Bottneuro advances into the clinical phase

Based in Basel, Bottneuro has been developing the Miamind Neurostimulator, custom-made based on MRI images - 3D printed – to enable precise, non-invasive neuromodulation using mild alternating currents to train neural activity in targeted brain regions. The treating medical staff individually defines the number and position of electrodes and various stimulation parameters. Subsequently, Bottneuro creates a computer-aided simulation to visually display the induced electric fields and enable a final determination of the parameters. After finalizing all parameters, Bottneuro manufactures the personalized Miamind Neurostimulator and delivers it to the clinic within a few weeks. Thanks to the integrated EEG function of the Miamind Neurostimulator, the effects of the therapy on brain activity can be directly measured without the need for a separate EEG measurement.

After receiving all necessary approvals, the startup is now set to conduct its first-in-human clinical trial with the personalized Miamind Neurostimulator in healthy volunteers. The study is conducted at the Department of Neurosurgery at the USB by Raphael Guzman, with Bottneuro as the sponsor and supported by Prof. Raphael Guzman at the University Hospital Basel and clinical research partner HEMEX.

MINDSTIM is a single-arm, monocentric pilot study investigating the safety, feasibility, and biological effects of transcranial alternate current stimulation with Miamind Neurostimulator. Eight healthy volunteers over 18 will be enrolled, with results expected at the end of March 2024. MINDSTIM paves the path for the clinical application of the Miamind Neurostimulator for home-based, repetitive neuromodulation.

The results will be used to progress the development of neuromodulation therapies for psychiatric and neurological conditions, starting with investigating the efficiency of tACS in Alzheimer’s Disease patients. These trials are performed in accordance with the regulatory authorities to receive clearance and finally help patients in need.

(RAN)