Identifying disease from breath
Medlyse is developing a next-generation diagnostic solution that uses breath-gas analysis and AI-based interpretation to detect disease quickly and non-invasively.
The solution supports doctors’ clinical decision-making at an even earlier stage.
Technology for analysing breath gases
Medlyse's technology is based on biomarkers measured from exhaled breath.
Our devices use high-end sensors whose data is designed to help AI identify possible diseases at an early stage.
The method is painless and requires no laboratory tests.
Everyone has their own profile
Biomarkers form a unique pattern in your breath — as one-of-a-kind as a fingerprint.
Even small changes in breath reveal a great deal
Medlyse's solution spans the entire lifespan, from newborns to the elderly.
Medlyse can identify possible complications before they become critical.
Current methods based on blood tests are extremely painful for premature infants.
Disease library
Medlyse aims to have its algorithms compare a patient's breath VOC profile against disease-state profiles being established through clinical studies. The panel shown is an illustrative example — not a real patient measurement or diagnosis.
A roadmap to breath diagnostics
We advance step by step, from clinical pilots to market and platform expansion. The timeline is indicative and will sharpen as partnerships develop.
Clinical pilots
The collaboration with HUS (Helsinki University Hospital) begins. First pilots in neonatal sepsis and hypoglycaemia — we gather VOC data in a clinical setting. The technology advances from TRL 4 to TRL 6.
Software platform and regulatory path
Clinician software view and disease-library expansion. We prepare the FDA pathway and CE marking. First US pilot late in the year.
Targeting FDA clearance and market entry
Targeting FDA 510(k) clearance and commercial launch in the United States.
CE marking & Europe
Applying for CE marking and opening the European market.
Platform expansion
The same device + disease-library expansion to new diseases.
Partnership
Become a partner to develop clinical piloting, the software platform, or distribution.
Get in touch
The latest from Medlyse
Medlyse’s first clinical tests begin in the HUS neonatal intensive care unit
Medlyse begins its first clinical pilot at the HUS New Children’s Hospital — detecting sepsis and hypoglycaemia in premature infants through breath-gas analytics.
Get in touch
Let's talk about clinical piloting, partnership, or the technology. We reply on business days.