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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - Nocturne (The eye as a window to the brain, extending lifelong brain health)

Teaser

Summary

Up to 1 billion people, nearly one in six of the worldâ€™s population, suffer from neurological disorders, from Alzheimer and Parkinson disease, strokes, multiple sclerosis and epilepsy to migraine, brain injuries and neuroinfections, with some 6.8 million dying of the diseases each year, according to a new United Nations report.
The UN World Health Organization study â€“ Neurological disorders: Public health challenges â€“ shows that people in all countries, irrespective of age, sex, education or income are affected, that the economic cost of such diseases in Europe reached some â‚¬139 billion in 2004 and it continues to grow every year, while access to appropriate care is lacking in many parts of the world.
Health systems need to be strengthened to deliver better care for people with neurological disorders. Neurological care must be integrated into primary health care since for many people, primary care is the only access to medical treatment that they have and doctors can use low-technology interventions.
Reasons for non-availability of care include inadequate health delivery systems, lack of trained personnel, and absence of essential drugs.
As the global population ages, the impact of neurological disorders will be felt both in developed and developing countries, reaching a significant proportion in countries with a growing percentage of the population over 65 years.
Unprecedented innovation in technology is rapidly revolutionizing human life when it comes to healthcare and have the potential to vastly accelerate clinical development, and in turn advance how we prevent, diagnose early, monitor and potentially even cure severe diseases.
People with neurological conditions each have their own individual journey. What works for one patient, does not necessarily work for all. In these types of neurological conditions, many influences come into play beyond the visible symptoms. A patientâ€™s mood, their sleep patterns, even their diet, can influence their symptoms and their overall condition, and can make a positive contribution towards their quality of life.
Our technology was developed to provide better care and, above all, to prevent and detect neurological diseases at an early stage. Nocturne expects that its optical coherence-based retinal image analysis will allow neurologists short-term diagnostic decisions, which will reduce the need for external costly MRIs. Ultimate goal is to offer specialized screening analysis for early detection of neurological disorders, that is fast and affordable even in developing countries.

Work performed

During the SME instrument Phase 1 Nocturne GmbH conducted in-depth analysis of target markets, market entry strategy, competitors on the market, potential industry partners, FTO analysis and IP strategy, and business plan development.
Market research revealed that among neurological diseases we focus on, the multiple sclerosis segment accounted for the largest market share with 66.1% in 2018 and is expected to continuously grow. The global AI in healthcare is expected to grow at an annual rate of 43.5% from 2018 and reach $27.6 billion by 2025, and the hardware manufacturer market used to acquire retinal imaging has been valued at USD 719.0 million in 2015 and is expected to grow at a rate of 11.2% for 2024. Based on market analysis, Germany, France, and the UK are the priority markets to enter. The second priority markets include Austria, Ireland, Finland and US. Competitors analysis showed the main competitive advantages of Nocturne: the usage of existing and established hardware, its device agnostic aspect, the possibility of easy integration, the developement in close-collaboration with neurologist, and the unique insights provided into the retina through AI-based 3D morphometry.

Nocturne also carried out an extensive usability analysis and analysis on regulatory requirements, especially regarding data protection with hospital centers in Germany, France and Ireland. As a result, Nocturne validated and made design changes to the reports and parameters it provides. Also, its cloud-based solution platform was changed to a local installable appplication to ease the integration and to overcome the fragmented aspects of the data protection regulations.
During the patent landscape analysis Nocturneâ€™s team along with patent attorneys thoroughly studied related patents, and filled its three patents for EU, US, Canada, and Japan.
Finally, Nocturne developed a business model based on market research and several discussion with digital health stakeholders from the target countries for the market entry. The company will focus on four customer segments: academic research for further R&D and service provided in terms of clinical research study analysis (Nocturne is already generating revenue through this channel), pharmaceutical research for clinical drug trials (Nocturne has already a partnership with a European leading CRO), industry hardware manufacturer partners (Nocturne started two collaborations with two market leaders for developing and integrating its software solution; future revenue will be generated by license contracts, while benefiting from the sales channels of the manufacturer), and large hospitals and specialized centers (the process of certification for a medical product class IIa is done, and the certification is expected in the following months; the business model developed is SaaS).

Final results

Despite numerous challenges, there has been considerable progress in the digital transformation of health care, which we expect will continue in 2020 and beyond. With digital finding traction, the health care systems will witness a shift in data management that can be monetized and support population health management and value-based care.
During the past year we intensively discussed with various players in the digital health field, startups, representatives of health insurer and pharmaceutical companies, research organizations, and various physician and were very pleased to witness that new technologies are being adopted, and concrete strategies for more personalized and accessible care are being implemented.
Concretely, for our targeted diseases, we were very enthusiastic to see that more and more solutions are going towards the direction of prevention, since early intervention can delay disability by years. This has enormous benefits for all.
Even more the development of home monitoring, cost-effective hardware devices for imaging the retina opens new possibilities for developing countries where expensive and time consuming tests that are required to establish diagnosis and to provide an optimal monitoring are scarce at best.
Nocturneâ€™s strategy is to work together with specialized centers to enable the reduction of the number of misdiagnosed patients and to provide better monitoring for a more personalized care, currently missing. Since the hardware device is more and more used for early screening for eye diseases, our second goal is to provide our solution for this purpose in order to detect neurological diseases as early as possible. This would not only give patients the opportunity to start early prevention treatments, but also pharmaceutical companies to develop new drugs.
Nocturne already started collaborations with two market leader hardware manufacturers, and will continue to collaborate in developing a compact medical device that will be cost-effective enough to be further used in developing countries.