Company targets regulatory submission and commercialization of non-invasive treatment platform, currently in pivotal human trials.
Neurotech firm Cognito Therapeutics today announced an oversubscribed $105 million Series C financing as it prepares for a pivotal clinical data readout and potential regulatory submission for its non-invasive sensory stimulation Alzheimer’s therapy. The Cambridge, MA–based company is the creator of Spectris – a physician-prescribed, at-home therapeutic platform designed to influence neural activity in the brain.
Cognito’s approach is based on the idea that Alzheimer’s disease is associated with disrupted neuronal signaling across large-scale brain networks. Designated a “Breakthrough Device” by the FDA, Spectris was developed to restore aspects of that activity through precisely timed visual and auditory stimulation. The company said the new funding will support its push towards regulatory review and commercialization of the device, which it hopes to bring to market in 2027.
“Spectris has the potential to become the world’s first physician-prescribed, at-home neuroprotective therapy for patients diagnosed with Alzheimer’s, designed to preserve cognition and daily function,” said Cognito CEO Christian Howell.
How Spectris works
Neurons communicate through electrical signals that create rhythmic patterns known as brain waves. Among these patterns are gamma oscillations, a high-frequency brain wave range associated with learning, memory formation and other cognitive processes. Research has shown that gamma wave activity is altered in Alzheimer’s disease, reflecting disruptions in the coordinated firing of neurons. The Spectris system is designed to evoke gamma oscillations through synchronized flashes of light and pulses of sound delivered through a wearable device.
“By engaging neural network function through the brain’s natural sensory pathways, we aim to preserve cognition, daily function, and brain structure in people diagnosed with Alzheimer’s disease,” Howell told us.
Cognito’s scientific hypothesis extends beyond the immediate generation of gamma rhythms. According to the company, inducing gamma activity may trigger downstream biological processes linked to brain health, including increased expression of genes and proteins involved in synaptic function and myelin maintenance. Synapses are the communication junctions between neurons, while myelin is the insulating layer that helps electrical signals travel efficiently along nerve fibers. Both structures are known to deteriorate during the progression of Alzheimer’s disease.
“Our approach is grounded in rigorous neuroscience research and informed by a network-based understanding of brain health,” said Howell. “Spectris has been evaluated in feasibility and randomized clinical studies, with findings suggesting the potential to slow decline in cognition and daily function and to reduce measures of brain atrophy in patients with mild-to-moderate Alzheimer’s disease.”
Pivotal trial underway
Cognito’s previous OVERTURE feasibility study enrolled 76 patients with mild-to-moderate Alzheimer’s disease in a randomized, sham-controlled, double-blind, multicenter trial lasting six months. Results from the study suggested that patients receiving active treatment experienced slower decline across several measures of disease progression compared with the control group. MRI scans also indicated a 69 percent reduction in the rate of brain volume loss among treated patients.
The company’s latest HOPE study is designed to build on those findings with a larger, randomized pivotal trial involving 673 participants across 70 investigational sites in the United States. The study is evaluating the effects of daily Spectris treatment over a longer period on cognitive performance, daily function and structural brain changes measured by imaging.
“The ongoing HOPE pivotal study is fully enrolled, and we anticipate top-line data later this year as we advance toward regulatory submission,” said Howell. “Our focus remains on generating the rigorous evidence required to support FDA review and, if authorized, preparing for planned commercialization in 2027 as a scalable, at-home neuroprotective therapy for patients and families living with Alzheimer’s disease.”
The Series C financing was led by Morningside Ventures, IAG Capital Partners and Starbloom Capital, with participation from new investors including New Vintage, Apollo Health Ventures and Benvolio Group. Proceeds from the round will also be used to continue clinical development of the Spectris platform and to expand research into additional neurodegenerative diseases through collaborations with academic partners.
“Spectris has the potential to redefine how a broad category of neurodegenerative diseases are treated, by moving therapy into the home, reducing burden on patients and caregivers, and scaling impact globally.” said Morningside founder Gerald Chan.
“Novel technologies like Cognito’s, which are non-invasive and accessible, will be an important part of the broad and comprehensive treatment approach that will define the future of Alzheimer’s care,” said Alzheimer’s Drug Discovery Foundation co-founder Dr Howard Fillit. “Ultimately, we will be able to combine therapeutics, lifestyle interventions, and devices to treat each patient based on their individual risk profiles.”
