Technology & Clinical Overview

The Intelligence Pipeline: Sense to Respond

Better Stride V2 operates on a true closed-loop, autonomous architecture. While traditional mobility aids offer static or reactive support, our platform continuously monitors human kinematics and neuromuscular signals, calculating and executing biomechanical interventions before physical instability results in a fall.

 

[10-MODALITY SENSOR GRID] ──> [50 Hz EDGE INFERENCE] ──> [DECISION ENGINE] ──> [≤20ms DYNAMIC ACTUATION]

 

 

 

⚡ Core Technical Specifications

 

On-Device Edge Computing

  • 50 Hz AI Inference Rate: An on-device microprocessor processes continuous gait data streams via an INT8-quantized LSTM/TCN predictive network.
  • ≤20 ms Total Latency: Complete end-to-end latency—from initial multi-modal sensor acquisition to physical actuator engagement—occurs in under 20 milliseconds.
  • Continuous Federated Learning: The active AI model continuously adapts to individual user gait profiles locally, securely optimization-pooling fleet data via over-the-air (OTA) cloud updates.

 

10-Modality Sensor Grid

  • 6x IMU Array: Positioned circumferentially at 60-degree intervals for real-time, 360-degree limb kinematics characterization via Madgwick quaternion fusion.
  • 8-Channel sEMG: 2000 Hz acquisition via a 24-bit ADC, specifically targeting the tibialis anterior, gastrocnemius, soleus, and peroneal muscle groups.
  • Solid-State LiDAR: Lateral malleolus multizone time-of-flight mapping with a 4-meter downward lookahead to classify upcoming terrain, stairs, and obstacles.
  • Physiological Sensors: Precision barometric MEMS tracking for altitude gradients alongside thermal and Galvanic Skin Response (GSR) sensors to monitor fatigue and stress states.

 

4-Part Coordinated Actuation Stack

  • Functional Electrical Stimulation (FES): A 6-channel biphasic, IEC 60601-2-10 compliant array providing volitional reinforcement to weakened muscle groups.
  • Micro-Pneumatic Bladders: 4x individually-addressable anatomical bladders delivering localized micro-stabilization pulses and anti-tip stiffness in under 150 ms.
  • Tendon Cable Drives: Soft-robotic high-strength synthetic cable tensioning lines providing active bilateral, "All-Wheel Drive" (AWD) mechanical power distribution.
  • Shape Memory Alloy (SMA) Bands: High-density Nitinol bands distributed along the limb frame for rapid-stiffening stabilization and structural brace locking.

 

 

🏥 Targeted Clinical Operational Modes

The hardware maintains a standardized, highly scalable manufacturing footprint, while specialized software profiles switch over-the-air to target distinct patient populations:

  • Stroke Rehabilitation Mode: Detects initial volitional sEMG signals to trigger immediate, synchronized FES muscle reinforcement. It features progressive therapeutic task protocols and exports full session analytics via HL7 FHIR R4 clinical compliance.
  • Parkinson Gait Mode: A secondary on-device LSTM network runs a continuous Freezing-of-Gait (FoG) detector. Upon detection, it overrides abnormalities with rhythmic vibrotactile cues via 4 directional linear resonant actuators (LRAs).
  • Vestibular Substitution Mode: Utilizes a spatially-encoded vibrotactile balance compass to provide sub-perceptual positional sway cueing. This provides continuous, automatic postural correction for individuals with bilateral vestibulopathy.
  • Guardian Fall Watch Mode: Heightens predictive fall-risk sensitivity by lowering the internal instability trigger thresholds. If a sudden fall trajectory is confirmed, all bladders inflate to max pressure to form a rigid structural splint while automatically broadcasting a caregiver alert with real-time GPS coordinates via LTE.

 

 

🔒 7-Layer Hardware-Enforced Safety Stack

Medical-grade security means the system operates independently of primary software execution to guarantee patient protection:

  • Analog Current Limiting: Per-channel electrical limits built directly into the FES driver hardware alongside a 100 ms automated watchdog cutoff switch.
  • Thermal Safety Interlock: Non-bypassable physical thermal monitors that instantly cut off all hardware activation if any skin-contact sensor site exceeds 40°C.
  • Dual-Battery Redundancy: A secondary backup cell automatically engages at 15% primary battery levels to maintain emergency stabilization loops and wireless communication.
  • Passive Mechanical Failsafe: In the event of a total system power depletion, the sleeve transitions to an unpowered mechanical lockdown. Mechanical spring-loaded tendon locks snap shut and pneumatic check-valves trap internal bladder air, transforming the flexible sleeve into a rigid structural brace without consuming a single watt of electricity.

 

⚖️ Regulatory Strategy & Pathway Verification

Rather than pursuing a costly, multi-year De Novo pathway, Better Stride V2 utilizes an explicit dual-predicate 510(k) framework, combining two well-established Class II medical device categories:

  • Primary Predicate (Electrical/Neuromuscular): Formally matching standard cleared Functional Electrical Stimulation (FES) systems (Product Code: GZI, per 21 CFR 882.5810).
  • Secondary Predicate (Mechanical/Robotic): Formally matching active motorized, computer-controlled lower-limb orthoses and exoskeletons (Product Code: PHH, per 21 CFR 890.3480).
  • The AI Layer Architecture: Our closed-loop predictive AI model operates entirely under FDA Software as a Medical Device (SaMD) guidelines as an interpretive optimization layer, which does not alter the fundamental safety or intended use profiles of the underlying physical predicates.

