Your mouth is the new sleep lab. $42B market. 1 billion people with sleep disorders.
80% of sleep apnea goes undiagnosed
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The Problem: Three Interconnected Disorders
Millions suffer from interconnected sleep disorders that current devices treat in isolation.
Bruxism
Unconscious clenching or grinding of teeth, causing dental damage, headaches, and jaw pain. Often linked to stress or sleep apnea.
Obstructed Airway
Soft tissue at the back of the throat relaxes during sleep, blocking the airway. This leads to sleep apnea, snoring, and interrupted breathing.
Poor Sleep Quality
The cumulative effect of these disorders, resulting in fatigue, reduced cognitive function, and increased risk for chronic health issues.
The Solution
Sleep Fusion turns your mouth into a smart sleep lab that detects, predicts, and treats sleep disorders in real-time.
From sensing to healing - one device, complete solution
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4.5x More Problems Solved vs. Competitors
The Sleep Fusion Advantage
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Bruxism (Teeth Grinding)
Competitors: Passive night guards only protect teeth, offering no active therapy or real-time feedback.
Sleep Fusion: Actively detects grinding and delivers targeted micro-vibration therapy to relax jaw muscles, preventing damage and promoting relief.
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Sleep Apnea Detection
Competitors: Rely on single-night testing or inconvenient, expensive sleep studies for diagnosis.
Sleep Fusion: Provides continuous, AI-powered prediction and alerts 5 seconds before apnea episodes occur, enabling proactive intervention.
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Sleep Apnea Treatment
Competitors: Invasive CPAP machines (mechanical pressure) or surgical implants with lengthy recovery times.
Sleep Fusion: Offers non-invasive, closed-loop neuro-therapy via targeted light and sound, addressing the root cause without discomfort.
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Sleep Quality Optimization
Competitors: Limited to basic sleep tracking or focus on single, isolated problems.
Sleep Fusion: Delivers comprehensive sleep architecture restoration using advanced AI to improve overall sleep quality and well-being.
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Neurological Sleep Regulation
Competitors: Currently, no existing solutions directly address brain-level control of sleep.
Sleep Fusion: Utilizes AI-driven brain entrainment technology to restore natural sleep rhythms and optimize neurological sleep regulation.
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We Solve 4.5x More Problems
4.5x more problems = 4.5x bigger market opportunity
Sleep Fusion integrates multi-modal sensing, AI inference, and closed-loop neuro-stimulation to detect bruxism, predict apnea, and deliver real-time, non-invasive therapy. It unifies five physiological functions—detection, prediction, prevention, modulation, and neurological regulation—into a single intra-oral platform that restores natural sleep architecture and brain-wave coherence.
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Staged Market Entry
De-risked path to $42M revenue by 2029
2025: SenseGuard - Bruxism Detection
  • Market: $7.2B bruxism management
  • Revenue: $448K (Y1) → $4.8M by 2029
  • FDA: Class I exempt (fastest path to market)
2026: NeuroSense - OSA Detection
  • Market: $18.3B sleep apnea devices
  • Revenue: $720K (Y1) → $14.4M by 2029
  • FDA: 510(k) predicate pathway
2027: NeuroLoop - Closed-Loop Therapy
  • Market: $1.5M (Y1) → $19.5M by 2029
  • FDA: De Novo Class II approval
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Business Model: Diversified Revenue Streams
Multiple revenue streams, strong margins
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Hardware Sales
55% Gross Margins
  • SenseGuard: $800 retail
  • NeuroSense: $2,500 retail
  • NeuroLoop: $8,000 retail
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SaaS Subscriptions
80% Gross Margins
  • $10/month per device for AI insights
  • Clinician dashboard: $50/month
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Data Licensing
90% Gross Margins
  • Sleep pattern insights to pharma/research
  • API access for healthcare platforms
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Traction & Milestones
Proof of Progress
Prototype Validated
Successfully tested the SenseGuard prototype with patients, confirming functionality and user acceptance.
Patent Pending
Filed for a patent covering Oral EEG and Neuro-entrainment technology, securing our core intellectual property.
