Sama Therapeutics

Explainable AI/ML analytics connecting neuropsychiatric symptoms to underlying mechanisms across drug/device development and clinical care

About Sama Therapeutics

Neuropsychiatric patient care and clinical trial outcomes are less connected to underlying physiological causes than any other branch of medicine. We predict treatment response by analyzing relationships between neurophysiological signals and symptoms to reduce clinical trial failure rates and advance beyond the current “trial-and-error” state of neuropsychiatric care. Our vertically integrated iMAGiNE™ platform aggregates and synthesizes multimodal neural, physiological, and multi-omic biomarker signals with an in-house, mobile clinical and neurocognitive assessment battery developed by our leading psychometricians to produce dynamic readouts of patterns related to mechanisms underlying neuropsychiatric disorders. This approach breaks down knowledge silos in academia and industry to generate and validate unique models to bring precision methods to drug/device trials and ultimately enable personalized care protocols.

Sama Therapeutics' low-code/no-code analytics pipelines will be advanced in parallel for FDA “Software as Medical Device” 510(k) and de novo regulatory clearance. We are operationalizing our software both as a stand-alone, hardware-agnostic platform and as an API plug-in with strategic hardware partners. We invite partners to join our mission unlocking brain health through integrative neurotechnology and proven transdiagnostic and “transprognostic” algorithms.

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Problem statement

Neuropsychiatric disorders are the single largest cause of disability in the world, with ~1B people suffering worldwide, and costing over $1.5T annually in the US alone. In the clinic, only 30-40% of major depression patients achieve remission with first-line SSRIs, and clinical workflows have unacceptable degrees of trial and error. Additionally, 9 of the largest 20 pharmaceutical companies have decreased neuroscience research and development. The current diagnostic paradigm relies heavily on the DSM-5-TR (“Diagnostic & Statistical Manual of Mental Disorders, 5th Edition, Text Revision”), which often obscures subtle variations within, as well as common overlap across, across disorders. Psychiatric care proceeds via "trial & error," lacking objective neurobiological assessment to reliably guide clinical decision making. Fundamental neuroscientific discovery remains "siloed" within pockets of academia and industry despite convergence in advanced AI/ML techniques and big data that offer revolutionary new methods. We synthesize this expertise in one platform.

Traction information

We currently have 8 contracts/LOIs with other startups. Two are revenue generating contracts from drug developers for platform analytics related to preclinical and human phase 1 trials. Two more are with preclinical CROs, and another two are with clinic networks to provide neurophysiological patient reports. The last two contracts are with medical device companies, one of which is a collaboration with cutting-edge EEG hardware startup for whom we are developing a software plug-in to enable their expansion into psychiatric clinics. We are setting up a rigorous clinical trial at Mass General Hospital through an advisor on our scientific advisory board for prospective validation of our precision AI/ML approach. Lastly, we are the North American partner of BrainClinics Foundation with access to their two decades of neurophysiological and clinical data. This will augment our aggregated public/proprietary database of already over 10,000 patients with neuropsychological data.

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Funding

Currently raising capital

$0
committed
$5,000,000
goal
Total raised to date:$1,250,000