PRE-SEED | MEDTECH | TGA CLASS IIa PATHWAY
CNN AI Classification • Non-Invasive • Objective

The First AI-Powered
Gut Monitoring Device

GutScope uses CNN AI classification to turn bowel sounds into actionable clinical intelligence. Five biomarkers from a single 3-minute recording. Non-invasive. Objective. Continuous.

Giving gastroenterologists the first objective measure of gut motility between appointments.

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PRODUCT DEMO /

See GutScope in Action

Three-minute recording, five biomarkers, on-device CNN classification. Characterise, never diagnose.

THE CLINICAL PROBLEM /

No Objective Gut Monitoring
Between Appointments

🏥

Manometry

Invasive. $2,000+. Hospital-only. A single snapshot that misses what happens at home, after meals, during stress.

📋

Patient Self-Report

Subjective. Unreliable. Recall bias. No trend data. Gastroenterologists make treatment decisions with no objective data between visits.

🩺

Manual Auscultation

Gastroenterologists have listened to bowels since the stethoscope. But it's subjective, inconsistent, and impossible to quantify or trend.

The diagnostic information is in the sound. What's been missing is AI that can hear what the human ear can't — classify, quantify, and trend it automatically.

THE TECHNOLOGY /

How GutScope Works

A dedicated piezo acoustic sensor with embedded CNN AI that classifies bowel sounds into clinically meaningful categories.

GutScope device concept render

~5cm • BLE 5.0 • USB-C • Piezo acoustic sensor

1

Acoustic Capture

Piezo sensor captures bowel sounds through tissue contact at 44.1kHz. Proprietary bandpass filtering (20-2000Hz) isolates gut motility signals from noise.

2

CNN AI Classification

An on-device CNN classifies gut sounds into clinically meaningful categories in real time, with confidence scoring on every result.

3

Non-Invasive Motility Insight

Designed to characterise gut-motility patterns non-invasively — patterns that today are typically only visible through invasive clinical procedures.

4

Five Biomarkers, One Device

Gut motility + heart rate (BCG) + breathing rate + vagal tone + stress coherence. All from a single 3-minute recording. Clinical-grade report generated automatically.

Inside GutScope

Every component engineered for clinical-grade acoustic capture, continuous biomarker sensing, and medical-grade durability.

GutScope exploded view showing internal components: microphone array, SoC with nRF52832 BLE, optical sensor (HR/PPG/SpO2), acoustic coupler, Li-ion battery, haptic motor, and IP68 polymer casing

Hardware Stack

🧠

XIAO ESP32-S3

Dual-core 240MHz, BLE 5.0, WiFi, TFLite capable. Runs CNN on-device.

🔊

Piezo Sensor

DFR0052 + 35mm bare discs. Tissue-coupled acoustic capture, 20-2000Hz bandwidth.

📡

MAX9814 Preamp

Auto gain control, low noise, optimised for gut sound frequencies.

📐

AltIMU-10 v6

9-DOF IMU for BCG heart rate detection and breathing analysis via accelerometer.

BOM: ~$76 AUD (prototype) → ~$28 AUD at volume • Device price: $299-$499 AUD

Validated Performance

Hard metrics on held-out data, not marketing claims. Values current as of 24 April 2026.

78%+

CNN gut motility accuracy

3-class classification on held-out test set. EfficientNet-B0 backbone, ~5M parameters, TFLite deployable.

±1 BPM

Heart rate accuracy (BCG)

Measured across 20 testers, 1,000+ sessions. Ballistocardiography via accelerometer, no optical sensor required.

4,500

Annotated acoustic samples

Two consented, de-identified public academic datasets: Kaggle (1,606) + Figshare (2,908).

<200ms

On-device inference latency

Measured on mid-range Android (app tier). Sub-200ms target envelope on ESP32-S3; on-silicon validation Q3 2026.

VALIDATION PATHWAY /

From Smartphone to Clinical Device

We validate the signal processing pipeline with real users before building hardware. De-risk first, then scale.

LIVE NOW Phase 1

Smartphone App, Biomarker Validation

Shipping on Google Play (iOS in App Review). Real users generate real data. Validates all 5 biomarkers from phone-on-abdomen recordings. Builds CNN training dataset from every session. Generates revenue ($9.99/month) while hardware develops.

5 Biomarkers Validated Revenue Generating Building Dataset
Get it on Google Play
Q2 2026 Phase 2

Clinical Stethoscope Integration

Integrating a clinical-grade digital stethoscope partner via BLE for a wider-bandwidth audio source. Validates the unified pipeline architecture before GutScope hardware is ready. Internal testing with practitioners.

In Integration Clinical-Grade Audio
Q3 2026 Phase 3

GutScope Prototype + CNN Model v1

First working GutScope prototype built at Griffith University fabrication lab. CNN classifier v1 trained on Kaggle dataset + app recordings. On-device inference via TFLite on ESP32-S3. University partnership formalised.

Griffith Fab Lab TFLite On-Device
2027 Phase 4

Manometry Validation Study

Simultaneous manometry + GutScope acoustic recording. 30-50 participants. Quantifies CNN classification accuracy against the gold standard. Ethics approval through university research partner. Published results.

