Sana Health

What Sana Health does

Sana Health, Inc. is a Louisville, Colorado-based private health technology company that develops and sells the Sana Device, a non-invasive wearable audiovisual neuromodulation headset, and the companion Sana Relief mobile application. The hardware delivers patented rhythmic sequences of synchronized light and sound through a light-emitting mask and wired headphones, designed to entrain groups of neurons and affect the central nervous system to produce relaxation and pain-relief states. A built-in heart-rate sensor feeds a patented feedback-loop algorithm that personalizes session parameters; the iOS/Android app controls the device and displays usage data. The platform is supported by 7 granted US patents covering the core AVS method, feedback loops, and therapeutic applications including pain, addiction withdrawal, and fibromyalgia.

The company sells direct-to-consumer through its own e-commerce storefront (sana.io) on a subscription/lease basis with 3-, 6-, and 18-month product terms, with the 18-month term conveying device ownership. Pricing is not publicly disclosed, and a discounted clinical-study product term is offered to trial participants. The company is currently organized as a small team (11-50 employees) operating exclusively in the United States, with manufacturing also located domestically.

Sana Health's commercial and clinical positioning is anchored by three FDA milestones: a 513(g) General Wellness Device classification (August 2020), a Breakthrough Device Designation, and a De Novo clearance in January 2026 for adjunctive treatment of temporary relief of neuropathic pain in adults 18+, which created an entirely new device category (Audio-Visual Stimulator for Pain Relief, 21 CFR 890.5775). The company is pursuing additional indications through Department of Defense-funded PTSD clinical trials with MUSC and BAMC, and academic fibromyalgia and neuropathy studies at Duke University and Mount Sinai Health System. Customer segments today are individuals with neuropathic pain, individuals participating in PTSD or fibromyalgia clinical trials, and wellness consumers seeking relaxation, stress reduction, and sleep improvement.

Name

Sana Health

Legal name

Sana Health, Inc.

Website

http://www.sana.io

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Sana Health develops the Sana Device, a wearable audiovisual neuromodulation headset with a companion mobile app that delivers patented light-and-sound stimulation for temporary relief of neuropathic pain, sleep, and stress. The company sells direct-to-consumer via subscription leases and holds FDA De Novo clearance in this category.

Ownership category

akta.pro rank

Product category

Wearable Neuromodulation Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

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

akta.pro primary industry

Connected Medical Devices & Wearables (Sensors, Patches, Implantables) (HLACAPAB)

akta.pro secondary industries

Digital Rehabilitation & Physical Therapy Therapeutics (HLACANAJ), Therapeutic Companion Apps (Drug-Device-Digital Combination) (HLACANAH), Mental Wellness & Stress Management Devices (Biofeedback, Meditation/Neurostimulation Devices) (CRACAQAL)

Keywords

• Wearable neuromodulation devices
• Audiovisual stimulation therapy
• Neuropathic pain management
• Consumer medical wearables
• Digital health therapeutics

Headquarters

HQ city

Louisville

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Device Subscription (Sana Product Term): The Sana device is leased through subscription terms (3-month, 6-month, 18-month periods). Users pay monthly through the duration of their Product Term. The 18-month term results in ownership after all payments are completed. This is the primary revenue stream.
2. Venture Funding: The company raised $5.8 million in venture funds in 2020 through a combination of preferred stock and convertible notes from 44 investors, with a target fundraising goal of $9 million.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Sana Health sells and leases the Sana Device, a non-invasive wearable headset that delivers patented audiovisual neuromodulation sequences through coordinated light (light-emitting mask) and sound (wired headphones) to synchronize neuronal activity and provide temporary relief of neuropathic pain. The device is FDA De Novo cleared (January 2026) under a new medical device category and is paired with the Sana Relief mobile app for session control and biometric (heart rate) monitoring. The product is offered to individual consumers via subscription leases (3/6/18 months) and through clinical trial participation programs.

Product overview

Sana Health offers a core hardware-plus-software product consisting of the Sana Device (a non-invasive wearable audiovisual neuromodulation headset) and the companion Sana Relief mobile app. The Sana Device delivers patented audiovisual stimulation sequences through light and sound to affect the central nervous system, providing relief for neuropathic pain and supporting mental well-being. The Sana Relief app connects to the device via Bluetooth, enabling session delivery and biometric data monitoring. The company also provides clinical trial participation programs and subscription-based access to the device. The portfolio is anchored by the Sana Device, which received FDA De Novo clearance in January 2026, establishing a new regulatory classification for Audio-Visual Stimulators for Pain Relief.

