Annual Report 2022
Bittium in 2022
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Medical Technologies Business Unit

Products and Services for Biosignal Monitoring

In the Medical Technologies product and service area, Bittium offers its customers healthcare technology products and services in biosignal measuring in the areas of cardiology, neurology, rehabilitation, occupational health, and sports medicine. Combining healthcare technologies with Bittium´s long-term experience and competence in wireless and security technologies gives Bittium an excellent basis to serve its customers in the healthcare sector.

Bittium Faros™ is a versatile waterproof ECG device that is used for early detection of cardiac abnormalities in everyday life. Bittium Faros is ultra-small and lightweight, which enables precise full disclosure ECG measurements for long-term holtering, cardiac event monitoring, mobile cardiac telemetry and assessing the autonomic nervous system functions. Bittium Faros outpatient monitoring solutions include several software options for cardiac monitoring. The built-in arrhythmia detection algorithms on the Bittium Faros device are used for event recording and cardiac event monitoring. Bittium´s solutions enable the earlier discharge of patients and the ability to react to detected arrhythmias faster.

Bittium OmegaSnap™ Product Family
Bittium OmegaSnap™ 1-CH ECG Electrode (released in January 2021) – Bittium OmegaSnap one-channel electrode is the most cost-effective, patient compliant and reliable patch electrode for long-term ECG measurements. It is also suitable for HRV applications and heart monitoring for stroke patients.

Bittium MiniSnap™ Sensitive 1-CH ECG Electrode – Bittium MiniSnap Sensitive one-channel electrode is the most suitable electrode for 24h ECG measurements on small adults and children.

Bittium OmegaSnap™ 2-CH ECG Electrode – Bittium OmegaSnap two-channel electrode is the best choice when more than one-channel measurement is needed for more comprehensive arrhythmia analysis while maximizing patient compliance.

Bittium OmegaSnap™ 3-CH ECG Electrode – Bittium OmegaSnap three-channel electrode is the most patient-compliant way to perform traditional three-channel measurements.

Bittium OmegaSnap™ 1-CH Adapter and Bittium OmegaSnap™ Multi-CH Adapter – Bittium OmegaSnap ECG electrode and Bittium Faros ECG device are connected to each other through the lightweight and discreet Bittium OmegaSnap Adapter. The adapter also allows the Faros device to be temporarily detached from the patch electrode when charging, for example. In the case of remote heart monitoring, such as the Bittium HolterPlus solution, it significantly enhances the long-term use of the same electrode, thus ensuring that the skin contacts of the attached electrode remain optimal for the measurement to continue. There are two adapter versions available: Bittium OmegaSnap 1-CH Adapter is designed for one-channel electrodes, and Bittium OmegaSnap Multi-CH Adapter is designed for two- and three-channel electrodes.

Bittium Cardiac Navigator™ is a completely new software solution for analyzing clinical Holter EKG recordings. Its user-friendly and informative way of presenting data and intuitive analysis tools make it easier and more efficient to analyze ECG measurements lasting several days. Bittium Cardiac Navigator is designed to efficiently go through longer measurements in a short time and thus speed up the final diagnosis.

Bittium HolterPlus™ is a web-based remote cardiac monitoring solution, consisting of a Bittium Faros ECG device and Bittium MedicalSuite mobile application integrated into a secure smart device and Medical Suite remote service platform. Bittium HolterPlus enables remote monitoring and earlier discharge of the patient and allows the ECG measurement data of the remotely monitored patient to be wirelessly transferred securely from the monitoring device to the Bittium MedicalSuite remote diagnostics service platform. From the platform the ECG recording can be downloaded to a cardiologist for the diagnosis and the diagnosis will be uploaded for the treating physician for further patient care.

Bittium MedicalSuite™ is an advanced remote monitoring service platform that utilizes wireless data transfer. Bittium Medical Suite is mainly aimed at service providers to facilitate secure information sharing and workflow management between service providers, clinics, and specialists. The Bittium MedicalSuite platform allows specialists to perform remote consultations regardless of location. The Service is a combination of intelligent analysis, wireless data transfer, reporting, and management modules that you can optimize according to your needs. The easy-to-use web user interface allows dashboard customization for different user groups, which ensures effortless workflow and improves efficiency. Currently, the system supports cardiac monitoring services, but the same technology can be applied to any biosignal measurements, such as brain monitoring and home sleep apnea testing services.

Bittium BrainStatus™ is a wireless compact EEG amplifier, which is used together with a disposable, easy and quick-to-wear Bittium BrainStatus electrode headband, for example, to diagnose epileptic seizures and brain stroke. Bittium BrainStatus enables quick measurement in field conditions as well as in hospitals, thus making the treatment process of the patient faster. Bittium Brain Status can be used for wireless real-time remote EEG monitoring, or data can be recorded to the device memory.

Bittium BrainStatus™ with Cerenion C-Trend® is the world´s first practical method for measuring the brain function of intensive care patients. Bittium BrainStatus measures and monitors the electrical activity in the brain, and with the help of Cerenion C-Trend analysis tool, the brain´s state is displayed as a straight-forward and simple-to-interpret numeric value by making use of machine learning algorithms and artificial intelligence.

Bittium NeurOne™ is one of the quickest and most accurate EEG measuring devices in the world designed for clinical and research use. Bittium NeurOne system enables fully synchronized group measuring of up to 30 persons simultaneously, for example, in different types of psychological studies. The solution is optimized for use with transcranial magnetic stimulators (TMS-EEG), with an optional possibility to use it during magnetic resonance imaging procedures (fMRI-EEG).

