Finnish startup Nukute Ltd. receives medical device CE marking after raising five million euros of equity capital for the R&D of its sleep disorder innovation - now begins entry to the European market

Nukute Collare™ has been issued the certificate of compliance with the Directive 93/42/EEC on Medical devices. This now enables the launch of the company’s sleep disorder biosignal recorder to the European market. First shipment of products was agreed upon immediately after the issuing of the CE marking.

Nukute Collare™ crucially expedites physicians’ sleep apnea (apnoea) diagnostics and frees up nursing staffs' resources. It monitors and records vital physiological signals related to sleep apnea - breathing sounds, pulse, and oxygen saturation in blood. It also detects the patient’s sleeping position during monitoring. Nukute Collare combines tracheal measurement of breathing sounds with cloud-based evaluation of these measurements, which the physician then utilises in the clinical decision making. Nukute’s innovation brings reliability, speed and user friendliness to both the patient and the physician.

Current means of home monitoring and diagnostics of sleep apnea are plagued by difficulties in preparing for the session and equipment discomfort caused to the patient, which in turn contribute significantly to the disruption of the patient’s normal sleep rhythm and affects the monitoring outcome. Usability testing conducted on the premises of and in collaboration with the Oulu University Hospital, indicates that when compared to previous solutions, Nukute Collare is significantly easier to use and substantially more unnoticeable to the patient. A lightweight device placed on the patient’s collum, accompanied by a finger sensor, do not affect the quality of sleep. A small tablet device presents the patient with simple and illustrated steps to begin the home monitoring. The good usability of the device also takes special groups into account.

Nukute Collare has been developed in collaboration with the Oulu University Hospital’s department of clinical neurophysiology. The very same department took care of the Nukute Collare’s mandatory clinical trials. Also, preclinical usability, safety and efficiency tests have been a crucial prerequisite for the issuing of the now received CE marking.

“The CE marking was truly a highly anticipated reward for our team’s perseverance in the last few years. We are quite excited that we are finally off to commercialise our company’s first product. The plan is to rapidly progress into the whole of Europe by first launching the product in Finland and right after in the Nordics”, states the company’s founder, Mr. Tuukka Visuri.  “In the future, we’ll be further advancing our line of respiratory monitors to meet both existing and also new emerging needs – such is our Nukute Monitor® solution, that’s in the process of going through clinical trials and can profoundly ease the remote monitoring of, e.g. COVID-19 patients”, Visuri continues.

An astonishing number of 936 million people worldwide suffer from different stages of sleep apnea.

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30198-5/fulltext

For more information, kindly contact:

Janne Regelin

Chief Marketing Officer

janne.regelin@nukute.com

+35850 376 8277

www.nukute.com

Photos: copyright Nukute Ltd., freely to be used with the reportage of this press release:

- Nukute’s head of validation Katja Koskinen and project manager Joonas Pääkkönen showcase Nukute's innovation at their place of work, photographs by Janne Regelin, Nukute Ltd.

- Two promotional product photos.