MetaBrain Builds the Closed-Loop Metabolic Control Layer.
MetaboCore™ connects metabolic sensing, ECG/HRV autonomic safety gating, deterministic state classification, and bounded dual-channel micro-delivery under clinician-defined limits.
- Investigational Platform
- Supervised Clinical Use
- Predefined Nutrition-Grade Channels
- Safety-First Control
The Loop Is the Product.
MetaBrain is not a dashboard, pump, patch, or algorithm alone. The product is the supervised closed loop connecting sensing, inference, bounded actuation, and independent safety.
MetaBrain BioSystems is building a closed-loop metabolic control layer: a supervised system that reads metabolic and autonomic signals, infers bounded state descriptors, actuates predefined nutrition-grade channels, and stops automatically when safety limits are approached.
MetaboPatch™ + MetaboBelt™
Continuous metabolic and autonomic signal acquisition, including interstitial biomarkers, ECG/HRV-derived autonomic proxies, motion context, and signal-quality scoring.
MetaboCore™
Sensor fusion and deterministic state classification convert multi-source inputs into non-diagnostic control descriptors, confidence scores, and safety-relevant state transitions.
MetaboPump™
Bounded dual-channel micro-delivery executes predefined nutrition-grade channel states within clinician-defined and hardware-enforced limits.
Independent Safety Kernel
Pump-local safety, autonomic gating, metabolic constraints, stale-data handling, and STOP / HOLD / CONTINUE logic remain dominant over any control objective.
The loop closes only when signal integrity, physiologic envelope, clinician-defined limits, and pump-local safety are all satisfied.
One controlled system, designed for the clinic and beyond.
MetaboPatch™ sensing, the MetaboCore™ controller, and MetaboPump™ bounded delivery — packaged and presented as a disciplined medical-device system.
Images are concept renderings of an investigational device under development.
One System. Four Layers. One Controlled Loop.
MetaBrain is a closed-loop metabolic control system. It senses metabolic and autonomic signals, classifies the current control state, checks safety permission, and selects a predefined delivery state through MetaboPump™.
Sensing Layer
MetaboPatch™ and the MetaboBelt™ ECG/HRV layer capture metabolic and autonomic signals.
Classification Layer
MetaboCore™ converts signals into non-diagnostic control states.
Safety Layer
Autonomic, metabolic, signal-quality, and pump-local constraints determine whether action is allowed.
Delivery Layer
MetaboPump™ executes Channel A, Channel B, A+B, or No Delivery within fixed limits.
The controlled loop
MetaboPatch™: Real-Time Metabolic Sensing for the Control Loop.
MetaboPatch™ is the sensing node of the MetaBrain system. It captures metabolic, redox, oxygenation, contact, motion, and temperature signals that allow MetaboCore™ to understand whether the signal environment is stable, energy-deficient, stressed, recovering, or ambiguous.
Metabolic Inputs
Continuous metabolic substrate and energy-state signals.
Optical & Oxygenation Context
Optical metabolic and tissue-oxygenation context.
Signal Integrity
Contact, temperature, and motion-gating signals.
Clean Handoff
Filtered, confidence-scored signal frames to MetaboCore™.
MetaboBelt™: The ECG/HRV Guardrail.
MetaboBelt™ is the autonomic sensing node of the MetaBrain system. Worn at the chest, it captures ECG and HRV-derived signals that give MetaboCore™ autonomic context — helping it distinguish metabolic stress, autonomic stress, motion artifact, or low-confidence data, and preventing stress misclassification.
Signal Quality
ECG SQI determines whether autonomic data can be trusted.
HRV Context
HR and RR-derived metrics provide stress and recovery context.
Motion Awareness
Motion flags reduce false interpretation during activity.
Safety Permission
Autonomic stress can force HOLD or prevent escalation.
| Input | Role |
|---|---|
| HR | Physiologic trend |
| RR intervals | HRV computation |
| SQI | Signal quality |
| RMSSD / HRV | Vagal / autonomic context |
| Autonomic stress indicator | Sympathetic stress context |
| Motion state | Artifact context |
This layer is not presented as direct vagus nerve measurement. It provides autonomic proxies used for safety gating.
MetaboCore™: The Fusion and Control Layer.
MetaboCore™ is the logic layer that brings the system together. It aligns sensor signals, computes state descriptors, applies safety logic, and selects one of four delivery states.