2027-2028 Phase 5

TGA Class IIa → Medicare Reimbursement

TGA Class IIa Software as a Medical Device (SaMD) application. Published validation study as evidence base. Medicare reimbursement pathway for gastroenterology consultations using GutScope. Hospitals buy devices, not subscriptions.

MARKET OPPORTUNITY /

A $50 Billion Market With No Objective Measurement

1.1B

People with IBS globally

14.1% prevalence (Rome IV)

$50B+

Gut-brain disorder market

Growing to $52.6B by 2030

$1.75B

IBS DTx market by 2033

17.2% CAGR from $420M

$77M

Nerva valuation

IBS hypnotherapy — no measurement

Competitive Landscape

Every competitor either treats the brain (Nerva, Zemedy — hypnotherapy, CBT) or stimulates the vagus nerve (Pulsetto, Sensate — VNS devices). None measure the gut's response.

GutScope is the only device that measures what the gut is actually doing — and proves whether interventions work with objective before/after data. Bayer acquired Cara Care (gut diary, no measurement) in Dec 2024, validating the market.

BUSINESS MODEL /

Three Revenue Tiers

Revenue from day one. Clinical hardware is the long-term play.

LIVE

Consumer App

$9.99/month

Smartphone gut-brain biofeedback for IBS self-management. Validates biomarkers, builds dataset, generates revenue. App Store + Google Play.

Wellness biofeedback • No TGA required

NEXT QUARTER

Practitioner

$79/month

Practitioner dashboard with client management, session sharing, branded PDF reports. Naturopaths, integrative GPs, dietitians.

B2B SaaS • Wellness biofeedback • No TGA required

2027

Clinical GutScope

$299-499 device

Dedicated hardware + $299/month clinical software licence. Hospital procurement. Medicare reimbursement pathway. Something gastroenterologists can prescribe.

TGA Class IIa SaMD • Medicare target

Revenue Projections

Year 1

$180K

Consumer app + early practitioners

Year 2

$720K

Practitioner scale + pilot GutScope

Year 3

$2.4M

Clinical GutScope + global expansion

USE OF FUNDS /

$350K–$500K Pre-Seed

Fund the validation study and bring GutScope to market.

Validation Study

40%

Ethics approval, simultaneous manometry + GutScope study (30-50 participants), clinical partner, published results.

GutScope Hardware

25%

Prototype to clinical-grade units. PCB design, injection mold tooling, firmware development, 50-unit pilot run.

CNN AI Development

20%

ML engineer (Suresh), compute infrastructure, dataset labelling, model validation, TFLite optimisation for ESP32-S3.

Regulatory & Operations

15%

TGA SaMD preparation, IP protection (provisional patent), regulatory consulting, 12-month runway extension.

Grant Pipeline

R&D Tax Incentive 43.5% refundable offset
Google for Startups Cloud $100K cloud credits
ARC Linkage $100K-$300K (3yr)
Advance Queensland $50K-$250K
MRFF $100K-$500K
SME Boost Voucher (Griffith) $10K-$25K
THE TEAM /

Built to Ship

Michael Bishopp

Michael Bishopp

CEO & Founder

29 years health industry. Personal gut surgery recovery drove the mission. Signal processing pipeline architect.

Merryck Webley-Bishopp

Merryck Webley-Bishopp

CTO

Hardware + software integration. Stethoscope SDK, GutScope prototype, BLE streaming architecture.

Maitland

Maitland

Legal & Regulatory

Corporate lawyer. TGA Class IIa SaMD application lead. IP protection and governance.

Suresh Prasad

Suresh Prasad

AI/ML Lead

AI/ML Masters (QUT). CNN bowel sound classifier. Transfer learning, TFLite deployment, model validation.

Kate Roberts

Kate Roberts

Client Services

Practitioner support and account management. Owns the post-signup relationship that turns trial users into long-term paying practitioners.

Research & Industry Partners

AiSteth (India)

Hardware R&D collaborator. BLE acoustic stethoscope; units in integration testing.

AI Highway Research (India)

AI R&D collaborator. Scope spans ML research, engineering capacity, training dataset contribution, and validation support.

Griffith University (Queensland)

Fabrication lab access for GutScope prototype build. SME Boost Voucher pathway.

QUT

ARC Linkage co-application. CNN classification workstream. ML research partnership.

Data boundary

Collaboration operates on de-identified public academic training data, shared engineering artefacts, and hardware reference units only. No patient data crosses any border; all patient-signal storage remains on AWS infrastructure in the ap-southeast-2 (Sydney) region.

Clinical Validation (In Discussion)

In discussion with Australia's leading motility centres and universities on a clinical validation study. Protocol development underway for the 2026 roadmap.

GET IN TOUCH /

Let's Talk

💰

Investors

We're raising a pre-seed round to fund the GutScope validation study and TGA pathway.

🔬

Researchers

We're seeking a university partner for an ARC Linkage co-application and validation study.

🩺

Clinicians

We're looking for gastroenterologists interested in a manometry + GutScope validation study.

Michael Bishopp

CEO & Founder, Bishopp Lab Pty Ltd

Gold Coast, Australia

michael@neurogutai.com

0401 687 714

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