Company News · May 2026

Neurotype Awarded NIH Phase II SBIR Support to Advance NeuromarkR™

After passing all Phase I go/no-go milestones, Neurotype advances to a controlled clinical study — moving the first EEG-based clinical decision support platform for opioid cue reactivity toward clinical practice.

Opioid use disorder is a chronic, relapsing condition. At least half of those who enter treatment return to opioid use within months — not because medications stop working, but because the brain's response to drug-related environmental cues can persist long after a patient reports feeling better. This drug cue reactivity can drive drug-seeking behavior below the threshold of conscious awareness, and current clinical care has no objective way to see it. No FDA-authorized device exists to measure this response at the point of care. That's the gap NeuromarkR™ is designed to address.

Neurotype Inc. has received Phase II Small Business Innovation Research (SBIR) support from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (Award No. R44DA059517), to continue development of NeuromarkR™ — an investigational EEG-based clinical decision support platform that assesses cue reactivity to opioid-related visual stimuli and delivers neurophysiological summaries to support clinician-patient discussions and treatment planning. The award provides up to approximately $2.5M over three years, subject to milestone achievement.

Phase I: All milestones passed

The Phase II award reflects NIDA's peer-reviewed confidence in Neurotype's Phase I results. Phase I addressed three go/no-go criteria spanning technical feasibility (accurate EEG/ERP synchronization), clinical usability (demonstrated with non-EEG-expert clinicians), and commercial viability (a hardware partnership with an FDA 510(k)-cleared EEG manufacturer). All three passed. The platform also received US Patent No. 12,343,157 (issued July 2025) for its core EEG and machine learning approach to cue-reactive brain state assessment in addiction.

Phase II: From proof of concept to clinical study

Phase II will support continued product development, an IRB-approved controlled clinical study evaluating NeuromarkR™ in outpatient OUD care, and regulatory-pathway preparation toward an FDA De Novo authorization. Neurotype has been engaged with FDA's Center for Devices and Radiological Health (CDRH) throughout the platform's development; the Phase II study design reflects that ongoing dialogue.

NeuromarkR™ outputs are intended to supplement, not replace, clinical judgment. The platform is not intended for continuous monitoring, emergency use, or diagnosis.

About NeuromarkR™

NeuromarkR™ is Neurotype's investigational EEG-based clinical decision support platform intended to assess cue reactivity to opioid-related visual stimuli in adults with OUD. It is investigational and is not cleared or approved by the FDA for diagnostic use. Learn more about the technology platform.

Related work at Neurotype

Research reported on this website is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number R44DA059517. The content is solely the responsibility of Neurotype Inc. and does not necessarily represent the official views of the National Institutes of Health. The public award record is available on NIH RePORTER.

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