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 a good 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 for 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™ software is a flexible and versatile software solution for performing clinical Holter ECG analysis. Its user-friendly and informative data presentation and intuitive analysis tools make the software efficient and easy to use when analyzing multiple days of ECG recordings. The software allows for scanning long measurements efficiently in a shorter time, thus speeding 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 MedicalSuite is mainly aimed at service providers to facilitate secure information sharing and workflow management between service providers, clinics, and specialists. 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 BrainStatus 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.
During 2021, the medical technology market clearly began to recover from the downturn caused by the coronavirus pandemic. Demand from the service providers recovered, which was also clearly reflected in the development of net sales. During the past year, the medical remote diagnostics market was consolidated as major service providers merged, which might lead to higher device sales volumes, thus creating growth opportunities for device manufacturers.
The importance of remote care and remote monitoring has increased during the coronavirus pandemic due to insufficient medical resources and cost pressures. Remote monitoring and remote diagnostics solutions alleviate these problems, which was also reflected in increased sales of Bittium´s medical remote diagnostics solutions. Component shortages limited the growth during the past year and component shortages are expected to continue at least until 2022. All of Bittium´s cardiology and neurophysiology solutions operate on the cloud-based MedicalSuite service platform, enabling service operators to further digitize their remote diagnostic service processes. Along with an aging population, the coronavirus pandemic has provided a strong incentive to streamline and digitize primary care and specialist care. Together, these factors are driving demand for the device and total service solutions in the medical technology market.
The transitional periods for the application of the European Medical Device Safety Regulation (MDR) (EU 2017/745) expired and entered into force in full on May 26, 2021. The regulation harmonises European health legislation and replaces the old MD and AIMD directives on medical and implantable devices. The change has caused a backlog of quality system audits and product approvals and thus a significant delay in application lead times. Bittium has several medical device approvals underway in several countries.
Early in the year, Bittium launched a new home sleep apnea testing solution, Bittium Respiro™. MDR approval of the solution is still pending due to lead time delays. Based on current information, approval is expected in the second half of this year. The device, designed for home use, has received positive feedback, especially due to its compact size and ease of use. Deliveries of the product variant of the device that is targeted at the Finnish market, began during the autumn of 2021, and demand developed positively.
The temporary overload in intensive care units by the patients with coronavirus infection affected the ability of intensive care units to promote the introduction of new technologies and solutions. This slowed down the demand for Bittium´s EEG devices designed for intensive care. Bittium BrainStatus™ EEG measuring devices were delivered to customers for pilot use, but the overload of patients with coronavirus slowed down the progress of the pilots.
Demand for Bittium Faros™ ECG measuring devices increased during the past year. The majority of product deliveries were made to Preventice, a provider of remote monitoring services in the U.S. ECG market. The global shortage of components declined the amount of product deliveries. Demand for disposable Bittium OmegaSnap™ patch electrodes designed for Faros devices for long-term ECG measurement increased and deliveries progressed well.
During the last year, Bittium launched new products and software versions and they have been very well received. Product management, product development and production organizations were strengthened, and the quality system and operating processes were developed in accordance with the new MDR requirements. To further increase the international sales, the sales organization was strengthened, and the international distribution network expanded.
In September, Bittium announced to have signed an agreement under which Bittium planned to buy a 25 percent stake in Technomed, a British provider of ECG diagnostic services. Since the technical conditions required for the share purchase were not met, Bittium canceled the agreement. However, the cooperation between Bittium and Technomed will continue in the measurement and monitoring of biosignals and the development of analysis software, and the companies signed a distributor agreement for Bittium Faros™ ECG measuring devices and Bittium Respiro™ home sleep apnea measuring devices and software. The agreement sets out the distribution rights for both devices. Technomed is granted an exclusive right to use Bittium Faros™ ECG devices to provide cardiology diagnostic services in the UK. In other respects, the agreement does not define exclusive rights related to sales rights. Under the agreement, Technomed will commit to minimum purchases of both devices for the period 20222024.
Medical ECG and EEG Remote Monitoring Markets
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 health care 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.
As the coronavirus pandemic spread, the number of non-emergency patients going to treatments and tests to healthcare providers decreased. Several hospitals and medical care facilities have postponed their non-emergency tests and examinations and focused on the treatment of the pandemic patients as well as on the actions aimed to prevent the virus from spreading. The pandemic situation varies from country to country, but generally the market is beginning to get back to normal again. In the long-term, the pandemic will accelerate the use of remote services in hospitals and medical care facilities, and thus create positive development on the demand for remote monitoring products and services.
The global shortage of components affects the availability of various components used in products and can affect the company´s ability to deliver products to its customers on time.