✓What MetaboCore™ does
- ✓Aggregates metabolic and autonomic inputs
- ✓Checks signal quality and system confidence
- ✓Classifies non-diagnostic control states
- ✓Operates within clinician-defined limits and fixed safety rules
- ✓Blocks action when safety is not satisfied
- ✓Selects Channel A, Channel B, A+B, or No Delivery
- ✓Records session activity for review
—What MetaboCore™ does not do
- —It does not diagnose disease
- —It does not act outside clinician-defined parameters
- —It does not create substances dynamically
- —Its independent safety logic is fixed and cannot change during use
- —It does not operate without clinician-defined parameters
- —It does not replace clinical judgment
State descriptors
MetaboPump™: Bounded Dual-Channel Execution.
MetaboPump™ is the execution layer. It delivers two predefined nutrition-grade channels through a deterministic, safety-bounded dual-channel micro-delivery platform.
Two Independent Channels
Channel A and Channel B remain separate and controllable.
Bounded Delivery
Delivery is constrained by predefined limits.
Pump-Local Safety
Air-in-line, occlusion, comms loss, power fault, and hard STOP are handled locally.
Clinician Workflow
Touchscreen supports workflow only; safety functions are independent.
Four predefined delivery states
Channel A active
Only Channel A is active.
Channel B active
Only Channel B is active.
Channel A + B active
Both predefined channels are active.
No Delivery
Delivery is off / not authorized.
Bounded by design. Defined by the clinician.
The system operates inside a fixed, clinician-defined envelope. It is not an autonomous therapy.
- The system does not dynamically create or formulate substances.
- The system does not autonomously choose therapy.
- The system selects among predefined delivery states within fixed limits.
- The clinician assigns channels, thresholds, and protocol limits.
Investigational Metabolic Signal Conflict.
A controllability concept under supervised clinical development.
MetaBrain is investigating whether supervised, bounded metabolic signal conflict can be induced, measured, maintained, and safely stopped. The platform uses predefined nutrition-grade channel states to create measurable tension between energy-availability and energy-stress signals, while independent safety layers remain dominant.
Energy-Availability Signal
A predefined channel state intended to represent a controlled nutrition-grade energy-availability input under clinician-defined protocol limits.
Energy-Stress Signal
A predefined channel state intended to represent a controlled nutrition-grade low-energy or stress-context input under strict safety and exposure caps.
Bounded Conflict Window
MetaboCore™ evaluates whether signal patterns remain inside a controlled, reversible, and safety-bounded operating envelope. Degraded confidence, autonomic stress, or safety proximity forces HOLD or STOP.
Safety Dominates Control.
MetaBrain is designed so that safety permission comes before delivery. If signal confidence is low, autonomic stress is high, metabolic risk is present, or pump-local safety detects a fault, the system holds or stops rather than escalating.
Within bounds
Signals are valid, physiology is within the permitted envelope, and delivery may continue within bounds.
Uncertainty
The system detects uncertainty, degraded data, stress ambiguity, or moderate risk. Delivery is paused, reduced, or not escalated.
Critical condition
A critical safety condition is detected. Delivery stops and requires recovery workflow.
Safety hierarchy — highest authority first
Pump-local safety
Handled independently of the touchscreen, cloud, and higher-level control logic.
Autonomic safety gating
Dominates metabolic control authorization.
Metabolic safety constraints
Constrain the allowable control envelope.
Control objective
Always subordinate to the safety layers above.
Engineered for determinism and traceability.
Safety-critical control is governed by deterministic, locked logic and independent safety constraints — not by adaptive models.
Multi-modal metabolic sensing
Concurrent acquisition of metabolic, redox, oxygenation, and contact signals from a single wearable sensing layer.
Sensor fusion & confidence scoring
Time-aligned fusion produces bounded state descriptors with explicit confidence and risk scoring that feed the gating logic.
Bounded model-based control
A model-based controller selects delivery within clinician-defined and hardware-enforced limits; an independent, locked safety kernel can override it at any time.
Dual-channel bounded delivery
Two clinician-assigned nutrition-grade channels with hardware-enforced rate and ramp limits and a defined set of delivery states.
Signal integrity & artifact rejection
Motion gating, contact checks, and signal-quality thresholds reject degraded data before it can influence delivery.
