INBRAIN Neuroelectronics, a health-tech company dedicated to developing intelligent graphene-neural platform, has announced that its Intelligent Network Modulation System has been granted Breakthrough Device Designation (BDD) from the U.S. Food & Drug Administration (FDA) as an adjunctive therapy for treating Parkinson’s disease.
The INBRAIN system uses graphene, whose electrical and mechanical properties make it ideal for neurotechnology innovation. INBRAIN’s neural platform technology enables ultra-high signal resolution and uses machine learning software that decodes therapy-specific biomarkers to deliver highly focused, adaptive neuroelectronic therapy that re-balances 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,” said INBRAIN Neuroelectronics Clinical Affairs Head Dan Gnansia. “We look forward to working with the agency to help bring this important advance into clinical practice.”
Breakthrough designation recognizes devices that represent a breakthrough or offer a reasonable proof of significant advantage over existing approved or cleared alternatives. It also expedites the development and FDA review of new devices with the potential to more effectively treat or diagnose life-threatening or irreversibly debilitating conditions.
“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,” said 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.”
FDA recognition of the INBRAIN system as a Breakthrough Device means the company will receive feedback throughout the regulatory process, as well as prioritized review by the agency.
“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.”