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Combatting the global depression epidemic by mainstreaming the effective, safe and drug-free Sooma Depression Therapy

Periodic Reporting for period 1 - SOOMA (Combatting the global depression epidemic by mainstreaming the effective, safe and drug-free Sooma Depression Therapy)

Reporting period: 2020-07-01 to 2021-06-30

Depression is one of the top global health problems. Direct and indirect costs caused by depression are high in particular in developed countries. According to WHO estimates a total of USD 1 trillion is lost each year related to depression and anxiety. Costs are incurred from lost productivity, early retirement, treatment etc. Alarming statistics from health professionals and health care payers in different countries show that mental health related costs are rising, in particular costs related to depression. In particular rates of depression in working population aged below 40 are rising rapidly. [http://www.who.int/mental_health/management/depression/en/].
According to the various sources, such as CDC (Center for the Disease Control), only just over third of patients suffering from severe depression have seen a professional [https://www.cdc.gov/mentalhealth/basics/mental-illness/depression.htm]. About 50% of patients suffering from depression, receive adequate treatment from the first line of treatment. [WHO stats] Current available treatments for depression include pharmacotherapy, psychotherapy, transcranial magnetic stimulation (TMS) and finally for severe depression electroconvulsive therapy (ECT).

The objective of this project is to build a scalable treatment system based on evidence-based brain stimulation technologies to help solve the overwhelming problem of access-to-care and ineffective treatments. The objective is to build a brain stimulation platform with remote care capabilities, such that clinicians can monitor the adherence to the treatment and view patient analytics to optimize treatment outcomes. Further, the overall objective of the project is to improve the mass production capability of the unique patented patient interface material such that the product can be offered to wider audience by reducing the cost of goods.
Work Package 1
The objective for Work Package 1 is to launch a digital therapy platform allowing healthcare professionals to monitor and support remotely their patients prescribed to Sooma tDCS depression treatment.
The first deliverable was the development of Sooma Online digital therapy platform. The development work started based on the current prototype platform and feedback collected with it. During the architecture planning, it was soon detected that the technical stack of the first prototype product could not be utilized in the new product. We made decision to develop the platform with novel well-known technologies, so that the product will be secure and easily scalable. Development work was started with external development team, while recruiting in-house developer. Currently we have built clinical platform for managing Sooma tDCS treatments and skeleton for mobile application for patient users. The key features such as creating users, creating patients, assigning treatment protocols and outcome measurements for patients are implemented. The work continues with device management features and mobile application.
At the same time, we started hardware project. Most of the design work including industrial and mechanical design, user interface, hardware design, embedded software is done. The first prototype of the new device is produced and is under functional testing. The development will continue according to the prototype test results.

Work Package 2
The aim in the work package 2 is to increase the production capability and decrease the cost of the hydrogel product used as a contact media in Sooma tDCS therapy device. The first action item was to optimize the drying process to be easily repeatable for large volumes. We have now found solution for drying and this enables us to dry five times more material at a time.
Production process rework was started with designing of the new reactor, which is already done, and the new reactor is currently under construction. We have found new premises for the production laboratory and the assembly work of the laboratory equipment was started in July.
Instead of investing on cutting and packaging tools it was found out to be more cost effective to work with subcontractor related on post processing. We have now selected a competent subcontractor to cut and pack the end-product. The initial tests are done and the subcontractor has proved to be able to deliver similar quality compared to our own production.

Work Package 3
To excel in this work package, we have successfully recruited a new team member. Working with tasks is delayed due to delays in Work Package 1. Planning work with the clinical trial protocol has been started in August 2021.

Work Package 4
Working on planning, forecasting and distribution aspects of the therapy platform product
lifecycle in the global context. The key is to bring our internal capacities up to TRL8 level equivalent
to secure a successful market introduction and scaling following the EIC project.

US FDA market access plan prepared. IP evaluation activies initiated. Expansion of distribution network to cover new markets in EU and outside of EU. We have completed some of the strategic management and administration duties to ensure technical capability to scale operations to TRL8 level.

1.2.5 Work Package 5
Ethical considerations of the project have been implemented by applying for ethics board and research approval for software testing in patients at Turku University hospital. The research permit and ethics board endorsement were granted. Further approvals may be needed at the validation phase. Those approvals will be processed as the validation scope and technical content of validation become clear after the WP1 delivers the product ready for clinical validation.
In the beginning of the project the company had initial market feedback from the first generation product and its limitations with respect to scalability and large-scale usage. Now the company has been able to take into account the customer feedback and desires about the technical product requirements from different markets and usability.
The company manufacturing capability of patient kits was at capped at 300-400 products per month with high degree of variability in product quality and the cutting phase of the hydrogel as a bottleneck. Since the project started, the company has been able to automate the cutting process and find a suitable partner to carry out the post-processing of the product and thus removing a major scalability issues from the post-processing of the patient kit and reducing the cost thereof.
Since the project start the Sooma therapy has become more popular and public healthcare institutions have initiated multiple public tender processes and are planning to start offering the treatment as a standard service and thus relieving the urgent patient need.
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