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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - PREDICT (PREDICT)

Teaser

Summary

The PREDICT project targets the need for personalized medicine and better informed clinical decisions in the treatment of Major Depressive Disorder (MDD). The current problem affecting the mental health care sector is the high rate of inadequate treatment for MDD patients, which is forecasted to be the biggest cause of illness burden in the EU by 2030 (based on the WHO forecasts). Despite its devastating implications, MDD diagnosis and treatment havenâ€™t changed for several decades. However, an innovative technology has recently become available for MDD treatment: Transcranial Magnetic Stimulation (TMS). It is a non-invasive neurostimulation procedure that uses magnetic fields to modulate activity in discrete cortical regions. TMS was found to have therapeutic effects in various neuropsychiatric disorders, including MDD - even when first line treatments, such as antidepressants and psychotherapy, were ineffective. Despite the huge number of depressed patients in Europe and the need to use superior technologies as a second line of treatment, there are still some hurdles in adopting TMS in Europe: (1) About 50 % of MDD patients respond to this procedure, but there is currently no way to predict who will respond prior to treatment completion. (2) In most EU countries the high treatment costs are not covered by statutory health insurance. (3) The treatment requires 4-6 weeks (5 days/week) of TMS sessions of 20-30 minutes each. Since TMS-induced cortical changes may only happen after several sessions, this can cause patients to prematurely terminate the treatment. (4) Policy makers and health insurers havenâ€™t yet been provided with a solution for integrating TMS as a cost efficient treatment into the MDD standard care. As a result, and despite its advantages, TMS has not yet been widely adopted by the European health market.
To tackle these problems of integrating TMS as an effective and cost-efficient pharmaco-therapy alternative for MDD, the ability to predict TMS responsiveness and ensure an optimal stimulation protocol for individual cases from the first treatment session would be vital. Accordingly, over the last decade elminda has been developing a software tool called \'PREDICT\', which estimates the likelihood of a patient to benefit from the treatment based on validated electroencephalogram (EEG) biomarkers. By providing the patient and treating clinician with an optimal treatment recommendation, PREDICT will substantially improve the medical care for MDD patients and will significantly reduce both primary and secondary costs for society. The latter is based on PREDICTâ€™s capability to make lengthy and costly trial and error treatment protocols unnecessary. This does not only reduce direct costs of treatment and hospitalization, but also allows a faster re-integration of MDD patients into the working environment. Considering that the overall costs of depression sum up to â‚¬170 billion per year in the EU, the potential savings associated with PREDICT are huge.
The objective of H2020 Phase 1 feasibility study was to allow us to gain valuable insights on the market, adjust our business plan accordingly and eventually, to have better chances attracting international interest in PREDICT and succeeding in its future commercialization.

Work performed

The first activity undertaken during the H2020 Phase 1 project was market research to investigate the commercial potential for PREDICT in the EU. The market research included analyses of the MDD and TMS market trends and sizes, identifying priority areas, clientsâ€™ needs, potential beta-users, reviewing local and global competitors and their solutions in terms of economic and technological maturity, and collecting feedbacks from private and public payers, healthcare experts and psychiatrists.
This market research revealed that the need of the European mental healthcare sector goes beyond the sole capability to predict the effectiveness of TMS treatment for a specific patient, and that reliable predictions regarding classic psychopharmacological therapy would be of equally high value to patients, clinicians, and insurers. In addition, turning PREDICT into a general prediction tool for MDD treatment also protects PREDICT from being affected by the partially conservative forecast of the adoption rate of TMS by the European market over the next 5 years, which we encountered during interviews with experts in the field. Thus, to meet the stakeholders needs and to ensure a successful market adoption, we decided to widen the value proposition of PREDICT and integrate extra capabilities. Specifically, PREDICT has been re-designed to not only predict treatment outcome of TMS, but to also predict response to antidepressants and to ensure patient compliance to either treatment approach by estimating the time it will take a patient to respond to a selected treatment. Such additional capabilities were further developed and validated during the feasibility study period.
Following the insights from the market research, the second set of activities undertaken during this project focused on developing go-to-market strategies to exploit the market opportunities. This included analysis of the expected costs, turnover and revenue forecast for the 6 years following market launch, and the identification of regulatory and reimbursement pathways for different EU markets. Moreover, IPR strategy and FTO have been assessed with the aim of continuously enhancing elminda\'s IP position. Given the pre-existing IP portfolio and future strategy for IP protection, elminda was found to be well positioned to execute full commercial exploitation of PREDICT. Finally, we initiated discussions with EU KOLs to perform a multi-center clinical study to demonstrate the PREDICT\'s clinical value, as part of a Phase 2 SME instrument proposal.

Final results

elminda built an international network supporting the full commercialization of PREDICT in the next 3 years. PREDICTâ€™s distribution is expected to be made via sales in focused EU countries (e.g. Germany, Italy, and the Netherlands). The product plan includes official exposure to strategic partners and execution of a validation study to prove the clinical value of the PREDICT. We aim to initially sell PREDICT to clinics with \'hands-on\' experience and a desire to integrate TMS to reduce treatment resistance in MDD patients. Over time, elminda will promote PREDICT directly to general health system providers who will benefit from PREDICTâ€™s costs reimbursement by insurers. Our strategic plan targets both B2C customers (e.g. psychiatrists, psychologists and neurologists) and B2B customers (e.g. public and private psychiatry centers/hospitals and clinics). Once the economic value of PREDICT will be proven, weâ€™ll approach and target leading public and private healthcare providers in Europe, the US, and the local market (Israel). Even a very conservative growth projection directly associated with the PREDICT project, will allow elminda to boost its growth and support its ability to become a sustainable company, that will help physicians to reduce trial and error treatment in mental health and provide personalized care to patients.