Clinical Partnerships
Secured crucial clinical trial partnerships with leading institutions, including UCSF and the VA system.
Caltech Collaboration
Established an ongoing collaboration with Caltech for advanced research into sensing materials.
FDA Pre-submission
Scheduled our pre-submission meeting with the FDA for Q1 2026, advancing our regulatory pathway.
Commercial Launch
Aiming to ship the first commercial SenseGuard units in Q4 2025, bringing our solution to market.
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The Ask
Securing the capital to redefine sleep health.
Pre-Seed Round
Seeking $1.5M Pre-Seed with a $10M cap.
This investment will provide an 18-month runway, leading to our Series A.
Use of Funds:
60%
R&D and Product Development
Accelerating core technology and hardware innovation.
25%
Clinical Trials & Regulatory
Ensuring compliance and validating efficacy for FDA pathways.
15%
Team Expansion
Scaling our expert team to meet development and market needs.
Series A Target
Aiming for $15M at a $60M valuation in Q4 2026.
This next round will fuel full-scale market penetration and continued innovation.
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Staged market entry strategy: SenseGuard (2025) → NeuroSense (2026) → NeuroLoop (2027) → Exit (2029)
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Why Now?
A confluence of market trends, technological advancements, and regulatory clarity creates the perfect moment for Sleep Fusion.
Increased Awareness
COVID-19 boosted sleep disorder awareness by 300%, highlighting the critical role of sleep in overall health.
Accelerated Home Care
Home healthcare adoption surged, accelerating its trajectory by 5 years and making at-home monitoring widely accepted.
Cost Inflection Point
AI and sensor technology costs have reached an inflection point, enabling sophisticated, affordable devices.
Clear Regulations
Recent FDA precedents have established a clear and defined regulatory pathway for innovative sleep devices.
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"From fragmented nights to restorative sleep - this is why we built Sleep Fusion"
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Vision: From Bruxism to Breathing
Sleep Fusion Solves the Night
Transforming sleep medicine from diagnosis to lasting relief
2025: Solve Bruxism
Targeting the $7.2B teeth grinding market with SenseGuard.
2026: Detect Sleep Apnea
Entering the $18.3B sleep apnea market with NeuroSense.
2027: Treat Sleep Disorders
Revolutionizing the $24.4B sleep therapy market with NeuroLoop.
Clear Exit Strategy
  • Strategic acquisition by industry leaders like ResMed, Philips, or Inspire.
  • Recent comparable exits: BioTelemetry ($1.1B), Brightree ($800M).
  • Target valuation: $500M - $1B acquisition by 2028.
Breathe Better. Sleep Deeper. Live Longer.
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Key Talking Points for Q&A
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Regulatory Risk
We start with FDA-exempt devices and build regulatory expertise for each stage, ensuring a de-risked pathway to market.
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Competition
No one else connects oral sensing with closed-loop therapy – it's our unique moat, providing a comprehensive, integrated solution.
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Market Size
Sleep disorders are the largest undiagnosed health epidemic – the market is massive and growing, with over 1 billion sufferers globally.
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Team Risk
We have robust clinical expertise (UCSF), strong technical execution (Hassan), and a clear regulatory pathway (VA partnership).
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Go-to-Market
Dentists already prescribe oral devices – we leverage existing distribution channels, ensuring efficient and trusted adoption.
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The Hardware Stack
Our unique device combines advanced sensors and treatment features into a discreet, comfortable device worn inside the mouth.
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Intra-Oral Device Components
  • Smart Mouthguard Shell (Caltech-derived liquid-metal microchannels): Detects minute pressure changes (resolves <50 Pa) with high flexibility (>200% strain range).
  • EOG Electrodes (flexible fabric): Placed on lip surfaces for highly accurate sleep stage classification (>90% accurate).
  • PPG Optics (Red/infrared LEDs + photodiodes): Continuously monitors heart rate and blood oxygen saturation in real-time.
  • Optical CO₂ Sensor (PDMS luminescent film): Measures carbon dioxide levels through the skin using micro-LEDs and a photodiode.
  • Micro-IMU (3-axis accelerometer/gyroscope): Provides precise tracking of head position and body orientation during sleep.
