Bittium Respiro™ Home Sleep Apnea Test and Analysis Solution Receives CE Approval for the European Market

Press release

Free for publication on December 14, 2022, at 2.00 p.m. (CET +1)

Bittium Respiro™ Home Sleep Apnea Test and Analysis Solution Receives CE Approval for the European Market  

Oulu, Finland, 14.12.2022 – Bittium’s advanced Home Sleep Apnea Test and Analysis Solution, Bittium Respiro™, has received CE approval. Bittium Respiro™ is an end-to-end solution consisting of a measurement device, analysis software, tailored accessories, and a service platform. The Medical Devices Regulation (MDR) of the European Union contains requirements for medical device manufacturers, importers, distributors, and authorized representatives regarding device compliance, device safety, and device traceability. Bittium Respiro™ Home Sleep Apnea Test and Analysis Solution has met the requirements of EU legislation with the MDR approval.

Bittium Respiro™ focuses on night-time polygraphy (PG level) measurement performed at home. This solution will record and analyze typical sleep-disordered breathing and it uses artificial intelligence to speed up the analysis work. Bittium Respiro™ pre-analyzes the data obtained from the home study and converts it into a visual and informative format. This solution optimizes the workflow of the clinical team in further analysis and diagnosis.

"The importance of remote care and remote monitoring has grown with the resource challenges and cost pressures of medical care. Bittium Respiro™ offers a very competitive end-to-end solution for remote healthcare services providers. Our modern solution and time and place-independent diagnosis enable the recording of high-quality measurement data, which allows us to speed up the diagnostic time and thus reduce the use of healthcare resources in the diagnosis of sleep apnea. We have piloted the solution with our current partners and potential customers, and the feedback received has been very promising," says Antti Näykki, Senior Vice President of Bittium's Medical Technologies business area.

Bittium Respiro™ supports different sensor configurations and service models, and it adapts to varying measurement needs and business models. It is suitable for high-volume sleep clinics as well as for sleep researchers who may require a wider array of biosignals. The sensor configuration is modified with the help of accessories.

The goal is to offer customers two different service models, which are traditional offline and modern online. In the offline service model, the data is stored within the device and the data is analyzed when the device returns to the clinic. In the online service model, secure and wireless data transmission enables the data to be transferred to the clinic during recording. This mode allows for a quicker analysis regardless of the patient or device’s location.

"During the past year, we have built a strong distribution network for our solution with both existing and new partners. With the CE approval received today, we can move forward in terms of sales and marketing to offer Respiro to our customers in the European market. The demand for sleep apnea testing solutions has grown, which will help us to support our Medical Technologies business growth goals from this market area," Mr. Näykki continues.

According to research, there are more than 936 million adults aged 30-69 years worldwide with sleep apnea[1], and in industrialized countries, sleep apnea has become a substantial public health problem. Sleep apnea is an underdiagnosed disease,[2] so the number of patients is constantly increasing. Untreated sleep apnea reduces the ability to work and worsens the quality of life. If sleep apnea is left untreated, it is associated with an array of adverse health consequences, including cardiovascular disease, metabolic disorders, diabetes, cognitive impairment, and depression. Registration of sleep-disordered breathing done at home is a natural, easy, cost-effective, and quick way to determine if a patient has a sleep-related breathing disorder.

Further information:

Antti Näykki
Senior Vice President, Medical Technologies
Tel. +358 40 344 3507
 

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Bittium

In the field of healthcare technology, Bittium offers solutions for the measurement and monitoring of biosignals in the areas of cardiology, neurophysiology, and sports medicine. In addition, Bittium specializes in the development of reliable, secure communications and connectivity solutions, leveraging its 35-year legacy of expertise in advanced radio communication technologies. Bittium provides innovative products and services, and customized solutions based on its product platforms and R&D services. Net sales in 2021 were EUR 86.9 million and operating profit was EUR 3.2 million. Bittium is listed on Nasdaq Helsinki. www.bittium.com