Graphene-based neural platform earns breakthrough device status
The Intelligent Network Modulation System refines deep brain stimulation
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Inbrain Neuroelectronics’ neural platform for its potential to provide more effective deep brain stimulation (DBS) as an add-on Parkinson’s treatment.
The platform — called Intelligent Network Modulation System — combines skin-like graphene material and artificial intelligence (AI)-powered data analysis to understand and control the brain’s neural networks to better ease Parkinson’s symptoms.
The designation, which recognizes medical devices that represent a breakthrough or offer improvements over existing ones for life-threatening or irreversibly debilitating diseases, sprints Inbrain’s platform into a fast lane through the FDA’s regulatory review process. Other advantages include frequent interaction with the agency.
“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,” Dan Gnansia, PhD, head of neuroelectronics clinical affairs at Inbrain, said in a press release.
“We look forward to working with the agency to help bring this important advance into clinical practice,” Gnansia added.
Deep brain stimulation is a Parkinson’s treatment that involves a surgical procedure in which doctors place one or more small wires, called leads, into the deep structures of the brain. The leads are connected to a battery-powered stimulator that’s usually placed under the skin in the chest or abdomen.
The stimulator sends electrical pulses through the leads and into the brain to block the irregular signals that cause tremor and uncontrolled movements. As such, DBS is expected to reduce motor symptoms and potentially the need for Parkinson’s medications.
Inbrain’s Intelligent Network Modulation System uses graphene for neural implants capable of delivering DBS.
What is graphene?
The thinnest material known — one million times thinner than a human hair — graphene is a lightweight single layer of carbon atoms arranged in a honeycomb pattern. It’s also incredibly strong and conducts electricity very well, making it an ideal material for electronics.
According to Inbrain’s webpage, their “semiconductor high-density micro-scale graphene technology offers 10-100x higher resolution, allowing unprecedented brain decoding and modulation increasing treatment efficiency.”
“Inbrain is dedicated to leveraging new discoveries in materials science, and transforming them into safe and effective breakthrough therapy applications,” said Carolina Aguilar, Inbrain’s co-founder and CEO.
Most current DBS devices work in open loop, meaning they release constant electrical pulses regardless of a patient’s symptoms. This not only can lead to unwanted side effects, but also consumes energy, meaning more surgical procedures to replace batteries.
Moreover, “current leads have restrictions regarding their relatively large size and low density, limiting their precision for targeting of small deep [brain] structures … and the spatial or signal resolution when sensing the local brain electrical activity,” said Helen Bronte-Stewart, MD, professor of neurology at Stanford University School of Medicine in California.
Inbrain’s platform uses graphene-based neural implants that release high-resolution electrical pulses while also reading inputs from the brain’s neural networks, forming a closed loop that allows them to generate stimulation only as needed, and in real time.
Machine learning adapts to each patient
This tailored stimulation is driven by machine learning, a branch of AI that uses algorithms to teach computers to learn from experience. This allows DBS systems to learn and adapt to each patient to deliver more personalized treatment.
Also, the implantable neural processor runs on a wireless rechargeable battery, cutting the need for extra surgical procedures.
“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,” Bronte-Stewart said.
“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,” Bronte-Stewart added.