  • Therapeutic System (Bone-Conduction Transducer + Micro-LEDs): Delivers personalized neuromodulation for targeted intervention.
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Core Electronics
  • Analog Front-End (Texas Instruments ADS1299): High-fidelity component for amplifying subtle biological signals.
  • Processing (ARM Cortex-M4 microcontroller with BLE 5.0): Ensures efficient data handling and processing.
  • Power (200mAh Li-ion battery): Features wireless inductive charging for extended and convenient use.
  • Connectivity (Secure BLE transmission): Enables seamless and secure data transfer to a companion receiver/charging dock.
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The Software Stack
Our robust, scalable cloud-native architecture ensures secure, real-time data flow and actionable insights from device to clinician.
Edge Layer: Device Firmware
  • Real-time Sensing: Captures sensor data instantly and processes it using advanced digital filters (like wavelet decomposition).
  • On-device Event Detection: Identifies key events directly on the device, such as breathing pauses (apnea/hypopnea) and teeth grinding (bruxism spikes).
  • Efficient Data Transmission: Compresses data for quick and reliable wireless communication using low-energy Bluetooth (BLE).
  • Ultra-low Power: Engineered for extended use, optimizing for over 8 hours of continuous operation on a single charge.
Application Layer: User Interfaces
  • Patient Mobile Apps: Available on iOS and Android, allowing patients to view real-time health metrics and provide feedback.
  • Clinician Web Dashboards: Web-based portal for healthcare professionals to review sleep reports and adjust patient therapies.
  • Device Management: Handles device authentication, initial setup, and ensures secure, synchronized data transfer.
Backend Services: Cloud Infrastructure
  • Secure Data Ingestion: Receives and processes encrypted data from devices using industry-standard APIs (REST/gRPC).
  • Scalable Data Storage: Stores all data, including raw sensor readings, using flexible and powerful databases (SQL/NoSQL and object storage).
  • Smart Analytics Engine: Automatically generates alerts based on rules and applies machine learning models for deeper insights and predictions.
  • EHR Integration: Connects seamlessly with existing healthcare systems using industry-standard (FHIR-compliant) protocols.
Compliance & Security
  • End-to-End Encryption: Data is encrypted from the device (BLE) to the cloud (TLS), ensuring privacy and security.
  • Regulatory Compliance: Adheres to major data privacy regulations like HIPAA and GDPR.
  • Controlled Access & Auditing: Implements role-based access control and comprehensive audit logging to track all data activities.
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The AI Stack
🤖 Smart Sleep Intelligence: Unlocking Deeper Insights
Our AI system processes complex sleep data to provide precise diagnoses and personalized treatment plans.
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Data Preparation
We combine information from multiple sensors (like eye movement, blood oxygen, carbon dioxide, and body motion) and clean it by removing noise and errors to ensure reliable data.
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Key Data Analysis
We analyze important health indicators such as heart rate changes, drops in oxygen levels, breathing patterns, teeth grinding force, and eye movements during sleep.
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Sleep Stage Detection
Using advanced neural networks (CNNs), we accurately identify different sleep stages, primarily by analyzing eye movement data.
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Sleep Event Identification
We precisely differentiate between types of breathing interruptions (obstructive vs. central apnea) using respiratory airflow, carbon dioxide levels through the skin, and head position.
Personalized Health Intelligence
  • Population Modeling: We create individual health baselines by grouping users with similar health characteristics.
  • Risk Assessment: We use advanced techniques to place individuals within a health-state map, identifying potential risks.
  • AI Health Coach: Our AI uses learning algorithms to offer personalized recommendations and optimize treatment plans.
Experimental Brainwave Synchronization
  • Brainwave Optimization: We use quantum-inspired simulations to fine-tune patterns for brainwave synchronization.
  • Adaptive Stimulation: We deliver optimized sound (binaural beats) and light pulses through bone conduction and micro-LEDs, testing various patterns simultaneously.
Clinical Outcomes
  • AHI (Apnea-Hypopnea Index) calculation and sleep efficiency scores.
  • Tailored therapy suggestions.
  • Ready-to-use diagnostic reports for healthcare providers.
