Innovatie

Cardea3EGA

Opschaling

We previously showed that detection of depression is accurate by nonlinear analysis of electroencephalogram of a patient. Recently we added the decision support service for detection of depression by utilizing variability heart rate, which is possible and easy with portable heart monitoring. By utilization of this portable device, we can detect both dangerous cardiac irregularities and abnormal complexity characteristic for unipolar depression, which is forecasted to become the second largest cause of disability before 2030.

Medisch technologische innovaties

(Tele)monitoring

Wearable

Regio Noord-Holland

Milena Cukic

https://3ega.nl/en

Probleemstelling

Most cardiac deaths are due to dangerous (malignant) arrhythmias, most often due to the inability to get timely and accurate diagnostics. Arrhythmia is a predictor of stroke and a heart infarction, but with wearing a classical holter only some 30% of them are detected. Variability heart rate showed to be changed in people having depression as well as burn out syndrome. It is well established in the scientific literature that cardiac irregularities are related to majority of mood disorders and variability heart rate is a good biomarker for that.

Oplossing

The World's most advanced portable heart monitoring solution.
Cardea-3 is intended for fast detection of heart rhythm disturbances. It can be used
at homes or in clinics and hospitals, both by medical experts and by the general
population. It learns through AI and is proven to have a clinical level of accuracy as standard 12 leads ECG device.

Doelgroep

healthy individuals/customers who are aware of the need to monitor their health. Or who want to help their old parents to monitor their health in cooperation with their dedicated doctors. Medical professionals like family doctors, physiatrists, psychiatrists, caretakers in nursery homes and hospitals. Also, sport trainers, those who are engaged in any sport, professionals or amateurs. Until now we communicated the idea with organization of family doctors, several smal clinics for physiatric rehabilitation as well as some medical professionals and psychiatrists.

Verdienmodel

The Cardea-3 device will be sold to the general public (cca 30% revenue generation) and medical professionals (cca 70% revenue generation) as identified above and proposed as a device+app only or including reading / interpretation service.

The following revenue channels are foreseen:

General public/ sportsmen via a dedicated online channel.
 Device + base application only
 Device + base application /specific application + reading service (subscription model)

Medical professionals
Via business development ambassadors (paid on commission) as well as directly through a dedicated online channel (in the main online shop) and proposed in the following packages:
Direct / online sales
 Device + base application only
 Device + specific application (i.e. physiotherapists)
Subscription model
 Device + base application /specific application + reading service (subscription model)
The promotional price for devices will be 249 EUR, but we are going to focus on seling service to most of our professional customers. The model of selling it via mobile operators with the 2-year contrats is also an option. Monthly costs of premium package for analysis would be 10-12 EUR.

Geïnvesteerd vermogen

€ 1-10 miljoen

Concurrentie

WIWE-gadget (Cardioloogie Centra Netherlands) HartWatch, telemedicine application fully reimbursed (with one channel only; Cardea-3 has three leads recording plus authomatic recognition of arrhythmias)

Unieke kenmerken

Medical-grade ECG anytime, anywhere. The device is small enough for your pocket. No preparation needed. Early detection of symptoms. Uses dry electrodes. State of the art machine learning and artificial intelligence. Works on all skin types and without the need to shave. Automated messaging and multiple profiles. Advanced analytics. Store your heart data over time to reveal greater insights.

Intellectueel eigendom

We applied for Provisional Patent in 2017 in the USA, but later withdrew it. we realize that the best protection is to have a product on market. Trade secrets serve you better than official Patent, according to our experience.

Organisatie

3EGA is operating in the Netherlands from 2017 based on previous scientific research held in several different neuroscience laboratories, and Humeds is working in the field of developing electronic devices. Since the previous concept of detecting depression with the utilization of electroencephalogram showed that a good decision support service is possible, we opted to use variability heart rate as another biomarker and broadened the concept to detect both heart irregularities and physiological complexities of depression.

Beschrijving pilotfase

After Serbian validation of Cardea3 we started research with Universidad Complutense in Madrid, Spain to confirm the possibility of differentiating between unipolar depression and bipolar depressive disorder based on measurements of variability heart rate(VHR). We also have an ongoing study in Slovenia, Ljubljana Clinical Center (Psychiatry department) in order to forecast the sucess of a treatment (transcranial magnetic stimulation) based on changes in VHR. Another validation is organized with a small physiatric practice to monitor the progress of midle-aged healthy people who are trying to improve their overall physical health.

Betrokken partners

Universidad Complutense in association with la Clínica Nuestra Señora de la Paz de Madrid (pertenece a la Orden Hospitalaria San Juan de Dios), Madrid, Spain; Clinical Center Ljubljana, Psychiatry department, Slovenia; Fysiotrain practice, Amsterdam the Netherlands; Humeds, Belgrade, Serbia

Aantal gebruikers pilot

11-100

Onderzoeksresultaten

We have only preliminary results until now, only partially published with our Spanish partners

Rapportage pilot

CAEPIA2018_paper_84.pdf

Implementatiestrategie

We are planning to start with selling the device to the customer market, basically selling the clinical level of measurement device over the counter. Also, medical professionals working as physiotherapists showed interest in using it for monitoring the progress of their patients in rehabilitation, as well as family doctors who can prevent unnecessary visits of patients to urgency units. The nursery homes may use this option for monitoring every patient on daily basis without of engagement of medical staff, and trainers can prevent cardiac arrest in people who are active in the sport by monitoring their heart rates regularly. Those in GGZ can use this wearable device to easily find out about the depression and even burnout. Burnout is also interesting for ARBO Artzs, or Company doctors, in order to prevent risks and detect early something which may lead to unability to work for longer periods. End users can cooperate with their medical specialists but they have the opportunity to record their ECG whenever they feel something strange. Even wearing a Holter lead to detection of just 30% of arrhythmias, which is not good enough for prevention. Certain clinics can opt to collect and monitor the data, especially if they suspect that something is developing.

Behaalde prestaties of gewonnen awards

3EGA was awarded with Acceleration Program HealthInc (AHTI) in Amsterdam by recommendation of Martijn de Boer, an Innovation Manager in Gemeente Amsterdam in 2017, also on a business side of IAmsterdam. We were also involved in Diatomic Conzortia Program 2018, at the moment competing for the second round of Diatomic European Commission Funds. Several publications with our results from last five years research in the field of automated detection and classification in mental healthcare are online, and a book about the novel approaches to treating depression are expected to be published on spring 2019.

Productontwikkeling

We are planning to start offering Cardea3 device to the general population but also estabilish coopeation with interested medical professionals who can use it for monitoring of their patients state. Those can be familly doctors (the visits to secondary care can be rationalized), physiatrists who want to make more secure rehabilitation process of their patients, or to encourage them with showing them a progress in figures, or psychiatrists who have problPsihijatrija i fizijatrijaems with comorbidity or overlapping simptoms in their patients (also to check wether their patient is already in remission or stil in episode to manage the treatment accordingly).
Added functionality is also that Cardea3 can be used on the spot, for example in many sports training, because you can record clinical level of the signal in the middle of the field.
We plan to start selling online to the general public in the Netherlands as of March 2019.
Simultaneously we are recruiting the product development ambassadors who will be scouting the medical professionals and working on commission.

Internationale ambitie

After establishing Cardea3EGA in the Netherlands, we are offering our services in Switzerland, Belgium, and Germany. We are also planning to work in Spain and Slovenia where we are already working on research of further developing different analytical tools in medicine.