Neurovalens

What Neurovalens does

Neurovalens Limited is a Belfast-headquartered, privately-held medical device company founded in 2015 by Dr. Jason McKeown that develops prescription-only, non-invasive neurostimulation devices under the Modius brand. The proprietary platform delivers low-level electrical pulses through skin-contact electrodes behind the ear to stimulate the vestibular nerve, modulating deep brain regions including the hypothalamus and brain stem to treat neurological and metabolic conditions without drugs, surgery or implants. The company has secured four FDA authorizations: Modius Sleep (510(k), October 2023) for chronic insomnia, Modius Stress/Calm (510(k), April 2024) for Generalized Anxiety Disorder, Modius Lean (De Novo, December 2025) for weight management, and Modius Spero (De Novo, May 2026) for PTSD symptoms — the world's first neuromodulation device to receive FDA authorization for PTSD. Modius Sleep additionally received EU MDR compliance and UK MHRA registration in March 2026. A 182-patient Type 2 Diabetes trial completed in 2024 and a planned Major Depressive Disorder study round out the indication pipeline.

The business operates three principal revenue channels. The direct-to-consumer Shopify storefront (neurovalens.com) sells Modius Sleep at US$2,265 per device with a 30-day money-back guarantee, free US shipping, and a 3-year limited warranty, supplemented by recurring revenue from stimulation-pad refill consumables. A US physician and prescription channel is led by VP Commercialization Kate Willis (Cincinnati, OH) with a Beluga Health telehealth prescription pipeline, while a B2G channel distributes Modius Sleep, Calm and Spero to U.S. veterans through the Department of Veterans Affairs (including deployment at the Houston VA Medical Center TBI Polytrauma program). Pricing carries no subscription fee on the hardware; consumables and warranty replacement services provide recurring or service elements. As of August 2025 the company had raised approximately £20m in cumulative equity and debt from UK investors including IFNI/Clarendon, IQ Capital, Techstart Ventures, ACF Investors, Wharton Asset Management, Whiterock, Beltrae Partners, Innovation Ulster and the British Business Bank, and had stated intent to raise a $40m-$50m Series B.

Name

Neurovalens

Legal name

Neurovalens Limited

Website

https://neurovalens.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Neurovalens is a Belfast-based medical device company that builds FDA-cleared, prescription-only Modius headsets delivering non-invasive vestibular nerve stimulation to treat insomnia, anxiety, weight management, and PTSD, sold via DTC e-commerce, US physicians and the U.S. Veterans Affairs program.

Ownership category

akta.pro rank

Product category

Neuromodulation Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK)

akta.pro secondary industries

Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE), Mental Wellness & Stress Management Devices (Biofeedback, Meditation/Neurostimulation Devices) (CRACAQAL)

Keywords

• Non-invasive neurostimulation devices
• Vestibular nerve stimulation
• Prescription medical devices
• Sleep neuromodulation therapy
• Neurological medical devices

Headquarters

HQ city

Belfast

HQ country

United Kingdom

HQ region

Europe

Offices4 records

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Supply Chain, Marketing or Sales, Operations, Infrastructure

Revenue model

1. Direct device sales (one-time): One-time hardware sale of FDA-cleared prescription Modius devices via own e-commerce storefront at US$2,265 per device, paid up-front before dispatch. Pricing captured at order; 30-day money-back guarantee (minus US$35 return fee).
2. Consumables (stimulation pad refills): Recurring revenue from stimulation pad refill packs ordered via online store, replenished as users consume gel pads during treatment.
3. B2B/B2G channel sales via VA program: Sales of Modius Sleep, Modius Calm, and Modius Spero to U.S. Department of Veterans Affairs for distribution to veterans as a covered benefit; pursued parallel private-insurance reimbursement approvals.
4. Limited warranty replacement services: Three-year limited warranty on Modius Sleep, providing replacement or refund for defective products within warranty terms.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels10 records

Core offering

Neurovalens designs, manufactures and sells prescription non-invasive neurostimulation headsets under the Modius brand that deliver 30-minute daily sessions of low-level electrical pulses via skin-contact electrodes behind the ear to stimulate the vestibular nerve and modulate deep brain regions. The product portfolio includes Modius Sleep (chronic insomnia), Modius Calm (generalized anxiety disorder), Modius Lean (weight management) and Modius Spero (PTSD symptoms), supported by a companion mobile app and replacement stimulation pad consumables.

