LLC EVA Bioengineering

Russian Federation, Moscow, per. Khitrovsky, 3

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EVA Bioengineering

Introduction of modern technologies to save human lives

Development of the complex systems for round-the-clock monitoring and prevention of the development of sudden cardiac pathology based on artificial intelligence

Issues

Heart and vascular diseases are the leading cause of death and disability in the world

47,8%

Russia No. 1 in the number of
deaths from CVD

17 500 000

die every year in the world

944 843

die every year in Russia

108

die every hour in Russia

47%

deaths caused by CVD

A heart attack is is frequent, sudden and can happen to everyone and at any time of the day

Solution

80%

Heart attacks can be prevented using EVA Bioengineering

Signum-V monitoring and warning system complex

The EVA Bioengineering team has developed a unique solution that has no analogues. This is a system complex of high-tech solutions for the introduction of a system for diagnosing cardiovascular diseases and monitoring patient health into modern medical practice.

How the system complex works:

Unique microchip

Implanted subcutaneously, by minor surgical intervention

Patient Application

Reception and monitoring, set on the basis of the patient's medical indicators, critical values

Server

Processing data received from the patient's smartphone for further analysis of the criticality of the situation, based on AI

Geolocation

Automatic determination of the patient's location in the event of a critical situation

App for loved ones

Notification of all trusted persons marked in the patient's personal account (the possibility of independent remote monitoring of a loved one or relative)

Application for a doctor

Notification to the attending physician attached to the patient's personal account (the possibility of independent remote monitoring of the patient and taking readings at any necessary time)

Help and hospitalization

Conducting an online consultation by a doctor attached to the patient (24/7 chat, Telemed) and calling an ambulance team at the patient's location

Unique microchip

Implanted subcutaneously, by minor surgical intervention

Patient Application

Reception and monitoring, set on the basis of the patient's medical indicators, critical values

Server

Processing data received from the patient's smartphone for further analysis of the criticality of the situation, based on AI

Geolocation

Automatic determination of the patient's location in the event of a critical situation

App for loved ones

Notification of all trusted persons marked in the patient's personal account (the possibility of independent remote monitoring of a loved one or relative)

Application for a doctor

Notification to the attending physician attached to the patient's personal account (the possibility of independent remote monitoring of the patient and taking readings at any necessary time)

Help and hospitalization

Conducting an online consultation by a doctor attached to the patient (24/7 chat, Telemed) and calling an ambulance team at the patient's location

More about each of the parts of the system complex:

Unique microchip

Chip size:

20 mm in diameter

Lifetime:

About 2 years without recharging

Unique microchip

A programmable device for round-the-clock and continuous monitoring of ECG and other physiological parameters of a person in the form of a chip hidden in a shell of non-oxidizable inert material implanted under the skin of the chest.

The sensor allows the patient, around the clock and regardless of location, to be under constant supervision of the Signum-V system complex and Artificial Intelligence in order to record critical indicators for the patient's life in time and save life.

  • The request for the data necessary for calculating the cardiogram is carried out by a command from the mobile application.
  • Working communication distance: up to 10 meters in open space and up to 5 meters indoors.
  • Parameters for sensor measurements are configured through the mobile application.
  • QI wireless power transfer charge time: 30 minutes
  • Battery life without recharging: about 2 years.
  • App link technology: Bluetooth (BLE4.0)

Central server

Central server

Cloud system for processing and analyzing data (obtained from the patient's application), based on deep machine learning (Artificial Intelligence), for further decision-making on the criticality of the situation.

  • Accept all incoming patient data
  • Processing and analysis of the criticality of the situation
  • Alert the doctor about the occurrence of a critical situation through the application of the attending physician
  • Notification of relatives about the occurrence of a critical situation through the applications of a patient's relative
  • Locate a patient in an emergency

Mobile app

An application that fixes the indicators transmitted by the sensor

Patient
Relative
Doctor

A system for receiving a signal from an implantable sensor, in order to monitor and evaluate the occurrence of critical indicators, for further uploading data to a server for subsequent processing by AI.

