NightWare
NightWare is a digital health company that has developed the first and only FDA-cleared prescription digital therapeutic using Apple Watch and proprietary AI to detect and interrupt nightmares in adults 22+ with Nightmare Disorder or PTSD-related nightmares, initially serving VA, DoD, and select commercial populations.
- Company typePrivate
- Founded2017
- HeadquartersHopkins, United States
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What NightWare does
NightWare is a Delaware-incorporated digital health company headquartered in Hopkins, Minnesota that has developed the first and only FDA-cleared prescription digital therapeutic for the reduction of sleep disturbance related to Nightmare Disorder or PTSD-related nightmares in adults aged 22 and older. The company's core product is an integrated system combining a preprogrammed Apple Watch and iPhone with proprietary, patented AI algorithms that continuously process biometric data (heart rate and body movement) to compute a patient-specific stress index, detect nightmare onset in real time, and deliver personalized vibrotactile stimulation to the wrist that interrupts the nightmare without waking the patient. The system was FDA-designated a Breakthrough Device in 2020 and received marketing authorization in November 2020 under De Novo (DEN200045) as a Class II prescription medical device.
The company's go-to-market is sales-led and prescription-driven, anchored by an enterprise field sales motion through the Veterans Administration (VA) and Department of Defense (DoD) — both selected because of the high concentration of PTSD patients in need and their ability to provide rapid patient access. Beyond the federal channel, NightWare has secured medical policy coverage with Highmark Health BCBS and is actively pursuing Medicare reimbursement through the MCIT Breakthrough CMS pathway as a precursor to broader commercial insurance coverage. The revenue model has historically been a one-time license (hardware kit), and the company is explicitly transitioning toward a recurring revenue model via a patient management program, supported by an ongoing Series C financing at a $10 million pre-money valuation with strategic lead Exit 156 Capital. Customers and partners include the Minneapolis VA, Tampa VA, Walter Reed National Military Medical Center (running a randomized controlled trial), Highmark Health BCBS, and Apple (hardware platform), with 2024 launches adding commercial insurance pilots with fire and police departments and a national VA Pathfinder Innovation Pilot.
NightWare is venture-backed and early-stage, with 1-10 employees, total disclosed funding of roughly $7.5 million across multiple rounds between 2019 and 2026, and revenue not publicly disclosed. Leadership transitioned in July 2024 when Matthew Tucker (formerly Chief Commercial Officer and board member, with prior executive roles at Baxter Healthcare, Mylan Pharmaceuticals, and Highmark Health) assumed the CEO role from founder Grady Hannah, who moved to Chief Product Officer — a change that signals a shift from research-led to commercial-execution-led operating posture. The company is currently running a pivotal randomized, double-blind, placebo-controlled trial (NCT04040387) designed to enroll up to 480 adults with PTSD and nightmares, with clinical efficacy already demonstrated through a 3.3-point PSQI-A improvement versus 1.4 points for sham.
NightWare firmographics
Firmographics- Name
- NightWare
- Legal name
- NightWare, Inc.
- Website
- https://nightware.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- NightWare is a digital health company that has developed the first and only FDA-cleared prescription digital therapeutic using Apple Watch and proprietary AI to detect and interrupt nightmares in adults 22+ with Nightmare Disorder or PTSD-related nightmares, initially serving VA, DoD, and select commercial populations.
- Ownership category
- akta.pro rank
NightWare industry classification
Industry- Product category
- Digital Therapeutics
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)
- SIC
- Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Behavioral Health & Neurocognitive Therapeutics (Digital) (HLACANAI)
- akta.pro secondary industries
- SaMD – Digital Biomarkers & Algorithmic Endpoints (HLACANAF), Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE), Crisis Support, Suicide Prevention & Acute Behavioral Triage Platforms (HLALAEAI), Sleep Tech Wearables (CRACAIAG)
Keywords
Where NightWare is headquartered
LocationHeadquarters
- HQ city
- Hopkins
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
NightWare business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Supply Chain, Operations
Revenue model
- Prescription Digital Therapeutic Device: NightWare sells an FDA-cleared prescription digital therapeutic system that includes a preprogrammed Apple Watch and iPhone. The company is expanding toward a recurring revenue model through its patient management program while pursuing Medicare and commercial insurance coverage.
