There currently exist no disease-modifying-therapy (DMT)-based devices for Alzheimer’s disease, with the space currently dominated by pharmaceuticals such as Biogen’s Leqembi. Credit: MMD Creative / Shutterstock.com

Cognito Therapeutics has raised $105m to advance the clinical development and commercial preparedness for its Alzheimer’s disease therapeutic.

The Massachusetts-based company’s oversubscribed Series C financing round was led by Morningside Ventures, IAG Capital Partners and Starbloom Capital. New investors, including Apollo Health Ventures and Benvolio Group, also participated.

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Cognito’s Spectris is a physician-prescribed at home headset and control, which is designed to engage neural network function through the brain’s natural sensory pathways. These signals are non-invasive visual and auditory stimulation to preserve cognition, daily function, and brain structure in patients who have been diagnosed with mild-to-moderate Alzheimer’s disease.

Funds from the Series C round will go towards Spectris’s ongoing clinical development while supporting various regulatory and commercial activities ahead of the system’s anticipated US market entry in 2027.

Cognito CEO Christian Howell said: “With this financing, we are entering a pivotal moment for our company, and for the patients and families waiting for new options in Alzheimer’s disease.

“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. This funding allows us to make this therapy accessible to those who need it most.”

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The headset is currently being evaluated in the HOPE pivotal trial (NCT05637801), for which a readout is anticipated later this year. The randomised trial has enrolled approximately 670 patients who will receive daily treatment, either with Spectris or a sham sensory stimulation system, for 12 months.

Efficacy outcomes of the trial will be measured using the Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).

Disease-modifying therapies for Alzheimer’s disease

While devices such as Medical Microinstrument’s surgical robot for treating Alzheimer’s disease are in the early development stages, there are currently no disease-modifying therapy (DMT) devices on the US market for addressing the condition.

Instead, pharmacologic approaches to Alzheimer’s disease have stolen much of the limelight in recent years following the US Food and Drug Administration’s (FDA) approval of Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab) in 2023 and 2024, respectively. According to GlobalData analysts, sales of Leqembi and Kisunla could generate respective global sales of $2.63bn and $2.39bn in 2030.