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Non-invasive technology for remote screening and personalised therapy of sleeping disorders: EU piloting and commercialisation project

Periodic Reporting for period 2 - PREDESA (Non-invasive technology for remote screening and personalised therapy of sleeping disorders: EU piloting and commercialisation project)

Reporting period: 2018-11-01 to 2020-01-31

Apart from insomnia, obstructive sleep apnea (OSA) has the highest prevalence in the general population of all sleep disorders. It affects approximately 3–7% of the middle-aged male population and 2– 5% of middle-aged women. Despite increased diagnostic and treatment facilities, the majority are still undiagnosed, over 93% of estimated population.

Identifying patients who are likely to have obstructive sleep apnea (OSA) is vital. As overnight polysomnography, the criterion standard diagnostic test, is expensive and limited in its availability, many people with OSA, perhaps as many as 93%, remain undiagnosed. Effective screening in primary care settings could increase the number of OSA patients identified, who can then be offered continuous positive airway pressure—an intervention that might reduce morbidity and mortality.

Studies have indicated that undiagnosed obstructive sleep apnea, with or without symptoms, is independently associated with increased likelihood of hypertension, cardiovascular disease, stroke, daytime sleepiness, motor vehicle accidents, and diminished quality of life. In the US, the annual direct and indirect economic cost of OSA has been estimated to be US 65-165 billion dollars (coming from diagnosis and treatment, hidden health-care costs, traffic accidents, workplace accidents and loss of productivity). The disease does not only affect the patient, but those who are sleeping in a same room. Strategies to decrease the high prevalence and associated morbidity of obstructive sleep apnea are critically needed.

Nukute is developing a novel, user-friendly and cost effective technology to pre-screen and assist in diagnose and treatment of sleep apnea patients. The basic system is based on tracheal electronic stethoscope (microphone), accelerometers and pulse oximeter combined with mobile application. Nukute patient-oriented screening collar identifies and prognoses upcoming sleep apnea events which is called apnea hypopnea index (AHI). Nukute collar monitors the breathing quality and profile for patient-oriented screening and diagnosing purposes with very easy and comfortable way. Main objective is to pilot and commercialize Nukute's tehchnology inside EU area.

The PREDESA project is piloting and commercialisation pre-screening and dignostics device market in EU. The main objectives of the project are:

1. Securing Intellectual Property

2. Creation of quality management system for the company

3. Clinical trials first in Finaland and after inside EU area

4. Preparation of market entry and business plan update
"Nukute hired a patent attorney office to perform Freedom to Operate study in order search third party patent rights that may be relevant to Nukute and analyze the third party patents revealed in the search for determining their relevance to Nukute current and future products. Third party patent rights may be pending patent applications, registered utility models, granted patents and design patents. Existing third party patent rights grant their holders exclusive rights that can be used to deny others from commercially exploiting the technical solutions or designs covered by the rights. Commercial exploitation covers:

• making, offering, putting on the market or using a product covered by the patent, or importing or possessing such product for these purposes;
• using a process covered by the patent, or offering such process for use in the territory of the third party right;
• offering, putting on the market or using a product obtained by a process covered by the patent or importing or possessing such product for these purposes.

As part of the project, Nukute created the Quality Management System (QMS) for the company. The QMS is structured according to ISO 13485:2003 and complies with the requirements of this standard as well of the MDD and the annexes used (Annex II). The Nukute QMS covers all the processes and activities in Nukute that relate to the management, provision of resources, product realization and measurement, analysis and improvement. All documents in the QMS are subject to document control. QMS excludes out Nukute operations but the co-operation between the departments is documented in processes.

As part of the project, company market entry plan was updated with the business plan. Nukute will make the first market entry in Scandinavia at phase 1. Germany market entry will be prepared and launched in phase 2 and rest of the Europe in phase 3.

From the beginning of the EU PREDESA2 project Nukute started developing an early stage ""zero series"" product for clinical validations in Oulu University Hospital (OYS). We had 3 prototype rounds before we achieved neck-band that was approved by chief medical physician in Clinical Neurophysiology department.

PREDESA project includes the following parts: Nukute Collar, Nukute Tutti (pulse oxymeter), Nukute Cloud, Nukute Patient UI and Nukute Hospital UI. Our first Nukute demo was represented to sleep doctors on 11.10.2018. In the beginning Nukute had issue in collecting samples in Oulu University Hospital (OYS) and got only 3 samples per month. This was because of lack of nurse resources. Nukute solved the problem by hiring it's own nurse in OYS. Nukute has collected 40 clinical samples so far. Results are good but we need to improve our mechanics more robust."
"Sleep apnea is not just disease anymore - it can be called worldwide epidemic problem. This problem affects:

• Annual economic cost of moderate and severe OSA in US: $65-165$B
• Greater than asthma, heart failure, stroke and hypertensive disease
• Causing problems in many levels:
• Daytime dysfunction-sleepiness
• Increased risk of developing type 2 diabetes
• More that 50% of people with diabetes 2 have sleep apnea
• Severe increase in prevalence of high blood pressure, heart problems and stroke
• Increased risk and cost of traffic accidents
• More than 800,000 drivers were involved in OSA-related motor-vehicle collisions (in 2000)
• Cost of collisions: $15.9 billion and 1,400 lives (in 2000).
• In the US, treating all drivers suffering from OSAS with Continuous Positive Airway Pressure (CPAP) would cost $3.18 billion, save $11.1 billion in collision costs, and save 980 lives annually (in 2004)

PREDESA Nukute project solves the problems above by decreasing patient queues and prioritising them. Patient can be measured more efficient way and it lowers the barriers to make the diagnose. It moves patients from hospital care to home care. Patient-oriented pre-screening of sleep apnea decreses patient queues in central hospital approximately 40% according to Oulu University Hospital. Currently approximately 50 % of central hospitals measurement results are negative. Measuring sleep apnea at home instead of hospital visits saves also hospital resources. Compared to current measurement technologies Nukute technology can be easily used at home and doctors can see the AHI results ""real-time"" from Nukute cloud in next morning. If measurement has not been successful the Nukute system informs patient to make another measurement in next day. Currently patient guidance takes time approximately 45 minutes - Nukute guidance takes time approximately two minutes. This decreases patient visits in hospital and saves hospital resources and patients time.

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