Differentiator

Problem solved

Functional benefit

Products and services

• Sana Device A non-invasive wearable audiovisual neuromodulation device consisting of a light-emitting mask and wired headphones that delivers patented sequences of rhythmic light and sound through a headset to affect the central nervous system. FDA De Novo cleared as an adjunctive treatment for temporary relief of neuropathic pain in patients aged 18 and older. Integrates a heart rate sensor for biometric data collection. Manufactured in the United States. Sold to individual consumers via direct-to-consumer subscription lease terms (3, 6, or 18 months) on the company's own website, with ownership transferring after 18 monthly payments; also distributed to clinical trial participants at Duke University, Mount Sinai Health System, MUSC, and BAMC.
• Sana Relief App A companion mobile application available on iOS and Android that connects to the Sana Device via Bluetooth to deliver personalized audiovisual stimulation sessions. It controls device sessions and monitors biometric data including heart rate collected through the Sana Device sensor, displaying usage information to the user.

Quantifiable outcome

• 74% positive response rate in pilot studies - participants described Sana as calming, life-changing, meditative, and relaxing
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Duke UniversitycoreStrategic or Co-development PartnerClinical trials for fibromyalgia being conducted at Duke University as part of FDA certification pathway.
• Mount Sinai Health SystemcoreStrategic or Co-development PartnerBroader neuropathy study being conducted at Mount Sinai Health System in New York as part of clinical trial program.
• Medical University of South Carolina (MUSC)coreStrategic or Co-development PartnerDOD-funded PTSD research collaboration with MUSC.
• Brooke Army Medical Center (BAMC)coreStrategic or Co-development PartnerDOD-funded pain and sleep research collaboration with BAMC.
• Journal of Traumatic Stress Disorders & TreatmentminorOthersPeer-reviewed publication of pilot randomized controlled trial on effectiveness of Sana device in management of PTSD.
• FedEx / UPSminorOthersShipping carriers for Sana Product fulfillment.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Muse (Interaxon): Muse makes EEG-based brain-sensing meditation headbands sold direct-to-consumer with a subscription app model. Closely comparable to Sana on wearable consumer neurotechnology, subscription revenue model, and anxiety/sleep/focus use cases.
• Fisher Wallace Laboratories: Fisher Wallace markets FDA-cleared wearable cranial electrotherapy stimulators for insomnia, depression, and anxiety. Direct competitor in the consumer-grade neurostimulation category and a relevant precedent for the FDA-cleared neuromodulation pathway Sana is pursuing.
• Dreem: Dreem builds a wearable sleep neurotechnology headband with companion app for sleep tracking and stimulation-based sleep improvement. Overlaps with Sana on wearable EEG/auditory stimulation, sleep indication, and consumer subscription model.
• Apollo Neuroscience: Apollo Neuroscience produces a wearable audio/vibrational neurostimulation device for stress, sleep, and focus. Direct peer to Sana — same target customer (wellness consumer seeking drug-free relief), overlapping modality (wearable stimulation), and subscription GTM.

Broad incumbents

• NeuroPace: NeuroPace develops the RNS System, an FDA-approved implantable neuromodulation device for refractory epilepsy. Comparable as a regulated neurostimulation medical-device company, though operating at a higher acuity (implantable) and different price point than Sana's wearable.
• electroCore: electroCore manufactures non-invasive vagus nerve stimulation (nVNS) devices cleared for migraine, cluster headache, and other indications. Comparable regulatory and neuromodulation playbook, with broader indication footprint and a publicly listed commercial-stage business.
• Neuronetics: Neuronetics markets NeuroStar, a transcranial magnetic stimulation (TMS) system for major depressive disorder. Comparable as a publicly-traded commercial-stage neurostimulation company targeting psychiatric indications with FDA-cleared device-based therapy.

Emerging players

• Brain.fm: Brain.fm delivers AI-generated functional music designed to entrain neural activity for focus, relaxation, and sleep. Adjacent modality (audio-only neuromodulation) and overlapping target customer, but distributed as a software subscription rather than a hardware device.
• Pear Therapeutics: Pear Therapeutics developed FDA-authorized prescription digital therapeutics for substance use disorder, insomnia, and other psychiatric indications. Comparable as a regulated digital therapeutics company pursuing payer-reimbursed software-driven therapies for overlapping clinical indications.
• Cereve: Cereve developed a forehead-worn sleep device using targeted cooling/thermal neuromodulation for insomnia. Comparable as a consumer/clinical wearable neurotechnology targeting sleep — overlapping use cases with Sana's sleep-improvement positioning.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/Sana_Health
• Facebookfacebook.com/SanaHealthInc
• LinkedInlinkedin.com/company/sana-health

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds16 records

Investors28 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 Sana Health