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Reporting period: 2016-03-01 to 2016-08-31

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. 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 Ltd. a Finnish SME, has a user-friendly and cost effective technology to pre-screen and assist in the diagnosis and treatment of sleep apnea patients. The novelty comes from using sensor technology to detect sleep apnea and using stimulus for the patient when sleep apnea occurs. The therapeutic device conditions the patient to change sleeping position and strengthen obstructive muscles to avoid snoring and apnea.
Approximately 80% of estimated sleep apnea patients - half a billion people – are undiagnosed! Moreover, the disease does not only affect the patient, but those who are sleeping in the same room, too.

The PREDESA project explores the feasibility of market entry to pre-screening and treatment device market. The main objectives of the project are:

1. Securing Intellectual Property and checking of freedom to operate

2. Creation of quality management system for the company

3. 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 and North America market entry will be prepared and launched in phase 2 and rest of the Europe in phase 3.
Obstructive sleep apnea (OSA) is a common disease, affecting 2–7% of population, but 83% of them are still undiagnosed. Snoring which predicts sleep apnea is also common problem. 50% people who snores has OSA.

• 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)

The European sleep apnea devices market is expected to grow from USD 1,153.0 million in 2015 to USD 1,860.4 million by 2021, at a CAGR of 8.3% from 2016 to 2021. The major share of the European sleep apnea devices market was taken up by the therapeutic segment. The therapeutic devices market was valued at USD 1,064.0 million in 2015, and is expected to grow at a CAGR of 8.6% to reach USD 1,743.7 million by 2021

Nukute vision is to be the market leader in rapid diagnostics and treatment in the area of sleep apnea and snoring. This is achieved by focusing on simple, small and robust sensor technology to enable comfortable, quick and relevant measurement and treatment for the consumers and the patients.
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