Does your company have any third party certifications, such as ISO?
We are currently working on getting the CE marking classification in Europe to comply with highest health and safety standards set by MDR. Class I categorisation is expected to be in place by end of Q1 2023, while Class II is expected in early 2024.
Specify the name, medical use case(s), regulatory, and reimbursement status per country, of your main product.
We are currently running the largest clinical trial globally, counting 266 treatment resistant schizophrenia patients. New trials in Australia and USA are being set up as of January 2023. In July 2023 we will start additional trial with Eating Disorders patients in Denmark. Reimbursement strategy is ongoing for European markets (Denmark primarily).