  • Vascular resistance measures
  • Indicators of the speed of propagation of the pulse wave
  • Indicators of aortic heart disease
  • Ability to download additional studies prescribed by the attending physician
  • Formation of an online outpatient patient card
8 more functions

System for remote monitoring of the condition of a loved one and determining the location of the patient after fixing critical changes

  • Personal account of a relative
  • Remote access to data and metrics in the patient app
  • Remote on-demand patient measurement via app
  • Determination of the patient's geolocation in the event of a heart attack
  • Chat with the attending physician attached to the patient
  • Access to the relative's online outpatient card

An online monitoring system for an attached patient, with remote monitoring of the state of vital signs.

  • Personal account of the attending physician
  • List of assigned patients with 24/7 access to data and vital signs
  • Access to the online outpatient card of each attached patient
  • Notification about fixing the criticality of indicators of the attached patient
  • Chat with a patient
  • Assignment of additional studies through the application, with further loading of the results into an outpatient online patient record
  • Remote on-demand patient measurement via app

Geolocation

Help and hospitalization

Geolocation

The system for determining the location of the patient at the time of fixing critical indicators, in order to call an ambulance and notify the patient's relatives and the attending physician

Help and hospitalization

Online consultation and patient management service until the arrival of an ambulance and further hospitalization of the patient

What you should know about the implantable chip

Monitoring methods

Sphygmography

Monitoring by sphygmography is a study of hemodynamics and diagnosis of certain forms of pathology of the cardiovascular system, based on graphic registration of pulse oscillations of the blood vessel wall.

  • Pulse wave velocity is a “Proxy” indicator of arterial stiffness and their possible damage to atherosclerosis
  • Increase or decrease in blood pressure, relative to normal levels
  • Increase or decrease in blood pressure, relative to normal levels
  • Pulse properties: frequency, rhythm, filling, tension, pitch
  • Determining the patency of peripheral vessels;
  • Lower vascular resistance
  • Aortic heart disease

Potential difference definitions

Graphic registration of electrical potentials arising from the work of the heart on the surface of the body. This is a study of the electrical activity of the heart. There is a registration of bioelectric potentials arising during operation

Indications

Implantable monitoring system, activated both automatically and by the patient, recording a subcutaneous ECG. Its use is shown in the following cases:

  • patients with clinical symptoms of cardiac arrhythmias or in circumstances of increased risk of cardiac arrhythmias
  • patients with intermittent symptoms suggestive of cardiac arrhythmias
Contraindications

There are no known contraindications to sensor implantation. However, some patient conditions may cause tolerability or intolerance to a chronically implanted subcutaneous device.

Warnings, Precautions, and Recommendations for Physicians Performing Medical Procedures on Patients with the Device

The impact of medical equipment on implanted devices varies significantly depending on the type of device and energy levels used. In a known risky situation, always interrogate the device and save the data before the start of the procedure and check the operation of the device after it ends.

Magnetic Resonance Imaging (MRI) - Although the use of the Signum-V system for MRI is relatively safe under certain conditions, other implanted devices or the individual characteristics of the patient's condition may affect safety and dictate the need for additional examination.

General information to be taken into account before implantation

Before implanting a transducer, consider whether a mammogram, breast implants, or other implanted devices are factors that could influence the decision to implant a device or implant site.

Mammography

During mammography, compression of the chest between two plates is performed in order to obtain various radiological projections. During a mammography procedure, manipulation of the device or its angular compression between the plates can cause tissue injury, vascular injury, pain, or impaired device sensing. Before prescribing a mammogram, the cardiologist and the physician performing the mammography should weigh the possible risks and benefits and evaluate the possibility of performing other diagnostic tests. To minimize device manipulation or angle compression that a mammography procedure can cause, sufficient time should be allowed before the procedure is performed to allow the tissue pocket of the device and the operating incision to heal.

