Periodic Reporting for period 2 - GrayMatters for PTSD - GfP (A NON-INVASIVE, ADAPTIVE DIGITAL THERAPEUTIC SOLUTION FOR POST-TRAUMATIC STRESS DISORDER AND OTHER MENTAL DISORDERS)
Reporting period: 2023-09-01 to 2025-05-31
Post-traumatic stress disorder (PTSD) is a severe mental disorder, annually affecting 3.2% of the population with global market-size estimated at €7.5B. Current treatments’ success is marginal, costly, with severe side-effects. GrayMatters is the first to introduce a non-invasive therapeutic device harnessing brain plasticity to help PTSD patients control abnormal brain-region activity. Our patented innovation uses proprietary models to fuse fMRI data from amygdala volume with EEG signal to produce specific biomarkers such that patients learn to self-control them using affordable EEG-Neurofeedback device. Initial clinical-trials on stress-resilience & PTSD patients showed significant positive clinical results. The founders have 25+ years experience in commercialization, healthcare & technology with several startups exits/IPOs. The company has won several prestigious awards and grants.
During the proposed project, GrayMatters will implement 4 work packages, in order to reach the project's main objective of launching Prism in the EU market (TRL8): 1) Conducting a large scale clinical KOL study in EU, 2) furthering the company algorithms to support future products delivering better care, 3) preparing for a commercial launch in EU, starting in Germany.
During the proposed project, GrayMatters will implement 4 work packages, in order to reach the project's main objective of launching Prism in the EU market (TRL8): 1) Conducting a large scale clinical KOL study in EU, 2) furthering the company algorithms to support future products delivering better care, 3) preparing for a commercial launch in EU, starting in Germany.
Work performed is per the plan submitted as reported in the periodic meeting.
On a high level, the key activity, a PTSD patient study was kicked off in 4 sites in Germany and two more sites will join in September 2023
On a high level, the key activity, a PTSD patient study was kicked off in 4 sites in Germany and two more sites will join in September 2023