- Insurance Reimbursement: The company is actively seeking coverage by Medicare through the MCIT Breakthrough CMS pathway. Upon Medicare coverage determination, they will approach private insurance companies. NightWare has medical policy coverage with Highmark Health BCBS. VA and DoD provide access to patients.
Go-to-market motion3 records
Distribution channels3 records
Marketing channels6 records
NightWare product offering
Product offeringCore offering
NightWare develops and sells the NightWare Digital Therapeutic System, an FDA-cleared Class II prescription digital therapeutic for adults 22 and older with Nightmare Disorder or PTSD-related nightmares. The system pairs a preprogrammed Apple Watch and iPhone with proprietary AI that monitors heart rate and motion, detects nightmares in real time via a patient-specific stress index, and delivers personalized vibrotactile stimulation to interrupt nightmares without waking the user. The product is prescription-only and is sold through healthcare providers and institutional payers including the VA, DoD, and Highmark Health BCBS.
Product overview
NightWare offers a single unified product: the NightWare Digital Therapeutic System. This is a prescription digital therapeutic that combines a preprogrammed Apple Watch and iPhone (provided as part of an all-inclusive kit) with proprietary AI-powered software. The system monitors sleep through Apple Watch biometric sensors, uses AI algorithms to detect nightmares in real time, and delivers customized vibrotactile stimulation to interrupt nightmares without waking the patient. It is FDA-cleared (November 2020) and designated as a Breakthrough Device for the reduction of sleep disturbance related to Nightmare Disorder or PTSD-related nightmares in adults 22 and older.
Differentiator
Problem solved
Functional benefit
Products and services
- NightWare Digital Therapeutic System FDA-cleared Class II prescription digital therapeutic that pairs a preprogrammed Apple Watch and iPhone with proprietary AI software to monitor heart rate and motion during sleep, detect nightmares in real time via a patient-specific stress index, and deliver personalized vibrotactile stimulation to interrupt nightmares without waking the patient. Indicated for adults 22+ with Nightmare Disorder or PTSD-related nightmares and sold only via clinician prescription.
Quantifiable outcome
- 3.2-point improvement on Pittsburgh Sleep Quality Index (PSQI) in ongoing randomized controlled trial, exceeding minimal clinically important difference
- +4 more outcomes
Companies that use NightWare
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles4 records
NightWare technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability3 records
Feature4 records
NightWare partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- Walter Reed National Military Medical CentercoreWalter Reed is conducting a clinical trial of NightWare in a randomized controlled trial to establish safety and efficacy of the NightWare digital therapeutic system for treatment of nightmare disorder associated with PTSD-related sleep disturbance.
- Minneapolis Veterans Affairs Health Care SystemcorePrimary site for NightWare's randomized, double-blind, placebo-controlled clinical trial (NW101002) enrolling adults with PTSD and nightmares. Conducted at the Minneapolis VA Health Care System.
- Tampa VA FacilityminorSecond site for NightWare's pivotal trial continuing the clinical development program following Breakthrough Device designation.
- ApplecoreNightWare uses Apple Watch as the hardware platform for its FDA-cleared prescription digital therapeutic, utilizing the Apple Watch heart monitor sensor and other biometric sensors to detect nightmares and deliver vibrotactile stimulation.
Scale indicators8 records
Recent moves6 records
Expansion highlights6 records
NightWare competitors and assessment
Company assessmentDirect peers
- Big Health: Big Health (maker of Sleepio) is a prescription digital therapeutic for insomnia and anxiety, the closest direct competitor in FDA-cleared sleep DTx. Both companies target sleep disturbance with prescription digital therapeutics and pursue payer coverage through employer and health plan channels.
- Akili Interactive: Akili Interactive pioneered the prescription digital therapeutic category with FDA clearance for EndeavorRx (ADHD). Both companies pursue the prescription DTx regulatory pathway via FDA SaMD/Class II authorization and rely on adaptive digital interventions to treat cognitive/behavioral conditions.