Product overview

Neurovalens is a Belfast-based global health-tech company built around a single underlying neurostimulation platform branded Modius. The platform uses low-level electrical vestibular nerve stimulation (VeNS/VSS) delivered through skin-contact electrodes behind the ear to non-invasively influence deep brain regions such as the hypothalamus and brain stem, offering drug-free, at-home treatments for serious neurological and metabolic conditions. On top of this shared technology platform, Neurovalens offers a portfolio of prescription medical devices: Modius Sleep (FDA-cleared for chronic insomnia, also EU MDR / UK MHRA cleared), Modius Calm (FDA-cleared for Generalized Anxiety Disorder), Modius Lean (FDA De Novo-approved for weight management), and Modius Spero (FDA De Novo-approved for PTSD symptoms). A companion Modius mobile application automatically syncs device session data and captures optional user health metrics. Together, the Modius platform, the named product variants, and the mobile app form an integrated suite for clinical and at-home neurostimulation therapy.

Differentiator

Problem solved

Functional benefit

Brands

• Modius Sleep: FDA-cleared, non-invasive neurostimulation device for the treatment of chronic insomnia, delivered via electrical vestibular stimulation (VeNS).
• Modius Stress (also marketed as Modius Calm)
• Modius Spero
• Modius Lean

Products and services

• Modius Sleep FDA-cleared, prescription-only, non-invasive wearable neurostimulation headset for the treatment of chronic insomnia. It delivers 30 minutes of low-level electrical pulses to the vestibular nerve via skin-contact electrodes behind the ear before bedtime, using vestibular nerve stimulation (VeNS/VSS) to influence sleep-regulating brain regions such as the hypothalamus. Available in the US at US$2,265 with free shipping and a 30-day money-back guarantee; also EU MDR-compliant and UK MHRA-registered (March 2026).
• Modius Calm (formerly Modius Stress) FDA-cleared, prescription-only, non-invasive wearable neurostimulation headset for the treatment of Generalized Anxiety Disorder (GAD). Originally cleared under the name Modius Stress in April 2024, it delivers 30 minutes of low-level electrical pulses to the head before bed to regulate neural pathways associated with anxiety. Available to U.S. veterans through the VA program.
• Modius Lean FDA De Novo-approved, prescription-only, non-invasive neurostimulation device for weight management, developed in collaboration with Stanford Neurosurgery. Uses low-level electrical stimulation to target brain regions involved in metabolic regulation to reduce visceral fat as a non-pharmacologic treatment option.
• Modius Spero FDA De Novo-approved, prescription-only wearable neuromodulation device for the treatment of PTSD symptoms in adults aged 22+. Delivers 30-minute daily non-invasive electrical pulses behind the ear. The world's first neuromodulation device to receive FDA authorization for PTSD treatment, available through the US Department of Veterans Affairs.
• Modius Mobile Application Companion mobile application for the Modius device that automatically syncs session data from the headset, captures optional health information such as weight records and sleep scores, and supports device management. Hosted in the EU.

Quantifiable outcome

• Two-thirds of Modius Spero trial participants (n=383) reported clinically meaningful PTSD symptom improvement vs. sham
• +3 more outcomes

Named customers3 records

Segments6 records

Ideal customer profiles6 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration8 records

Feature7 records

Partnerships

Eleven partnerships are on record, tiered core, flagship and minor.

