Periodic Reporting for period 2 - SOOMA (Combatting the global depression epidemic by mainstreaming the effective, safe and drug-free Sooma Depression Therapy)
Reporting period: 2021-07-01 to 2023-03-31
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 the 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 a wider audience by reducing the cost of goods.
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 a wider audience by reducing the cost of goods.
Work Package 1
The objective for Work Package 1 was to launch a digital therapy platform allowing healthcare professionals to monitor and support remotely their patients prescribed to Sooma tDCS depression treatment.
The development work started based on the previous 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, mostly due to the regulatory compliance reasons. Existing technological solutions cannot be easily modified in the medical devices space. We made the 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 an external development team, while recruiting in-house developers.
At the same time, we started a hardware project also with the help of an external team. After several prototype rounds the design passed verification and validation tests and was forwarded to usability and clinical performance tests with clinicians and patient users.
As a result of the project we built a Sooma Online digital therapy platform consisting of the treatment device, clinical platform for managing Sooma tDCS treatments and a mobile application for patient users. The product is currently in the design transfer phase and we are preparing for commercial launch after the system is granted with CE approval.
Work Package 2
The aim in the work package 2 was 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 a solution for drying and this enables us to dry five times more material compared to the previous process.
Production process rework was started with designing of the new reactor based on the feedback from the previous model. We set up new premises for the production laboratory and the assembly work of the laboratory equipment was started in July 2021. New laboratory was approved for production in June 2022.
Instead of investing on cutting and packaging tools it was found out to be more cost effective to work with subcontractor related to post processing. We have now selected a competent subcontractor to cut and pack the end-product. The production process with the subcontractor has been validated and collaboration on optimization of the yield continues.
Work Package 3
WP3 was about carrying out clinical trials in patient settings. The goal was to demonstrate that Sooma Online platform and associated tools (1) are usable by patients and doctors, (2) provide therapeutic and predictive value in the intended population, and (3) provide cost-effective data that supports therapy reimbursement applications on target markets.
To excel in this work package, we successfully recruited a new team member. Working with tasks was delayed due to delays in Work Package 1. Usability study with Sooma Online platform was conducted during Autumn 2022 in collaboration with Turku University Hospital. This study concluded that the new treatment platform is suitable for clinical use both in clinicians’ and patients’ perspectives.
Work Package 4
WP4 objective was working on planning, forecasting and distribution aspects of the therapy platform product lifecycle in the global context. The key was 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. We started the process by applying for FDA breakthrough device designation that was granted in March 2023. IP evaluation activities have been initiated and are ongoing. 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. As a results full plan to scale the product.
The objective for Work Package 1 was to launch a digital therapy platform allowing healthcare professionals to monitor and support remotely their patients prescribed to Sooma tDCS depression treatment.
The development work started based on the previous 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, mostly due to the regulatory compliance reasons. Existing technological solutions cannot be easily modified in the medical devices space. We made the 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 an external development team, while recruiting in-house developers.
At the same time, we started a hardware project also with the help of an external team. After several prototype rounds the design passed verification and validation tests and was forwarded to usability and clinical performance tests with clinicians and patient users.
As a result of the project we built a Sooma Online digital therapy platform consisting of the treatment device, clinical platform for managing Sooma tDCS treatments and a mobile application for patient users. The product is currently in the design transfer phase and we are preparing for commercial launch after the system is granted with CE approval.
Work Package 2
The aim in the work package 2 was 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 a solution for drying and this enables us to dry five times more material compared to the previous process.
Production process rework was started with designing of the new reactor based on the feedback from the previous model. We set up new premises for the production laboratory and the assembly work of the laboratory equipment was started in July 2021. New laboratory was approved for production in June 2022.
Instead of investing on cutting and packaging tools it was found out to be more cost effective to work with subcontractor related to post processing. We have now selected a competent subcontractor to cut and pack the end-product. The production process with the subcontractor has been validated and collaboration on optimization of the yield continues.
Work Package 3
WP3 was about carrying out clinical trials in patient settings. The goal was to demonstrate that Sooma Online platform and associated tools (1) are usable by patients and doctors, (2) provide therapeutic and predictive value in the intended population, and (3) provide cost-effective data that supports therapy reimbursement applications on target markets.
To excel in this work package, we successfully recruited a new team member. Working with tasks was delayed due to delays in Work Package 1. Usability study with Sooma Online platform was conducted during Autumn 2022 in collaboration with Turku University Hospital. This study concluded that the new treatment platform is suitable for clinical use both in clinicians’ and patients’ perspectives.
Work Package 4
WP4 objective was working on planning, forecasting and distribution aspects of the therapy platform product lifecycle in the global context. The key was 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. We started the process by applying for FDA breakthrough device designation that was granted in March 2023. IP evaluation activities have been initiated and are ongoing. 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. As a results full plan to scale the product.
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 limited. 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 major scalability issues from the post-processing of the patient kit and reducing the cost thereof.
Since the project started 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.
The company manufacturing capability of patient kits was limited. 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 major scalability issues from the post-processing of the patient kit and reducing the cost thereof.
Since the project started 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.