Be the One Who Redefines Gut Health With a Single Breath
Vire is pioneering a new era of diagnostics: non-invasive, AI-powered breath analysis that can spot hidden gut imbalances – tailored to each individual. This is your chance to lead the revolution.
Investment Highlights
Strong fundamentals with validated technology and clear commercial pathway
Loan-and-refurb loop cuts device costs by ~50%, enabling scalable deployment.
Proven 94% accuracy in distinguishing fasting vs post-meal states on pilot data.
Initial MDR and AI Act mapping completed; planning data collection for risk class validation.
Doctor-prescribed pathway anchors trust and accelerates reimbursement.
Market Snapshot
Long-term horizon beyond current raise.
Addressable Segments
SIBO breath testing (Nordics)
IBS & gut dysfunction diagnostics (EU)
Wider breath-based biomarkers
(future expansion)
Market Drivers
- 1 in 3 adults suffer from chronic digestive symptoms
- Up to 40% of IBS cases may be SIBO-related
- Half of SIBO cases go undiagnosed
- Current tests cost €300–700 and require clinic visits
- Growing demand for fast, non-invasive alternatives
Use of Funds
Strategic deployment of €500K to deliver MVP and de-risk go-to-market
Milestones This Round Will Unlock
Regulatory Milestone Roadmap
Key development phases leading to CE and Health Canada submissions
Prototype V2 finalized
Custom PCB, BLE firmware, and sensor integration ready for pilot testing.
Laurea Living Lab pilot
Collecting baseline breath data from 50 healthy participants on-site (Autumn 2025).
70-patient data-lock
Clinical-grade breath data milestone to support regulatory documentation.
CE & Health Canada dossier filing
Begin formal submissions under MDR IIa and HC Class II for AI-powered diagnostics.
Vire Advantage
Unique positioning with adaptive AI and capital-efficient business model
Self-Improving AI Model
Our model learns from every new breath–meal pair, increasing accuracy with real-world use.
50% Lower Device Costs
We operate a closed-loop refurb system – devices are loaned, sterilized, and re-used across patients, reducing CAPEX.
Built for Regulation from Day One
MDR and AI Act compliance embedded from the start – no costly retrofitting later.
Clinical-Grade Testing – Without the Clinic
Doctor-prescribed use at home captures gold-standard diagnostic data, minus the hospital overhead.
Join Us in Transforming Gut Health Diagnostics
© 2025 Vire. All rights reserved. This device is not yet approved for clinical use. Information provided is for research purposes only and should not be used for medical diagnosis.
Forward-looking statements are projections and subject to change. Vire Sense devices remain investigational and unapproved.