INBRAIN Neuroelectronics S.L., member of CataloniaBio & HealthTech, a health-tech company dedicated to developing the world’s first intelligent graphene-neural platform, 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 harnesses the power of graphene, a two-dimensional material made of a lattice of carbon atoms only one atom thick. The thinnest material known, yet stronger than steel, graphene’s unique combination of electrical and mechanical properties makes it ideal for neurotechnology innovation. INBRAIN’s neural platform technology enables ultra-high signal resolution at levels never seen before, 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.
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.”
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