First Mover in Clinically-Validated
IBD Flare Prediction
Flarity combines wearable physiological monitoring with clinical symptom indices to predict IBD flares before they occur. Built on peer-reviewed Mount Sinai research. B2B2C distribution through gastroenterologist referrals.
The Market Opportunity
Why Now?
The Solution: Hybrid Detection
Our core innovation, and defensible moat, is combining objective wearable signals with validated clinical symptom indices in a single risk score.
Wearable Layer
16+ physiological signals from Apple Watch, Oura, Whoop, Garmin, Fitbit
- Heart rate variability (HRV)
- Resting heart rate
- Sleep duration & efficiency
- Body temperature
- Blood oxygen (SpO2)
- Activity & steps
Symptom Layer
Validated clinical indices, not proprietary surveys
- Harvey-Bradshaw Index (HBI) for Crohn's
- Simple Clinical Colitis Activity Index (SCCAI) for UC
- Montreal Classification
- Medication adherence tracking
Clinical-Grade Score
Mirrors how gastroenterologists diagnose: biomarkers + clinical exam
Why hybrid matters: Wearables alone can't assess abdominal pain, urgency, or stool frequency. Symptoms alone rely on patient memory and miss early physiological changes. Combined assessment catches what each layer misses.
Clinical Validation
We're not claiming "AI-powered wellness." We're building on peer-reviewed research published in the highest-impact gastroenterology journal.
"Circadian patterns of heart rate variability, along with heart rate, oxygenation, and daily activity, were significantly altered when inflammation or symptoms were present."Read on PubMed →
Regulatory & Privacy
Flarity is positioned as a wellness application, not a Software as a Medical Device (SaMD). Privacy-first architecture:
- No FDA 510(k) clearance required for current functionality
- HIPAA-aligned design: On-device AI processing, minimal data transmission
- GDPR compliant: Full data portability, right to deletion, EU-ready
- Health data stays on device; only user-initiated sharing
- Future SaMD pathway available if clinical claims desired
Business Model
B2B2C Distribution
Gastroenterologists recommend Flarity to patients. This creates:
- Lower CAC: GI referral vs. paid acquisition
- Higher trust: Doctor recommendation = credibility
- Better retention: Clinical accountability
- Network effects: More GIs = more patients = more GIs
Consumer Subscription
USD/CAD pricing. UK: £9.99/mo. 21-day free trial.
Future Revenue Streams
- Practice licensing: Enterprise tier for GI practices
- Payer contracts: Flare prevention = cost reduction
- Pharma partnerships: Real-world adherence data
- Research partnerships: De-identified outcomes data
Unit Economics Target
B2B2C model drives superior economics: GI recommendation = high-intent user with near-zero acquisition cost.
Competitive Landscape
No direct competitor combines wearable physiological monitoring with validated clinical symptom indices for IBD flare prediction.
| Capability | Flarity | Oshi Health | Vivante | Generic Trackers |
|---|---|---|---|---|
| Deep wearable integration | ✓ | ✗ | ✗ | ◐ |
| HBI/SCCAI clinical indices | ✓ | ✓ | ◐ | ✗ |
| Hybrid detection algorithm | ✓ | ✗ | ✗ | ✗ |
| GI-ready PDF reports | ✓ | ✓ | ◐ | ✗ |
| Peer-reviewed validation | ✓ | ✗ | ✗ | ✗ |
| No physician portal required | ✓ | ✗ | ✗ | ✓ |
| Capital efficient (founder-led + AI) | ✓ | ✗ | ✗ | ◐ |
Defensible Moat
Team
Founder & CEO
15 years of B2B SaaS sales leadership at high-growth companies including OneTrust, Sprinto, and Kobalt.io. Deep expertise in GRC and compliance, directly applicable to healthcare privacy and regulatory requirements.
Also a Crohn's patient. After an ileocecal resection in 2024, he built the tool he wished existed: continuous monitoring that speaks his gastroenterologist's language. The founder combines enterprise sales expertise with firsthand patient experience to build and distribute a clinically-credible solution.
Advisory Board
Building relationships with IBD specialists at major academic medical centers. Formal advisory board to be announced.
Current Status
iOS App Development
Full-featured app with wearable integration, symptom tracking, and report generation.
Clinician Landing Site
B2B site targeting gastroenterologists with sample reports and recommendation tools.
TestFlight Beta
Onboarding initial users for feedback and iteration before public launch.
GI Practice Pilots
Conversations with gastroenterology practices for structured pilot programs.
Request Investor Deck
Get the full pitch deck with detailed financials, product roadmap, and go-to-market strategy.
The Opportunity
IBD affects millions of people with no cure. Flares are unpredictable, costly, and disruptive. Gastroenterologists want better data. Patients want control. Payers want to reduce hospitalizations.
Flarity is the first solution with peer-reviewed clinical validation, hybrid detection architecture, and a capital-efficient path to market.
Flaresense Inc. • Toronto, Canada