Pulvinar Neuro

What Pulvinar Neuro does

Pulvinar Neuro is a neurotechnology company that develops non-invasive brain stimulation devices for neuroscience research and therapeutic applications. Founded in 2016 as a spin-off from Dr. Flavio Frohlich's lab at the University of North Carolina at Chapel Hill, the company builds transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) systems engineered for rigorous randomized, double-blind, placebo-controlled studies. Its product portfolio includes the legacy XCSITE 100 research device (discontinued from sale but still supported, and cited in 8 peer-reviewed publications) and the next-generation XCSITE-RD research device, which adds user-defined custom waveforms, higher stimulation amplitudes (up to ±4 mA), double-blind active-sham software, and cloud connectivity.

The company's therapeutic pipeline targets major depressive disorder (MDD) via EEG-triggered closed-loop tACS, which received FDA Breakthrough Device designation in late 2024 and is the subject of a pivotal clinical trial planned for 2025. A proof-of-concept study reported 80% of patients free of clinical depression symptoms two weeks after completing treatment. Pulvinar also pursues transcranial stimulation applications for substance use disorder and other psychiatric indications.

Pulvinar generates revenue primarily through NIH-funded SBIR grants (including a $3.06 million Phase II award from NIMH in 2023) and limited sales of research-grade devices to academic and clinical research institutions. Since 2022 the company has operated as a wholly owned subsidiary of Electromedical Products International, Inc. (EPI), a privately held medical device manufacturer and the marketer of FDA-cleared Alpha-Stim technology. Headcount is 1-10 employees and the company is headquartered in Durham, NC.

Name

Pulvinar Neuro

Legal name

Pulvinar Neuro

Website

https://pulvinarneuro.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Pulvinar Neuro develops non-invasive brain stimulation devices (tDCS/tACS) for academic neuroscience research and therapeutic development in psychiatric disorders. Operating as a subsidiary of EPI, the company holds FDA Breakthrough Device designation for closed-loop treatment of major depressive disorder.

Ownership category

akta.pro rank

Product category

Neurotechnology / Brain Stimulation Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Behavioral Health & Neurocognitive Therapeutics (Digital) (HLACANAI)

akta.pro secondary industries

Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE), Prescription Digital Therapeutics (PDT) (HLACANAB)

Keywords

• Transcranial stimulation devices
• Brain stimulation research
• TDCS tACS equipment
• Neuroscience research devices
• Non-invasive neurotechnology

Headquarters

HQ city

Durham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Research Device Sales: Sale of research-grade brain stimulation devices (XCSITE 100, XCSITE-RD) to academic institutions and research labs for use in clinical studies. XCSITE 100 has been utilized in 8 peer-reviewed publications.
2. Government Research Grants: SBIR grants from NIH/NIMH and NIDA funding therapeutic development. $3.06M Phase II SBIR grant from NIMH for closed-loop tACS for MDD. R43MH119872 and R43DA054848 grants supporting clinical development.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Pulvinar Neuro designs and manufactures non-invasive transcranial electrical stimulation devices (tDCS and tACS) for neuroscience research laboratories. Its devices support randomized, double-blind, placebo-controlled clinical studies and are used as a development platform for closed-loop therapeutic applications targeting Major Depressive Disorder (with FDA Breakthrough Device Designation) and substance use disorder.

Product overview

Pulvinar Neuro is a neurotechnology company that develops brain stimulation devices for research and therapeutic applications. The company offers two main products: the first-generation XCSITE 100 research device (discontinued but supported) and the XCSITE-RD next-generation research device (in development). Both products support transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) for randomized, double-blind, placebo-controlled research studies. The XCSITE-RD also serves as the development platform for the company's therapeutic pipeline targeting major depressive disorder (with FDA Breakthrough Device designation) and substance use disorder. Pulvinar Neuro operates as a wholly owned subsidiary of Electromedical Products International, Inc. (EPI).

Differentiator

Problem solved

Functional benefit

Brands

• XCSITE 100: First generation research grade tDCS/tACS device designed for randomized, double-blind, placebo-controlled studies. Released in 2016 and no longer sold but still supported.
• XCSITE-RD
• XCSITE

Products and services

• XCSITE 100 First-generation research-grade transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) device designed to enable high-quality randomized, double-blind, placebo-controlled neuroscience studies with user-friendly operation and validation features; no longer sold but still supported for existing research customers.
• XCSITE-RD

Quantifiable outcome

• 80% of patients were found to be free of clinical depression symptoms two weeks after completing closed-loop tACS treatment
• +1 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature3 records

Partnerships

One partnership is on record.

• Electromedical Products International, Inc. (EPI)coreStrategic or Co-development Partner · 1 March 2022Pulvinar Neuro was acquired in 2022 and became a wholly owned subsidiary of EPI. EPI is a privately held, SBIR-eligible medical device manufacturer and leader in non-invasive brain stimulation for psychiatric disorders. EPI markets FDA-cleared Alpha-Stim technology for anxiety, insomnia, depression, and pain. The partnership accelerates non-invasive brain stimulation development including tACS, individualized feedback stimulation, and cloud-enabled therapeutics.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Soterix Medical: Soterix manufactures non-invasive tDCS/tACS research and clinical systems (e.g., 1x1, 4x1, High-Definition platforms) and is the most direct competitor to Pulvinar's XCSITE-RD in the brain stimulation research device market.
• Neuroelectrics: Neuroelectrics offers Starstim, a combined tDCS/tACS + EEG system, and is developing therapeutic applications in depression and epilepsy. Highly comparable to Pulvinar in combining EEG-based monitoring with non-invasive stimulation.
• Flow Neuroscience: Flow has developed a home-use tDCS headset for depression and is advancing clinical evidence in MDD, directly competing with Pulvinar's MDD pipeline and addressing the same treatment-resistant depression patient.
• Caputron: Caputron is a distributor and developer of non-invasive brain stimulation devices (tDCS, tACS, CES) for research and consumer use, directly competing with Pulvinar in the research device channel.

Broad incumbents

• Neuronetics (NeuroStar): Neuronetics markets the FDA-cleared NeuroStar TMS system for MDD and is the established non-invasive brain stimulation incumbent in depression. Relevant as a benchmark for the regulatory and commercial pathway Pulvinar is targeting.
• Brainsway: Brainsway markets FDA-cleared deep TMS systems for depression, OCD, and other psychiatric indications. Competes in the same clinical end market (MDD treatment) using a different non-invasive modality.
• Magstim: Magstim manufactures TMS research and clinical systems used widely in academic and clinical neurostimulation research, broadly comparable to Pulvinar's research device business.
• LivaNova: LivaNova markets the FDA-cleared Vagus Nerve Stimulation (VNS) system for treatment-resistant depression and epilepsy. A broader neuromodulation incumbent competing in the same TRD patient population via an invasive modality.

Emerging players

• Akili Interactive: Akili develops prescription digital therapeutics (e.g., EndeavorRx) including cognitive and behavioral health applications. Comparable to Pulvinar's FDA Breakthrough pathway for MDD from a software/digital therapeutic regulatory and commercialization standpoint.

Others

• Pear Therapeutics (now defunct): Pear was a pioneer in FDA-authorized prescription digital therapeutics including for psychiatric conditions. Its trajectory (commercialization challenges, bankruptcy) is relevant context for Pulvinar's digital-therapeutic-class regulatory ambitions.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/pulvinarneuro

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds2 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pulvinar Neuro