Bittium Respiro™ is a modern sleep apnea screening device and analysis service solution for service providers, hospitals, clinics, and health centers. It is focused on Home Sleep Apnea Testing (HSAT) and intended to record standard PG level data and analyze typical sleep-related breathing disorders, such as obstructive sleep apnea, central sleep apnea, mixed sleep apnea, hypopnea and Cheyne-Stokes breathing.

Bittium Respiro Analyst™ software provides a web-based intuitive user interface which utilizes artificial intelligence to accelerate analysis work. The software pre-analyses the massive amount of measurement data and converts it to a more visual and informative format. This makes it easier and quicker for healthcare personnel to perform further analysis and diagnosis. Bittium MedicalSuite provides the same cloud backend system for all Bittium medical products and services and enables fast and location-independent data analysis.

Year 2022

The medical technology market has recovered from the uncertainty caused by the coronavirus pandemic. The importance of remote care and remote monitoring is still growing with the inadequacy of medical care resources and cost pressures. Remote monitoring and remote diagnostics solutions alleviate these problems, which will support the development of sales of Bittium´s medical remote diagnostics solutions in the future.

Bittium has medical device approvals in progress in many different countries. The new European Medical Device Product Safety Regulation, or MDR (Medical Device Regulation, EU 2017/745), entered into full force on May 26, 2021. The change has caused a backlog of quality system audits and device approvals, and thus a delay in application turnaround times.

In December, Bittium Respiro™, the advanced home sleep apnea test and analysis solution, received MDR approval. Respiro focuses on nighttime polygraphy measurement at home and records and analyzes typical breathing disorders during sleep. Respiro uses artificial intelligence to speed up the analysis work. It supports various sensor configurations and service models, thanks to which it adapts to varying measurement needs and different business models.

Respiro´s FDA (Food and Drug Administration) medical device approval for the North American market has progressed, and approval is expected during the first half of 2023.

The component shortage significantly slowed down the manufacture and deliveries of devices, but also the reception of orders. The reason for the decrease in order intake is the existing contracts with our largest customers, according to which we are obliged to deliver the ordered products within a certain time after the order.

The demand for Bittium Faros™ ECG measuring devices in the European market increased during the past year. A significant part of the product deliveries of the past year was still made to Preventice Solutions (a subsidiary of Boston Scientific Group), a customer offering remote monitoring services in the US ECG market. At the beginning of the year, Bittium and Preventice signed an agreement according to which Bittium will continue the supply contract for BodyGuardian® MINI devices that monitor cardiac arrhythmias to Preventice. In addition, the cooperation in the development of new ECG technology tailored to the use of Preventice Solutions continues.

The Bittium Faros product family was expanded with the new Bittium Faros 180L ECG measuring device, which measures ECG continuously for at least 14 days on one battery charge. The new version improves the diagnosis of arrhythmias due to the extended measurement time. The device also enables patients to be discharged earlier and better conditions to quickly detect and react to possible arrhythmias.

In the neurophysiology market, Bittium BrainStatus™ EEG measurement device pilots progressed, and new pilots started. There are, e.g., Finnish and European university hospitals that test the use of BrainStatus in their intensive care units. The market for BrainStatus in intensive care is just opening as the recommendations for intensive care are slowly changing to a more demanding direction regarding EEG measurement.

In October, Bittium announced it has established a Clinical Advisory Board to support the business of its healthcare technology products. The Clinical Advisory Board brings Bittium medical expertise and an international forum for the continuous development of products. Its task is to provide feedback and conduct clinical research on Bittium´s products, and assist Bittium with its own expertise in developing even more competitive solutions.

Market Outlook

Medical ECG, EEG, and Sleep Apnea Remote Monitoring Market

The medical technology market is undergoing significant development in patient care, especially outside hospitals. There is an increasing focus on the prevention of diseases and health problems through early diagnosis and the discharge of patients at an earlier stage to reduce hospital and treatment days. These actions significantly increase efficiency in healthcare processes and lower costs.

A prerequisite for early hospital discharge is the enabling of accurate and precise follow-up and measurement opportunities in home conditions, which would be enabled through remote monitoring. Remote monitoring and remote diagnostics also enable specialists´ diagnoses regardless of time and place. Also, evolving artificial intelligence-based algorithms become more common in supporting physicians in making diagnoses. Remote monitoring and remote diagnostics make it possible and faster to obtain more accurate diagnoses, which, in turn, speeds up the start of the right kind of treatment. The market change will enable several new providers to join the overall care service chain without compromising the quality of specialist services.

For remote monitoring and remote diagnostics, Bittium provides its Bittium Faros™ product family for remote heart monitoring, Bittium BrainStatus™ for measuring the electrical activity of the brain, home sleep apnea testing solution Bittium Respiro™, and different kinds of diagnostics software offered by Bittium.

During the coronavirus pandemic, non-urgent patients seeking treatment and examinations decreased. Several hospitals, treatment facilities, and service providers in the healthcare sector switched to more extensive use of remote diagnostics solutions. The pandemic will accelerate the introduction of digital remote services in hospitals and care facilities, creating a positive development in the demand for remote monitoring products and services.

The global component shortage affects the availability of various components used in the products, which affects the company´s ability to deliver products to its customers on the agreed schedule. The component shortage is expected to ease by the end of 2023.