Neuroelectrics Seeks FDA Approval for Non-Invasive Headcap for Epilepsy Treatment

By Thea Felicity

Jun 14, 2024 10:51 AM EDT

Neuroelectrics

(Photo : Screenshot from Neuroelectrics Official Website)

Barcelona-based start-up Neuroelectrics is on the cutting edge of brain science, developing a headcap that uses mild electrical currents to monitor and stimulate the brain, aimed at improving the lives of those with brain diseases such as epilepsy, depression, and Alzheimer's.

According to CNBC, the company, which manufactures around 400 devices annually and ships to 75 countries, is seeking FDA approval for its new treatment.

Co-founder and CEO Ana Maiques underlines the potential of their technology to transform epilepsy treatment, especially for the one-third of the 60 million epilepsy patients worldwide who do not respond to medication. 

Traditional treatments for these patients often involve invasive surgery, but Neuroelectrics offers a noninvasive alternative.

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FDA Approval for Neuroelectrics Epilepsy Treatment

A 17-patient study approved by the FDA demonstrated a median seizure reduction of 41%, boosting the company's case as it aims for FDA approval by September 2025. In addition to epilepsy, Maiques and her team are optimistic about the headgear's potential to treat depression and Alzheimer's.

Neuroelectrics' R&D director for brain modeling,  Roser Sanchez-Todo, explains that their devices "read and inject" electricity into affected brain areas without being invasive.

The ultimate goal is for patients to use the head cap at home, requiring ten daily 20-minute sessions over eight weeks to see results. This could greatly improve the quality of life for patients who do not respond to medication. 

As for possible costs, an FDA approval would likely increase the company's market presence and demand, potentially affecting the pricing of their devices. Initially, prices remain high due to research, development, and production costs, but could decrease over time as the technology becomes more widespread and production scales up.

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