- Pear Therapeutics: Pear Therapeutics was the leading prescription DTx company (reSET, reSET-O, Somryst for chronic insomnia) before its 2023 bankruptcy. Pear is a direct comparable for NightWare's commercial trajectory challenges and validates the prescription DTx business model structure.
Broad incumbents
- Calm Health: Calm Health extends the consumer Calm app into clinically-validated mental health and sleep programs, including B2B employer and health plan distribution. Overlaps with NightWare in sleep and mental health treatment, though primarily a self-pay/consumer model vs. NightWare's prescription model.
- Headspace Health: Headspace Health (now part of Bending Spoons) provides mental health and sleep support via employer and health plan channels. Comparable in targeting sleep/mental health through digital interventions and pursuing B2B distribution, though via self-guided content rather than prescription FDA pathway.
Emerging players
- Limbic: Limbic is an AI-powered digital mental health platform with NHS approval in the UK serving as a CE-marked SaMD for mental health. Comparable as a clinically-validated, AI-driven mental health digital therapeutic with regulatory pathway focus.
- Oura: Oura is a consumer sleep and recovery wearable ring with biometric tracking (heart rate, sleep stages) comparable to Apple Watch biometrics in NightWare's stack. Comparable through sleep-tracking wearable technology and consumer health data platform, though consumer-only and not a prescription therapeutic.
- Eight Sleep: Eight Sleep makes the Pod smart mattress cover with biometric sleep tracking and temperature modulation. Comparable as a sleep technology company using sensors and AI to intervene during sleep, though hardware-form-factor differs and not a prescription therapeutic.
- CureApp: CureApp is a Japanese prescription digital therapeutic company with multiple FDA-equivalent approvals for hypertension, nicotine dependence, and other conditions. Comparable as a prescription SaMD DTx company navigating payer coverage in non-US healthcare systems.
- BehaVR: BehaVR (now Sumitomo Pharma-backed) develops prescription digital therapeutics using VR and immersive experiences for mental health conditions including anxiety, depression, and PTSD. Comparable in VR/digital-therapeutic approach to behavioral health conditions, including PTSD overlapping with NightWare's indication.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
NightWare social profiles
Digital presenceNightWare compliance and trust
Trust signalCompliance1 record
NightWare financial estimates
Financial estimateRevenue estimate
Valuation estimate
NightWare leadership team
Management profileNumber of profiles
Profiles7 records
NightWare funding detail
Funding detailFunding overview
Funding rounds5 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
NightWare M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about NightWare
What does NightWare do?
NightWare develops and sells the NightWare Digital Therapeutic System, an FDA-cleared Class II prescription digital therapeutic for adults 22 and older with Nightmare Disorder or PTSD-related nightmares. The system pairs a preprogrammed Apple Watch and iPhone with proprietary AI that monitors heart rate and motion, detects nightmares in real time via a patient-specific stress index, and delivers personalized vibrotactile stimulation to interrupt nightmares without waking the user. The product is prescription-only and is sold through healthcare providers and institutional payers including the VA, DoD, and Highmark Health BCBS.
Is NightWare a public or private company?
NightWare is a private company. It is classified as venture growth investor backed and is currently operating.
When was NightWare founded?
NightWare was founded in 2017. It employs 1 to 10 people.
Where is NightWare based?
NightWare is headquartered in Hopkins, United States, in the North America region.
How does NightWare make money?
Two revenue lines are on record. Prescription Digital Therapeutic Device is the primary driver. The others are insurance Reimbursement.
Who are NightWare's main competitors?
Direct peers on record are Big Health, Akili Interactive and Pear Therapeutics. Broad incumbents are Calm Health and Headspace Health. Emerging players are Limbic, Oura, Eight Sleep, CureApp and BehaVR.
Does NightWare have an API?
No public API is recorded for NightWare.
What industry is NightWare in?
NightWare's product category is Digital Therapeutics. Its primary akta.pro industry code is HLACANAI, Behavioral Health & Neurocognitive Therapeutics (Digital), with a secondary code of HLACANAF, SaMD – Digital Biomarkers & Algorithmic Endpoints. Its NAICS code is 334510 and its SIC code is 3845.