• Association of British HealthTech Industries (ABHI)coreGTM or Marketing Partner · 9 February 2026Neurovalens joined the ABHI UK Pavilion at WHX Dubai 2026 (formerly Arab Health), 9-12 February 2026 at Expo City Dubai, exhibiting Modius Sleep and Modius Calm; ABHI is the exclusive UK representative for Informa Markets' healthcare portfolio.
• U.S. Department of Veterans Affairs (VA)flagshipChannel Partner/ Reseller/ Distributor · 24 February 2025Modius Sleep made available to U.S. veterans through the VA program from February 2025; expanded with Modius Calm (anxiety) and Modius Spero (PTSD); covered as part of VA healthcare benefits with clinical care team support. Houston VA Medical Center uses Modius Sleep in TBI Polytrauma program.
• University of California, San Diego (UCSD) - Department of PsychiatryflagshipStrategic or Co-development Partner · 26 April 2024Long-term research collaboration beginning in 2015 at the Center for Brain and Cognition; CEO Dr. Jason McKeown appointed Visiting Scholar at UCSD Department of Psychiatry in April 2024; UCSD investigator Peter Colvonen PhD led the pivotal 383-patient Modius Spero PTSD clinical trial.
• Royal Academy of Engineering (Shott Scale Up Accelerator)minorImplementation/ SI/ Consulting Partner · 26 March 2024Chief Project Officer Iain Hendrick joined the Shott Scale Up Accelerator 2024 cohort with the Royal Academy of Engineering, gaining 12 months of leadership training across People & Culture, Governance, Customer Acquisition, Product & Service Development, Growth Capital and New Markets.
• Stanford Neurosurgery (Stanford Medicine)flagshipStrategic or Co-development PartnerStanford Neurosurgery Clinical Instructor Dr. Paul D. McGeoch and Visiting Scholar Dr. Jason McKeown secured FDA approval for Modius Lean (non-invasive weight management); collaboration reflects Stanford's commitment to translating neuroscience into real-world health solutions.
• Ulster UniversitycoreStrategic or Co-development PartnerConducted Phase III / Pivotal clinical trials for Modius Stress in the UK and Ireland in mid-2023, supporting the FDA 510(k) clearance; future Major Depressive Disorder study planned in collaboration with Ulster University and US sites.
• Indian Center of Neurophysiology (ICN)coreStrategic or Co-development PartnerConducted Phase III / Pivotal clinical trials in India for Modius Stress in mid-2023, supporting the April 2024 FDA 510(k) clearance for Generalized Anxiety Disorder.
• Beluga HealthcoreTechnology or IntegrationUS telehealth partner that conducts online medical consultations and issues prescriptions for Modius devices; handles protected health information under HIPAA with processors including Jotform, Keragon, Google Workspace and Zendesk.
• Shopify International LtdcoreTechnology or IntegrationHosts part of the Neurovalens website (e-commerce storefront); data transfers conducted pursuant to EU adequacy decision for Canada where Shopify Inc. is headquartered.
• StripecoreTechnology or IntegrationPayment processor for the neurovalens.com storefront; Visa, MasterCard, American Express, Discover and PayPal supported.
• KlaviyocoreTechnology or IntegrationCustomer relationship management and email marketing platform integrated into the website for newsletter and lifecycle marketing.

Scale indicators12 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Electrocore: Electrocore manufactures gammaCore, a non-invasive vagus nerve stimulation (nVNS) handheld prescribed for migraine and cluster headache. It is the closest direct peer to Neurovalens in non-invasive, FDA-cleared prescription neurostimulation delivered at home.
• Cala Health: Cala Health produces Cala Trio and Cala kIQ, FDA-cleared wearable peripheral nerve stimulation devices for essential tremor and Parkinson's tremor. It shares Neurovalens' model of a prescription, wearable, non-invasive electrical neurostim product sold direct and reimbursed.
• Fisher Wallace Laboratories: Fisher Wallace makes a non-invasive transcranial electrical stimulation headset for depression, insomnia and anxiety. It overlaps directly with Neurovalens on at-home non-drug brain stimulation for sleep and anxiety indications.
• Apollo Neuroscience: Apollo makes a wearable vibroacoustic stress and sleep device sold direct-to-consumer. It targets overlapping anxiety/sleep use cases with a wearable neurostimulation-adjacent platform, positioning it as a direct competitor at the consumer end of the market.
• Dreem: Dreem sells a wearable EEG-based sleep headband with stimulation features for insomnia and stress. It overlaps with Neurovalens on the prescription/wellness sleep market and shares the head-worn, app-connected device form factor.

Emerging players

• Neurolief: Neurolief develops non-invasive neuromodulation (Relivion) for migraine and depression using head-mounted electrodes. It is an emerging competitor pursuing similar multi-indication, non-invasive, prescription neurostim claims as Neurovalens.
• Interaxon (Muse): Muse makes EEG brain-sensing headbands for meditation, sleep and focus sold direct-to-consumer. It competes for overlapping anxiety, sleep and stress-management consumer use cases with Neurovalens' Modius Calm and Sleep.

Broad incumbents

• Inspire Medical Systems: Inspire Medical Systems makes an implantable neurostim device for obstructive sleep apnea. It is a broad incumbent in neuromodulation for sleep-disordered breathing, with deeper reimbursement infrastructure and a public-market valuation.
• NeuroPace: NeuroPace manufactures the RNS System, an implanted closed-loop brain stimulator for refractory epilepsy. It is a broader incumbent in therapeutic neuromodulation and a relevant comparability anchor for device economics and reimbursement dynamics.
• Axonics: Axonics builds implantable sacral and pudendal neuromodulation devices for incontinence. It is a broad incumbent in prescription neuromodulation with comparable reimbursement, regulatory and commercial dynamics to Neurovalens.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/neurovalens
• Facebookfacebook.com/Neurovalens
• LinkedInlinkedin.com/company/neurovalens
• Instagraminstagram.com/neurovalens

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds12 records

Investors15 records

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M&A

Investments

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

Frequently asked questions about Neurovalens