Periodic Reporting for period 1 - PREDICT (PREDICT)
Reporting period: 2018-02-01 to 2018-07-31
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 PREDICT’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 €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.
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.