Ultra-small implanted neurostimulation device for the treatment of Obstructive Sleep Apnea

Project Information

Nyxoah

Grant agreement ID: 729044

DOI

10.3030/729044

Project closed

EC signature date 21 May 2016

Start date 1 June 2016

End date 30 September 2016

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

NYXOAH SA
Belgium

Periodic Reporting for period 1 - Nyxoah (Ultra-small implanted neurostimulation device for the treatment of Obstructive Sleep Apnea)

Reporting period: 2016-06-01 to 2016-09-30

Summary of the context and overall objectives of the project

Nyxoah project aims to introduce to the market a tiny HypoGlossal Nerve Stimulation (HGNS) system for the treatment of moderate to severe OSA patients who are not compliant with CPAP therapy. The key objectives of the project are to gather sufficient clinical evidence to commercialise the system as a CE certified medical device in Europe.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the Phase 1 Feasibility Assessment, Nyxoah accomplished a full analysis of the business potential of the Nyxoah’s GenioTM. Throughout the duration of the project, Nyxoah increased its knowledge of the medical device market, including regulations, medical device reimbursement standards, market size and competitors.
In the feasibility study, Nyxoah estimated that there are around 4.6 million OSA sufferers in Europe who need an alternative solution to treat this sleep disorder breathing. Nyxoah decided to primarily target already diagnosed patients who are non-compliant with CPAP (700K) or refuse CPAP (100K), sizing the potential market at 800K patients.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Nyxoah’s disruptive technology will promote health and wellbeing, and improve patient quality of life. Nyxoah proposes an innovative OSA treatment for patients and sleep specialists. Nyxoah’s GenioTM will offer a minimally invasive, effective and easy-to-use OSA alternative therapy to millions of OSA sufferers and thousands of sleep specialists.

Nyxoah’s GenioTM implant

Nyxoah’s GenioTM patch

Nyxoah’s GenioTM