Breast implants

Breast implants or breast augmentation is a surgical procedure that changes the appearance of the breasts with liquid or gel-filled implants. Due to the location of the device implantation sites and their proximity to the breast, care must be taken when tunneling and inserting the device to avoid damaging the breast implants.

Joint implantation of a cardiac monitor and a pacemaker or a defibrillator

To minimize the risk of interaction between the programming head and telemetry with a pacemaker or defibrillator, the device must be implanted no closer than 7.5 cm from any other implanted device.

Note: If a patient with the device has an implanted pacemaker or defibrillator, the device's automatic detection of arrhythmia episodes may be affected by a paced heart rate.

Possible complications

When using the system complex, the following undesirable phenomena are possible:

  • device rejection phenomena (including local tissue reaction);
  • Device migration, infections, and pressure sores on the skin.
Handling and disposal

Shipping and transport

Recommended transient temperature limits for shipping and handling: -18°C to 55°C. When shipping and transporting, keep the package in a dry place, protected from direct sunlight.

Storage - Recommended storage temperature range: 5°C to 40°C. Store the packaging in a dry place away from direct sunlight.

Operation - Operating temperature range: 17°C to 45°C.

Storage

Recommended temperature limits for storage: 5°C to 40°C. Store the packaging in a dry place away from direct sunlight.

Operation

Operating temperature range: 17°C to 45°C.

Help

The device is unlikely to be damaged by proper handling, but it should not be implanted under the following circumstances:

  • The device has been dropped onto a hard surface from a height of 30 cm or more, which may damage the components of the device.
  • During inspection, it was found that the packaging in which the device was stored was punctured, damaged, deformed, or otherwise altered, which could lead to loss of sterility of the device or implantation instruments.

Expiration date

Before opening the sterile package, check the “use by date” indicated on it. Do not implant a device with an expired "best before" date. Implanting a device after the "best before" date may shorten the life of the device.

Sterility test

The device was sterilized before shipping, which is marked on the packaging. The lid of the sterile package has an illustration with opening instructions. Before opening a sterile package, check for signs of damage that could compromise the sterility of the contents. If there is any doubt about the sterility of the package, do not implant the device. Return non-sterile devices.

Attention! The implant device and instruments are protected by a single sterile barrier. The lid of the sterile package should only be opened in the sterile field.

Changing the position of the device during implantation

During implantation, it may be necessary to reposition the device if the original incision location does not meet sensing performance requirements. Removing the device from the tissue pocket, reloading the device into the implantation tool and re-placement of the device in a new tissue pocket is allowed if the device and implantation tools remained in the sterile field. If the device and implantation instruments were removed from the sterile field, re-sterilization is not allowed.

Disposal of the implant tool

Dispose of disposable implant instruments in accordance with applicable local environmental regulations.

Extraction and disposal

Please note the following information regarding device removal and disposal:

  • Remove the device when it is no longer needed, after the battery is depleted, or before a funeral or cremation.
  • In some countries, removal of battery-operated implantable devices is mandatory due to environmental concerns. Check if extraction is required according to local regulations. In addition, the cremation process can cause the battery to explode.
  • Implantable devices are for single patient use only. Re-sterilization and re-implantation of removed devices is prohibited.

Our purpose: Reduce mortality from cardiovascular disease

To achieve the most effective performance, we divided users into four groups:

>10,000,000 people People at risk or already under medical supervision after a heart attack

>10,000,000 people People at risk or already under medical supervision after a heart attack

Implementation of the system complex in the daily life of a person and medical practice:

  • Conclusion of an agreement on joint cooperation with medical institutions for the purpose of implementing the Signum-V system complex and maintaining system subscribers in the controlled region
  • Creation of emergency response points in all regions of the Russian Federation
  • Informing citizens about the importance of making a decision to implant a vital sensor for monitoring and monitoring the patient's condition

Price of using the system:

  • Transducer implantation and connection - established by the partner medical organization
  • The system user fee is 290 ₽ in a month per user for one user

>5,000,000 people People whose activities are associated with high risks (military personnel, rescuers, firefighters, law enforcement officers, emergency response teams, shift workers, etc.)

