Personalized Neurostimulation Approach for the Treatment of Depression

Mental disorders such as depression compose one of the most common modern day illnesses, as it currently affects more than 300 million people worldwide (an increase of over 18% between 2005 and 2015). In Europe, each year, approx. 7% of the population suffer from a major depression issue, and the number rises to 25% when considering anxiety and lighter forms of depression. Despite the grave impact this has on society, there are not any efficient nor customized treatment options, these often falling within conventional solutions (e.g. cognitive therapy), medication or neurostimulation techniques that do not acknowledge an individual rehabilitation for the patient. Moreover, 50% of major depressions are untreated in Europe, costing society and estimated €170Bn per year. PlatoScience has started an ambitious project to provide a technical solution to this societal problem, which can offer relief for individuals suffering from depression - and thus for society as a whole.

The current feasibility study has been used to assess the overall business feasibility, and the key objectives, as described in the work packages in the SME phase 1 application, are:
1) To set up the regulatory and certification strategy, as well as defining the IP approach;
2) Evaluation and assortment of market potential partnerships for the viability of the business model, and road to market;
3) To set up partnerships with potential customers for trial-tests and demonstration activities among others;
4) To plan SME instrument phase 2 by assessing the most efficient and credible value chain.

We have fulfilled all four of these objectives, and consider the output of the feasibility report as highly positive in further building the foundations of a successful introduction of PlatoCure to the market.
1) We have set up regulatory and IPR Strategies for penetrating markets of interest. While the US market at first glance seems easier to penetrate from a legal perspective, there are strong indicators that US law around tDCS and similar devices will change in the near-to-mid future creating a great deal of uncertainty about future requirements. For this reason we will initially focus on penetrating the EU market which has recently updated and clarified its laws around neurostimulation devices. We will further focus on Denmark and Germany due to our physical location, confirmed network, and market properties of these countries including affluence, a high incidence rate of depression, scepticism of current treatment options and shortage of doctors.
As part of this objective we have also performed a thorough analysis of our freedom to operate and revealed untapped areas of possible patents, which we have incorporated into our IP strategy.
2) We have developed a robust and feasible business plan which will allow us to enter our focus markets, as well as updated all aspects of our market analysis described in the SME phase 1 application with a focus on competitors, new technology and key segments.
3) We have created a large network of collaborators covering all necessary stakeholders and collaborators in the PlatoCure value chain. We have experienced a large amount of interest in the PlatoCure based on the initial success of introducing the PlatoWork tDCS device, and have collected an extensive list of therapists and retailers around the world that have contacted us about future collaborations.
4) Lastly we have formulated a timeplan for actions to be taken after a successful SME phase 2 application from now until market entry in 2022.

The future plan involves:

1) Optimization of the tDCS-EEG loop system and the possible incorporation of other supportive technologies for brain activity monitoring.
2) Implementing a quality management system (QMS) for internal ISO accreditation (ISO 13485)
3) Clinical evaluation for CE Certification and implementation of final QMS Protocols
4) Design for manufacturing (DFM) of the current PlatoCure device
5) Development of a IT-system for, and the handling of, online data Collection from PlatoCure users
6) Demonstration activities for feedback within the two largest cities in Denmark, Copenhagen and Aarhus
7) Home Treatment & online cognitive testing protocols
8) Machine learning for novel biomarkers of depression
9) Dissemination and communication of our latest findings
10) Refinement of business development and price strategy
11) Commercialization and exploitation strategies to support the scalability of the production and treatment

Periodic Reporting for period 1 - PLATOSCIENCE (Personalized Neurostimulation Approach for the Treatment of Depression)

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