Better Stride V2 is currently undergoing pre-clinical evaluation and engineering verification. The platform is being developed in alignment with ISO 13485 Quality Management Systems and is targeting an FDA 510(k) clearance pathway as a Class II medical device. It is not yet cleared for commercial distribution or clinical prescriptive use.

 

 

🌐 Commercialization Pathways & Clinical Integration

Better Stride V2 is engineered as a dual-revenue, high-margin platform. By standardizing our physical hardware production, we maximize market expansion across multiple parallel commercial channels.

🎯 Standardized Hardware Footprint. Multi-Channel Revenue Scale.

  • 🏥 Clinical & Hospital Channel: Prescriptive inpatient deployment with automated enterprise EHR synchronization.
  • ⚙️ OEM Licensing Channel: Deep integration of our proprietary sensor-fusion AI core, emotional algorithms, and low-latency actuation stack into industrial robotics or external hardware.
  • 🏡 Direct-to-Consumer Channel: Active predictive fall prevention and caregiver tracking systems tailored directly for aging adults and independent living.

 

1. Enterprise Clinical & Hospital Integration

Our platform bridges the gap between inpatient clinical therapy and home-based patient compliance.

  • Automated EHR Synchronization: Built-in HL7 FHIR R4 clinical compliance engines automatically export granular gait-efficiency and rehabilitation progress scores.
  • Remote Therapeutic Monitoring (RTM): Clinicians can safely monitor user compliance, neuromuscular profiling data, and functional changes via a secure dashboard.
  • Scalable Fleet Management: Hospital systems can deploy standardized sleeves across multiple departments, switching active operational profiles instantly over-the-air.

 

2. OEM Technology Licensing Channels

For industrial, corporate, or established medical hardware manufacturers, our core intellectual property is available for direct system integration.

  • Sensor-Fusion AI Core: License our proprietary on-device 50 Hz LSTM/TCN feature-extraction and classification networks.
  • Emotional AI Software Layers: Integrate our unique physiological micro-vibration and skin-response classification algorithms into adjacent wearable tech.
  • Multi-Modal Actuation Stack: Adopt our synchronized, low-latency control logic (FES + Tendon + Pneumatic + SMA) for specialized robotics.

 

3. Direct-to-Consumer (DTC) Caregiver Models

Targeted toward the massive aging-in-place market, providing families with proactive safety assurance.

  • Predictive Fall Mitigation: Active mechanical intervention triggers inside critical instability windows to prevent injuries.
  • Remote Caregiver Alert Network: Confirmed emergencies instantly broadcast real-time GPS coordinates and event data directly via independent cellular LTE.

 

 

💰 Insurance Reimbursement & CPT Coding Framework

Better Stride V2 is built from the ground up to utilize existing, highly lucrative insurance reimbursement pathways, eliminating out-of-pocket friction for healthcare systems, clinics, and patients. Providers can directly bill public and private payers using two primary models:

 

A. Remote Therapeutic Monitoring (RTM) Model

Clinics can monitor user progress remotely and bill monthly for musculoskeletal device usage and data management under established CMS codes:

  • CPT 98975: Initial setup, onboarding, and patient education on the wearable device.
  • CPT 98977: Musculoskeletal device supply and automated edge data transmission (supporting standard 16–30 day monitoring windows).
  • CPT 98985: Virtual therapy monitoring support and short-duration data acquisition (supporting 2–15 day clinical checkpoints).
  • CPT 98980: Interactive remote clinical review and treatment management time (first 20 minutes per calendar month).
  • CPT 98979: Each additional 20 minutes of remote clinical evaluation and management time.

 

B. Durable Medical Equipment (DME) Orthotic Model

For long-term home prescription, the physical sleeve qualifies under standard lower-limb orthotic billing infrastructure:

  • L-Code HCPCS Categories: Positioned for prescriptive coverage within established Custom Neuro-Orthotic and Ankle-Foot Orthosis (AFO) classifications, allowing direct device acquisition coverage through major private insurance networks.

 

 

🔬 Clinical Trial & Institutional IRB Intake Pipeline

⚠️ Phase 1 Enrollment Status: Currently Evaluating Active Site Applications

Better Stride V2 is currently selecting a restricted cohort of clinical partners for our late 2026/early 2027 multi-center usability trials. We are actively reviewing formal intakes from neuro-rehabilitation departments, university biomechanics labs, and orthopedic research centers.

  • Site Selection Criteria: Candidate facilities must possess active IRB infrastructure, a minimum throughput of 50+ stroke or Parkinsonian patients per month, and compatibility with secure HL7 FHIR R4 server exports.
  • Incentive Allocation: Accepted beta-cohort institutions are guaranteed priority hardware fleet allocations, dedicated enterprise clinician dashboard setups, and full technical cloud support at zero direct program cost.