can be observed.

Service | App

Profile

Finally, the app is completed by the Profile tab. Here you can make changes to the app‘s behavior and especially to your personal information.

 

This means that users do not have to re-enter all data relevant to medical professionals every time they make a booking, but can manage and update this information centrally

Service | App

Dashboard

If you log in to the app with an account for qualified personnel, the app provides access to the practice dashboard. Here, operators can release appointment slots and manage bookings.

The integrated evaluation tools provide professional users with an overview of economic key figures such as the development of the booking numbers over time or the amount of new users.

05 Opportunities

The heart is the organ with the most fatal disease processes. For this reason, both prudent precaution and aftercare are important means of preventing heart disease such as sudden cardiac death. Every year, 1,975 inpatient cases per 100,000 inhabitants are reported alone in Germany, according to the German Society of Cardiology in the 27th German Heart Report. The use of the CS-MAG X offers potentials and chances for use in manifested heart diseases and post-operative treatments. Especially for people with a striking family history or for ambitious recreational athletes with an upcoming sportive challenge it offers the possibility to have their heart checked. Aftercare can be provided for people with an acute or recently survived heart disease. The CS-MAG X offers the perfect possibility to prevent and cure heart diseases.

The example of Germany shows which cities are suitable for the installation of a CS-MAG X. The minimum number of inhabitants for an ideal catchment area is about 800,000 people. Berlin, Hamburg, Munich and Cologne would be cities with enormous potential to operate an MCG. Two well-known German university hospitals are already working together with bmp.

With the CS-MAG III (research device) at the Charité in Berlin and other centers for research, approx. 6,000 patients have already been examined to proof function and results. The medical evidence is proven in several international studies in comparison to other diagnostic procedures of the heart. A complete heart check can be performed within 10 minutes.

As already mentioned at the beginning, CHD is the main cause of death in Europe with 119 deaths per 100,000 inhabitants. With 3,669,491 people, Berlin is the most populous city in Germany. Extrapolated, 4,366 people in Berlin alone could be saved from CHD with extensive screening.

Widening the availability of the CS-MAG X is important in order to be able to use the full potential of the MCG technology and form the new gold standard in the diagnosis of cardiovascular disease.

Opportunities

Cost Model

The following cost model illustrates that a MCG practice can quickly pay for itself even in a conservatively estimated scenario. Taking into account the acquisition costs for a device and the annual costs for its maintenance, the occupation of two MTA positions as well as the rent and additional costs in the cities of Berlin, Munich, Hamburg and Cologne, the break-even point is reached after just over a year with only one examination per hour.

Due to the short duration of the examination, however, it is easily possible to perform up to four examinations per hour, which can increase the annual result many times over.