Motif Neurotech — First-in-Human Trials for Next-Gen Brain Stimulation

Motif Neurotech developed an ultra-small, minimally invasive brain stimulation implant for treatment-resistant depression. bioaccess® enabled their first human trials in Latin America.

Study facts

• Sponsor / company: Motif Neurotech
• Indication / area: Neurotechnology / Psychiatry
• Country: Colombia
• Study type: First-in-Human (FIH)

Key metrics

• Trial Type: FIH
• Indication: Depression
• Approach: Minimally invasive
• Cost Model: Capital-efficient

The challenge

Treatment-resistant depression affects millions globally with limited options. Motif Neurotech's device required human safety validation before pursuing FDA pathways, but the startup needed to move quickly while preserving capital for ongoing R&D.

bioaccess® solution

bioaccess® identified leading neurosurgery centers in Colombia, managed the full regulatory and ethics submission process, coordinated surgical procedures, and oversaw patient monitoring and data collection in compliance with FDA expectations for a future US submission.

Results

• First-in-human implantation completed successfully
• Safety and feasibility validated in human subjects
• Rapid ethics and regulatory approval achieved
• Clinical data designed for FDA Pre-Submission meeting
• Preserved startup capital with LATAM cost efficiencies

Frequently asked

What did bioaccess® do for Motif Neurotech?

bioaccess® identified leading neurosurgery centers in Colombia, managed the full regulatory and ethics submission process, coordinated surgical procedures, and oversaw patient monitoring and data collection in compliance with FDA expectations for a future US submission.

Where was the Motif Neurotech First-in-Human (FIH) study run?

The Motif Neurotech First-in-Human (FIH) study was executed in Colombia by bioaccess® in the neurotechnology / psychiatry area.

What was the outcome of the Motif Neurotech study?

Reported outcomes for Motif Neurotech's device: First-in-human implantation completed successfully; Safety and feasibility validated in human subjects; Rapid ethics and regulatory approval achieved.

Run a similar trial: Clinical trials in Colombia

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