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Competitive Analysis
This competitive analysis evaluates key players in the sleep health market, including Sleep Fusion, Inspire Medical Systems, ResMed, Philips Respironics, Oura Ring, WHOOP, Eight Sleep, Nox Medical, Itamar Medical, and WatchPAT. The comparison spans critical categories such as Market Cap/Valuation, Key Strengths, Key Weaknesses, and their specific Sleep Focus Advantage. Sleep Fusion distinguishes itself significantly by offering a single, integrated, and non-invasive solution designed to address multiple sleep disorders. Unlike competitors who often focus on a single issue like sleep apnea (e.g., Inspire Medical Systems, ResMed) or basic tracking (e.g., Oura Ring, WHOOP), Sleep Fusion's strategic advantage lies in its comprehensive approach. This allows it to tackle a broader spectrum of problems—from bruxism to neurological sleep regulation—within one device, setting it apart as a versatile and potent competitor in the evolving sleep technology landscape.
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Financial Model
Our financial model outlines a robust path to significant growth and profitability, projecting revenue from three distinct product lines: SenseGuard (bruxism), NeuroSense (sleep regulation), and NeuroLoop (neuromodulation). The model meticulously details our revenue projections, aiming for an impressive $42M by 2029, culminating in a projected acquisition target of $500M-$1B. Key to this growth are our diversified revenue streams, which include hardware sales, recurring SaaS subscriptions for advanced features and analytics, and data licensing opportunities for insights generated from anonymized user data.
Our unit economics are designed for high profitability, with hardware sales (SenseGuard, NeuroSense, NeuroLoop devices) boasting a healthy 55% margin. The SaaS subscriptions, offering continuous value to users, are projected at an 80% margin, while data licensing, leveraging our unique dataset, achieves an exceptional 90% margin. This tiered margin structure ensures sustainable profitability as we scale. The cost structure is optimized for efficiency, focusing on R&D for continuous innovation, scalable manufacturing, and targeted marketing efforts to drive market penetration.
The growth metrics are ambitious yet achievable, based on conservative market penetration assumptions for each product line. The model forecasts a clear profitability timeline, demonstrating positive cash flow as early as product launch. Initial investment requirements include a pre-seed round of $1.5M, which has successfully funded initial development and prototyping. This will be followed by a Series A round of $15M at a $60M valuation, crucial for scaling production, expanding market reach, and further R&D. This strategic financial roadmap supports our journey from early-stage development through significant market penetration and ultimately positions Sleep Fusion as a prime acquisition target within the rapidly expanding sleep health market.
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Tam_Sam_Som
Our market analysis, as depicted in the TAM/SAM/SOM chart, demonstrates the vast opportunity within the sleep health technology sector. The Total Addressable Market (TAM) for Sleep Fusion's innovative solutions is estimated at a substantial $42 billion, encompassing all individuals globally who could benefit from advanced sleep monitoring, regulation, and neuromodulation therapies. This broad market includes those suffering from bruxism (targeted by SenseGuard), various sleep disorders (addressed by NeuroSense), and individuals seeking general cognitive enhancement through neuromodulation (with NeuroLoop).
The Serviceable Addressable Market (SAM) focuses on the segment of the TAM that Sleep Fusion can realistically reach with its current product offerings and distribution channels. This segment represents a significant portion of the total market, reflecting the widespread need for non-invasive, data-driven sleep health solutions. Finally, the Serviceable Obtainable Market (SOM) outlines the specific market share Sleep Fusion aims to capture within its SAM over the next several years. This highly focused segment is where our strategic sales and marketing efforts will be concentrated to achieve our ambitious growth targets.
This granular market sizing directly supports our projected revenue of $42 million by 2029. By methodically targeting segments of the SOM for each of our product lines – SenseGuard, NeuroSense, and NeuroLoop – we are confident in our ability to penetrate the market effectively and convert a meaningful portion of the serviceable market into recurring revenue. The $42 billion TAM underscores the immense potential for long-term expansion and validates our aggressive growth strategy, positioning Sleep Fusion to become a leader in the rapidly evolving sleep health technology landscape.
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