>5,000,000 people People whose activities are associated with high risks (military personnel, rescuers, firefighters, law enforcement officers, emergency response teams, shift workers, etc.)

Implementation of the Signum-V 2.0 health and death monitoring system (advanced functionality, reinforced case, separate operating system):

  • Conclusion of partnership agreements with enterprises and representative offices
  • Creation of monitoring points and emergency medical care on the basis of enterprises and departments

Price of using the system:

  • Transducer implantation and connection - established by the partner medical organization
  • The system user fee is 510 ₽ in a month per user for 1 user

>15 000 000 people People who find themselves in an emergency situation and situation in a certain territory as a result of an accident, a dangerous natural phenomenon, a catastrophe or a natural disaster.

>15 000 000 people People who find themselves in an emergency situation and situation in a certain territory as a result of an accident, a dangerous natural phenomenon, a catastrophe or a natural disaster.

Addition of a system complex for monitoring the state of an athlete Signum-V sport (reinforced body, separate operating system, advanced functionality) to the program of daily training and competitions:

  • Conclusion of an agreement on joint cooperation with sports organizations and clubs in order to implant the device and monitor the athlete's condition
  • Establishment of monitoring points and emergency medical care on the basis of clubs and sports organizations

Price of using the system:

  • Transducer implantation and connection - established by the partner medical organization
  • The system user fee is 430 ₽ in a month per user for 1 user

>20 000 000 people People who find themselves in an emergency situation and situation in a certain territory as a result of an accident, a dangerous natural phenomenon, a catastrophe or a natural disaster.

>20 000 000 people People who find themselves in an emergency situation and situation in a certain territory as a result of an accident, a dangerous natural phenomenon, a catastrophe or a natural disaster.

Implementation of the system complex in the daily life of a person:

  • Conclusion of an agreement on joint cooperation with medical institutions in order to introduce the Signum-V system complex and maintain system subscribers in the region under their control
  • Creation of emergency response points in all regions of the Russian Federation
  • Informing citizens about the importance of making a decision to implant a vital control sensor, monitoring the condition and determining the geolocation of a person in trouble, for further evacuation and first aid

Price of using the system:

  • Transducer implantation and connection - established by the partner medical organization
  • The system user fee is 290 ₽ in a month per user for 1 user

Attention: Each sensor, regardless of the direction of its use, is programmed independently through the settings in the mobile application for any of the above groups

The next stage of development on the way to reducing mortality from CVD is the creation of territorial Emergency Response Points

What is the Signum-V Emergency Response Point:

  • A team of doctors on duty (24/7), with subscribers of the CVD monitoring system attached to them, responsible for coordinating actions in case the system fixes critical indicators of a patient, according to their territorial area of ​​responsibility
  • A fleet of vehicles with the latest medical equipment (defibrillator, electrocardiograph, oxygen equipment, etc.) for the timely implementation of the most important diagnostic procedures, monitoring the patient's condition, maintaining his viability and carrying out resuscitation by highly qualified medical and paramedic mobile teams
  • Transportation to any medical institution at the choice of the patient or his relatives for further hospitalization

Presence plans for 2023–2024

With the support and cooperation

We work with the heart

Modern technologies do not make human mistakes, they are so perfect that they correct them themselves, thereby prolonging human life.

The task of the Signum - V system complex developed by us is to provide quick remote medical advice or assistance by emergency medical response bodies to people at risk and under medical supervision, who are outside the hospital and within the access zone of cellular communication systems when the main vital signs deteriorate their health, as well as timely notification of the attending physician, family members, relatives or others about a sudden crisis or death of people, including the place and time of the incident.

Let's boldly go into the future together, thereby preserving the lives of people close to us!

With respect and hope for understanding.

Pavel Karchevsky

Founder, CEO, Chairman and Founder of the Foundation for the Development of High-Tech Medicine and Transplantation

Pavel Karchevsky

Founder, CEO, Chairman and Founder of the Foundation for the Development of High-Tech Medicine and Transplantation