Cybersecurity & telemetry integrity
Authentication, encryption, replay protection, and a tamper-evident session record are designed in line with recognized medical-device security practice.
Built on design discipline, not unsupported claims.
MetaBrain is building the MetaboCore™ system around design evidence, verification evidence, validation planning, and future clinical evidence. The evidence architecture is intended to show how the system is specified, tested, and controlled before clinical claims are made.
System Architecture Evidence
Defines system boundary, product layers, and closed-loop behavior.
Design EvidenceUnder developmentSensor Evidence
Supports MetaboPatch™ signal acquisition, calibration, and artifact rejection.
Verification EvidenceBench verification plannedControl Evidence
Supports state classification, safety gating, and channel-state selection.
Verification EvidenceAlgorithm verification plannedPump Evidence
Supports bounded dual-channel delivery and pump-local safety.
Verification EvidenceSubsystem verification plannedAutonomic Evidence
Supports ECG/HRV stress discrimination and safety gating.
Verification EvidenceIntegration verification plannedRisk Evidence
Supports hazard identification and risk-control strategy.
Quality EvidenceRisk file under developmentSoftware Evidence
Supports deterministic logic, telemetry, and safety behavior.
Design EvidenceSoftware file plannedCybersecurity Evidence
Supports authentication, integrity, and update control.
Cybersecurity EvidenceSecurity verification plannedUsability Evidence
Supports safe setup, alerts, and clinical workflow.
Validation EvidenceHuman factors validation plannedBiocompatibility Evidence
Supports patient-contact material safety.
Quality EvidenceBiocompatibility program plannedFormulation Evidence
Supports fixed nutrition-grade channel identity and QC.
Verification EvidenceFormulation verification plannedClinical Evidence
Future supervised feasibility evidence.
Clinical EvidenceFuture IRB-supervised workEvidence Roadmap
A phased path from component verification to supervised clinical feasibility.
Traceability chain
Every requirement is intended to trace from user need through risk control to verification and validation.
Request the Confidential GEN-1 Investor Brief
Access the detailed GEN-1 investor materials, including the signal-conflict thesis, protected system architecture, proof pathway, IP pillars, execution plan, and financing roadmap.
Request Investor Brief →Investor materials are provided under confidentiality. Public website content is intentionally limited to investigational, regulatory-safe system information.
Clinical Context: Supervised Metabolic Management.
MetaBrain's investigational focus is explored exclusively under future IRB-supervised clinical investigation. The platform is investigational; it is not a treatment, and no therapeutic benefit or efficacy is claimed. Safety and feasibility must be established first. Specific indications and clinical detail are reserved for confidential investor and clinical materials.
Investigational focus — pursued under future supervised studies; no approved indications
Request the Confidential GEN-1 Investor Brief
Access the detailed GEN-1 investor materials, including the signal-conflict thesis, protected system architecture, proof pathway, IP pillars, execution plan, and financing roadmap.
Request Investor Brief →Investor materials are provided under confidentiality. Public website content is intentionally limited to investigational, regulatory-safe system information.
Built Around Design Controls.
Development is organized around recognized medical-device standards and a design-history-file approach to traceability.
Build the Closed-Loop Metabolic Control System With Us.
MetaBrain is seeking strategic partners across clinical research, biosensing, infusion systems, medical-device engineering, software safety, regulatory strategy, quality systems, and translational metabolism.
A multidisciplinary medical-device team.
Roles are shown until approved bios exist.
System concept, closed-loop metabolic control architecture, sensing-to-delivery strategy.
Requirements, interfaces, state logic, safety architecture.
Electrochemical, optical, impedance, and motion systems.
Deterministic logic, telemetry, safety states, cybersecurity.
Supervised clinical workflow, claims discipline, Q-Sub and IRB alignment.
Design controls, risk management, V&V, supplier and manufacturing quality.
Request the Confidential GEN-1 Investor Brief
Access the detailed GEN-1 investor materials, including the signal-conflict thesis, protected system architecture, proof pathway, IP pillars, execution plan, and financing roadmap.
Request Investor Brief →Investor materials are provided under confidentiality. Public website content is intentionally limited to investigational, regulatory-safe system information.
Request Access to MetaBrain Materials.
Select Investor Brief for confidential GEN-1 materials, or choose another collaboration category for technical, clinical, regulatory, or partnership inquiries.