INBRAIN Gets Breakthrough Nod for Intelligent Network Modulation System

INBRAIN Neuroelectronics, a company developing the world’s first intelligent graphene-neural platform, has been granted breakthrough status from the U.S. Food and Drug Administration (FDA) for its Intelligent Network Modulation system as an adjunctive therapy to treat Parkinson’s disease.
 
The INBRAIN system uses graphene, a two-dimensional material made of a lattice of carbon atoms that is one atom thick. Graphene’s combination of electrical and mechanical properties makes it ideal for neurotechnology innovation, the company said.
 
INBRAIN’s neural platform tech allows ultra-high signal resolution and uses machine learning software to decode therapy-specific biomarkers to deliver highly focused, adaptive neuroelectronic therapy to re-balance pathological neural networks.
 
“Breakthrough device designation from the FDA signifies the potential of the INBRAIN neural platform to further improve the lives of patients with Parkinson’s disease,” INBRAIN Neuroelectronics Clinical Affairs Head Dan Gnansia told the press. “We look forward to working with the agency to help bring this important advance into clinical practice.”
 
“From the current available clinical brain interfaces, deep brain stimulation is a successful therapy to treat Parkinson’s disease. However, current leads have restrictions regarding their relatively large size and low density, limiting their precision for targeting of small deep structures such as the subthalamic nucleus (STN), and the spatial or signal resolution when sensing the local brain electrical activity,” added Helen Bronte Stewart, professor of neurology and neurological sciences at Stanford University School of Medicine. “INBRAIN’s new generation of ultrathin graphene-based high resolution interfaces and associated network platform may vastly improve the precision, efficiency and efficacy of DBS and closed-loop or adaptive modulation. The FDA breakthrough device designation is a statement to how this technology may be a paradigm shift in the scope of neuromodulation for people with Parkinson’s disease and hopefully for other neuropsychiatric diseases in the future.”
 
“INBRAIN is dedicated to leveraging new discoveries in materials science, and transforming them into safe and effective breakthrough therapy applications,” added Carolina Aguilar, INBRAIN Neuroelectronics CEO and co-founder “We anticipate developing our technology to treat other conditions affecting the central and peripheral nervous systems to make BCI technology relevant in neuro and bioelectronics.”